Heidi Splete

Higher concentrations of specific volatile organic compounds (VOCs) in daycare centers were significantly associated with an increased risk for wheezing in children who attended these centers, based on data from more than 500 children.

“There is an increasing concern about of the role of Indoor Air Quality (IAQ) in development of respiratory disorders like asthma, especially in children whose immune system is under development, and they are more vulnerable to the effects of poor air quality,” lead author Ioannis Sakellaris, PhD, of Université Paris-Saclay, Villejuif, France, said in an interview. However, the effects of specific pollutants on the health of young children in daycare settings has not been examined, he said. 

In a presentation at the European Respiratory Society Congress, Sakellaris reviewed data from the French CRESPI cohort study, an epidemiological study of the impact of exposures to disinfectants and cleaning products on workers and children in daycare centers in France.

The study population included 532 children (47.4% girls) with a mean age of 22.3 months (aged 3 months to 4 years) in 106 daycare centers. A total of 171 children reportedly experienced at least one episode of wheezing since birth. 

A total of 67 VOCs were measured during one day, and concentrations were studied in four categories based on quartiles. The researchers evaluated three child wheezing outcomes based on parental questionnaires: Ever wheeze since birth, recurrent wheeze (≥ 3 times since birth), and ever wheeze with inhaled corticosteroid use. The researchers adjusted for factors including child age and parental smoking status and education level.

Overall, ever wheezing was significantly associated with higher concentrations of 1,2,4-trimethylbenzene (odds ratio [OR] for Q4 vs Q1, 1.56; P = .08 for trend), 1-methoxy-2-propylacetate (OR, 1.62; P = .01), decamethylcyclopentasiloxane (OR, 2.12; P = .004), and methylisobutylcetone (OR, 1.85; P < .001).

The results emphasize the significant role of IAQ in respiratory health, said Sakellaris. “Further efforts to reduce pollutant concentrations and limit sources are needed,” he said. In addition, more studies on the combined effect of multiple VOCs are necessary for a deeper understanding of the complex relations between IAQ and children’s respiratory health, he said.
 

Pay Attention to Indoor Pollutants

“Since the COVID-19 pandemic, the use of cleaning products and disinfectants has exploded,” Alexander S. Rabin, MD, of the University of Michigan, Ann Arbor, Michigan, said in an interview. Although many of these cleaning agents contain chemicals, including VOCs, that are known respiratory irritants, little is known about the relationship between VOCs and children’s respiratory outcomes in daycare settings, said Rabin, who was not involved in the study.

“I was struck by the wide array of VOCs detected in daycare settings,” Rabin said. However, the relationship to childhood wheeze was not entirely surprising as the VOCs included the known irritants benzene and toluene, he added.

The results suggest that exposure to VOCs, not only in cleaning agents but also building materials and other consumer products in daycare settings, may be associated with an increased risk for wheeze in children, said Rabin. 

However, “it is important to know more about confounding variables, including concurrent rates of respiratory infection that are common among children,” said Rabin. “As the authors highlight, further work on the compound effects of multiple pollutants would be of interest. Lastly, it would be helpful to clearly identify the most common sources of VOCs that place children at greatest risk for wheeze, so that appropriate steps can be taken to mitigate risk,” he said.

The original CRESPI cohort study was supported by ANSES, ADEME, Fondation de France, and ARS Ile-de-France. Sakellaris and Rabin had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Higher concentrations of specific volatile organic compounds (VOCs) in daycare centers were significantly associated with an increased risk for wheezing in children who attended these centers, based on data from more than 500 children.

“There is an increasing concern about of the role of Indoor Air Quality (IAQ) in development of respiratory disorders like asthma, especially in children whose immune system is under development, and they are more vulnerable to the effects of poor air quality,” lead author Ioannis Sakellaris, PhD, of Université Paris-Saclay, Villejuif, France, said in an interview. However, the effects of specific pollutants on the health of young children in daycare settings has not been examined, he said. 

In a presentation at the European Respiratory Society Congress, Sakellaris reviewed data from the French CRESPI cohort study, an epidemiological study of the impact of exposures to disinfectants and cleaning products on workers and children in daycare centers in France.

The study population included 532 children (47.4% girls) with a mean age of 22.3 months (aged 3 months to 4 years) in 106 daycare centers. A total of 171 children reportedly experienced at least one episode of wheezing since birth. 

A total of 67 VOCs were measured during one day, and concentrations were studied in four categories based on quartiles. The researchers evaluated three child wheezing outcomes based on parental questionnaires: Ever wheeze since birth, recurrent wheeze (≥ 3 times since birth), and ever wheeze with inhaled corticosteroid use. The researchers adjusted for factors including child age and parental smoking status and education level.

Overall, ever wheezing was significantly associated with higher concentrations of 1,2,4-trimethylbenzene (odds ratio [OR] for Q4 vs Q1, 1.56; P = .08 for trend), 1-methoxy-2-propylacetate (OR, 1.62; P = .01), decamethylcyclopentasiloxane (OR, 2.12; P = .004), and methylisobutylcetone (OR, 1.85; P < .001).

The results emphasize the significant role of IAQ in respiratory health, said Sakellaris. “Further efforts to reduce pollutant concentrations and limit sources are needed,” he said. In addition, more studies on the combined effect of multiple VOCs are necessary for a deeper understanding of the complex relations between IAQ and children’s respiratory health, he said.
 

Pay Attention to Indoor Pollutants

“Since the COVID-19 pandemic, the use of cleaning products and disinfectants has exploded,” Alexander S. Rabin, MD, of the University of Michigan, Ann Arbor, Michigan, said in an interview. Although many of these cleaning agents contain chemicals, including VOCs, that are known respiratory irritants, little is known about the relationship between VOCs and children’s respiratory outcomes in daycare settings, said Rabin, who was not involved in the study.

“I was struck by the wide array of VOCs detected in daycare settings,” Rabin said. However, the relationship to childhood wheeze was not entirely surprising as the VOCs included the known irritants benzene and toluene, he added.

The results suggest that exposure to VOCs, not only in cleaning agents but also building materials and other consumer products in daycare settings, may be associated with an increased risk for wheeze in children, said Rabin. 

However, “it is important to know more about confounding variables, including concurrent rates of respiratory infection that are common among children,” said Rabin. “As the authors highlight, further work on the compound effects of multiple pollutants would be of interest. Lastly, it would be helpful to clearly identify the most common sources of VOCs that place children at greatest risk for wheeze, so that appropriate steps can be taken to mitigate risk,” he said.

The original CRESPI cohort study was supported by ANSES, ADEME, Fondation de France, and ARS Ile-de-France. Sakellaris and Rabin had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Higher concentrations of specific volatile organic compounds (VOCs) in daycare centers were significantly associated with an increased risk for wheezing in children who attended these centers, based on data from more than 500 children.

