Why Lung Cancer Screening Is Not for Everyone

Article Type
Changed
Wed, 04/24/2024 - 12:29

 

A study conducted in the United States showed that many individuals undergo lung cancer screening despite having a higher likelihood of experiencing harm rather than benefit. Why does this happen? Could it also occur in Italy?

Reasons in Favor

The authors of the study, which was published in Annals of Family Medicine interviewed 40 former military personnel with a significant history of smoking. Though the patients presented with various comorbidities and had a limited life expectancy, the Veterans Health Administration had offered them lung cancer screening.

Of the 40 respondents, 26 had accepted the screening test. When asked why they had done so, they responded, “to take care of my health and achieve my life goals,” “because screening is an opportunity to identify potential issues,” “because it was recommended by a doctor I trust,” and “because I don’t want to regret not accepting it.” Strangely, when deciding about lung cancer screening, the respondents did not consider their poor health or life expectancy.
 

Potential Harms 

The screening was also welcomed because low-dose computed tomography (LDCT) is a noninvasive test. However, many participants were unaware that the screening needed to be repeated annually and that further imaging or other types of tests could follow LDCT, such as biopsies and bronchoscopies.

Many did not recall discussing with the doctor the potential harms of screening, including overdiagnosis, stress due to false positives, and complications and risks associated with investigations and treatments. Informed about this, several patients stated that they would not necessarily undergo further tests or antitumor treatments, especially if intensive or invasive.

The authors of the article emphasized the importance of shared decision-making with patients who have a marginal expected benefit from screening. But is it correct to offer screening under these conditions? Guidelines advise against screening individuals with limited life expectancy and multiple comorbidities because the risk-benefit ratio is not favorable.
 

Screening in Italy

Italy has no organized public program for lung screening. However, in 2022, the Rete Italiana Screening Polmonare (RISP) program for early lung cancer diagnosis was launched. Supported by European funds, it is coordinated by the National Cancer Institute (INT) in Milan and aims to recruit 10,000 high-risk candidates for free screening at 18 hospitals across Italy.

Optimizing participant selection is important in any screening, but in a program like RISP, it is essential, said Alessandro Pardolesi, MD, a thoracic surgeon at INT. “Subjects with multiple comorbidities would create a limit to the study, because there would be too many confounding factors. By maintaining correct inclusion criteria, we can build a reproducible model to demonstrate that screening has a clear social and economic impact. Only after proving its effectiveness can we consider extending it to patients with pre-existing issues or who are very elderly,” he said. The RISP project is limited to participants aged 55-75 years. Participants must be smokers or have quit smoking no more than 15 years ago, with an average consumption of 20 cigarettes per day for 30 years.

Participant selection for the RISP program is also dictated by the costs to be incurred. “If something emerges from the CT scan, whether oncologic or not, it needs to be investigated, triggering mechanisms that consume time, space, and resources,” said Dr. Pardolesi. The economic aspect is crucial for determining the effectiveness of screening. “We need to demonstrate that in addition to increasing the patient’s life expectancy, healthcare costs are reduced. By anticipating the diagnosis, the intervention is less expensive, the patient is discharged in three days, and there’s no need for therapy, so there’s a saving. This is important, given the increasingly evident economic problems of the Italian public health system,” said Dr. Pardolesi.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

A study conducted in the United States showed that many individuals undergo lung cancer screening despite having a higher likelihood of experiencing harm rather than benefit. Why does this happen? Could it also occur in Italy?

Reasons in Favor

The authors of the study, which was published in Annals of Family Medicine interviewed 40 former military personnel with a significant history of smoking. Though the patients presented with various comorbidities and had a limited life expectancy, the Veterans Health Administration had offered them lung cancer screening.

Of the 40 respondents, 26 had accepted the screening test. When asked why they had done so, they responded, “to take care of my health and achieve my life goals,” “because screening is an opportunity to identify potential issues,” “because it was recommended by a doctor I trust,” and “because I don’t want to regret not accepting it.” Strangely, when deciding about lung cancer screening, the respondents did not consider their poor health or life expectancy.
 

Potential Harms 

The screening was also welcomed because low-dose computed tomography (LDCT) is a noninvasive test. However, many participants were unaware that the screening needed to be repeated annually and that further imaging or other types of tests could follow LDCT, such as biopsies and bronchoscopies.

Many did not recall discussing with the doctor the potential harms of screening, including overdiagnosis, stress due to false positives, and complications and risks associated with investigations and treatments. Informed about this, several patients stated that they would not necessarily undergo further tests or antitumor treatments, especially if intensive or invasive.

The authors of the article emphasized the importance of shared decision-making with patients who have a marginal expected benefit from screening. But is it correct to offer screening under these conditions? Guidelines advise against screening individuals with limited life expectancy and multiple comorbidities because the risk-benefit ratio is not favorable.
 

Screening in Italy

Italy has no organized public program for lung screening. However, in 2022, the Rete Italiana Screening Polmonare (RISP) program for early lung cancer diagnosis was launched. Supported by European funds, it is coordinated by the National Cancer Institute (INT) in Milan and aims to recruit 10,000 high-risk candidates for free screening at 18 hospitals across Italy.

Optimizing participant selection is important in any screening, but in a program like RISP, it is essential, said Alessandro Pardolesi, MD, a thoracic surgeon at INT. “Subjects with multiple comorbidities would create a limit to the study, because there would be too many confounding factors. By maintaining correct inclusion criteria, we can build a reproducible model to demonstrate that screening has a clear social and economic impact. Only after proving its effectiveness can we consider extending it to patients with pre-existing issues or who are very elderly,” he said. The RISP project is limited to participants aged 55-75 years. Participants must be smokers or have quit smoking no more than 15 years ago, with an average consumption of 20 cigarettes per day for 30 years.

Participant selection for the RISP program is also dictated by the costs to be incurred. “If something emerges from the CT scan, whether oncologic or not, it needs to be investigated, triggering mechanisms that consume time, space, and resources,” said Dr. Pardolesi. The economic aspect is crucial for determining the effectiveness of screening. “We need to demonstrate that in addition to increasing the patient’s life expectancy, healthcare costs are reduced. By anticipating the diagnosis, the intervention is less expensive, the patient is discharged in three days, and there’s no need for therapy, so there’s a saving. This is important, given the increasingly evident economic problems of the Italian public health system,” said Dr. Pardolesi.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

A study conducted in the United States showed that many individuals undergo lung cancer screening despite having a higher likelihood of experiencing harm rather than benefit. Why does this happen? Could it also occur in Italy?

Reasons in Favor

The authors of the study, which was published in Annals of Family Medicine interviewed 40 former military personnel with a significant history of smoking. Though the patients presented with various comorbidities and had a limited life expectancy, the Veterans Health Administration had offered them lung cancer screening.

Of the 40 respondents, 26 had accepted the screening test. When asked why they had done so, they responded, “to take care of my health and achieve my life goals,” “because screening is an opportunity to identify potential issues,” “because it was recommended by a doctor I trust,” and “because I don’t want to regret not accepting it.” Strangely, when deciding about lung cancer screening, the respondents did not consider their poor health or life expectancy.
 

Potential Harms 

The screening was also welcomed because low-dose computed tomography (LDCT) is a noninvasive test. However, many participants were unaware that the screening needed to be repeated annually and that further imaging or other types of tests could follow LDCT, such as biopsies and bronchoscopies.

Many did not recall discussing with the doctor the potential harms of screening, including overdiagnosis, stress due to false positives, and complications and risks associated with investigations and treatments. Informed about this, several patients stated that they would not necessarily undergo further tests or antitumor treatments, especially if intensive or invasive.

The authors of the article emphasized the importance of shared decision-making with patients who have a marginal expected benefit from screening. But is it correct to offer screening under these conditions? Guidelines advise against screening individuals with limited life expectancy and multiple comorbidities because the risk-benefit ratio is not favorable.
 

Screening in Italy

Italy has no organized public program for lung screening. However, in 2022, the Rete Italiana Screening Polmonare (RISP) program for early lung cancer diagnosis was launched. Supported by European funds, it is coordinated by the National Cancer Institute (INT) in Milan and aims to recruit 10,000 high-risk candidates for free screening at 18 hospitals across Italy.

Optimizing participant selection is important in any screening, but in a program like RISP, it is essential, said Alessandro Pardolesi, MD, a thoracic surgeon at INT. “Subjects with multiple comorbidities would create a limit to the study, because there would be too many confounding factors. By maintaining correct inclusion criteria, we can build a reproducible model to demonstrate that screening has a clear social and economic impact. Only after proving its effectiveness can we consider extending it to patients with pre-existing issues or who are very elderly,” he said. The RISP project is limited to participants aged 55-75 years. Participants must be smokers or have quit smoking no more than 15 years ago, with an average consumption of 20 cigarettes per day for 30 years.

Participant selection for the RISP program is also dictated by the costs to be incurred. “If something emerges from the CT scan, whether oncologic or not, it needs to be investigated, triggering mechanisms that consume time, space, and resources,” said Dr. Pardolesi. The economic aspect is crucial for determining the effectiveness of screening. “We need to demonstrate that in addition to increasing the patient’s life expectancy, healthcare costs are reduced. By anticipating the diagnosis, the intervention is less expensive, the patient is discharged in three days, and there’s no need for therapy, so there’s a saving. This is important, given the increasingly evident economic problems of the Italian public health system,” said Dr. Pardolesi.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

What Are Platanus Cough and Thunderstorm Asthma?

Article Type
Changed
Wed, 04/17/2024 - 16:26

Because of climate change, heat waves, storms, heavy rainfalls, and floods are now occurring in areas that seldom experienced these phenomena before. “Extreme weather events are rare, but in terms of their extent, duration, and scale, they are unusual. And they are increasing due to climate change,” said Andrea Elmer, MD, an internal medicine and pulmonology specialist at the DKD Helios Clinic in Wiesbaden, Germany. She spoke at the Congress of the German Society for Pneumology and Respiratory Medicine.

Dr. Elmer referred to the 2023 status report by the Robert Koch Institute and the 2023 Synthesis Report by the Intergovernmental Panel on Climate Change, in which the likelihood of extreme weather events was acknowledged to be significantly higher than previously recognized. “Knowing about such extreme weather events is important to assess the consequences for our patients and to identify possible medical care needs,” said Dr. Elmer. She focused on the effects of platanus (plane tree) cough and thunderstorm asthma.
 

Platanus Cough

The severe symptoms of 40 students at a comprehensive school in Wiesbaden, including shortness of breath, coughing, and irritated eyes, led to a major operation involving the fire brigade and police on May 11, 2022. The symptoms worsened when the children left the building and waited in the schoolyard. Initially, a chemical attack with irritant gas was suspected because the school is located near an industrial area. There were no indications of a pollen cloud.

Eventually, doctors and firefighters found that the symptoms were caused by platanus cough, which is induced by the fine star-shaped hair found on young platanus leaves, bark, young branches, and buds. If strong winds move the leaves after prolonged dryness, these trichomes can break off when touched, creating platanus dust.

At that time, there were unusual climatic conditions. The temperature was 29 °C, it was dry, and wind gusts reached 50 km/h. The schoolyard was enclosed and densely planted with tall, old plane trees. Initial symptoms occurred in classrooms with open windows.

Twenty-five children had to be admitted to the hospital. Treatment included lorazepam and salbutamol. All students had normal oxygen levels, and the symptoms were reversed.
 

Cough or Allergy?

The clinical differential diagnosis for an allergy is quite simple, said Dr. Elmer. Platanus cough mainly shows symptoms of irritation, a feeling of a foreign body, and scratching in the eyes, throat, and nose. Coughing can also occur. In an allergy, there is often a runny nose and itching in the eyes and nose. Such allergic symptoms do not occur with platanus cough.

It should also be noted that the sensitization rates for a platanus allergy in Germany range between 5% and 11%. “Having so many platanus allergy sufferers in one place was relatively unlikely,” said Dr. Elmer.

She expects an increase in cases of platanus cough, especially in cities with dense construction, such as in narrow schoolyards. High concentrations of platanus dust can occur, especially when it is warm, dry, and windy. “Platanus cough does not occur every time we walk under plane trees. It strongly depends on warmth, dryness, and wind,” said Dr. Elmer.

Patients can protect themselves by avoiding skin and mucous membrane contact under appropriate climatic conditions and by wearing protective glasses and masks. Leaves and branches should not be swept but vacuumed. “Under no circumstances should plane trees be cut down. We need trees, especially in cities,” said Dr. Elmer. Moreover, the trichomes act as biofilters for air pollutants. In critical environments such as schoolyards, seasonal spraying of plane trees with a mixture of apple pectin and water can prevent the star hair from breaking off.
 

 

 

Thunderstorm Asthma

For patients with asthma, wildfires, storms, heavy rainfall, and thunderstorms can lead to exacerbations. Emergency room visits and hospital admissions generally increase after extreme weather events.

A study examining the consequences of the fires in California from 2004 to 2009, for example, reported that hospital visits related to asthma increased by 10.3%. Those related to respiratory problems increased by 3.3%. Infants and children up to age 5 years were most affected.

Thunderstorms are increasing because of global warming. Thunderstorm asthma arises under specific meteorological conditions. It typically occurs in patients with aeroallergies (eg, to pollen and fungal spores) in combination with thunderstorms and lightning. Large pollen grains, which normally remain in the upper airways, ascend into higher atmospheric layers and break apart due to updrafts. These very small particles are pushed back to ground level by downdrafts, enter the lower airways, and cause acute asthma.

Worldwide, cases of thunderstorm asthma are rare. About 30 events have been documented. Thunderstorm asthma was first observed in 1983 in Birmingham, England. Fungal spores were the trigger.

The most significant incident so far was a severe thunderstorm on November 21, 2016, in Melbourne, Australia. Worldwide attention was drawn to the storm because of an unusually high number of asthma cases. Within 30 hours, 3365 patients were admitted to emergency rooms. “This is also a high burden for a city with 4.6 million inhabitants,” said Dr. Elmer. Of the patients in Melbourne, 35 were admitted to the intensive care unit and 5 patients died.

Dr. Elmer calculated the corresponding number of patients for Wiesbaden and Mainz. “Assuming a population of 500,000 in this region, that would be 400 patients in emergency rooms within 30 hours, which would be a significant number.”

Such events are mainly observed in Australia, where two events per decade are expected. However, due to climate change, the risk could also increase in Europe, leading to more cases of thunderstorm asthma.
 

Risk Factors

The following environmental factors increase the risk:

  • High pollen concentrations in the days before a thunderstorm
  • Precipitation and high humidity, thunderstorms, and lightning
  • Sudden temperature changes
  • Increases in aeroallergen biomass and extreme weather events because of climate change

In Australia, grass pollen was often the trigger for thunderstorm asthma. In the United Kingdom, it was fungal spores. In Italy, olive pollen has a similar potential.

Patients with preexisting asthma, uncontrolled asthma, and high serum-specific immunoglobulin E levels are at risk. The risk is also increased for patients with poor compliance with inhaled steroid (ICS) therapy and for patients who have previously been hospitalized because of their asthma.

Patients with hay fever (ie, seasonal allergic rhinitis) have a significantly higher risk. As Dr. Elmer observed, 88% of patients in the emergency room in Melbourne had seasonal allergic rhinitis. “Fifty-seven percent of the patients in the emergency room did not have previously known asthma, but more than half showed symptoms indicating latent asthma. These patients had latent asthma but had not yet been diagnosed.”

Dr. Elmer emphasized how important it is not to underestimate mild asthma, which should be treated. For patients with hay fever, hyposensitization should be considered.
 

 

 

Reducing Risk

Many factors must come together for thunderstorm asthma to develop, according to Dr. Elmer. Because this convergence is difficult to predict, however, preparation and risk reduction are important. They consist of individual precautions and public health strategies.