“There is an increasing concern about of the role of Indoor Air Quality (IAQ) in development of respiratory disorders like asthma, especially in children whose immune system is under development, and they are more vulnerable to the effects of poor air quality,” lead author Ioannis Sakellaris, PhD, of Université Paris-Saclay, Villejuif, France, said in an interview. However, the effects of specific pollutants on the health of young children in daycare settings has not been examined, he said. 

In a presentation at the European Respiratory Society Congress, Sakellaris reviewed data from the French CRESPI cohort study, an epidemiological study of the impact of exposures to disinfectants and cleaning products on workers and children in daycare centers in France.

The study population included 532 children (47.4% girls) with a mean age of 22.3 months (aged 3 months to 4 years) in 106 daycare centers. A total of 171 children reportedly experienced at least one episode of wheezing since birth. 

A total of 67 VOCs were measured during one day, and concentrations were studied in four categories based on quartiles. The researchers evaluated three child wheezing outcomes based on parental questionnaires: Ever wheeze since birth, recurrent wheeze (≥ 3 times since birth), and ever wheeze with inhaled corticosteroid use. The researchers adjusted for factors including child age and parental smoking status and education level.

Overall, ever wheezing was significantly associated with higher concentrations of 1,2,4-trimethylbenzene (odds ratio [OR] for Q4 vs Q1, 1.56; P = .08 for trend), 1-methoxy-2-propylacetate (OR, 1.62; P = .01), decamethylcyclopentasiloxane (OR, 2.12; P = .004), and methylisobutylcetone (OR, 1.85; P < .001).

The results emphasize the significant role of IAQ in respiratory health, said Sakellaris. “Further efforts to reduce pollutant concentrations and limit sources are needed,” he said. In addition, more studies on the combined effect of multiple VOCs are necessary for a deeper understanding of the complex relations between IAQ and children’s respiratory health, he said.
 

Pay Attention to Indoor Pollutants

“Since the COVID-19 pandemic, the use of cleaning products and disinfectants has exploded,” Alexander S. Rabin, MD, of the University of Michigan, Ann Arbor, Michigan, said in an interview. Although many of these cleaning agents contain chemicals, including VOCs, that are known respiratory irritants, little is known about the relationship between VOCs and children’s respiratory outcomes in daycare settings, said Rabin, who was not involved in the study.

“I was struck by the wide array of VOCs detected in daycare settings,” Rabin said. However, the relationship to childhood wheeze was not entirely surprising as the VOCs included the known irritants benzene and toluene, he added.

The results suggest that exposure to VOCs, not only in cleaning agents but also building materials and other consumer products in daycare settings, may be associated with an increased risk for wheeze in children, said Rabin. 

However, “it is important to know more about confounding variables, including concurrent rates of respiratory infection that are common among children,” said Rabin. “As the authors highlight, further work on the compound effects of multiple pollutants would be of interest. Lastly, it would be helpful to clearly identify the most common sources of VOCs that place children at greatest risk for wheeze, so that appropriate steps can be taken to mitigate risk,” he said.

The original CRESPI cohort study was supported by ANSES, ADEME, Fondation de France, and ARS Ile-de-France. Sakellaris and Rabin had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

New data from the Centers for Disease Control and Prevention (CDC) show significant spikes in pertussis cases compared with last year, especially in several urban areas including New York, Illinois, Florida, and Colorado. Cases are rising at the same time that rates of vaccination have been on the decline.

Notably, the current pertussis case count in Illinois as of September 21, 2024, was five times higher than the total cases in 2023 (1058 vs 50). New York City alone had reported 624 cases as of September 21, compared with 38 cases in 2023. 

Additional data from the CDC on vaccination coverage and exemptions of school-aged children showed an increase from 3.0% last year to 3.3% in 2024 of children who were exempted from recommended vaccination requirements. Although nearly 93% of kindergarteners in the United States received recommended vaccines (including Tdap), similar to last year, this number shows a steady decline from 94% in the 2021-2021 school year and 93% in the 2021-2022 school year, according to previous CDC reports.
 

What’s Happening in the Clinic

Clinical experience and the most recent CDC data point to under vaccination as a driver of the increased pertussis cases this year, David J. Cennimo, MD, associate professor of medicine and pediatrics in the division of infectious disease at Rutgers New Jersey Medical School, Newark, New Jersey, said in an interview.

Although the pertussis vaccination rates in infancy are still very good, clinicians are seeing a drop-off in school-aged children and adults, and the lingering anti-vaccine efforts from the COVID-19 pandemic period are undoubtedly playing a part, said Dr. Cennimo. “Unfortunately, pertussis is contagious, and the vaccine effectiveness wears off. Having decreased numbers of people protected results in more rapid spread,” he said. 

Dr. Cennimo agreed that the number of cases in the United States is underreported, and even higher than the data suggest. “I’m sure of it; the initial clinical presentation may be mistaken for a viral upper respiratory tract infection (common cold),” he told this news organization.

Many older children and adults with pertussis do not manifest the classic “whooping cough” seen in infants and young children, so making a clinical diagnosis can be difficult, he said. “One classical component of the illness is a prolonged cough. I have wondered if some people now reporting a lingering cough had pertussis that was missed,” Dr. Cennimo noted. 

“Clinicians should stress the value of boosters in a vaccine-preventable illness where we know immunity wanes overtime,” Dr. Cennimo said. “We have a great remedy in the Tdap vaccine, which we should all be getting very 10 years,” he said. 

He also emphasized that clinicians remind pregnant women of the current recommendations to receive the Tdap vaccine for every pregnancy. “Vaccination during pregnancy is the best way to protect both the pregnant person and the newborn. 

Even for the vaccine hesitant, this vaccine has a long track record of safety so should not be a significant concern,” he said.

The ultimate take-home message is not a new one, and applies to all illnesses, Dr. Cennimo told this news organization. Simply put, “Stay home if you are sick. Social distancing is not just for COVID-19,” he said.

Dr. Cennimo had no financial conflicts to disclose.
 

A version of this article first appeared on Medscape.com.

New data from the Centers for Disease Control and Prevention (CDC) show significant spikes in pertussis cases compared with last year, especially in several urban areas including New York, Illinois, Florida, and Colorado. Cases are rising at the same time that rates of vaccination have been on the decline.

Notably, the current pertussis case count in Illinois as of September 21, 2024, was five times higher than the total cases in 2023 (1058 vs 50). New York City alone had reported 624 cases as of September 21, compared with 38 cases in 2023. 

Additional data from the CDC on vaccination coverage and exemptions of school-aged children showed an increase from 3.0% last year to 3.3% in 2024 of children who were exempted from recommended vaccination requirements. Although nearly 93% of kindergarteners in the United States received recommended vaccines (including Tdap), similar to last year, this number shows a steady decline from 94% in the 2021-2021 school year and 93% in the 2021-2022 school year, according to previous CDC reports.
 

What’s Happening in the Clinic

Clinical experience and the most recent CDC data point to under vaccination as a driver of the increased pertussis cases this year, David J. Cennimo, MD, associate professor of medicine and pediatrics in the division of infectious disease at Rutgers New Jersey Medical School, Newark, New Jersey, said in an interview.

Although the pertussis vaccination rates in infancy are still very good, clinicians are seeing a drop-off in school-aged children and adults, and the lingering anti-vaccine efforts from the COVID-19 pandemic period are undoubtedly playing a part, said Dr. Cennimo. “Unfortunately, pertussis is contagious, and the vaccine effectiveness wears off. Having decreased numbers of people protected results in more rapid spread,” he said. 

Dr. Cennimo agreed that the number of cases in the United States is underreported, and even higher than the data suggest. “I’m sure of it; the initial clinical presentation may be mistaken for a viral upper respiratory tract infection (common cold),” he told this news organization.

Many older children and adults with pertussis do not manifest the classic “whooping cough” seen in infants and young children, so making a clinical diagnosis can be difficult, he said. “One classical component of the illness is a prolonged cough. I have wondered if some people now reporting a lingering cough had pertussis that was missed,” Dr. Cennimo noted. 

“Clinicians should stress the value of boosters in a vaccine-preventable illness where we know immunity wanes overtime,” Dr. Cennimo said. “We have a great remedy in the Tdap vaccine, which we should all be getting very 10 years,” he said. 

He also emphasized that clinicians remind pregnant women of the current recommendations to receive the Tdap vaccine for every pregnancy. “Vaccination during pregnancy is the best way to protect both the pregnant person and the newborn. 

Even for the vaccine hesitant, this vaccine has a long track record of safety so should not be a significant concern,” he said.

The ultimate take-home message is not a new one, and applies to all illnesses, Dr. Cennimo told this news organization. Simply put, “Stay home if you are sick. Social distancing is not just for COVID-19,” he said.

Dr. Cennimo had no financial conflicts to disclose.
 

A version of this article first appeared on Medscape.com.

New data from the Centers for Disease Control and Prevention (CDC) show significant spikes in pertussis cases compared with last year, especially in several urban areas including New York, Illinois, Florida, and Colorado. Cases are rising at the same time that rates of vaccination have been on the decline.

Notably, the current pertussis case count in Illinois as of September 21, 2024, was five times higher than the total cases in 2023 (1058 vs 50). New York City alone had reported 624 cases as of September 21, compared with 38 cases in 2023. 

Additional data from the CDC on vaccination coverage and exemptions of school-aged children showed an increase from 3.0% last year to 3.3% in 2024 of children who were exempted from recommended vaccination requirements. Although nearly 93% of kindergarteners in the United States received recommended vaccines (including Tdap), similar to last year, this number shows a steady decline from 94% in the 2021-2021 school year and 93% in the 2021-2022 school year, according to previous CDC reports.
 

What’s Happening in the Clinic

Clinical experience and the most recent CDC data point to under vaccination as a driver of the increased pertussis cases this year, David J. Cennimo, MD, associate professor of medicine and pediatrics in the division of infectious disease at Rutgers New Jersey Medical School, Newark, New Jersey, said in an interview.

Although the pertussis vaccination rates in infancy are still very good, clinicians are seeing a drop-off in school-aged children and adults, and the lingering anti-vaccine efforts from the COVID-19 pandemic period are undoubtedly playing a part, said Dr. Cennimo. “Unfortunately, pertussis is contagious, and the vaccine effectiveness wears off. Having decreased numbers of people protected results in more rapid spread,” he said. 

Dr. Cennimo agreed that the number of cases in the United States is underreported, and even higher than the data suggest. “I’m sure of it; the initial clinical presentation may be mistaken for a viral upper respiratory tract infection (common cold),” he told this news organization.

Many older children and adults with pertussis do not manifest the classic “whooping cough” seen in infants and young children, so making a clinical diagnosis can be difficult, he said. “One classical component of the illness is a prolonged cough. I have wondered if some people now reporting a lingering cough had pertussis that was missed,” Dr. Cennimo noted. 

“Clinicians should stress the value of boosters in a vaccine-preventable illness where we know immunity wanes overtime,” Dr. Cennimo said. “We have a great remedy in the Tdap vaccine, which we should all be getting very 10 years,” he said. 

He also emphasized that clinicians remind pregnant women of the current recommendations to receive the Tdap vaccine for every pregnancy. “Vaccination during pregnancy is the best way to protect both the pregnant person and the newborn. 

Even for the vaccine hesitant, this vaccine has a long track record of safety so should not be a significant concern,” he said.

The ultimate take-home message is not a new one, and applies to all illnesses, Dr. Cennimo told this news organization. Simply put, “Stay home if you are sick. Social distancing is not just for COVID-19,” he said.

Dr. Cennimo had no financial conflicts to disclose.
 

A version of this article first appeared on Medscape.com.

Use of a modified sleep apnea index can identify cardiovascular risk factors in adults with moderate to severe obstructive sleep apnea (OSA), according to results from a new study presented at the American Academy of Otolaryngology–Head and Neck Surgery 2024 Annual Meeting.

The modified sleep apnea severity index (mSASI) combines patient anatomy, weight, sleep study metrics, and symptoms, to provide a more nuanced measure of OSA than the standard apnea-hypopnea index (AHI), said Jennifer A. Goldfarb, MHS, a medical student at Thomas Jefferson University, Philadelphia, Pennsylvania, who presented the findings.

OSA has an association with many negative cardiovascular comorbidities; however, “the AHI provides only a single metric and does not provide a holistic assessment of the individual patient’s disease severity,” said senior author Colin T. Huntley, MD, also of Thomas Jefferson University. 

“OSA is very complex, and having a robust system to assess the disease may be a better predictor of overall severity,” he told this news organization. 

Previous research has shown a correlation between mSASI and mean arterial pressure and serum C-reactive protein in OSA patients, but the connection with cardiovascular risk factors has not been well studied, Ms. Goldfarb noted. 

In the retrospective cohort study, Ms. Goldfarb and colleagues looked at mSASI scores from 260 CPAP-intolerant patients with OSA who underwent upper airway stimulation, maxillomandibular advancement, or expansion sphincter pharyngoplasty at a single sleep surgery clinic between 2014 and 2021. The mSASI uses a score of 1-3, with 3 as the highest level of OSA severity.

Cardiovascular risk factors were assessed at the patient’s initial evaluation by the sleep surgery team. They included coronary artery disease, type 2 diabetes, atrial fibrillation, congestive heart failure, hypertension, and cerebrovascular accident. 

A total of 142 patients (55%) had an mSASI of 1; 91 (35%) had an mSASI of 2; and 27 (10%) had an mSASI of 3. At least one cardiovascular risk factor was present in 58%, 68%, and 63% of these groups, respectively (P = .3). 

Stratifying participants by mSASI scores, the researchers found that patients with an mSASI of 2 or 3 were significantly more likely than those with an mSASI of 1 to have more cardiovascular risk factors on initial presentation, and were significantly more likely to be diagnosed with hypertension (P = .02 for both). 

Using the AHI, however, patients with moderate to severe OSA (AHI > 15) had a similar number of cardiovascular risk factors as those with mild OSA (P > .05). 