The following steps can be taken at the individual level:

  • Identify risk groups, including patients with allergic rhinitis and high serum-specific immunoglobulin E levels. Patients with hay fever benefit from hyposensitization.
  • Avoid outdoor activities on risky days.
  • Diagnose asthma, and do not underestimate mild asthma. Improve therapy compliance with ICS therapy and use maintenance and reliever therapy. This way, the patient automatically increases the steroid dose with increased symptoms and is better protected against exacerbations.
  • Improve health literacy and understanding of asthma.

Thunderstorm asthma also affects healthcare professionals, Dr. Elmer warned. In Melbourne, 25% of responders themselves showed symptoms. Therefore, expect that some of these clinicians will also be unavailable.

Other steps are appropriate at the public health level. In addition to monitoring local pollen concentrations, one must identify risk groups, especially people working outdoors. “It is very difficult to predict an epidemic of thunderstorm asthma,” said Dr. Elmer. Therefore, it is important to increase awareness of the phenomenon and to develop an early warning system with emergency plans for patients and the healthcare system.

“Allergen immunotherapy is protective,” she added. “This has been well studied, and for Melbourne, it has been demonstrated. Patients with allergic rhinitis who had received immunotherapy were protected. These patients did not have to visit the emergency room. This shows that we can do something, and we should hyposensitize,” Dr. Elmer concluded.
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Publications
Topics
Sections

Because of climate change, heat waves, storms, heavy rainfalls, and floods are now occurring in areas that seldom experienced these phenomena before. “Extreme weather events are rare, but in terms of their extent, duration, and scale, they are unusual. And they are increasing due to climate change,” said Andrea Elmer, MD, an internal medicine and pulmonology specialist at the DKD Helios Clinic in Wiesbaden, Germany. She spoke at the Congress of the German Society for Pneumology and Respiratory Medicine.

Dr. Elmer referred to the 2023 status report by the Robert Koch Institute and the 2023 Synthesis Report by the Intergovernmental Panel on Climate Change, in which the likelihood of extreme weather events was acknowledged to be significantly higher than previously recognized. “Knowing about such extreme weather events is important to assess the consequences for our patients and to identify possible medical care needs,” said Dr. Elmer. She focused on the effects of platanus (plane tree) cough and thunderstorm asthma.
 

Platanus Cough

The severe symptoms of 40 students at a comprehensive school in Wiesbaden, including shortness of breath, coughing, and irritated eyes, led to a major operation involving the fire brigade and police on May 11, 2022. The symptoms worsened when the children left the building and waited in the schoolyard. Initially, a chemical attack with irritant gas was suspected because the school is located near an industrial area. There were no indications of a pollen cloud.

Eventually, doctors and firefighters found that the symptoms were caused by platanus cough, which is induced by the fine star-shaped hair found on young platanus leaves, bark, young branches, and buds. If strong winds move the leaves after prolonged dryness, these trichomes can break off when touched, creating platanus dust.

At that time, there were unusual climatic conditions. The temperature was 29 °C, it was dry, and wind gusts reached 50 km/h. The schoolyard was enclosed and densely planted with tall, old plane trees. Initial symptoms occurred in classrooms with open windows.

Twenty-five children had to be admitted to the hospital. Treatment included lorazepam and salbutamol. All students had normal oxygen levels, and the symptoms were reversed.
 

Cough or Allergy?

The clinical differential diagnosis for an allergy is quite simple, said Dr. Elmer. Platanus cough mainly shows symptoms of irritation, a feeling of a foreign body, and scratching in the eyes, throat, and nose. Coughing can also occur. In an allergy, there is often a runny nose and itching in the eyes and nose. Such allergic symptoms do not occur with platanus cough.

It should also be noted that the sensitization rates for a platanus allergy in Germany range between 5% and 11%. “Having so many platanus allergy sufferers in one place was relatively unlikely,” said Dr. Elmer.

She expects an increase in cases of platanus cough, especially in cities with dense construction, such as in narrow schoolyards. High concentrations of platanus dust can occur, especially when it is warm, dry, and windy. “Platanus cough does not occur every time we walk under plane trees. It strongly depends on warmth, dryness, and wind,” said Dr. Elmer.

Patients can protect themselves by avoiding skin and mucous membrane contact under appropriate climatic conditions and by wearing protective glasses and masks. Leaves and branches should not be swept but vacuumed. “Under no circumstances should plane trees be cut down. We need trees, especially in cities,” said Dr. Elmer. Moreover, the trichomes act as biofilters for air pollutants. In critical environments such as schoolyards, seasonal spraying of plane trees with a mixture of apple pectin and water can prevent the star hair from breaking off.
 

 

 

Thunderstorm Asthma

For patients with asthma, wildfires, storms, heavy rainfall, and thunderstorms can lead to exacerbations. Emergency room visits and hospital admissions generally increase after extreme weather events.

A study examining the consequences of the fires in California from 2004 to 2009, for example, reported that hospital visits related to asthma increased by 10.3%. Those related to respiratory problems increased by 3.3%. Infants and children up to age 5 years were most affected.

Thunderstorms are increasing because of global warming. Thunderstorm asthma arises under specific meteorological conditions. It typically occurs in patients with aeroallergies (eg, to pollen and fungal spores) in combination with thunderstorms and lightning. Large pollen grains, which normally remain in the upper airways, ascend into higher atmospheric layers and break apart due to updrafts. These very small particles are pushed back to ground level by downdrafts, enter the lower airways, and cause acute asthma.

Worldwide, cases of thunderstorm asthma are rare. About 30 events have been documented. Thunderstorm asthma was first observed in 1983 in Birmingham, England. Fungal spores were the trigger.

The most significant incident so far was a severe thunderstorm on November 21, 2016, in Melbourne, Australia. Worldwide attention was drawn to the storm because of an unusually high number of asthma cases. Within 30 hours, 3365 patients were admitted to emergency rooms. “This is also a high burden for a city with 4.6 million inhabitants,” said Dr. Elmer. Of the patients in Melbourne, 35 were admitted to the intensive care unit and 5 patients died.

Dr. Elmer calculated the corresponding number of patients for Wiesbaden and Mainz. “Assuming a population of 500,000 in this region, that would be 400 patients in emergency rooms within 30 hours, which would be a significant number.”

Such events are mainly observed in Australia, where two events per decade are expected. However, due to climate change, the risk could also increase in Europe, leading to more cases of thunderstorm asthma.
 

Risk Factors

The following environmental factors increase the risk:

  • High pollen concentrations in the days before a thunderstorm
  • Precipitation and high humidity, thunderstorms, and lightning
  • Sudden temperature changes
  • Increases in aeroallergen biomass and extreme weather events because of climate change

In Australia, grass pollen was often the trigger for thunderstorm asthma. In the United Kingdom, it was fungal spores. In Italy, olive pollen has a similar potential.

Patients with preexisting asthma, uncontrolled asthma, and high serum-specific immunoglobulin E levels are at risk. The risk is also increased for patients with poor compliance with inhaled steroid (ICS) therapy and for patients who have previously been hospitalized because of their asthma.

Patients with hay fever (ie, seasonal allergic rhinitis) have a significantly higher risk. As Dr. Elmer observed, 88% of patients in the emergency room in Melbourne had seasonal allergic rhinitis. “Fifty-seven percent of the patients in the emergency room did not have previously known asthma, but more than half showed symptoms indicating latent asthma. These patients had latent asthma but had not yet been diagnosed.”

Dr. Elmer emphasized how important it is not to underestimate mild asthma, which should be treated. For patients with hay fever, hyposensitization should be considered.
 

 

 

Reducing Risk

Many factors must come together for thunderstorm asthma to develop, according to Dr. Elmer. Because this convergence is difficult to predict, however, preparation and risk reduction are important. They consist of individual precautions and public health strategies.

The following steps can be taken at the individual level:

  • Identify risk groups, including patients with allergic rhinitis and high serum-specific immunoglobulin E levels. Patients with hay fever benefit from hyposensitization.
  • Avoid outdoor activities on risky days.
  • Diagnose asthma, and do not underestimate mild asthma. Improve therapy compliance with ICS therapy and use maintenance and reliever therapy. This way, the patient automatically increases the steroid dose with increased symptoms and is better protected against exacerbations.
  • Improve health literacy and understanding of asthma.

Thunderstorm asthma also affects healthcare professionals, Dr. Elmer warned. In Melbourne, 25% of responders themselves showed symptoms. Therefore, expect that some of these clinicians will also be unavailable.

Other steps are appropriate at the public health level. In addition to monitoring local pollen concentrations, one must identify risk groups, especially people working outdoors. “It is very difficult to predict an epidemic of thunderstorm asthma,” said Dr. Elmer. Therefore, it is important to increase awareness of the phenomenon and to develop an early warning system with emergency plans for patients and the healthcare system.

“Allergen immunotherapy is protective,” she added. “This has been well studied, and for Melbourne, it has been demonstrated. Patients with allergic rhinitis who had received immunotherapy were protected. These patients did not have to visit the emergency room. This shows that we can do something, and we should hyposensitize,” Dr. Elmer concluded.
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Because of climate change, heat waves, storms, heavy rainfalls, and floods are now occurring in areas that seldom experienced these phenomena before. “Extreme weather events are rare, but in terms of their extent, duration, and scale, they are unusual. And they are increasing due to climate change,” said Andrea Elmer, MD, an internal medicine and pulmonology specialist at the DKD Helios Clinic in Wiesbaden, Germany. She spoke at the Congress of the German Society for Pneumology and Respiratory Medicine.

Dr. Elmer referred to the 2023 status report by the Robert Koch Institute and the 2023 Synthesis Report by the Intergovernmental Panel on Climate Change, in which the likelihood of extreme weather events was acknowledged to be significantly higher than previously recognized. “Knowing about such extreme weather events is important to assess the consequences for our patients and to identify possible medical care needs,” said Dr. Elmer. She focused on the effects of platanus (plane tree) cough and thunderstorm asthma.
 

Platanus Cough

The severe symptoms of 40 students at a comprehensive school in Wiesbaden, including shortness of breath, coughing, and irritated eyes, led to a major operation involving the fire brigade and police on May 11, 2022. The symptoms worsened when the children left the building and waited in the schoolyard. Initially, a chemical attack with irritant gas was suspected because the school is located near an industrial area. There were no indications of a pollen cloud.

Eventually, doctors and firefighters found that the symptoms were caused by platanus cough, which is induced by the fine star-shaped hair found on young platanus leaves, bark, young branches, and buds. If strong winds move the leaves after prolonged dryness, these trichomes can break off when touched, creating platanus dust.

At that time, there were unusual climatic conditions. The temperature was 29 °C, it was dry, and wind gusts reached 50 km/h. The schoolyard was enclosed and densely planted with tall, old plane trees. Initial symptoms occurred in classrooms with open windows.

Twenty-five children had to be admitted to the hospital. Treatment included lorazepam and salbutamol. All students had normal oxygen levels, and the symptoms were reversed.
 

Cough or Allergy?

The clinical differential diagnosis for an allergy is quite simple, said Dr. Elmer. Platanus cough mainly shows symptoms of irritation, a feeling of a foreign body, and scratching in the eyes, throat, and nose. Coughing can also occur. In an allergy, there is often a runny nose and itching in the eyes and nose. Such allergic symptoms do not occur with platanus cough.

It should also be noted that the sensitization rates for a platanus allergy in Germany range between 5% and 11%. “Having so many platanus allergy sufferers in one place was relatively unlikely,” said Dr. Elmer.

She expects an increase in cases of platanus cough, especially in cities with dense construction, such as in narrow schoolyards. High concentrations of platanus dust can occur, especially when it is warm, dry, and windy. “Platanus cough does not occur every time we walk under plane trees. It strongly depends on warmth, dryness, and wind,” said Dr. Elmer.

Patients can protect themselves by avoiding skin and mucous membrane contact under appropriate climatic conditions and by wearing protective glasses and masks. Leaves and branches should not be swept but vacuumed. “Under no circumstances should plane trees be cut down. We need trees, especially in cities,” said Dr. Elmer. Moreover, the trichomes act as biofilters for air pollutants. In critical environments such as schoolyards, seasonal spraying of plane trees with a mixture of apple pectin and water can prevent the star hair from breaking off.
 

 

 

Thunderstorm Asthma

For patients with asthma, wildfires, storms, heavy rainfall, and thunderstorms can lead to exacerbations. Emergency room visits and hospital admissions generally increase after extreme weather events.

A study examining the consequences of the fires in California from 2004 to 2009, for example, reported that hospital visits related to asthma increased by 10.3%. Those related to respiratory problems increased by 3.3%. Infants and children up to age 5 years were most affected.

Thunderstorms are increasing because of global warming. Thunderstorm asthma arises under specific meteorological conditions. It typically occurs in patients with aeroallergies (eg, to pollen and fungal spores) in combination with thunderstorms and lightning. Large pollen grains, which normally remain in the upper airways, ascend into higher atmospheric layers and break apart due to updrafts. These very small particles are pushed back to ground level by downdrafts, enter the lower airways, and cause acute asthma.

Worldwide, cases of thunderstorm asthma are rare. About 30 events have been documented. Thunderstorm asthma was first observed in 1983 in Birmingham, England. Fungal spores were the trigger.

The most significant incident so far was a severe thunderstorm on November 21, 2016, in Melbourne, Australia. Worldwide attention was drawn to the storm because of an unusually high number of asthma cases. Within 30 hours, 3365 patients were admitted to emergency rooms. “This is also a high burden for a city with 4.6 million inhabitants,” said Dr. Elmer. Of the patients in Melbourne, 35 were admitted to the intensive care unit and 5 patients died.

Dr. Elmer calculated the corresponding number of patients for Wiesbaden and Mainz. “Assuming a population of 500,000 in this region, that would be 400 patients in emergency rooms within 30 hours, which would be a significant number.”

Such events are mainly observed in Australia, where two events per decade are expected. However, due to climate change, the risk could also increase in Europe, leading to more cases of thunderstorm asthma.
 

Risk Factors

The following environmental factors increase the risk:

  • High pollen concentrations in the days before a thunderstorm
  • Precipitation and high humidity, thunderstorms, and lightning
  • Sudden temperature changes
  • Increases in aeroallergen biomass and extreme weather events because of climate change

In Australia, grass pollen was often the trigger for thunderstorm asthma. In the United Kingdom, it was fungal spores. In Italy, olive pollen has a similar potential.

Patients with preexisting asthma, uncontrolled asthma, and high serum-specific immunoglobulin E levels are at risk. The risk is also increased for patients with poor compliance with inhaled steroid (ICS) therapy and for patients who have previously been hospitalized because of their asthma.

Patients with hay fever (ie, seasonal allergic rhinitis) have a significantly higher risk. As Dr. Elmer observed, 88% of patients in the emergency room in Melbourne had seasonal allergic rhinitis. “Fifty-seven percent of the patients in the emergency room did not have previously known asthma, but more than half showed symptoms indicating latent asthma. These patients had latent asthma but had not yet been diagnosed.”

Dr. Elmer emphasized how important it is not to underestimate mild asthma, which should be treated. For patients with hay fever, hyposensitization should be considered.
 

 

 

Reducing Risk

Many factors must come together for thunderstorm asthma to develop, according to Dr. Elmer. Because this convergence is difficult to predict, however, preparation and risk reduction are important. They consist of individual precautions and public health strategies.

The following steps can be taken at the individual level:

  • Identify risk groups, including patients with allergic rhinitis and high serum-specific immunoglobulin E levels. Patients with hay fever benefit from hyposensitization.
  • Avoid outdoor activities on risky days.
  • Diagnose asthma, and do not underestimate mild asthma. Improve therapy compliance with ICS therapy and use maintenance and reliever therapy. This way, the patient automatically increases the steroid dose with increased symptoms and is better protected against exacerbations.
  • Improve health literacy and understanding of asthma.