“A higher mSASI score, which represents worse disease, was associated with a higher Framingham risk score, which supported our hypothesis; however, the AHI was not found to be associated with an increased Framingham score,” Dr. Huntley told this news organization.
 

Takeaways and Next Steps

These results suggest that the AHI, while a good metric, might not be the best tool for assessment of overall disease severity, given the complexity of OSA, the impact of the disease on patient quality of life, and the risk for downstream cardiovascular disease, said Dr. Huntley. 

The findings were limited by the retrospective design and use of data from a single center. 

Population-level data are needed to identify variables that may be meaningful to create a future tool that provides the best picture of the individual patient’s disease, he added. Additional prospective data are also needed to assess the impact of the scoring system on long-term treatment outcomes. 

“The current study is especially interesting as we are just beginning to understand the factors that predict cardiovascular risk for patients with obstructive sleep apnea,” Megan Durr, MD, of the University of California, San Francisco, said in an interview.

“For a long time, we primarily looked at the AHI and/or oxygen levels during sleep as risk factors, and we haven’t looked as much at other factors.” said Dr. Durr, who served as a moderator for the session in which the study was presented.

The current findings provide a more comprehensive look at cardiovascular risk; the inclusion of patient anatomy and symptoms add to the knowledge of this topic, and will lead to further work in this area, she added. 

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Huntley disclosed receiving research support from Nyxoah and Inspire, and serving as a consultant for Nyxoah, Inspire, and Avivomed. 

Dr. Durr had no financial conflicts to disclose. 
 

A version of this article appeared on Medscape.com.

Use of a modified sleep apnea index can identify cardiovascular risk factors in adults with moderate to severe obstructive sleep apnea (OSA), according to results from a new study presented at the American Academy of Otolaryngology–Head and Neck Surgery 2024 Annual Meeting.

The modified sleep apnea severity index (mSASI) combines patient anatomy, weight, sleep study metrics, and symptoms, to provide a more nuanced measure of OSA than the standard apnea-hypopnea index (AHI), said Jennifer A. Goldfarb, MHS, a medical student at Thomas Jefferson University, Philadelphia, Pennsylvania, who presented the findings.

OSA has an association with many negative cardiovascular comorbidities; however, “the AHI provides only a single metric and does not provide a holistic assessment of the individual patient’s disease severity,” said senior author Colin T. Huntley, MD, also of Thomas Jefferson University. 

“OSA is very complex, and having a robust system to assess the disease may be a better predictor of overall severity,” he told this news organization. 

Previous research has shown a correlation between mSASI and mean arterial pressure and serum C-reactive protein in OSA patients, but the connection with cardiovascular risk factors has not been well studied, Ms. Goldfarb noted. 

In the retrospective cohort study, Ms. Goldfarb and colleagues looked at mSASI scores from 260 CPAP-intolerant patients with OSA who underwent upper airway stimulation, maxillomandibular advancement, or expansion sphincter pharyngoplasty at a single sleep surgery clinic between 2014 and 2021. The mSASI uses a score of 1-3, with 3 as the highest level of OSA severity.

Cardiovascular risk factors were assessed at the patient’s initial evaluation by the sleep surgery team. They included coronary artery disease, type 2 diabetes, atrial fibrillation, congestive heart failure, hypertension, and cerebrovascular accident. 

A total of 142 patients (55%) had an mSASI of 1; 91 (35%) had an mSASI of 2; and 27 (10%) had an mSASI of 3. At least one cardiovascular risk factor was present in 58%, 68%, and 63% of these groups, respectively (P = .3). 

Stratifying participants by mSASI scores, the researchers found that patients with an mSASI of 2 or 3 were significantly more likely than those with an mSASI of 1 to have more cardiovascular risk factors on initial presentation, and were significantly more likely to be diagnosed with hypertension (P = .02 for both). 

Using the AHI, however, patients with moderate to severe OSA (AHI > 15) had a similar number of cardiovascular risk factors as those with mild OSA (P > .05). 

“A higher mSASI score, which represents worse disease, was associated with a higher Framingham risk score, which supported our hypothesis; however, the AHI was not found to be associated with an increased Framingham score,” Dr. Huntley told this news organization.
 

Takeaways and Next Steps

These results suggest that the AHI, while a good metric, might not be the best tool for assessment of overall disease severity, given the complexity of OSA, the impact of the disease on patient quality of life, and the risk for downstream cardiovascular disease, said Dr. Huntley. 

The findings were limited by the retrospective design and use of data from a single center. 

Population-level data are needed to identify variables that may be meaningful to create a future tool that provides the best picture of the individual patient’s disease, he added. Additional prospective data are also needed to assess the impact of the scoring system on long-term treatment outcomes. 

“The current study is especially interesting as we are just beginning to understand the factors that predict cardiovascular risk for patients with obstructive sleep apnea,” Megan Durr, MD, of the University of California, San Francisco, said in an interview.

“For a long time, we primarily looked at the AHI and/or oxygen levels during sleep as risk factors, and we haven’t looked as much at other factors.” said Dr. Durr, who served as a moderator for the session in which the study was presented.

The current findings provide a more comprehensive look at cardiovascular risk; the inclusion of patient anatomy and symptoms add to the knowledge of this topic, and will lead to further work in this area, she added. 

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Huntley disclosed receiving research support from Nyxoah and Inspire, and serving as a consultant for Nyxoah, Inspire, and Avivomed. 

Dr. Durr had no financial conflicts to disclose. 
 

A version of this article appeared on Medscape.com.

Use of a modified sleep apnea index can identify cardiovascular risk factors in adults with moderate to severe obstructive sleep apnea (OSA), according to results from a new study presented at the American Academy of Otolaryngology–Head and Neck Surgery 2024 Annual Meeting.

The modified sleep apnea severity index (mSASI) combines patient anatomy, weight, sleep study metrics, and symptoms, to provide a more nuanced measure of OSA than the standard apnea-hypopnea index (AHI), said Jennifer A. Goldfarb, MHS, a medical student at Thomas Jefferson University, Philadelphia, Pennsylvania, who presented the findings.

OSA has an association with many negative cardiovascular comorbidities; however, “the AHI provides only a single metric and does not provide a holistic assessment of the individual patient’s disease severity,” said senior author Colin T. Huntley, MD, also of Thomas Jefferson University. 

“OSA is very complex, and having a robust system to assess the disease may be a better predictor of overall severity,” he told this news organization. 

Previous research has shown a correlation between mSASI and mean arterial pressure and serum C-reactive protein in OSA patients, but the connection with cardiovascular risk factors has not been well studied, Ms. Goldfarb noted. 

In the retrospective cohort study, Ms. Goldfarb and colleagues looked at mSASI scores from 260 CPAP-intolerant patients with OSA who underwent upper airway stimulation, maxillomandibular advancement, or expansion sphincter pharyngoplasty at a single sleep surgery clinic between 2014 and 2021. The mSASI uses a score of 1-3, with 3 as the highest level of OSA severity.

Cardiovascular risk factors were assessed at the patient’s initial evaluation by the sleep surgery team. They included coronary artery disease, type 2 diabetes, atrial fibrillation, congestive heart failure, hypertension, and cerebrovascular accident. 

A total of 142 patients (55%) had an mSASI of 1; 91 (35%) had an mSASI of 2; and 27 (10%) had an mSASI of 3. At least one cardiovascular risk factor was present in 58%, 68%, and 63% of these groups, respectively (P = .3). 

Stratifying participants by mSASI scores, the researchers found that patients with an mSASI of 2 or 3 were significantly more likely than those with an mSASI of 1 to have more cardiovascular risk factors on initial presentation, and were significantly more likely to be diagnosed with hypertension (P = .02 for both). 

Using the AHI, however, patients with moderate to severe OSA (AHI > 15) had a similar number of cardiovascular risk factors as those with mild OSA (P > .05). 

“A higher mSASI score, which represents worse disease, was associated with a higher Framingham risk score, which supported our hypothesis; however, the AHI was not found to be associated with an increased Framingham score,” Dr. Huntley told this news organization.
 

Takeaways and Next Steps

These results suggest that the AHI, while a good metric, might not be the best tool for assessment of overall disease severity, given the complexity of OSA, the impact of the disease on patient quality of life, and the risk for downstream cardiovascular disease, said Dr. Huntley. 

The findings were limited by the retrospective design and use of data from a single center. 

Population-level data are needed to identify variables that may be meaningful to create a future tool that provides the best picture of the individual patient’s disease, he added. Additional prospective data are also needed to assess the impact of the scoring system on long-term treatment outcomes. 

“The current study is especially interesting as we are just beginning to understand the factors that predict cardiovascular risk for patients with obstructive sleep apnea,” Megan Durr, MD, of the University of California, San Francisco, said in an interview.

“For a long time, we primarily looked at the AHI and/or oxygen levels during sleep as risk factors, and we haven’t looked as much at other factors.” said Dr. Durr, who served as a moderator for the session in which the study was presented.

The current findings provide a more comprehensive look at cardiovascular risk; the inclusion of patient anatomy and symptoms add to the knowledge of this topic, and will lead to further work in this area, she added. 

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Huntley disclosed receiving research support from Nyxoah and Inspire, and serving as a consultant for Nyxoah, Inspire, and Avivomed. 

Dr. Durr had no financial conflicts to disclose. 
 

A version of this article appeared on Medscape.com.

Pertussis cases in the United States have increased fourfold compared with the same time period last year, according to data from the Centers for Disease Control and Prevention (CDC). Reports from several states illustrate this trend, thought to be due to reduced immunity across the country.

The Alaska Department of Health issued a statement on its website about the significant increase in pertussis cases in the state during the summer, with 90 cases in July and 61 in August, compared with 24 in June and a total of 26 cases in 2023.

Similarly, the Florida Department of Health reported a pertussis increase in July 2024 that was higher than the June 2024 case count and also above the previous 5-year average.

Experts in these and other states suggest that several factors are driving the nationwide increase, including the fact that fewer people are consistently wearing masks. The mass masking during the COVID-19 pandemic caused a significant drop in pertussis, but the latest data suggest a return to prepandemic levels, and waning immunity likely plays a role as well.

Pertussis, also known as whooping cough, typically begins with symptoms similar to those of the common cold, including runny nose, sneezing, mild fever, and cough, according to the CDC. However, babies with whooping cough may experience trouble breathing rather than a cough. The coughing fits often associated with pertussis may not start until 2 weeks after the onset of other symptoms, according to the CDC.

Those who have been vaccinated against pertussis can still become infected, but the risk is lower, and the illness, if it occurs, is likely to be milder. Complications such as apnea, pneumonia, and convulsions can occur in babies younger than 1 year, especially if they have not been vaccinated, according to the CDC.
 

Beyond Easing Pandemic Precautions

Many respiratory-based infections dipped during the COVID-19 pandemic, almost certainly from the multifactorial interventions of masking, distancing, and the general lack of comingling, said David J. Cennimo, MD, associate professor of medicine & pediatrics in the Division of Infectious Diseases at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

The number of cases of many of these diseases returned to previous levels after COVID-19 restrictions were lifted, he said.

“However, we know pertussis immunity wanes over time. Children get DTaP at 2, 4, 6, and 15 months, and a Tdap booster at 11-12 years old gets them to adulthood,” Dr. Cennimo said. Adults should be getting a Tdap every 10 years, he added.

The latest available CDC data indicate that Tdap vaccine coverage in adults is approximately 40%, which means that there may be a large number of susceptible people who can become infected and propagate to others, said Dr. Cennimo.
 

Not Just the Young Ones

A recent pertussis outbreak among college students in Virginia highlighted the fact that the infection can affect all ages, and that the effectiveness of childhood vaccines may decrease over time. The majority of the recently diagnosed cases occurred in individuals who had been previously vaccinated, according to a press release from the Virginia Department of Health.

Clinical Clues

The initial stage of pertussis infection looks like a common cold with symptoms of upper respiratory infection, Dr. Cennimo told this news organization. “Unless there is reason to suspect pertussis exposure, it would almost certainly be missed,” he noted.

The characteristic barking/seal-like cough is mostly seen in children, said Dr. Cennimo. Adults and children can experience coughing fits that can lead to shortness of breath and/or vomiting, which would raise suspicion for pertussis, but is not universally present, he said. The convalescent stage of pertussis can be prolonged and is characterized by chronic coughing. “In the past, pertussis had been called the 100-day cough,” and at that point, treatment is ineffective, Dr. Cennimo said.

In clinical practice, “I advise everyone to get the Tdap vaccine every 10 years,” and remember that the “Td” is the every 10-year tetanus shot as well, Dr. Cennimo told this news organization. Reassure patients that the Tdap can be given with other vaccines, he said, and remind patients that, as with any of the respiratory illnesses, they should stay home if sick, cover a cough, consider wearing a mask in public, and wash hands frequently, he said. 

Dr. Cennimo had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Pertussis cases in the United States have increased fourfold compared with the same time period last year, according to data from the Centers for Disease Control and Prevention (CDC). Reports from several states illustrate this trend, thought to be due to reduced immunity across the country.

The Alaska Department of Health issued a statement on its website about the significant increase in pertussis cases in the state during the summer, with 90 cases in July and 61 in August, compared with 24 in June and a total of 26 cases in 2023.

Similarly, the Florida Department of Health reported a pertussis increase in July 2024 that was higher than the June 2024 case count and also above the previous 5-year average.

Experts in these and other states suggest that several factors are driving the nationwide increase, including the fact that fewer people are consistently wearing masks. The mass masking during the COVID-19 pandemic caused a significant drop in pertussis, but the latest data suggest a return to prepandemic levels, and waning immunity likely plays a role as well.