Thunderstorm asthma also affects healthcare professionals, Dr. Elmer warned. In Melbourne, 25% of responders themselves showed symptoms. Therefore, expect that some of these clinicians will also be unavailable.

Other steps are appropriate at the public health level. In addition to monitoring local pollen concentrations, one must identify risk groups, especially people working outdoors. “It is very difficult to predict an epidemic of thunderstorm asthma,” said Dr. Elmer. Therefore, it is important to increase awareness of the phenomenon and to develop an early warning system with emergency plans for patients and the healthcare system.

“Allergen immunotherapy is protective,” she added. “This has been well studied, and for Melbourne, it has been demonstrated. Patients with allergic rhinitis who had received immunotherapy were protected. These patients did not have to visit the emergency room. This shows that we can do something, and we should hyposensitize,” Dr. Elmer concluded.
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

New Trial Deepens Debate Over Late-Preterm Steroids

Article Type
Changed
Mon, 04/15/2024 - 17:28

 

The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world.

As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786).

“These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered,” the researchers wrote.

The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there’s debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm.

As the study notes, “the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial.”

But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they’re more likely to need hearing aids and eyeglasses, said Kellie Murphy, MD, MSc, professor of obstetrics and gynecology, University of Toronto, Toronto, Ontario, Canada, in an interview. Dr. Murphy, who was not involved in the new trial, added that there are links between steroids and greater likelihood of poorer performance in school,

For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years).

The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote “may have influenced the primary outcome.” The total number of neonates was 883, including 58 twin pregnancies.

There was no significant difference in respiratory distress between groups, “defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life.” There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death.

Serious adverse events occurred in four neonates but none were linked to the intervention.

The study doesn’t discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective.

“Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial,” the authors of the new study reported. “The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97).”

The study authors, who didn’t respond to requests for comment, noted that their trial included twin pregnancies and patients with gestational diabetes; the ALPS trial did not.

Perinatologist Cynthia Gyamfi-Bannerman, MD, MS, chair and professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California,San Diego, and principal investigator of the ALPS study, said in an interview that the inclusion of twins in the new trial is “a fundamental flaw.”

“Because antenatal corticosteroids have not been shown to be useful in twins at any gestational age, it is not surprising that including twins likely moved the findings to the null in this study,” she said. “Twins were purposefully excluded from the ALPS trial for this reason.”

According to the new study, “the primary outcome among singleton neonates occurred in 4.8% (18/374) who received betamethasone and 5.1% (20/393) who received placebo (RR, 0.94; 95% CI, 0.51-1.75)

What should clinicians take from the study findings? In an accompanying commentary, Blair J. Wylie, MD, MPH, of Columbia University Medical Center, New York, NY, and Syed Asad Ali, MBBS, MPH, of Aga Khan University, Karachi, Pakistan, wrote that, “in settings similar to the US-based ALPS trial, the practice of administering a course of late-preterm antenatal corticosteroids should be continued, as espoused by our professional organizations.”

However, the new study suggests that “research in high-resource environments may not be generalizable to low-resource settings,” they write.

Neonatologist Elizabeth Asztalos, MD, MSc, an associate scientist with Sunnybrook Health Sciences Center in Toronto, Canada, said in an interview that she doesn’t worry about pregnant mothers not getting steroids later than 34 weeks. “We have tools in our armamentarium in the NICU setting to help babies if they need it,” said Dr. Asztalos, who didn’t take part in the new trial. “We can put them on CPAP if they have wet lung. If they have an element of respiratory distress, we can give them surfactants. These bigger babies have more ability to recover from all this compared to a baby who was born at 24, 25, 26 weeks.”

For her part, the University of Toronto’s Dr. Murphy said decision-making about late-preterm steroids is complicated. “You don’t want to miss the opportunity to give to provide benefits for the patients” via steroids, she said. “But on the flip side, it’s a double-edged sword. It’s not easy. It’s not straightforward.”

In the big picture, she said, “people need to be really clear why they’re giving an intervention and what they hope to achieve.”

Christian Medical College supported the study. The authors, Dr. Murphy, Dr. Asztalos, and commentary co-author Dr. Ali have no disclosures. Dr. Gyamfi-Bannerman discloses being principal investigator of the ALPS trial. Commentary co-author Dr. Wylie serves on the ultrasound quality assurance committee of a trial discussed in the commentary.

Publications
Topics
Sections

 

The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world.

As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786).

“These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered,” the researchers wrote.

The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there’s debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm.

As the study notes, “the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial.”

But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they’re more likely to need hearing aids and eyeglasses, said Kellie Murphy, MD, MSc, professor of obstetrics and gynecology, University of Toronto, Toronto, Ontario, Canada, in an interview. Dr. Murphy, who was not involved in the new trial, added that there are links between steroids and greater likelihood of poorer performance in school,

For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years).

The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote “may have influenced the primary outcome.” The total number of neonates was 883, including 58 twin pregnancies.

There was no significant difference in respiratory distress between groups, “defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life.” There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death.

Serious adverse events occurred in four neonates but none were linked to the intervention.

The study doesn’t discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective.

“Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial,” the authors of the new study reported. “The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97).”

The study authors, who didn’t respond to requests for comment, noted that their trial included twin pregnancies and patients with gestational diabetes; the ALPS trial did not.

Perinatologist Cynthia Gyamfi-Bannerman, MD, MS, chair and professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California,San Diego, and principal investigator of the ALPS study, said in an interview that the inclusion of twins in the new trial is “a fundamental flaw.”

“Because antenatal corticosteroids have not been shown to be useful in twins at any gestational age, it is not surprising that including twins likely moved the findings to the null in this study,” she said. “Twins were purposefully excluded from the ALPS trial for this reason.”

According to the new study, “the primary outcome among singleton neonates occurred in 4.8% (18/374) who received betamethasone and 5.1% (20/393) who received placebo (RR, 0.94; 95% CI, 0.51-1.75)

What should clinicians take from the study findings? In an accompanying commentary, Blair J. Wylie, MD, MPH, of Columbia University Medical Center, New York, NY, and Syed Asad Ali, MBBS, MPH, of Aga Khan University, Karachi, Pakistan, wrote that, “in settings similar to the US-based ALPS trial, the practice of administering a course of late-preterm antenatal corticosteroids should be continued, as espoused by our professional organizations.”

However, the new study suggests that “research in high-resource environments may not be generalizable to low-resource settings,” they write.

Neonatologist Elizabeth Asztalos, MD, MSc, an associate scientist with Sunnybrook Health Sciences Center in Toronto, Canada, said in an interview that she doesn’t worry about pregnant mothers not getting steroids later than 34 weeks. “We have tools in our armamentarium in the NICU setting to help babies if they need it,” said Dr. Asztalos, who didn’t take part in the new trial. “We can put them on CPAP if they have wet lung. If they have an element of respiratory distress, we can give them surfactants. These bigger babies have more ability to recover from all this compared to a baby who was born at 24, 25, 26 weeks.”

For her part, the University of Toronto’s Dr. Murphy said decision-making about late-preterm steroids is complicated. “You don’t want to miss the opportunity to give to provide benefits for the patients” via steroids, she said. “But on the flip side, it’s a double-edged sword. It’s not easy. It’s not straightforward.”

In the big picture, she said, “people need to be really clear why they’re giving an intervention and what they hope to achieve.”

Christian Medical College supported the study. The authors, Dr. Murphy, Dr. Asztalos, and commentary co-author Dr. Ali have no disclosures. Dr. Gyamfi-Bannerman discloses being principal investigator of the ALPS trial. Commentary co-author Dr. Wylie serves on the ultrasound quality assurance committee of a trial discussed in the commentary.

 

The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world.

As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786).

“These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered,” the researchers wrote.

The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there’s debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm.

As the study notes, “the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial.”

But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they’re more likely to need hearing aids and eyeglasses, said Kellie Murphy, MD, MSc, professor of obstetrics and gynecology, University of Toronto, Toronto, Ontario, Canada, in an interview. Dr. Murphy, who was not involved in the new trial, added that there are links between steroids and greater likelihood of poorer performance in school,

For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years).

The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote “may have influenced the primary outcome.” The total number of neonates was 883, including 58 twin pregnancies.

There was no significant difference in respiratory distress between groups, “defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life.” There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death.

Serious adverse events occurred in four neonates but none were linked to the intervention.

The study doesn’t discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective.

“Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial,” the authors of the new study reported. “The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97).”

The study authors, who didn’t respond to requests for comment, noted that their trial included twin pregnancies and patients with gestational diabetes; the ALPS trial did not.

Perinatologist Cynthia Gyamfi-Bannerman, MD, MS, chair and professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California,San Diego, and principal investigator of the ALPS study, said in an interview that the inclusion of twins in the new trial is “a fundamental flaw.”

“Because antenatal corticosteroids have not been shown to be useful in twins at any gestational age, it is not surprising that including twins likely moved the findings to the null in this study,” she said. “Twins were purposefully excluded from the ALPS trial for this reason.”

According to the new study, “the primary outcome among singleton neonates occurred in 4.8% (18/374) who received betamethasone and 5.1% (20/393) who received placebo (RR, 0.94; 95% CI, 0.51-1.75)

What should clinicians take from the study findings? In an accompanying commentary, Blair J. Wylie, MD, MPH, of Columbia University Medical Center, New York, NY, and Syed Asad Ali, MBBS, MPH, of Aga Khan University, Karachi, Pakistan, wrote that, “in settings similar to the US-based ALPS trial, the practice of administering a course of late-preterm antenatal corticosteroids should be continued, as espoused by our professional organizations.”

However, the new study suggests that “research in high-resource environments may not be generalizable to low-resource settings,” they write.

Neonatologist Elizabeth Asztalos, MD, MSc, an associate scientist with Sunnybrook Health Sciences Center in Toronto, Canada, said in an interview that she doesn’t worry about pregnant mothers not getting steroids later than 34 weeks. “We have tools in our armamentarium in the NICU setting to help babies if they need it,” said Dr. Asztalos, who didn’t take part in the new trial. “We can put them on CPAP if they have wet lung. If they have an element of respiratory distress, we can give them surfactants. These bigger babies have more ability to recover from all this compared to a baby who was born at 24, 25, 26 weeks.”

For her part, the University of Toronto’s Dr. Murphy said decision-making about late-preterm steroids is complicated. “You don’t want to miss the opportunity to give to provide benefits for the patients” via steroids, she said. “But on the flip side, it’s a double-edged sword. It’s not easy. It’s not straightforward.”

In the big picture, she said, “people need to be really clear why they’re giving an intervention and what they hope to achieve.”

Christian Medical College supported the study. The authors, Dr. Murphy, Dr. Asztalos, and commentary co-author Dr. Ali have no disclosures. Dr. Gyamfi-Bannerman discloses being principal investigator of the ALPS trial. Commentary co-author Dr. Wylie serves on the ultrasound quality assurance committee of a trial discussed in the commentary.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM OBSTETRICS & GYNECOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Antibiotics of Little Benefit in Lower Respiratory Tract Infection

Article Type
Changed
Mon, 04/15/2024 - 17:23

 

Antibiotics had no measurable effect on the severity or duration of coughs due to acute lower respiratory tract infection (LRTI, or acute bronchitis), a large prospective study found.

In fact, those receiving an antibiotic in the primary- and urgent-care setting had a small but significant increase in overall length of illness (17.5 vs 15.9 days; P = .05) — largely because patients with longer illness before the index visit were more likely to receive these drugs. The study adds further support for reducing the prescription of antibiotics for LRTIs.

“Importantly, the pathogen data demonstrated that the length of time until illness resolution for those with bacterial infection was the same as for those not receiving an antibiotic versus those receiving one (17.3 vs 17.4 days),” researchers led by Daniel J. Merenstein, MD, a professor and director of research programs, family medicine, at Georgetown University Medical Center in Washington, wrote in the Journal of General Internal Medicine (doi: 10.1007/s11606-024-08758-y).

Dr. Merenstein
Dr. Daniel J. Merenstein


Patients believed an antibiotic would shorten their illness by an average of about 4 days, from 13.4 days to 9.7 days, whereas the average duration of all coughs was more than 2 weeks regardless of pathogen type or receipt of an antibiotic.

“Patients had unrealistic expectations regarding the duration of LRTI and the effect of antibiotics, which should be the target of antibiotic stewardship efforts,” the group wrote.

LRTIs can, however, be dangerous, with 3%-5% progressing to pneumonia, “but not everyone has easy access at an initial visit to an x-ray, which may be the reason clinicians still give antibiotics without any other evidence of a bacterial infection,” Dr. Merenstein said in a news release. “Patients have come to expect antibiotics for a cough, even if it doesn’t help. Basic symptom-relieving medications plus time bring a resolution to most people’s infections.”

The authors noted that cough is the most common reason for an ambulatory care visit, accounting for 2.7 million outpatient visits and more than 4 million emergency department visits annually.
 

Risks

Overuse of antibiotics can result in dizziness, nausea, diarrhea, and rash, along with a roughly 4% chance of serious adverse effects including anaphylaxis; Stevens-Johnson syndrome, a serious skin and mucous membrane disorder; and Clostridioides difficile-associated diarrhea.

An estimated half of all antibiotic prescriptions for acute respiratory conditions are unnecessary. Before the COVID-19 pandemic, antibiotics were prescribed about 70% of the time for a diagnosis of uncomplicated cough and LRTI. The viral pandemic did not change this practice according to a meta-analysis of 130 studies showing that 78% of COVID-19 patients were prescribed an antibiotic.
 

The study

The study looked at a cohort of 718 patients, with a mean age of 38.9 years, 65.3% female, of whom 207 received an antibiotic and 511 did not. Of those with baseline data, 29% had an antibiotic prescribed at baseline, the most common (in 85%) being amoxicillin-clavulanate, azithromycin, doxycycline, and amoxicillin. Antibiotics had no effect on the duration or overall severity of cough in viral, bacterial, or mixed infections. Receipt of an antibiotic did, however, reduce the likelihood of a follow-up visit: 14.1% vs 8.2% (adjusted odds ratio, 0.47; 95% confidence interval, 0.26-0.84) — perhaps because it removed the motivation for seeking another consultation. Antibiotic recipients were more likely to receive a systemic corticosteroid (31.9% vs 4.5%, P <.001) and were also more likely to receive an albuterol inhaler (22.7% vs 7.6%, P <.001).

 

 

Jeffrey A. Linder, MD, MPH, a primary care physician and chief of internal medicine and geriatrics at Northwestern University Feinberg School of Medicine in Chicago, agrees that in the vast majority of LRTIs — usually acute bronchitis — antibiotics do not speed the healing process. “Forty years of research show that antibiotics do not make acute bronchitis go away any faster,” Dr. Linder, who was not involved in the current study, said in an interview. “There’s even growing evidence that a lot of pneumonia is viral as well, and 10 or 20 years from now we may often not be giving antibiotics for pneumonia because we’ll be able to see better if it’s caused by a virus.”

Northwestern Medicine
Dr. Jeffrey A. Linder


A large 2018 review by Dr. Linder and associates reported that 46% of antibiotics were prescribed without any infection-related diagnosis code and 20% without an office visit.

Dr. Linder routinely informs patients requesting an antibiotic about the risks of putting an ineffective chemical into their body. “I stress that it can cause rash and other allergic reactions, and even promote C diff infection,” he said. “And I also say it messes with the good bacteria in the microbiome, and they usually come around.”

Patients need to know, Dr. Linder added, that the normal course of healing the respiratory tract after acute bronchitis takes weeks. While a wet cough with sputum or phlegm will last a few days, it’s replaced with a dry annoying cough that persists for up to 3 weeks. “As long as they’re feeling generally better, that cough is normal,” he said. “A virus has run roughshod over their airways and they need a long time to heal and the cough is part of the healing process. Think how long it takes to heal a cut on a finger.”