Pertussis, also known as whooping cough, typically begins with symptoms similar to those of the common cold, including runny nose, sneezing, mild fever, and cough, according to the CDC. However, babies with whooping cough may experience trouble breathing rather than a cough. The coughing fits often associated with pertussis may not start until 2 weeks after the onset of other symptoms, according to the CDC.

Those who have been vaccinated against pertussis can still become infected, but the risk is lower, and the illness, if it occurs, is likely to be milder. Complications such as apnea, pneumonia, and convulsions can occur in babies younger than 1 year, especially if they have not been vaccinated, according to the CDC.
 

Beyond Easing Pandemic Precautions

Many respiratory-based infections dipped during the COVID-19 pandemic, almost certainly from the multifactorial interventions of masking, distancing, and the general lack of comingling, said David J. Cennimo, MD, associate professor of medicine & pediatrics in the Division of Infectious Diseases at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

The number of cases of many of these diseases returned to previous levels after COVID-19 restrictions were lifted, he said.

“However, we know pertussis immunity wanes over time. Children get DTaP at 2, 4, 6, and 15 months, and a Tdap booster at 11-12 years old gets them to adulthood,” Dr. Cennimo said. Adults should be getting a Tdap every 10 years, he added.

The latest available CDC data indicate that Tdap vaccine coverage in adults is approximately 40%, which means that there may be a large number of susceptible people who can become infected and propagate to others, said Dr. Cennimo.
 

Not Just the Young Ones

A recent pertussis outbreak among college students in Virginia highlighted the fact that the infection can affect all ages, and that the effectiveness of childhood vaccines may decrease over time. The majority of the recently diagnosed cases occurred in individuals who had been previously vaccinated, according to a press release from the Virginia Department of Health.

Clinical Clues

The initial stage of pertussis infection looks like a common cold with symptoms of upper respiratory infection, Dr. Cennimo told this news organization. “Unless there is reason to suspect pertussis exposure, it would almost certainly be missed,” he noted.

The characteristic barking/seal-like cough is mostly seen in children, said Dr. Cennimo. Adults and children can experience coughing fits that can lead to shortness of breath and/or vomiting, which would raise suspicion for pertussis, but is not universally present, he said. The convalescent stage of pertussis can be prolonged and is characterized by chronic coughing. “In the past, pertussis had been called the 100-day cough,” and at that point, treatment is ineffective, Dr. Cennimo said.

In clinical practice, “I advise everyone to get the Tdap vaccine every 10 years,” and remember that the “Td” is the every 10-year tetanus shot as well, Dr. Cennimo told this news organization. Reassure patients that the Tdap can be given with other vaccines, he said, and remind patients that, as with any of the respiratory illnesses, they should stay home if sick, cover a cough, consider wearing a mask in public, and wash hands frequently, he said. 

Dr. Cennimo had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Pertussis cases in the United States have increased fourfold compared with the same time period last year, according to data from the Centers for Disease Control and Prevention (CDC). Reports from several states illustrate this trend, thought to be due to reduced immunity across the country.

The Alaska Department of Health issued a statement on its website about the significant increase in pertussis cases in the state during the summer, with 90 cases in July and 61 in August, compared with 24 in June and a total of 26 cases in 2023.

Similarly, the Florida Department of Health reported a pertussis increase in July 2024 that was higher than the June 2024 case count and also above the previous 5-year average.

Experts in these and other states suggest that several factors are driving the nationwide increase, including the fact that fewer people are consistently wearing masks. The mass masking during the COVID-19 pandemic caused a significant drop in pertussis, but the latest data suggest a return to prepandemic levels, and waning immunity likely plays a role as well.

Pertussis, also known as whooping cough, typically begins with symptoms similar to those of the common cold, including runny nose, sneezing, mild fever, and cough, according to the CDC. However, babies with whooping cough may experience trouble breathing rather than a cough. The coughing fits often associated with pertussis may not start until 2 weeks after the onset of other symptoms, according to the CDC.

Those who have been vaccinated against pertussis can still become infected, but the risk is lower, and the illness, if it occurs, is likely to be milder. Complications such as apnea, pneumonia, and convulsions can occur in babies younger than 1 year, especially if they have not been vaccinated, according to the CDC.
 

Beyond Easing Pandemic Precautions

Many respiratory-based infections dipped during the COVID-19 pandemic, almost certainly from the multifactorial interventions of masking, distancing, and the general lack of comingling, said David J. Cennimo, MD, associate professor of medicine & pediatrics in the Division of Infectious Diseases at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

The number of cases of many of these diseases returned to previous levels after COVID-19 restrictions were lifted, he said.

“However, we know pertussis immunity wanes over time. Children get DTaP at 2, 4, 6, and 15 months, and a Tdap booster at 11-12 years old gets them to adulthood,” Dr. Cennimo said. Adults should be getting a Tdap every 10 years, he added.

The latest available CDC data indicate that Tdap vaccine coverage in adults is approximately 40%, which means that there may be a large number of susceptible people who can become infected and propagate to others, said Dr. Cennimo.
 

Not Just the Young Ones

A recent pertussis outbreak among college students in Virginia highlighted the fact that the infection can affect all ages, and that the effectiveness of childhood vaccines may decrease over time. The majority of the recently diagnosed cases occurred in individuals who had been previously vaccinated, according to a press release from the Virginia Department of Health.

Clinical Clues

The initial stage of pertussis infection looks like a common cold with symptoms of upper respiratory infection, Dr. Cennimo told this news organization. “Unless there is reason to suspect pertussis exposure, it would almost certainly be missed,” he noted.

The characteristic barking/seal-like cough is mostly seen in children, said Dr. Cennimo. Adults and children can experience coughing fits that can lead to shortness of breath and/or vomiting, which would raise suspicion for pertussis, but is not universally present, he said. The convalescent stage of pertussis can be prolonged and is characterized by chronic coughing. “In the past, pertussis had been called the 100-day cough,” and at that point, treatment is ineffective, Dr. Cennimo said.

In clinical practice, “I advise everyone to get the Tdap vaccine every 10 years,” and remember that the “Td” is the every 10-year tetanus shot as well, Dr. Cennimo told this news organization. Reassure patients that the Tdap can be given with other vaccines, he said, and remind patients that, as with any of the respiratory illnesses, they should stay home if sick, cover a cough, consider wearing a mask in public, and wash hands frequently, he said. 

Dr. Cennimo had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

An epilepsy drug sold in Europe as Ospolot and also known as sulthiame showed promise in reducing sleep disordered breathing and other symptoms of obstructive sleep apnea (OSA), based on data from nearly 300 individuals presented in a late-breaking study at the annual congress of the European Respiratory Society.

“Current therapies are mechanical and based on the notion of an airway splint,” presenting author Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and the University of Gothenburg, both in Sweden, said in an interview. “In other words, applying an airflow at elevated pressure [continuous positive airway pressure] or advancing the jaw with a dental device. Adherence to this type of therapy is limited. In the case of continuous positive airway pressure [CPAP], it is < 50% after 3-4 years of therapy.” Therefore, there is a need for a better-tolerated therapy, such as a drug, and possibly a combination of mechanical and pharmaceutical therapies.