In an era of escalating antimicrobial resistance fueled by antibiotic overuse, it’s become increasingly important to reserve antibiotics for necessary cases. According to a recent World Health Organization call to action, “Uncontrolled antimicrobial resistance is expected to lower life expectancy and lead to unprecedented health expenditure and economic losses.”

That said, there is important clinical work to be done to determine if there is a limited role for antibiotics in patients with cough, perhaps based on age and baseline severity. “Serious cough symptoms and how to treat them properly needs to be studied more, perhaps in a randomized clinical trial as this study was observational and there haven’t been any randomized trials looking at this issue since about 2012,” Dr. Merenstein said.

This research was funded by the Agency for Healthcare Research and Quality. The authors have no conflicts of interest to declare. Dr. Linder reported stock ownership in pharmaceutical companies but none that make antibiotics or other infectious disease drugs.

Publications
Topics
Sections

 

Antibiotics had no measurable effect on the severity or duration of coughs due to acute lower respiratory tract infection (LRTI, or acute bronchitis), a large prospective study found.

In fact, those receiving an antibiotic in the primary- and urgent-care setting had a small but significant increase in overall length of illness (17.5 vs 15.9 days; P = .05) — largely because patients with longer illness before the index visit were more likely to receive these drugs. The study adds further support for reducing the prescription of antibiotics for LRTIs.

“Importantly, the pathogen data demonstrated that the length of time until illness resolution for those with bacterial infection was the same as for those not receiving an antibiotic versus those receiving one (17.3 vs 17.4 days),” researchers led by Daniel J. Merenstein, MD, a professor and director of research programs, family medicine, at Georgetown University Medical Center in Washington, wrote in the Journal of General Internal Medicine (doi: 10.1007/s11606-024-08758-y).

Dr. Merenstein
Dr. Daniel J. Merenstein


Patients believed an antibiotic would shorten their illness by an average of about 4 days, from 13.4 days to 9.7 days, whereas the average duration of all coughs was more than 2 weeks regardless of pathogen type or receipt of an antibiotic.

“Patients had unrealistic expectations regarding the duration of LRTI and the effect of antibiotics, which should be the target of antibiotic stewardship efforts,” the group wrote.

LRTIs can, however, be dangerous, with 3%-5% progressing to pneumonia, “but not everyone has easy access at an initial visit to an x-ray, which may be the reason clinicians still give antibiotics without any other evidence of a bacterial infection,” Dr. Merenstein said in a news release. “Patients have come to expect antibiotics for a cough, even if it doesn’t help. Basic symptom-relieving medications plus time bring a resolution to most people’s infections.”

The authors noted that cough is the most common reason for an ambulatory care visit, accounting for 2.7 million outpatient visits and more than 4 million emergency department visits annually.
 

Risks

Overuse of antibiotics can result in dizziness, nausea, diarrhea, and rash, along with a roughly 4% chance of serious adverse effects including anaphylaxis; Stevens-Johnson syndrome, a serious skin and mucous membrane disorder; and Clostridioides difficile-associated diarrhea.

An estimated half of all antibiotic prescriptions for acute respiratory conditions are unnecessary. Before the COVID-19 pandemic, antibiotics were prescribed about 70% of the time for a diagnosis of uncomplicated cough and LRTI. The viral pandemic did not change this practice according to a meta-analysis of 130 studies showing that 78% of COVID-19 patients were prescribed an antibiotic.
 

The study

The study looked at a cohort of 718 patients, with a mean age of 38.9 years, 65.3% female, of whom 207 received an antibiotic and 511 did not. Of those with baseline data, 29% had an antibiotic prescribed at baseline, the most common (in 85%) being amoxicillin-clavulanate, azithromycin, doxycycline, and amoxicillin. Antibiotics had no effect on the duration or overall severity of cough in viral, bacterial, or mixed infections. Receipt of an antibiotic did, however, reduce the likelihood of a follow-up visit: 14.1% vs 8.2% (adjusted odds ratio, 0.47; 95% confidence interval, 0.26-0.84) — perhaps because it removed the motivation for seeking another consultation. Antibiotic recipients were more likely to receive a systemic corticosteroid (31.9% vs 4.5%, P <.001) and were also more likely to receive an albuterol inhaler (22.7% vs 7.6%, P <.001).

 

 

Jeffrey A. Linder, MD, MPH, a primary care physician and chief of internal medicine and geriatrics at Northwestern University Feinberg School of Medicine in Chicago, agrees that in the vast majority of LRTIs — usually acute bronchitis — antibiotics do not speed the healing process. “Forty years of research show that antibiotics do not make acute bronchitis go away any faster,” Dr. Linder, who was not involved in the current study, said in an interview. “There’s even growing evidence that a lot of pneumonia is viral as well, and 10 or 20 years from now we may often not be giving antibiotics for pneumonia because we’ll be able to see better if it’s caused by a virus.”

Northwestern Medicine
Dr. Jeffrey A. Linder


A large 2018 review by Dr. Linder and associates reported that 46% of antibiotics were prescribed without any infection-related diagnosis code and 20% without an office visit.

Dr. Linder routinely informs patients requesting an antibiotic about the risks of putting an ineffective chemical into their body. “I stress that it can cause rash and other allergic reactions, and even promote C diff infection,” he said. “And I also say it messes with the good bacteria in the microbiome, and they usually come around.”

Patients need to know, Dr. Linder added, that the normal course of healing the respiratory tract after acute bronchitis takes weeks. While a wet cough with sputum or phlegm will last a few days, it’s replaced with a dry annoying cough that persists for up to 3 weeks. “As long as they’re feeling generally better, that cough is normal,” he said. “A virus has run roughshod over their airways and they need a long time to heal and the cough is part of the healing process. Think how long it takes to heal a cut on a finger.”

In an era of escalating antimicrobial resistance fueled by antibiotic overuse, it’s become increasingly important to reserve antibiotics for necessary cases. According to a recent World Health Organization call to action, “Uncontrolled antimicrobial resistance is expected to lower life expectancy and lead to unprecedented health expenditure and economic losses.”

That said, there is important clinical work to be done to determine if there is a limited role for antibiotics in patients with cough, perhaps based on age and baseline severity. “Serious cough symptoms and how to treat them properly needs to be studied more, perhaps in a randomized clinical trial as this study was observational and there haven’t been any randomized trials looking at this issue since about 2012,” Dr. Merenstein said.

This research was funded by the Agency for Healthcare Research and Quality. The authors have no conflicts of interest to declare. Dr. Linder reported stock ownership in pharmaceutical companies but none that make antibiotics or other infectious disease drugs.

 

Antibiotics had no measurable effect on the severity or duration of coughs due to acute lower respiratory tract infection (LRTI, or acute bronchitis), a large prospective study found.

In fact, those receiving an antibiotic in the primary- and urgent-care setting had a small but significant increase in overall length of illness (17.5 vs 15.9 days; P = .05) — largely because patients with longer illness before the index visit were more likely to receive these drugs. The study adds further support for reducing the prescription of antibiotics for LRTIs.

“Importantly, the pathogen data demonstrated that the length of time until illness resolution for those with bacterial infection was the same as for those not receiving an antibiotic versus those receiving one (17.3 vs 17.4 days),” researchers led by Daniel J. Merenstein, MD, a professor and director of research programs, family medicine, at Georgetown University Medical Center in Washington, wrote in the Journal of General Internal Medicine (doi: 10.1007/s11606-024-08758-y).

Dr. Merenstein
Dr. Daniel J. Merenstein


Patients believed an antibiotic would shorten their illness by an average of about 4 days, from 13.4 days to 9.7 days, whereas the average duration of all coughs was more than 2 weeks regardless of pathogen type or receipt of an antibiotic.

“Patients had unrealistic expectations regarding the duration of LRTI and the effect of antibiotics, which should be the target of antibiotic stewardship efforts,” the group wrote.

LRTIs can, however, be dangerous, with 3%-5% progressing to pneumonia, “but not everyone has easy access at an initial visit to an x-ray, which may be the reason clinicians still give antibiotics without any other evidence of a bacterial infection,” Dr. Merenstein said in a news release. “Patients have come to expect antibiotics for a cough, even if it doesn’t help. Basic symptom-relieving medications plus time bring a resolution to most people’s infections.”

The authors noted that cough is the most common reason for an ambulatory care visit, accounting for 2.7 million outpatient visits and more than 4 million emergency department visits annually.
 

Risks

Overuse of antibiotics can result in dizziness, nausea, diarrhea, and rash, along with a roughly 4% chance of serious adverse effects including anaphylaxis; Stevens-Johnson syndrome, a serious skin and mucous membrane disorder; and Clostridioides difficile-associated diarrhea.

An estimated half of all antibiotic prescriptions for acute respiratory conditions are unnecessary. Before the COVID-19 pandemic, antibiotics were prescribed about 70% of the time for a diagnosis of uncomplicated cough and LRTI. The viral pandemic did not change this practice according to a meta-analysis of 130 studies showing that 78% of COVID-19 patients were prescribed an antibiotic.
 

The study

The study looked at a cohort of 718 patients, with a mean age of 38.9 years, 65.3% female, of whom 207 received an antibiotic and 511 did not. Of those with baseline data, 29% had an antibiotic prescribed at baseline, the most common (in 85%) being amoxicillin-clavulanate, azithromycin, doxycycline, and amoxicillin. Antibiotics had no effect on the duration or overall severity of cough in viral, bacterial, or mixed infections. Receipt of an antibiotic did, however, reduce the likelihood of a follow-up visit: 14.1% vs 8.2% (adjusted odds ratio, 0.47; 95% confidence interval, 0.26-0.84) — perhaps because it removed the motivation for seeking another consultation. Antibiotic recipients were more likely to receive a systemic corticosteroid (31.9% vs 4.5%, P <.001) and were also more likely to receive an albuterol inhaler (22.7% vs 7.6%, P <.001).

 

 

Jeffrey A. Linder, MD, MPH, a primary care physician and chief of internal medicine and geriatrics at Northwestern University Feinberg School of Medicine in Chicago, agrees that in the vast majority of LRTIs — usually acute bronchitis — antibiotics do not speed the healing process. “Forty years of research show that antibiotics do not make acute bronchitis go away any faster,” Dr. Linder, who was not involved in the current study, said in an interview. “There’s even growing evidence that a lot of pneumonia is viral as well, and 10 or 20 years from now we may often not be giving antibiotics for pneumonia because we’ll be able to see better if it’s caused by a virus.”

Northwestern Medicine
Dr. Jeffrey A. Linder


A large 2018 review by Dr. Linder and associates reported that 46% of antibiotics were prescribed without any infection-related diagnosis code and 20% without an office visit.

Dr. Linder routinely informs patients requesting an antibiotic about the risks of putting an ineffective chemical into their body. “I stress that it can cause rash and other allergic reactions, and even promote C diff infection,” he said. “And I also say it messes with the good bacteria in the microbiome, and they usually come around.”

Patients need to know, Dr. Linder added, that the normal course of healing the respiratory tract after acute bronchitis takes weeks. While a wet cough with sputum or phlegm will last a few days, it’s replaced with a dry annoying cough that persists for up to 3 weeks. “As long as they’re feeling generally better, that cough is normal,” he said. “A virus has run roughshod over their airways and they need a long time to heal and the cough is part of the healing process. Think how long it takes to heal a cut on a finger.”

In an era of escalating antimicrobial resistance fueled by antibiotic overuse, it’s become increasingly important to reserve antibiotics for necessary cases. According to a recent World Health Organization call to action, “Uncontrolled antimicrobial resistance is expected to lower life expectancy and lead to unprecedented health expenditure and economic losses.”

That said, there is important clinical work to be done to determine if there is a limited role for antibiotics in patients with cough, perhaps based on age and baseline severity. “Serious cough symptoms and how to treat them properly needs to be studied more, perhaps in a randomized clinical trial as this study was observational and there haven’t been any randomized trials looking at this issue since about 2012,” Dr. Merenstein said.

This research was funded by the Agency for Healthcare Research and Quality. The authors have no conflicts of interest to declare. Dr. Linder reported stock ownership in pharmaceutical companies but none that make antibiotics or other infectious disease drugs.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JOURNAL OF GENERAL INTERNAL MEDICINE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Are E-Cigarettes Bad for the Heart?

Article Type
Changed
Tue, 04/16/2024 - 11:52

E-cigarettes entered the market as consumer products without comprehensive toxicological testing,based on the assessment that they were 95% less harmful than traditional cigarettes. Further, consumer dvertising suggests that e-cigarettes are a good alternative to conventional combustible cigarettes and can serve as a gateway to quitting smoking.

However, hen considering damage to the endothelium and toxicity, e-cigarettes have a negative impact like that of conventional cigarettes. Moreover, switching to e-cigarettes often leads to dual use, said Stefan Andreas, MD, director of the Lungenfachklinik in Immenhausen, Germany, at the Congress of the German Respiratory Society and Intensive Care Medicine. 
 

Subclinical Atherosclerosis

Because e-cigarettes have emerged relatively recently, long-term studies on their cardiac consequences are not yet available. Dr. Andreas explained that the impact on endothelial function is relevant for risk assessment. Endothelial function is a biomarker for early, subclinical atherosclerosis. “If endothelial function is impaired, the risk for heart attack and stroke is significantly increased 5-10 years later,” said Dr. Andreas.

The results of a crossover study showed reduced vascular elasticity after consuming both tobacco cigarettes and e-cigarettes. The study included 20 smokers, and endothelial function was measured using flow-mediated vasodilation.

Significant effects on the vessels were also found in a study of 31 participants who had never smoked. The study participants inhaled a nicotine-free aerosol from e-cigarettes. Before and after, parameters of endothelial function were examined using a 3.0-T MRI. After aerosol inhalation, the resistance index was 2.3% higher (P < .05), and flow-mediated vascular dilation was reduced by 34% (P < .001).

A recent review involving 372 participants from China showed that e-cigarettes lead to an increase in pulse wave velocity, with a difference of 3.08 (P < .001). “Pulse wave velocity is also a marker of endothelial function: The stiffer the vessels, the higher the pulse wave velocity,” said Dr. Andreas. The authors of the review concluded that “e-cigarettes should not be promoted as a healthier alternative to tobacco smoking.”
 

No Harmless Alternative

A recent review compared the effects of tobacco smoking and e-cigarettes. The results showed that vaping e-cigarettes causes oxidative stress, inflammation, endothelial dysfunction, and related cardiovascular consequences. The authors attributed the findings to overlapping toxic compounds in vapor and tobacco smoke and similar pathomechanical features of vaping and smoking. Although the toxic mixture in smoke is more complex, both e-cigarettes and tobacco cigarettes “impaired endothelial function to a similar extent,” they wrote. The authors attributed this finding to oxidative stress as the central mechanism.

“There is increasing evidence that e-cigarettes are not a harmless alternative to tobacco cigarettes,” wrote Thomas Münzel, MD, professor of cardiology at the University of Mainz and his team in their 2020 review, which examined studies in humans and animals. They provided an overview of the effects of tobacco/hookah smoking and e-cigarette vaping on endothelial function. They also pointed to emerging adverse effects on the proteome, transcriptome, epigenome, microbiome, and circadian clock.

Finally, a toxicological review of e-cigarettes also found alarmingly high levels of carcinogens and toxins that could have long-term effects on other organs, including the development of neurological symptoms, lung cancer, cardiovascular diseases, and cavities.

Dr. Andreas observed that even small amounts, such as those obtained through secondhand smoking, can be harmful. In 2007, Dr. Andreas and his colleagues showed that even low exposure to tobacco smoke can lead to a significant increase in cardiovascular events.
 

 

 

Conflicts of Interest 

Dr. Andreas recommended closely examining the studies that suggest that e-cigarettes are less risky. “It is noticeable that there is a significant difference depending on whether publications were supported by the tobacco industry or not,” he emphasized.

Danish scientists found that a conflict of interest (COI) has a strong influence on study results. “In studies without a COI, e-cigarettes are found to cause damage 95% of the time. In contrast, when there is a strong conflict of interest, the result is often ‘no harm,’” said Dr. Andreas.

This effect is quite relevant for the discussion of e-cigarettes. “If scientists make a critical statement in a position paper, there will always be someone who says, ‘No, it’s different, there are these and those publications.’ The true nature of interest-driven publications on e-cigarettes is not always easy to discern,” said Dr. Andreas.
 

No Gateway to Quitting 

E-cigarettes are used in clinical studies for tobacco cessation. The results of a randomized study showed that significantly more smokers who were switched to e-cigarettes quit smoking, compared with controls. But there was no significant difference in complete smoking cessation between groups. Moreover, 45% of smokers who switched to e-cigarettes became dual users, compared with 11% of controls.

“Translating these results means that for one person who quits smoking by using e-cigarettes, they gain five people who use both traditional cigarettes and e-cigarettes,” explained Dr. Andreas.

In their recent review, Münzel and colleagues pointed out that the assessment that e-cigarettes could help with quitting might be wrong. Rather, it seems that “e-cigarettes have the opposite effect.” They also note that the age of initiation for e-cigarettes is generally lower than for tobacco cigarettes: Consumption often starts at age 13 or 14 years. And the consumption of e-cigarettes among children and adolescents increased by 7% from 2016 to 2023.

A meta-analysis published at the end of February also shows that e-cigarettes are about as dangerous as tobacco cigarettes. They are more dangerous than not smoking, and dual use is more dangerous than tobacco cigarettes alone. “There is a need to reassess the assumption that e-cigarette use provides substantial harm reduction across all cigarette-caused diseases, particularly accounting for dual use,” wrote the authors.

“One must always consider that e-cigarettes have only been available for a relatively short time. We can only see the cumulative toxicity in 10, 20 years when we have patients who have smoked e-cigarettes only for 20 years,” said Dr. Andreas. Ultimately, however, e-cigarettes promote dual use and, consequently, additive toxicity.
 

Nicotine Replacement Therapies 

Quitting smoking reduces the risk of cardiovascular events and premature death by 40%, even among patients with cardiovascular disease, according to a Cochrane meta-analysis. Smoking cessation reduces the risk for cardiovascular death by 39%, the risk for major adverse cardiovascular events by 43%, the risk for heart attack by 36%, the risk for stroke by 30%, and overall mortality by 40%.

Quitting smoking is the most effective measure for risk reduction, as a meta-analysis of 20 studies in patients with coronary heart disease found. Smoking cessation was associated with a 36% risk reduction compared with 29% risk reduction for statin therapy, 23% risk reduction with beta-blockers and ACE inhibitors and 15% risk reduction with aspirin.

Dr. Andreas emphasized that nicotine replacement therapies are well-researched and safe even in cardiovascular disease, as shown by a US study that included patients who had sustained a heart attack. A group of the participants was treated with nicotine patches for 10 weeks, while the other group received a placebo. After 14 weeks, 21% of the nicotine patch group achieved abstinence vs 9% of the placebo group (P = .001). Transdermal nicotine application does not lead to a significant increase in cardiovascular events in high-risk patients.

The German “Nonsmoker Heroes” app has proven to be an effective means of behavioral therapeutic coaching. A recent study of it included 17 study centers with 661 participants. About 21% of the subjects had chronic obstructive pulmonary disease, 19% had asthma. Smoking onset occurred at age 16 years. The subjects were highly dependent: > 72% had at least moderate dependence, > 58% had high to very high dependence, and the population had an average of 3.6 quit attempts. The odds ratio for self-reported abstinence was 2.2 after 6 months. “The app is not only effective, but also can be prescribed on an extrabudgetary basis,” said Dr. Andreas.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Publications
Topics
Sections

E-cigarettes entered the market as consumer products without comprehensive toxicological testing,based on the assessment that they were 95% less harmful than traditional cigarettes. Further, consumer dvertising suggests that e-cigarettes are a good alternative to conventional combustible cigarettes and can serve as a gateway to quitting smoking.

However, hen considering damage to the endothelium and toxicity, e-cigarettes have a negative impact like that of conventional cigarettes. Moreover, switching to e-cigarettes often leads to dual use, said Stefan Andreas, MD, director of the Lungenfachklinik in Immenhausen, Germany, at the Congress of the German Respiratory Society and Intensive Care Medicine. 
 

Subclinical Atherosclerosis

Because e-cigarettes have emerged relatively recently, long-term studies on their cardiac consequences are not yet available. Dr. Andreas explained that the impact on endothelial function is relevant for risk assessment. Endothelial function is a biomarker for early, subclinical atherosclerosis. “If endothelial function is impaired, the risk for heart attack and stroke is significantly increased 5-10 years later,” said Dr. Andreas.

The results of a crossover study showed reduced vascular elasticity after consuming both tobacco cigarettes and e-cigarettes. The study included 20 smokers, and endothelial function was measured using flow-mediated vasodilation.

Significant effects on the vessels were also found in a study of 31 participants who had never smoked. The study participants inhaled a nicotine-free aerosol from e-cigarettes. Before and after, parameters of endothelial function were examined using a 3.0-T MRI. After aerosol inhalation, the resistance index was 2.3% higher (P < .05), and flow-mediated vascular dilation was reduced by 34% (P < .001).

A recent review involving 372 participants from China showed that e-cigarettes lead to an increase in pulse wave velocity, with a difference of 3.08 (P < .001). “Pulse wave velocity is also a marker of endothelial function: The stiffer the vessels, the higher the pulse wave velocity,” said Dr. Andreas. The authors of the review concluded that “e-cigarettes should not be promoted as a healthier alternative to tobacco smoking.”
 

No Harmless Alternative

A recent review compared the effects of tobacco smoking and e-cigarettes. The results showed that vaping e-cigarettes causes oxidative stress, inflammation, endothelial dysfunction, and related cardiovascular consequences. The authors attributed the findings to overlapping toxic compounds in vapor and tobacco smoke and similar pathomechanical features of vaping and smoking. Although the toxic mixture in smoke is more complex, both e-cigarettes and tobacco cigarettes “impaired endothelial function to a similar extent,” they wrote. The authors attributed this finding to oxidative stress as the central mechanism.

“There is increasing evidence that e-cigarettes are not a harmless alternative to tobacco cigarettes,” wrote Thomas Münzel, MD, professor of cardiology at the University of Mainz and his team in their 2020 review, which examined studies in humans and animals. They provided an overview of the effects of tobacco/hookah smoking and e-cigarette vaping on endothelial function. They also pointed to emerging adverse effects on the proteome, transcriptome, epigenome, microbiome, and circadian clock.

Finally, a toxicological review of e-cigarettes also found alarmingly high levels of carcinogens and toxins that could have long-term effects on other organs, including the development of neurological symptoms, lung cancer, cardiovascular diseases, and cavities.

Dr. Andreas observed that even small amounts, such as those obtained through secondhand smoking, can be harmful. In 2007, Dr. Andreas and his colleagues showed that even low exposure to tobacco smoke can lead to a significant increase in cardiovascular events.
 

 

 

Conflicts of Interest 

Dr. Andreas recommended closely examining the studies that suggest that e-cigarettes are less risky. “It is noticeable that there is a significant difference depending on whether publications were supported by the tobacco industry or not,” he emphasized.

Danish scientists found that a conflict of interest (COI) has a strong influence on study results. “In studies without a COI, e-cigarettes are found to cause damage 95% of the time. In contrast, when there is a strong conflict of interest, the result is often ‘no harm,’” said Dr. Andreas.

This effect is quite relevant for the discussion of e-cigarettes. “If scientists make a critical statement in a position paper, there will always be someone who says, ‘No, it’s different, there are these and those publications.’ The true nature of interest-driven publications on e-cigarettes is not always easy to discern,” said Dr. Andreas.
 

No Gateway to Quitting 

E-cigarettes are used in clinical studies for tobacco cessation. The results of a randomized study showed that significantly more smokers who were switched to e-cigarettes quit smoking, compared with controls. But there was no significant difference in complete smoking cessation between groups. Moreover, 45% of smokers who switched to e-cigarettes became dual users, compared with 11% of controls.

“Translating these results means that for one person who quits smoking by using e-cigarettes, they gain five people who use both traditional cigarettes and e-cigarettes,” explained Dr. Andreas.

In their recent review, Münzel and colleagues pointed out that the assessment that e-cigarettes could help with quitting might be wrong. Rather, it seems that “e-cigarettes have the opposite effect.” They also note that the age of initiation for e-cigarettes is generally lower than for tobacco cigarettes: Consumption often starts at age 13 or 14 years. And the consumption of e-cigarettes among children and adolescents increased by 7% from 2016 to 2023.

A meta-analysis published at the end of February also shows that e-cigarettes are about as dangerous as tobacco cigarettes. They are more dangerous than not smoking, and dual use is more dangerous than tobacco cigarettes alone. “There is a need to reassess the assumption that e-cigarette use provides substantial harm reduction across all cigarette-caused diseases, particularly accounting for dual use,” wrote the authors.

“One must always consider that e-cigarettes have only been available for a relatively short time. We can only see the cumulative toxicity in 10, 20 years when we have patients who have smoked e-cigarettes only for 20 years,” said Dr. Andreas. Ultimately, however, e-cigarettes promote dual use and, consequently, additive toxicity.
 

Nicotine Replacement Therapies 

Quitting smoking reduces the risk of cardiovascular events and premature death by 40%, even among patients with cardiovascular disease, according to a Cochrane meta-analysis. Smoking cessation reduces the risk for cardiovascular death by 39%, the risk for major adverse cardiovascular events by 43%, the risk for heart attack by 36%, the risk for stroke by 30%, and overall mortality by 40%.

Quitting smoking is the most effective measure for risk reduction, as a meta-analysis of 20 studies in patients with coronary heart disease found. Smoking cessation was associated with a 36% risk reduction compared with 29% risk reduction for statin therapy, 23% risk reduction with beta-blockers and ACE inhibitors and 15% risk reduction with aspirin.

Dr. Andreas emphasized that nicotine replacement therapies are well-researched and safe even in cardiovascular disease, as shown by a US study that included patients who had sustained a heart attack. A group of the participants was treated with nicotine patches for 10 weeks, while the other group received a placebo. After 14 weeks, 21% of the nicotine patch group achieved abstinence vs 9% of the placebo group (P = .001). Transdermal nicotine application does not lead to a significant increase in cardiovascular events in high-risk patients.

The German “Nonsmoker Heroes” app has proven to be an effective means of behavioral therapeutic coaching. A recent study of it included 17 study centers with 661 participants. About 21% of the subjects had chronic obstructive pulmonary disease, 19% had asthma. Smoking onset occurred at age 16 years. The subjects were highly dependent: > 72% had at least moderate dependence, > 58% had high to very high dependence, and the population had an average of 3.6 quit attempts. The odds ratio for self-reported abstinence was 2.2 after 6 months. “The app is not only effective, but also can be prescribed on an extrabudgetary basis,” said Dr. Andreas.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

E-cigarettes entered the market as consumer products without comprehensive toxicological testing,based on the assessment that they were 95% less harmful than traditional cigarettes. Further, consumer dvertising suggests that e-cigarettes are a good alternative to conventional combustible cigarettes and can serve as a gateway to quitting smoking.

However, hen considering damage to the endothelium and toxicity, e-cigarettes have a negative impact like that of conventional cigarettes. Moreover, switching to e-cigarettes often leads to dual use, said Stefan Andreas, MD, director of the Lungenfachklinik in Immenhausen, Germany, at the Congress of the German Respiratory Society and Intensive Care Medicine. 
 

Subclinical Atherosclerosis

Because e-cigarettes have emerged relatively recently, long-term studies on their cardiac consequences are not yet available. Dr. Andreas explained that the impact on endothelial function is relevant for risk assessment. Endothelial function is a biomarker for early, subclinical atherosclerosis. “If endothelial function is impaired, the risk for heart attack and stroke is significantly increased 5-10 years later,” said Dr. Andreas.

The results of a crossover study showed reduced vascular elasticity after consuming both tobacco cigarettes and e-cigarettes. The study included 20 smokers, and endothelial function was measured using flow-mediated vasodilation.

Significant effects on the vessels were also found in a study of 31 participants who had never smoked. The study participants inhaled a nicotine-free aerosol from e-cigarettes. Before and after, parameters of endothelial function were examined using a 3.0-T MRI. After aerosol inhalation, the resistance index was 2.3% higher (P < .05), and flow-mediated vascular dilation was reduced by 34% (P < .001).

A recent review involving 372 participants from China showed that e-cigarettes lead to an increase in pulse wave velocity, with a difference of 3.08 (P < .001). “Pulse wave velocity is also a marker of endothelial function: The stiffer the vessels, the higher the pulse wave velocity,” said Dr. Andreas. The authors of the review concluded that “e-cigarettes should not be promoted as a healthier alternative to tobacco smoking.”
 

No Harmless Alternative

A recent review compared the effects of tobacco smoking and e-cigarettes. The results showed that vaping e-cigarettes causes oxidative stress, inflammation, endothelial dysfunction, and related cardiovascular consequences. The authors attributed the findings to overlapping toxic compounds in vapor and tobacco smoke and similar pathomechanical features of vaping and smoking. Although the toxic mixture in smoke is more complex, both e-cigarettes and tobacco cigarettes “impaired endothelial function to a similar extent,” they wrote. The authors attributed this finding to oxidative stress as the central mechanism.

“There is increasing evidence that e-cigarettes are not a harmless alternative to tobacco cigarettes,” wrote Thomas Münzel, MD, professor of cardiology at the University of Mainz and his team in their 2020 review, which examined studies in humans and animals. They provided an overview of the effects of tobacco/hookah smoking and e-cigarette vaping on endothelial function. They also pointed to emerging adverse effects on the proteome, transcriptome, epigenome, microbiome, and circadian clock.

Finally, a toxicological review of e-cigarettes also found alarmingly high levels of carcinogens and toxins that could have long-term effects on other organs, including the development of neurological symptoms, lung cancer, cardiovascular diseases, and cavities.

Dr. Andreas observed that even small amounts, such as those obtained through secondhand smoking, can be harmful. In 2007, Dr. Andreas and his colleagues showed that even low exposure to tobacco smoke can lead to a significant increase in cardiovascular events.
 

 

 

Conflicts of Interest 

Dr. Andreas recommended closely examining the studies that suggest that e-cigarettes are less risky. “It is noticeable that there is a significant difference depending on whether publications were supported by the tobacco industry or not,” he emphasized.

Danish scientists found that a conflict of interest (COI) has a strong influence on study results. “In studies without a COI, e-cigarettes are found to cause damage 95% of the time. In contrast, when there is a strong conflict of interest, the result is often ‘no harm,’” said Dr. Andreas.

This effect is quite relevant for the discussion of e-cigarettes. “If scientists make a critical statement in a position paper, there will always be someone who says, ‘No, it’s different, there are these and those publications.’ The true nature of interest-driven publications on e-cigarettes is not always easy to discern,” said Dr. Andreas.
 

No Gateway to Quitting 

E-cigarettes are used in clinical studies for tobacco cessation. The results of a randomized study showed that significantly more smokers who were switched to e-cigarettes quit smoking, compared with controls. But there was no significant difference in complete smoking cessation between groups. Moreover, 45% of smokers who switched to e-cigarettes became dual users, compared with 11% of controls.

“Translating these results means that for one person who quits smoking by using e-cigarettes, they gain five people who use both traditional cigarettes and e-cigarettes,” explained Dr. Andreas.