The use of medication has emerged as a viable option for OSA, with a high rate of compliance and acceptable safety profile, Dr. Hedner said in his presentation.

“Modified carbonic anhydrase activity may be a pathophysiological mechanism in OSA,” said Dr. Hedner. Sulthiame, a carbonic anhydrase inhibitor, showed safety and effectiveness for improving OSA in a previous phase 2b trial.

In the current study, the researchers sought to determine the most effective dose of sulthiame for patients with OSA. They randomized 298 adults with OSA who could not accept or tolerate oral splints or CPAP to 100 mg, 200 mg, or 300 mg of sulthiame daily (74, 74, and 75 patients, respectively) or placebo (75 patients).

The mean age of the patients was 56 years, 26.2% were women, and the average apnea-hypopnea index (AHI3a) at baseline was 29 n/h. Patients were treated at centers in Spain, France, Belgium, Germany, and the Czech Republic. Baseline demographics and clinical characteristics were similar among the treatment groups.

The primary endpoint was the change in AHI3a from baseline to 15 weeks, and significant changes occurred in patients who received the 100-mg, 200-mg, and 300-mg doses, with decreases of 17.8%, 34.8%, and 39.9%, respectively.

Peak efficacy occurred in the range of 200-300 mg and was similar for patients with moderate or severe OSA, Dr. Hedner said in his presentation.

Notably, in a post hoc analysis, apnea improved by 47.1% at a 300-mg dose when the AHI4 measure (apnea/hypopnea with ≥ 4% O₂ desaturation) was used in a placebo-adjusted dose-dependent reduction, the researchers wrote. The changes in AHI4 from baseline in this analysis also were significant for 200 mg and 100 mg doses (36.8% and 26.2%, respectively).

Patients underwent polysomnography at baseline and at weeks 4 and 12.

Mean overnight oxygen saturation also improved significantly from baseline with doses of 200 mg and 300 mg, compared with placebo (P < .0001 for both).

In addition, scores on the Epworth Sleepiness Scale (ESS) improved from baseline to week 15 in all dosage groups, and the subgroup of patients with ESS scores of ≥ 11 at baseline showed even greater improvement in ESS, Dr. Hedner said in his presentation.

Total arousal index and sleep quality also improved from baseline compared with placebo, and no clinically relevant reduction in REM sleep was noted, Dr. Hedner added.

Treatment-emergent adverse events were in line with the known safety profile of sulthiame and included paresthesia, headache, fatigue, and nausea; these were mainly moderate and dose-dependent, with no evidence of cardiovascular safety issues, he said.

Although the study results were not surprising given previous research, the investigators were pleased with the potency of the therapy. “We are also happy about potential added values such as a blood pressure lowering effect, which is beneficial in this group of patients; however, we need to further study these mechanisms in detail,” Dr. Hedner noted.

The study findings were limited by the relatively small scale, and larger studies on long-term efficacy and tolerability are also needed, he said.

“The current study was a dose-finding study, and we now have useful information on most suitable dose,” he said.

However, the results support sulthiame as an effective, well-tolerated, and promising novel candidate for drug therapy in patients with OSA, worthy of phase 3 studies, Dr. Hedner said.
 

Oral Option Could Be Game-Changer, But Not Yet

The gold standard of treatment for OSA is a CPAP machine, but the effectiveness is limited by patient tolerance, Q. Afifa Shamim-Uzzaman, MD, an associate professor and a sleep medicine specialist at the University of Michigan, Ann Arbor, said in an interview.

“Presently, there are no effective pharmacological treatments for OSA — having a pill that treats OSA would be a total game changer and huge advance for the treatment of OSA and the field of sleep medicine,” said Dr. Shamim-Uzzaman, who was not involved in the study. “More patients may be able to obtain treatment for OSA and thereby reduce the potential complications of untreated OSA.

“Carbonic anhydrase inhibitors such as acetazolamide and sulthiame have been studied with limited success for the treatment of other forms of sleep disordered breathing such as central sleep apnea [CSA] but have shown less efficacy for OSA and are presently not recommended in the treatment of OSA by the American Academy of Sleep Medicine,” Dr. Shamim-Uzzaman said.

Recently, emerging evidence about different phenotypes of OSA suggests that nonanatomic features (such as high loop gain) may play a role in patients with OSA, not only in those with CSA, she said. Whether carbonic anhydrase inhibitors could play a greater role in treating sleep apnea in patients with predominantly nonanatomic pathophysiologic traits remains to be seen.

The sulthiame data are promising, but more research is needed, Dr. Shamim-Uzzaman said. Although patients in the highest dose group showed a reduction in AHI of nearly 40%, they still would have moderate OSA, and the OSA did not appear to decrease to a normal range in any of the treatment groups.

“More research is needed to identify which types of patients would be responders to this form of therapy, to understand if these effects are maintained long term (beyond 15 weeks), to evaluate patient-centered outcomes, especially in different sleep apnea subgroups (such as phenotypes with high loop gain vs those without), and to assess interactions with other therapies,” she said.

The study was supported by manufacturer Desitin. Dr. Hedner disclosed serving as a consultant to AstraZeneca, Bayer, CereusScience, Jazz Pharmaceuticals, MSD, Weinmann, Desitin, SomnoMed, and Itamar Medical; serving on the speakers’ bureau for Almirall, AstraZeneca, Jazz Pharmaceuticals, ResMed, Philips Respironics, and Weinmann; and receiving grants or research support from Bayer, ResMed, Philips Respironics, and SomnoMed. He also disclosed shared ownership of intellectual property related to sleep apnea therapy. Dr. Shamim-Uzzaman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

An epilepsy drug sold in Europe as Ospolot and also known as sulthiame showed promise in reducing sleep disordered breathing and other symptoms of obstructive sleep apnea (OSA), based on data from nearly 300 individuals presented in a late-breaking study at the annual congress of the European Respiratory Society.

“Current therapies are mechanical and based on the notion of an airway splint,” presenting author Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and the University of Gothenburg, both in Sweden, said in an interview. “In other words, applying an airflow at elevated pressure [continuous positive airway pressure] or advancing the jaw with a dental device. Adherence to this type of therapy is limited. In the case of continuous positive airway pressure [CPAP], it is < 50% after 3-4 years of therapy.” Therefore, there is a need for a better-tolerated therapy, such as a drug, and possibly a combination of mechanical and pharmaceutical therapies.

The use of medication has emerged as a viable option for OSA, with a high rate of compliance and acceptable safety profile, Dr. Hedner said in his presentation.

“Modified carbonic anhydrase activity may be a pathophysiological mechanism in OSA,” said Dr. Hedner. Sulthiame, a carbonic anhydrase inhibitor, showed safety and effectiveness for improving OSA in a previous phase 2b trial.