In their recent review, Münzel and colleagues pointed out that the assessment that e-cigarettes could help with quitting might be wrong. Rather, it seems that “e-cigarettes have the opposite effect.” They also note that the age of initiation for e-cigarettes is generally lower than for tobacco cigarettes: Consumption often starts at age 13 or 14 years. And the consumption of e-cigarettes among children and adolescents increased by 7% from 2016 to 2023.

A meta-analysis published at the end of February also shows that e-cigarettes are about as dangerous as tobacco cigarettes. They are more dangerous than not smoking, and dual use is more dangerous than tobacco cigarettes alone. “There is a need to reassess the assumption that e-cigarette use provides substantial harm reduction across all cigarette-caused diseases, particularly accounting for dual use,” wrote the authors.

“One must always consider that e-cigarettes have only been available for a relatively short time. We can only see the cumulative toxicity in 10, 20 years when we have patients who have smoked e-cigarettes only for 20 years,” said Dr. Andreas. Ultimately, however, e-cigarettes promote dual use and, consequently, additive toxicity.
 

Nicotine Replacement Therapies 

Quitting smoking reduces the risk of cardiovascular events and premature death by 40%, even among patients with cardiovascular disease, according to a Cochrane meta-analysis. Smoking cessation reduces the risk for cardiovascular death by 39%, the risk for major adverse cardiovascular events by 43%, the risk for heart attack by 36%, the risk for stroke by 30%, and overall mortality by 40%.

Quitting smoking is the most effective measure for risk reduction, as a meta-analysis of 20 studies in patients with coronary heart disease found. Smoking cessation was associated with a 36% risk reduction compared with 29% risk reduction for statin therapy, 23% risk reduction with beta-blockers and ACE inhibitors and 15% risk reduction with aspirin.

Dr. Andreas emphasized that nicotine replacement therapies are well-researched and safe even in cardiovascular disease, as shown by a US study that included patients who had sustained a heart attack. A group of the participants was treated with nicotine patches for 10 weeks, while the other group received a placebo. After 14 weeks, 21% of the nicotine patch group achieved abstinence vs 9% of the placebo group (P = .001). Transdermal nicotine application does not lead to a significant increase in cardiovascular events in high-risk patients.

The German “Nonsmoker Heroes” app has proven to be an effective means of behavioral therapeutic coaching. A recent study of it included 17 study centers with 661 participants. About 21% of the subjects had chronic obstructive pulmonary disease, 19% had asthma. Smoking onset occurred at age 16 years. The subjects were highly dependent: > 72% had at least moderate dependence, > 58% had high to very high dependence, and the population had an average of 3.6 quit attempts. The odds ratio for self-reported abstinence was 2.2 after 6 months. “The app is not only effective, but also can be prescribed on an extrabudgetary basis,” said Dr. Andreas.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

High Infection Risk in Rheumatoid Arthritis–Associated Interstitial Lung Disease

Article Type
Changed
Wed, 04/17/2024 - 11:55

 

TOPLINE:

Patients with rheumatoid arthritis–associated interstitial lung disease (RA-ILD) have a high risk for serious and fatal infections, with age, inflammation, and corticosteroid therapy further increasing this risk.

METHODOLOGY:

  • Patients with RA who have extra-articular manifestations such as ILD are highly susceptible to infections, but information on the types of infections, risk factors, and associations of infections with hospitalization and mortality is limited.
  • This prospective multicenter cohort study evaluated infections in a cohort of 148 patients with RA-ILD (average age, 70 years; 57% women) recruited from 11 university hospitals in Spain between March 2015 and March 2023.
  • Joint, lung, and any infection-related variables were evaluated using clinical and laboratory evaluations at baseline and selected time points till the end of the follow-up period (mean, 56.7 months).
  • Researchers also investigated the common infectious sites, the etiology of the infection, vaccination status, variables associated with lung function, and clinical-therapeutic variables associated with RA.

TAKEAWAY:

  • During the follow-up period, almost all (96%) patients had at least one infection, with the median time to first infection being 21.2 months and 65% of the deaths being directly related to infections.
  • Respiratory infections were the most common first infections (74%) and led to death in 80% of the patients. Urinary tract (9.9%) and skin and soft tissue (9.1%) infections were the second and third most common first infections, respectively.
  • Most infections were caused by SARS-CoV-2 (33.5%), Streptococcus pneumoniae (11.9%), Escherichia coli (11.9%), and Pseudomonas aeruginosa (11.1%), with mortality at 25.8% for SARS-CoV-2, 12.9% for P aeruginosa (12.9%), and 9.6% for pneumococci (9.6%).
  • Increased age, disease activity, and the use of corticosteroids were associated with an elevated risk for infection and mortality in patients with RA-ILD.

IN PRACTICE:

“Our results demonstrate a high occurrence of serious infections among these patients, occurring early, recurring frequently, and proving fatal in 65% of cases,” the authors wrote.

SOURCE:

This study was led by Natalia Mena-Vázquez, MD, PhD, from Instituto de Investigación Biomédica de Málaga-Plataforma Bionand, Málaga, Spain, and published online March 27 in Frontiers in Immunology.

LIMITATIONS:

The findings of this study have been affected by the COVID-19 pandemic. The lack of a control group also limited the ability of this study to establish any causal relationships between ILD and the clinical outcomes analyzed.

DISCLOSURE:

This study was supported by Redes de Investigación Cooperativa Orientadas a Resultados en Salud and Fundación Andaluza de Reumatología. The authors declared having no conflicts of interest.
 

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

TOPLINE:

Patients with rheumatoid arthritis–associated interstitial lung disease (RA-ILD) have a high risk for serious and fatal infections, with age, inflammation, and corticosteroid therapy further increasing this risk.

METHODOLOGY:

  • Patients with RA who have extra-articular manifestations such as ILD are highly susceptible to infections, but information on the types of infections, risk factors, and associations of infections with hospitalization and mortality is limited.
  • This prospective multicenter cohort study evaluated infections in a cohort of 148 patients with RA-ILD (average age, 70 years; 57% women) recruited from 11 university hospitals in Spain between March 2015 and March 2023.
  • Joint, lung, and any infection-related variables were evaluated using clinical and laboratory evaluations at baseline and selected time points till the end of the follow-up period (mean, 56.7 months).
  • Researchers also investigated the common infectious sites, the etiology of the infection, vaccination status, variables associated with lung function, and clinical-therapeutic variables associated with RA.

TAKEAWAY:

  • During the follow-up period, almost all (96%) patients had at least one infection, with the median time to first infection being 21.2 months and 65% of the deaths being directly related to infections.
  • Respiratory infections were the most common first infections (74%) and led to death in 80% of the patients. Urinary tract (9.9%) and skin and soft tissue (9.1%) infections were the second and third most common first infections, respectively.
  • Most infections were caused by SARS-CoV-2 (33.5%), Streptococcus pneumoniae (11.9%), Escherichia coli (11.9%), and Pseudomonas aeruginosa (11.1%), with mortality at 25.8% for SARS-CoV-2, 12.9% for P aeruginosa (12.9%), and 9.6% for pneumococci (9.6%).
  • Increased age, disease activity, and the use of corticosteroids were associated with an elevated risk for infection and mortality in patients with RA-ILD.

IN PRACTICE:

“Our results demonstrate a high occurrence of serious infections among these patients, occurring early, recurring frequently, and proving fatal in 65% of cases,” the authors wrote.

SOURCE:

This study was led by Natalia Mena-Vázquez, MD, PhD, from Instituto de Investigación Biomédica de Málaga-Plataforma Bionand, Málaga, Spain, and published online March 27 in Frontiers in Immunology.

LIMITATIONS:

The findings of this study have been affected by the COVID-19 pandemic. The lack of a control group also limited the ability of this study to establish any causal relationships between ILD and the clinical outcomes analyzed.

DISCLOSURE:

This study was supported by Redes de Investigación Cooperativa Orientadas a Resultados en Salud and Fundación Andaluza de Reumatología. The authors declared having no conflicts of interest.
 

A version of this article appeared on Medscape.com.

 

TOPLINE:

Patients with rheumatoid arthritis–associated interstitial lung disease (RA-ILD) have a high risk for serious and fatal infections, with age, inflammation, and corticosteroid therapy further increasing this risk.

METHODOLOGY:

  • Patients with RA who have extra-articular manifestations such as ILD are highly susceptible to infections, but information on the types of infections, risk factors, and associations of infections with hospitalization and mortality is limited.
  • This prospective multicenter cohort study evaluated infections in a cohort of 148 patients with RA-ILD (average age, 70 years; 57% women) recruited from 11 university hospitals in Spain between March 2015 and March 2023.
  • Joint, lung, and any infection-related variables were evaluated using clinical and laboratory evaluations at baseline and selected time points till the end of the follow-up period (mean, 56.7 months).
  • Researchers also investigated the common infectious sites, the etiology of the infection, vaccination status, variables associated with lung function, and clinical-therapeutic variables associated with RA.

TAKEAWAY:

  • During the follow-up period, almost all (96%) patients had at least one infection, with the median time to first infection being 21.2 months and 65% of the deaths being directly related to infections.
  • Respiratory infections were the most common first infections (74%) and led to death in 80% of the patients. Urinary tract (9.9%) and skin and soft tissue (9.1%) infections were the second and third most common first infections, respectively.
  • Most infections were caused by SARS-CoV-2 (33.5%), Streptococcus pneumoniae (11.9%), Escherichia coli (11.9%), and Pseudomonas aeruginosa (11.1%), with mortality at 25.8% for SARS-CoV-2, 12.9% for P aeruginosa (12.9%), and 9.6% for pneumococci (9.6%).
  • Increased age, disease activity, and the use of corticosteroids were associated with an elevated risk for infection and mortality in patients with RA-ILD.

IN PRACTICE:

“Our results demonstrate a high occurrence of serious infections among these patients, occurring early, recurring frequently, and proving fatal in 65% of cases,” the authors wrote.

SOURCE:

This study was led by Natalia Mena-Vázquez, MD, PhD, from Instituto de Investigación Biomédica de Málaga-Plataforma Bionand, Málaga, Spain, and published online March 27 in Frontiers in Immunology.

LIMITATIONS:

The findings of this study have been affected by the COVID-19 pandemic. The lack of a control group also limited the ability of this study to establish any causal relationships between ILD and the clinical outcomes analyzed.

DISCLOSURE:

This study was supported by Redes de Investigación Cooperativa Orientadas a Resultados en Salud and Fundación Andaluza de Reumatología. The authors declared having no conflicts of interest.
 

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Nasal Cannula Dislodgement During Sleep in Veterans Receiving Long-term Oxygen Therapy for Hypoxemic Chronic Respiratory Failure

Article Type
Changed
Wed, 04/10/2024 - 16:42

The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).2-5 It has been well established that LTOT reduces all-cause mortality in patients with COPD and resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.6-8

Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.8,9 Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.10-13

The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on their hospitalizations for COPD exacerbations.

METHODS

We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.14 A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence.

Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.15 We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.

Data Analysis

Data were reported as mean (SD) where appropriate. The t test and Fisher exact test were used as indicated. P < .05 was considered statistically significant. The study protocol was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).

 

 

RESULTS

table 1

During the study period, 75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.

figure

Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2).

table 3
table 2

Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (P = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.

 

 

DISCUSSION

There are 3 new findings in this study. First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups.

Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.16 Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.11,13 Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.10,12 The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.

To the best of our knowledge, NCD during sleep has not been previously reported in patients with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.17-20 Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.

Limitations

This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare & Medicaid Services or commercial carrier data may be different.15,21 Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.14 This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD.

CONCLUSIONS

Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.

Acknowledgments

We thank Yolanda Davis, RRT, and George Adam for their assistance with this project.

References

1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. Natl Health Stat Report. 2021;(153):1-13. doi:10.15620/cdc:101659

2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. Int J Chron Obstruct Pulmon Dis. 2010;5:125-132. doi:10.2147/copd.s8047

3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. Chronic Obstr Pulm Dis. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201

4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. Cost Eff Resour Alloc. 2013;11:13. doi:10.1186/1478-7547-11-13

5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. Int J Chron Obstruct Pulmon Dis. 2022;17:1269-1283. doi:10.2147/COPD.S339323

6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2

7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI

8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST

9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007;52(8):1063-1068.

10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. PLoS One. 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618

11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC

12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. COPD. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357

13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. Respir Res. 2022;23(1):213. doi:10.1186/s12931-022-02123-5

14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947

15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf

16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20(121):183-194. doi:10.1183/09059180.00004311

17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS

18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. Expert Rev Clin Pharmacol. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457

19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. Respir Care. 2019;64(12):1574-1585. doi:10.4187/respcare.07135

20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. Ann Am Thorac Soc. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC

21. US Centers for Medicare & Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169

Article PDF
Author and Disclosure Information

Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b

Correspondence:  Israel Rubinstein (irubinst@uic.edu)

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois Chicago College of Pharmacy

Author roles

All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript.

Disclosures

This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).

Issue
Federal Practitioner - 41(4)a
Publications
Topics
Page Number
117
Sections
Author and Disclosure Information

Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b

Correspondence:  Israel Rubinstein (irubinst@uic.edu)

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois Chicago College of Pharmacy

Author roles

All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript.

Disclosures

This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).

Author and Disclosure Information

Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b

Correspondence:  Israel Rubinstein (irubinst@uic.edu)

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois Chicago College of Pharmacy

Author roles

All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript.

Disclosures

This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).

Article PDF
Article PDF

The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).2-5 It has been well established that LTOT reduces all-cause mortality in patients with COPD and resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.6-8

Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.8,9 Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.10-13

The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on their hospitalizations for COPD exacerbations.

METHODS

We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.14 A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence.

Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.15 We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.

Data Analysis

Data were reported as mean (SD) where appropriate. The t test and Fisher exact test were used as indicated. P < .05 was considered statistically significant. The study protocol was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).

 

 

RESULTS

table 1

During the study period, 75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.

figure

Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2).

table 3
table 2

Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (P = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.

 

 

DISCUSSION

There are 3 new findings in this study. First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups.

Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.16 Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.11,13 Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.10,12 The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.

To the best of our knowledge, NCD during sleep has not been previously reported in patients with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.17-20 Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.

Limitations

This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare & Medicaid Services or commercial carrier data may be different.15,21 Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.14 This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD.

CONCLUSIONS

Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.

Acknowledgments

We thank Yolanda Davis, RRT, and George Adam for their assistance with this project.

The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).2-5 It has been well established that LTOT reduces all-cause mortality in patients with COPD and resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.6-8

Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.8,9 Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.10-13

The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on their hospitalizations for COPD exacerbations.

METHODS

We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.14 A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence.

Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.15 We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.

Data Analysis

Data were reported as mean (SD) where appropriate. The t test and Fisher exact test were used as indicated. P < .05 was considered statistically significant. The study protocol was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).

 

 

RESULTS

table 1

During the study period, 75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.

figure

Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2).

table 3
table 2

Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (P = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.

 

 

DISCUSSION

There are 3 new findings in this study. First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups.

Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.16 Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.11,13 Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.10,12 The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.

To the best of our knowledge, NCD during sleep has not been previously reported in patients with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.17-20 Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.

Limitations

This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare & Medicaid Services or commercial carrier data may be different.15,21 Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.14 This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD.

CONCLUSIONS

Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.

Acknowledgments

We thank Yolanda Davis, RRT, and George Adam for their assistance with this project.

References

1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. Natl Health Stat Report. 2021;(153):1-13. doi:10.15620/cdc:101659

2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. Int J Chron Obstruct Pulmon Dis. 2010;5:125-132. doi:10.2147/copd.s8047

3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. Chronic Obstr Pulm Dis. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201

4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. Cost Eff Resour Alloc. 2013;11:13. doi:10.1186/1478-7547-11-13

5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. Int J Chron Obstruct Pulmon Dis. 2022;17:1269-1283. doi:10.2147/COPD.S339323

6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2

7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI

8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST

9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007;52(8):1063-1068.

10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. PLoS One. 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618

11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC

12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. COPD. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357

13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. Respir Res. 2022;23(1):213. doi:10.1186/s12931-022-02123-5

14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947

15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf

16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20(121):183-194. doi:10.1183/09059180.00004311

17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS

18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. Expert Rev Clin Pharmacol. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457

19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. Respir Care. 2019;64(12):1574-1585. doi:10.4187/respcare.07135

20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. Ann Am Thorac Soc. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC

21. US Centers for Medicare & Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169

References

1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. Natl Health Stat Report. 2021;(153):1-13. doi:10.15620/cdc:101659

2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. Int J Chron Obstruct Pulmon Dis. 2010;5:125-132. doi:10.2147/copd.s8047

3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. Chronic Obstr Pulm Dis. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201

4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. Cost Eff Resour Alloc. 2013;11:13. doi:10.1186/1478-7547-11-13

5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. Int J Chron Obstruct Pulmon Dis. 2022;17:1269-1283. doi:10.2147/COPD.S339323

6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2

7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI

8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST

9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007;52(8):1063-1068.

10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. PLoS One. 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618

11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC

12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. COPD. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357

13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. Respir Res. 2022;23(1):213. doi:10.1186/s12931-022-02123-5

14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947

15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf

16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20(121):183-194. doi:10.1183/09059180.00004311

17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS

18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. Expert Rev Clin Pharmacol. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457

19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. Respir Care. 2019;64(12):1574-1585. doi:10.4187/respcare.07135

20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. Ann Am Thorac Soc. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC

21. US Centers for Medicare & Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169

Issue
Federal Practitioner - 41(4)a
Issue
Federal Practitioner - 41(4)a
Page Number
117
Page Number
117
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

Tuberculosis Prevention Brings Economic Gains, Says WHO

Article Type
Changed
Fri, 04/05/2024 - 13:51

A new study conducted by the World Health Organization (WHO) suggests that in addition to providing significant improvements in public health, investment in the diagnosis and prevention of tuberculosis also generates economic benefits.

According to a survey conducted by governments and researchers from Brazil, Georgia, Kenya, and South Africa, even modest increases in funding for measures against tuberculosis can bring gains. Every $1 invested produces returns of as much as $39, it found.

The findings may remind governments and policymakers about the importance of investing in public health policies. According to the WHO, the study “provides strong economic arguments” about the true costs of tuberculosis and proves the benefits of increasing funding to accelerate the diagnosis and preventive treatment of the disease.
 

UN Targets Tuberculosis

In September 2023, during the last meeting of the United Nations General Assembly, following a widespread worsening of disease indicators because of the COVID-19 pandemic, world leaders signed a declaration committing to the expansion of efforts to combat tuberculosis during the next 5 years. The current WHO study was developed to provide a road map for the implementation of key measures against the disease.

The survey highlights two fundamental actions: The expansion of screening, especially in populations considered more vulnerable, and the provision of tuberculosis preventive treatment (TPT), which entails administering drugs to people who have been exposed to the disease but have not yet developed it.

“TPT is a proven and effective intervention to prevent the development of tuberculosis among exposed people, reducing the risk of developing the disease by about 60%-90% compared with individuals who did not receive it,” the document emphasized.

Investments Yield Returns

To achieve the necessary coverage levels, the study estimated that Brazil would need to increase annual per capita investment by $0.28 (about R$1.41) between 2024 and 2050. Brazilian society, in turn, would receive a return of $11 (R$55.27) for every dollar invested.

For South Africa, whose per capita investment increase is estimated at $1.10 per year, the return would be even more significant: $39 for every dollar allocated.

The WHO emphasized that funding for combating the disease is much lower than the value of the damage it causes to nations. “Tuberculosis has high costs for society. Only a small proportion of these costs go directly to the health system (ranging from 1.7% in South Africa to 7.8% in Kenya). Most are costs for patients and society.”

The study projected that between 2024 and 2050, the total cost of tuberculosis to Brazilian society would be $81.2 billion, with an average annual value of $3.01 billion. This figure represents, in 2024, 0.16% of the country’s gross domestic product.

Achieving screening and preventive treatment goals in Brazil would lead to a reduction of as much as 18% in the national incidence of the disease, as well as 1.9 million fewer deaths, between 2024 and 2050.

Although treatable and preventable, tuberculosis remains the leading cause of death from infectious agents worldwide. It is estimated that over 1.3 million people died from the disease in 2022.

The document provides the “health and economic justification for investing in evidence-based interventions recommended by WHO in tuberculosis screening and prevention,” according to WHO Director-General Tedros Adhanom Ghebreyesus, PhD.

“Today we have the knowledge, tools, and political commitment that can end this age-old disease that continues to be one of the leading causes of death from infectious diseases worldwide,” he added.

 

 

Emerging Concerns

Although the WHO highlighted the global increase in access to tuberculosis diagnosis and treatment in 2022, which coincided with the recovery of healthcare systems in several countries after the beginning of the pandemic, it emphasized that the implementation of preventive treatment for exposed individuals and high-vulnerability populations remains slow.

Another concern is the increase in drug resistance. Multidrug-resistant tuberculosis is considered a public health crisis. It is estimated that about 410,000 people had multidrug-resistant tuberculosis or rifampicin-resistant tuberculosis in 2022, but only two of every five patients had access to treatment.This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com .

Publications
Topics
Sections

A new study conducted by the World Health Organization (WHO) suggests that in addition to providing significant improvements in public health, investment in the diagnosis and prevention of tuberculosis also generates economic benefits.

According to a survey conducted by governments and researchers from Brazil, Georgia, Kenya, and South Africa, even modest increases in funding for measures against tuberculosis can bring gains. Every $1 invested produces returns of as much as $39, it found.

The findings may remind governments and policymakers about the importance of investing in public health policies. According to the WHO, the study “provides strong economic arguments” about the true costs of tuberculosis and proves the benefits of increasing funding to accelerate the diagnosis and preventive treatment of the disease.
 

UN Targets Tuberculosis

In September 2023, during the last meeting of the United Nations General Assembly, following a widespread worsening of disease indicators because of the COVID-19 pandemic, world leaders signed a declaration committing to the expansion of efforts to combat tuberculosis during the next 5 years. The current WHO study was developed to provide a road map for the implementation of key measures against the disease.

The survey highlights two fundamental actions: The expansion of screening, especially in populations considered more vulnerable, and the provision of tuberculosis preventive treatment (TPT), which entails administering drugs to people who have been exposed to the disease but have not yet developed it.

“TPT is a proven and effective intervention to prevent the development of tuberculosis among exposed people, reducing the risk of developing the disease by about 60%-90% compared with individuals who did not receive it,” the document emphasized.

Investments Yield Returns

To achieve the necessary coverage levels, the study estimated that Brazil would need to increase annual per capita investment by $0.28 (about R$1.41) between 2024 and 2050. Brazilian society, in turn, would receive a return of $11 (R$55.27) for every dollar invested.

For South Africa, whose per capita investment increase is estimated at $1.10 per year, the return would be even more significant: $39 for every dollar allocated.

The WHO emphasized that funding for combating the disease is much lower than the value of the damage it causes to nations. “Tuberculosis has high costs for society. Only a small proportion of these costs go directly to the health system (ranging from 1.7% in South Africa to 7.8% in Kenya). Most are costs for patients and society.”

The study projected that between 2024 and 2050, the total cost of tuberculosis to Brazilian society would be $81.2 billion, with an average annual value of $3.01 billion. This figure represents, in 2024, 0.16% of the country’s gross domestic product.

Achieving screening and preventive treatment goals in Brazil would lead to a reduction of as much as 18% in the national incidence of the disease, as well as 1.9 million fewer deaths, between 2024 and 2050.

Although treatable and preventable, tuberculosis remains the leading cause of death from infectious agents worldwide. It is estimated that over 1.3 million people died from the disease in 2022.

The document provides the “health and economic justification for investing in evidence-based interventions recommended by WHO in tuberculosis screening and prevention,” according to WHO Director-General Tedros Adhanom Ghebreyesus, PhD.

“Today we have the knowledge, tools, and political commitment that can end this age-old disease that continues to be one of the leading causes of death from infectious diseases worldwide,” he added.

 

 

Emerging Concerns

Although the WHO highlighted the global increase in access to tuberculosis diagnosis and treatment in 2022, which coincided with the recovery of healthcare systems in several countries after the beginning of the pandemic, it emphasized that the implementation of preventive treatment for exposed individuals and high-vulnerability populations remains slow.

Another concern is the increase in drug resistance. Multidrug-resistant tuberculosis is considered a public health crisis. It is estimated that about 410,000 people had multidrug-resistant tuberculosis or rifampicin-resistant tuberculosis in 2022, but only two of every five patients had access to treatment.This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com .

A new study conducted by the World Health Organization (WHO) suggests that in addition to providing significant improvements in public health, investment in the diagnosis and prevention of tuberculosis also generates economic benefits.

According to a survey conducted by governments and researchers from Brazil, Georgia, Kenya, and South Africa, even modest increases in funding for measures against tuberculosis can bring gains. Every $1 invested produces returns of as much as $39, it found.

The findings may remind governments and policymakers about the importance of investing in public health policies. According to the WHO, the study “provides strong economic arguments” about the true costs of tuberculosis and proves the benefits of increasing funding to accelerate the diagnosis and preventive treatment of the disease.
 

UN Targets Tuberculosis

In September 2023, during the last meeting of the United Nations General Assembly, following a widespread worsening of disease indicators because of the COVID-19 pandemic, world leaders signed a declaration committing to the expansion of efforts to combat tuberculosis during the next 5 years. The current WHO study was developed to provide a road map for the implementation of key measures against the disease.

The survey highlights two fundamental actions: The expansion of screening, especially in populations considered more vulnerable, and the provision of tuberculosis preventive treatment (TPT), which entails administering drugs to people who have been exposed to the disease but have not yet developed it.

“TPT is a proven and effective intervention to prevent the development of tuberculosis among exposed people, reducing the risk of developing the disease by about 60%-90% compared with individuals who did not receive it,” the document emphasized.

Investments Yield Returns

To achieve the necessary coverage levels, the study estimated that Brazil would need to increase annual per capita investment by $0.28 (about R$1.41) between 2024 and 2050. Brazilian society, in turn, would receive a return of $11 (R$55.27) for every dollar invested.

For South Africa, whose per capita investment increase is estimated at $1.10 per year, the return would be even more significant: $39 for every dollar allocated.

The WHO emphasized that funding for combating the disease is much lower than the value of the damage it causes to nations. “Tuberculosis has high costs for society. Only a small proportion of these costs go directly to the health system (ranging from 1.7% in South Africa to 7.8% in Kenya). Most are costs for patients and society.”

The study projected that between 2024 and 2050, the total cost of tuberculosis to Brazilian society would be $81.2 billion, with an average annual value of $3.01 billion. This figure represents, in 2024, 0.16% of the country’s gross domestic product.

Achieving screening and preventive treatment goals in Brazil would lead to a reduction of as much as 18% in the national incidence of the disease, as well as 1.9 million fewer deaths, between 2024 and 2050.

Although treatable and preventable, tuberculosis remains the leading cause of death from infectious agents worldwide. It is estimated that over 1.3 million people died from the disease in 2022.

The document provides the “health and economic justification for investing in evidence-based interventions recommended by WHO in tuberculosis screening and prevention,” according to WHO Director-General Tedros Adhanom Ghebreyesus, PhD.

“Today we have the knowledge, tools, and political commitment that can end this age-old disease that continues to be one of the leading causes of death from infectious diseases worldwide,” he added.

 

 

Emerging Concerns

Although the WHO highlighted the global increase in access to tuberculosis diagnosis and treatment in 2022, which coincided with the recovery of healthcare systems in several countries after the beginning of the pandemic, it emphasized that the implementation of preventive treatment for exposed individuals and high-vulnerability populations remains slow.

Another concern is the increase in drug resistance. Multidrug-resistant tuberculosis is considered a public health crisis. It is estimated that about 410,000 people had multidrug-resistant tuberculosis or rifampicin-resistant tuberculosis in 2022, but only two of every five patients had access to treatment.This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com .

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Study Shows Nirmatrelvir–Ritonavir No More Effective Than Placebo for COVID-19 Symptom Relief

Article Type
Changed
Thu, 04/11/2024 - 15:58

Paxlovid does not significantly alleviate symptoms of COVID-19 compared with placebo among nonhospitalized adults, a new study published April 3 in The New England Journal of Medicine found. 

The results suggest that the drug, a combination of nirmatrelvir and ritonavir, may not be particularly helpful for patients who are not at high risk for severe COVID-19. However, although the rate of hospitalization and death from any cause was low overall, the group that received Paxlovid had a reduced rate compared with people in the placebo group, according to the researchers. 

“Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19,” Rajesh T. Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital in Boston, wrote in an editorial accompanying the journal article. “This result supports guidelines that recommend nirmatrelvir–ritonavir only for persons who are at high risk for disease progression.”

The time from onset to relief of COVID-19 symptoms — including cough, shortness of breath, body aches, and chills — did not differ significantly between the two study groups, the researchers reported. The median time to sustained alleviation of symptoms was 12 days for the Paxlovid group compared with 13 days in the placebo group (P = .60).

However, the phase 2/3 trial found a 57.6% relative reduction in the risk for hospitalizations or death among people who took Paxlovid and were vaccinated but were at high risk for poor outcomes, according to Jennifer Hammond, PhD, head of antiviral development for Pfizer, which makes the drug, and the corresponding author on the study.

Paxlovid has “an increasing body of evidence supporting the strong clinical value of the treatment in preventing hospitalization and death among eligible patients across age groups, vaccination status, and predominant variants,” Dr. Hammond said. 

She and her colleagues analyzed data from 1250 adults with symptomatic COVID-19. Participants were fully vaccinated and had a high risk for progression to severe disease or were never vaccinated or had not been in the previous year and had no risk factors for progression to severe disease.

More than half of participants were women, 78.5% were White and 41.4% identified as Hispanic or Latinx. Almost three quarters underwent randomization within 3 days of the start of symptoms, and a little over half had previously received a COVID-19 vaccination. Almost half had one risk factor for severe illness, the most common of these being hypertension (12.3%). 

In a subgroup analysis of high-risk participants, hospitalization or death occurred in 0.9% of patients in the Paxlovid group and 2.2% in the placebo group (95% CI, -3.3 to 0.7). 

The study’s limitations include that the statistical analysis of COVID-19–related hospitalizations or death from any cause was only descriptive, “because the results for the primary efficacy end point were not significant,” the authors wrote. 

Participants who were vaccinated and at high risk were also enrolled regardless of when they had last had a vaccine dose. Furthermore, Paxlovid has a telltale taste, which may have affected the blinding. Finally, the trial was started when the B.1.617.2 (Delta) variant was predominant.

Dr. Gandhi and Dr. Hirsch pointed out that only 5% of participants in the trial were older than 65 years and that other than risk factors such as obesity and smoking, just 2% of people had heart or lung disease. 

“As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit,” Dr. Gandhi and Dr. Hirsch wrote in the editorial. “Thus, it appears reasonable to recommend nirmatrelvir–ritonavir primarily for the treatment of COVID-19 in older patients (particularly those ≥ 65 years of age), those who are immunocompromised, and those who have conditions that substantially increase the risk of severe COVID-19, regardless of previous vaccination or infection status.”

The study was supported by Pfizer. 

A version of this article appeared on Medscape.com .

Publications
Topics
Sections

Paxlovid does not significantly alleviate symptoms of COVID-19 compared with placebo among nonhospitalized adults, a new study published April 3 in The New England Journal of Medicine found. 

The results suggest that the drug, a combination of nirmatrelvir and ritonavir, may not be particularly helpful for patients who are not at high risk for severe COVID-19. However, although the rate of hospitalization and death from any cause was low overall, the group that received Paxlovid had a reduced rate compared with people in the placebo group, according to the researchers. 

“Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19,” Rajesh T. Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital in Boston, wrote in an editorial accompanying the journal article. “This result supports guidelines that recommend nirmatrelvir–ritonavir only for persons who are at high risk for disease progression.”

The time from onset to relief of COVID-19 symptoms — including cough, shortness of breath, body aches, and chills — did not differ significantly between the two study groups, the researchers reported. The median time to sustained alleviation of symptoms was 12 days for the Paxlovid group compared with 13 days in the placebo group (P = .60).

However, the phase 2/3 trial found a 57.6% relative reduction in the risk for hospitalizations or death among people who took Paxlovid and were vaccinated but were at high risk for poor outcomes, according to Jennifer Hammond, PhD, head of antiviral development for Pfizer, which makes the drug, and the corresponding author on the study.

Paxlovid has “an increasing body of evidence supporting the strong clinical value of the treatment in preventing hospitalization and death among eligible patients across age groups, vaccination status, and predominant variants,” Dr. Hammond said. 

She and her colleagues analyzed data from 1250 adults with symptomatic COVID-19. Participants were fully vaccinated and had a high risk for progression to severe disease or were never vaccinated or had not been in the previous year and had no risk factors for progression to severe disease.

More than half of participants were women, 78.5% were White and 41.4% identified as Hispanic or Latinx. Almost three quarters underwent randomization within 3 days of the start of symptoms, and a little over half had previously received a COVID-19 vaccination. Almost half had one risk factor for severe illness, the most common of these being hypertension (12.3%). 

In a subgroup analysis of high-risk participants, hospitalization or death occurred in 0.9% of patients in the Paxlovid group and 2.2% in the placebo group (95% CI, -3.3 to 0.7). 

The study’s limitations include that the statistical analysis of COVID-19–related hospitalizations or death from any cause was only descriptive, “because the results for the primary efficacy end point were not significant,” the authors wrote. 

Participants who were vaccinated and at high risk were also enrolled regardless of when they had last had a vaccine dose. Furthermore, Paxlovid has a telltale taste, which may have affected the blinding. Finally, the trial was started when the B.1.617.2 (Delta) variant was predominant.

Dr. Gandhi and Dr. Hirsch pointed out that only 5% of participants in the trial were older than 65 years and that other than risk factors such as obesity and smoking, just 2% of people had heart or lung disease. 

“As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit,” Dr. Gandhi and Dr. Hirsch wrote in the editorial. “Thus, it appears reasonable to recommend nirmatrelvir–ritonavir primarily for the treatment of COVID-19 in older patients (particularly those ≥ 65 years of age), those who are immunocompromised, and those who have conditions that substantially increase the risk of severe COVID-19, regardless of previous vaccination or infection status.”

The study was supported by Pfizer. 

A version of this article appeared on Medscape.com .

Paxlovid does not significantly alleviate symptoms of COVID-19 compared with placebo among nonhospitalized adults, a new study published April 3 in The New England Journal of Medicine found. 

The results suggest that the drug, a combination of nirmatrelvir and ritonavir, may not be particularly helpful for patients who are not at high risk for severe COVID-19. However, although the rate of hospitalization and death from any cause was low overall, the group that received Paxlovid had a reduced rate compared with people in the placebo group, according to the researchers. 

“Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19,” Rajesh T. Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital in Boston, wrote in an editorial accompanying the journal article. “This result supports guidelines that recommend nirmatrelvir–ritonavir only for persons who are at high risk for disease progression.”

The time from onset to relief of COVID-19 symptoms — including cough, shortness of breath, body aches, and chills — did not differ significantly between the two study groups, the researchers reported. The median time to sustained alleviation of symptoms was 12 days for the Paxlovid group compared with 13 days in the placebo group (P = .60).

However, the phase 2/3 trial found a 57.6% relative reduction in the risk for hospitalizations or death among people who took Paxlovid and were vaccinated but were at high risk for poor outcomes, according to Jennifer Hammond, PhD, head of antiviral development for Pfizer, which makes the drug, and the corresponding author on the study.

Paxlovid has “an increasing body of evidence supporting the strong clinical value of the treatment in preventing hospitalization and death among eligible patients across age groups, vaccination status, and predominant variants,” Dr. Hammond said. 

She and her colleagues analyzed data from 1250 adults with symptomatic COVID-19. Participants were fully vaccinated and had a high risk for progression to severe disease or were never vaccinated or had not been in the previous year and had no risk factors for progression to severe disease.

More than half of participants were women, 78.5% were White and 41.4% identified as Hispanic or Latinx. Almost three quarters underwent randomization within 3 days of the start of symptoms, and a little over half had previously received a COVID-19 vaccination. Almost half had one risk factor for severe illness, the most common of these being hypertension (12.3%). 

In a subgroup analysis of high-risk participants, hospitalization or death occurred in 0.9% of patients in the Paxlovid group and 2.2% in the placebo group (95% CI, -3.3 to 0.7). 

The study’s limitations include that the statistical analysis of COVID-19–related hospitalizations or death from any cause was only descriptive, “because the results for the primary efficacy end point were not significant,” the authors wrote. 

Participants who were vaccinated and at high risk were also enrolled regardless of when they had last had a vaccine dose. Furthermore, Paxlovid has a telltale taste, which may have affected the blinding. Finally, the trial was started when the B.1.617.2 (Delta) variant was predominant.

Dr. Gandhi and Dr. Hirsch pointed out that only 5% of participants in the trial were older than 65 years and that other than risk factors such as obesity and smoking, just 2% of people had heart or lung disease. 

“As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit,” Dr. Gandhi and Dr. Hirsch wrote in the editorial. “Thus, it appears reasonable to recommend nirmatrelvir–ritonavir primarily for the treatment of COVID-19 in older patients (particularly those ≥ 65 years of age), those who are immunocompromised, and those who have conditions that substantially increase the risk of severe COVID-19, regardless of previous vaccination or infection status.”

The study was supported by Pfizer. 

A version of this article appeared on Medscape.com .

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Isoniazid Resistance Linked With Tuberculosis Deaths

Article Type
Changed
Fri, 04/05/2024 - 11:07

In 2022, more than 78,000 new cases of tuberculosis (TB) were reported in Brazil, with an incidence of 36.3 cases per 100,000 inhabitants. According to researchers from the Regional Prospective Observational Research for Tuberculosis (RePORT)-Brazil consortium, the country could improve the control of this infection if all patients were subjected to a sensitivity test capable of early detection of resistance not only to rifampicin, but also to isoniazid, before starting treatment. A study by the consortium published this year in Open Forum Infectious Diseases found that monoresistance to isoniazid predicted unfavorable outcomes at the national level.

Isoniazid is part of the first-choice therapeutic regimen for patients with pulmonary TB. The regimen also includes rifampicin, pyrazinamide, and ethambutol. According to Bruno Andrade, MD, PhD, Afrânio Kritski, MD, PhD, and biotechnologist Mariana Araújo Pereira, PhD, researchers from RePORT International and RePORT-Brazil, this regimen is used during the intensive phase of treatment, which usually lasts for 2 months. It is followed by a maintenance phase of another 4 months, during which isoniazid and rifampicin continue to be administered. When monoresistance to isoniazid is detected, however, the recommendation is to use a regimen containing a quinolone instead of isoniazid.

Suboptimal Sensitivity Testing 

Since 2015, Brazil’s Ministry of Health has recommended sensitivity testing for all suspected TB cases. In practice, however, this approach is not carried out in the ideal manner. The three researchers told the Medscape Portuguese edition that, according to data from the National Notifiable Diseases Information System (Sinan) of the Ministry of Health, culture testing is conducted in about 30% of cases. Sensitivity testing to identify resistance to first-line drugs (rifampicin, isoniazid, ethambutol, and pyrazinamide) and second-line drugs (quinolone and amikacin) is performed in only 12% of cases.

The initiative of the RePORT-Brazil group analyzed 21,197 TB cases registered in Sinan between June 2015 and June 2019 and identified a rate of monoresistance to isoniazid of 1.4%.

For the researchers, the problem of monoresistance to isoniazid in Brazil is still underestimated. This underestimation results from the infrequent performance of culture and sensitivity testing to detect resistance to first- and second-line drugs and because the XPERT MTB RIF test, which detects only rifampicin resistance, is still used.

Resistance and Worse Outcomes

The study also showed that the frequency of unfavorable outcomes in antituberculosis treatment (death or therapeutic failure) was significantly higher among patients with monoresistance to isoniazid (9.1% vs 3.05%).

The finding serves as a warning about the importance of increasing the administration of sensitivity tests to detect resistance to drugs used in tuberculosis treatment, including isoniazid.

Testing sensitivity to rifampicin and isoniazid before starting treatment could transform tuberculosis control in Brazil, allowing for more targeted and effective treatments from the outset, said the researchers. “This not only increases the chances of successful individual treatment but also helps prevent the transmission of resistant strains and develop a more accurate understanding of drug resistance trends,” they emphasized.

They pointed out, however, that implementing this testing in the Unified Health System depends on improvements in resource allocation, coordination between the national TB program and state and municipal programs, and improvements in infrastructure and the technical staff of the Central Public Health Laboratories.

“Although the initial cost is considerable, these investments can be offset by long-term savings resulting from the reduction in the use of more expensive and prolonged treatments for resistant tuberculosis,” said the researchers.

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

In 2022, more than 78,000 new cases of tuberculosis (TB) were reported in Brazil, with an incidence of 36.3 cases per 100,000 inhabitants. According to researchers from the Regional Prospective Observational Research for Tuberculosis (RePORT)-Brazil consortium, the country could improve the control of this infection if all patients were subjected to a sensitivity test capable of early detection of resistance not only to rifampicin, but also to isoniazid, before starting treatment. A study by the consortium published this year in Open Forum Infectious Diseases found that monoresistance to isoniazid predicted unfavorable outcomes at the national level.

Isoniazid is part of the first-choice therapeutic regimen for patients with pulmonary TB. The regimen also includes rifampicin, pyrazinamide, and ethambutol. According to Bruno Andrade, MD, PhD, Afrânio Kritski, MD, PhD, and biotechnologist Mariana Araújo Pereira, PhD, researchers from RePORT International and RePORT-Brazil, this regimen is used during the intensive phase of treatment, which usually lasts for 2 months. It is followed by a maintenance phase of another 4 months, during which isoniazid and rifampicin continue to be administered. When monoresistance to isoniazid is detected, however, the recommendation is to use a regimen containing a quinolone instead of isoniazid.

Suboptimal Sensitivity Testing 

Since 2015, Brazil’s Ministry of Health has recommended sensitivity testing for all suspected TB cases. In practice, however, this approach is not carried out in the ideal manner. The three researchers told the Medscape Portuguese edition that, according to data from the National Notifiable Diseases Information System (Sinan) of the Ministry of Health, culture testing is conducted in about 30% of cases. Sensitivity testing to identify resistance to first-line drugs (rifampicin, isoniazid, ethambutol, and pyrazinamide) and second-line drugs (quinolone and amikacin) is performed in only 12% of cases.

The initiative of the RePORT-Brazil group analyzed 21,197 TB cases registered in Sinan between June 2015 and June 2019 and identified a rate of monoresistance to isoniazid of 1.4%.

For the researchers, the problem of monoresistance to isoniazid in Brazil is still underestimated. This underestimation results from the infrequent performance of culture and sensitivity testing to detect resistance to first- and second-line drugs and because the XPERT MTB RIF test, which detects only rifampicin resistance, is still used.

Resistance and Worse Outcomes

The study also showed that the frequency of unfavorable outcomes in antituberculosis treatment (death or therapeutic failure) was significantly higher among patients with monoresistance to isoniazid (9.1% vs 3.05%).

The finding serves as a warning about the importance of increasing the administration of sensitivity tests to detect resistance to drugs used in tuberculosis treatment, including isoniazid.

Testing sensitivity to rifampicin and isoniazid before starting treatment could transform tuberculosis control in Brazil, allowing for more targeted and effective treatments from the outset, said the researchers. “This not only increases the chances of successful individual treatment but also helps prevent the transmission of resistant strains and develop a more accurate understanding of drug resistance trends,” they emphasized.

They pointed out, however, that implementing this testing in the Unified Health System depends on improvements in resource allocation, coordination between the national TB program and state and municipal programs, and improvements in infrastructure and the technical staff of the Central Public Health Laboratories.

“Although the initial cost is considerable, these investments can be offset by long-term savings resulting from the reduction in the use of more expensive and prolonged treatments for resistant tuberculosis,” said the researchers.

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

In 2022, more than 78,000 new cases of tuberculosis (TB) were reported in Brazil, with an incidence of 36.3 cases per 100,000 inhabitants. According to researchers from the Regional Prospective Observational Research for Tuberculosis (RePORT)-Brazil consortium, the country could improve the control of this infection if all patients were subjected to a sensitivity test capable of early detection of resistance not only to rifampicin, but also to isoniazid, before starting treatment. A study by the consortium published this year in Open Forum Infectious Diseases found that monoresistance to isoniazid predicted unfavorable outcomes at the national level.

Isoniazid is part of the first-choice therapeutic regimen for patients with pulmonary TB. The regimen also includes rifampicin, pyrazinamide, and ethambutol. According to Bruno Andrade, MD, PhD, Afrânio Kritski, MD, PhD, and biotechnologist Mariana Araújo Pereira, PhD, researchers from RePORT International and RePORT-Brazil, this regimen is used during the intensive phase of treatment, which usually lasts for 2 months. It is followed by a maintenance phase of another 4 months, during which isoniazid and rifampicin continue to be administered. When monoresistance to isoniazid is detected, however, the recommendation is to use a regimen containing a quinolone instead of isoniazid.

Suboptimal Sensitivity Testing 

Since 2015, Brazil’s Ministry of Health has recommended sensitivity testing for all suspected TB cases. In practice, however, this approach is not carried out in the ideal manner. The three researchers told the Medscape Portuguese edition that, according to data from the National Notifiable Diseases Information System (Sinan) of the Ministry of Health, culture testing is conducted in about 30% of cases. Sensitivity testing to identify resistance to first-line drugs (rifampicin, isoniazid, ethambutol, and pyrazinamide) and second-line drugs (quinolone and amikacin) is performed in only 12% of cases.

The initiative of the RePORT-Brazil group analyzed 21,197 TB cases registered in Sinan between June 2015 and June 2019 and identified a rate of monoresistance to isoniazid of 1.4%.

For the researchers, the problem of monoresistance to isoniazid in Brazil is still underestimated. This underestimation results from the infrequent performance of culture and sensitivity testing to detect resistance to first- and second-line drugs and because the XPERT MTB RIF test, which detects only rifampicin resistance, is still used.

Resistance and Worse Outcomes

The study also showed that the frequency of unfavorable outcomes in antituberculosis treatment (death or therapeutic failure) was significantly higher among patients with monoresistance to isoniazid (9.1% vs 3.05%).

The finding serves as a warning about the importance of increasing the administration of sensitivity tests to detect resistance to drugs used in tuberculosis treatment, including isoniazid.

Testing sensitivity to rifampicin and isoniazid before starting treatment could transform tuberculosis control in Brazil, allowing for more targeted and effective treatments from the outset, said the researchers. “This not only increases the chances of successful individual treatment but also helps prevent the transmission of resistant strains and develop a more accurate understanding of drug resistance trends,” they emphasized.

They pointed out, however, that implementing this testing in the Unified Health System depends on improvements in resource allocation, coordination between the national TB program and state and municipal programs, and improvements in infrastructure and the technical staff of the Central Public Health Laboratories.

“Although the initial cost is considerable, these investments can be offset by long-term savings resulting from the reduction in the use of more expensive and prolonged treatments for resistant tuberculosis,” said the researchers.

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article