In the current study, the researchers sought to determine the most effective dose of sulthiame for patients with OSA. They randomized 298 adults with OSA who could not accept or tolerate oral splints or CPAP to 100 mg, 200 mg, or 300 mg of sulthiame daily (74, 74, and 75 patients, respectively) or placebo (75 patients).

The mean age of the patients was 56 years, 26.2% were women, and the average apnea-hypopnea index (AHI3a) at baseline was 29 n/h. Patients were treated at centers in Spain, France, Belgium, Germany, and the Czech Republic. Baseline demographics and clinical characteristics were similar among the treatment groups.

The primary endpoint was the change in AHI3a from baseline to 15 weeks, and significant changes occurred in patients who received the 100-mg, 200-mg, and 300-mg doses, with decreases of 17.8%, 34.8%, and 39.9%, respectively.

Peak efficacy occurred in the range of 200-300 mg and was similar for patients with moderate or severe OSA, Dr. Hedner said in his presentation.

Notably, in a post hoc analysis, apnea improved by 47.1% at a 300-mg dose when the AHI4 measure (apnea/hypopnea with ≥ 4% O₂ desaturation) was used in a placebo-adjusted dose-dependent reduction, the researchers wrote. The changes in AHI4 from baseline in this analysis also were significant for 200 mg and 100 mg doses (36.8% and 26.2%, respectively).

Patients underwent polysomnography at baseline and at weeks 4 and 12.

Mean overnight oxygen saturation also improved significantly from baseline with doses of 200 mg and 300 mg, compared with placebo (P < .0001 for both).

In addition, scores on the Epworth Sleepiness Scale (ESS) improved from baseline to week 15 in all dosage groups, and the subgroup of patients with ESS scores of ≥ 11 at baseline showed even greater improvement in ESS, Dr. Hedner said in his presentation.

Total arousal index and sleep quality also improved from baseline compared with placebo, and no clinically relevant reduction in REM sleep was noted, Dr. Hedner added.

Treatment-emergent adverse events were in line with the known safety profile of sulthiame and included paresthesia, headache, fatigue, and nausea; these were mainly moderate and dose-dependent, with no evidence of cardiovascular safety issues, he said.

Although the study results were not surprising given previous research, the investigators were pleased with the potency of the therapy. “We are also happy about potential added values such as a blood pressure lowering effect, which is beneficial in this group of patients; however, we need to further study these mechanisms in detail,” Dr. Hedner noted.

The study findings were limited by the relatively small scale, and larger studies on long-term efficacy and tolerability are also needed, he said.

“The current study was a dose-finding study, and we now have useful information on most suitable dose,” he said.

However, the results support sulthiame as an effective, well-tolerated, and promising novel candidate for drug therapy in patients with OSA, worthy of phase 3 studies, Dr. Hedner said.
 

Oral Option Could Be Game-Changer, But Not Yet

The gold standard of treatment for OSA is a CPAP machine, but the effectiveness is limited by patient tolerance, Q. Afifa Shamim-Uzzaman, MD, an associate professor and a sleep medicine specialist at the University of Michigan, Ann Arbor, said in an interview.

“Presently, there are no effective pharmacological treatments for OSA — having a pill that treats OSA would be a total game changer and huge advance for the treatment of OSA and the field of sleep medicine,” said Dr. Shamim-Uzzaman, who was not involved in the study. “More patients may be able to obtain treatment for OSA and thereby reduce the potential complications of untreated OSA.

“Carbonic anhydrase inhibitors such as acetazolamide and sulthiame have been studied with limited success for the treatment of other forms of sleep disordered breathing such as central sleep apnea [CSA] but have shown less efficacy for OSA and are presently not recommended in the treatment of OSA by the American Academy of Sleep Medicine,” Dr. Shamim-Uzzaman said.

Recently, emerging evidence about different phenotypes of OSA suggests that nonanatomic features (such as high loop gain) may play a role in patients with OSA, not only in those with CSA, she said. Whether carbonic anhydrase inhibitors could play a greater role in treating sleep apnea in patients with predominantly nonanatomic pathophysiologic traits remains to be seen.

The sulthiame data are promising, but more research is needed, Dr. Shamim-Uzzaman said. Although patients in the highest dose group showed a reduction in AHI of nearly 40%, they still would have moderate OSA, and the OSA did not appear to decrease to a normal range in any of the treatment groups.

“More research is needed to identify which types of patients would be responders to this form of therapy, to understand if these effects are maintained long term (beyond 15 weeks), to evaluate patient-centered outcomes, especially in different sleep apnea subgroups (such as phenotypes with high loop gain vs those without), and to assess interactions with other therapies,” she said.

The study was supported by manufacturer Desitin. Dr. Hedner disclosed serving as a consultant to AstraZeneca, Bayer, CereusScience, Jazz Pharmaceuticals, MSD, Weinmann, Desitin, SomnoMed, and Itamar Medical; serving on the speakers’ bureau for Almirall, AstraZeneca, Jazz Pharmaceuticals, ResMed, Philips Respironics, and Weinmann; and receiving grants or research support from Bayer, ResMed, Philips Respironics, and SomnoMed. He also disclosed shared ownership of intellectual property related to sleep apnea therapy. Dr. Shamim-Uzzaman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

An epilepsy drug sold in Europe as Ospolot and also known as sulthiame showed promise in reducing sleep disordered breathing and other symptoms of obstructive sleep apnea (OSA), based on data from nearly 300 individuals presented in a late-breaking study at the annual congress of the European Respiratory Society.

“Current therapies are mechanical and based on the notion of an airway splint,” presenting author Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and the University of Gothenburg, both in Sweden, said in an interview. “In other words, applying an airflow at elevated pressure [continuous positive airway pressure] or advancing the jaw with a dental device. Adherence to this type of therapy is limited. In the case of continuous positive airway pressure [CPAP], it is < 50% after 3-4 years of therapy.” Therefore, there is a need for a better-tolerated therapy, such as a drug, and possibly a combination of mechanical and pharmaceutical therapies.

The use of medication has emerged as a viable option for OSA, with a high rate of compliance and acceptable safety profile, Dr. Hedner said in his presentation.

“Modified carbonic anhydrase activity may be a pathophysiological mechanism in OSA,” said Dr. Hedner. Sulthiame, a carbonic anhydrase inhibitor, showed safety and effectiveness for improving OSA in a previous phase 2b trial.

In the current study, the researchers sought to determine the most effective dose of sulthiame for patients with OSA. They randomized 298 adults with OSA who could not accept or tolerate oral splints or CPAP to 100 mg, 200 mg, or 300 mg of sulthiame daily (74, 74, and 75 patients, respectively) or placebo (75 patients).

The mean age of the patients was 56 years, 26.2% were women, and the average apnea-hypopnea index (AHI3a) at baseline was 29 n/h. Patients were treated at centers in Spain, France, Belgium, Germany, and the Czech Republic. Baseline demographics and clinical characteristics were similar among the treatment groups.

The primary endpoint was the change in AHI3a from baseline to 15 weeks, and significant changes occurred in patients who received the 100-mg, 200-mg, and 300-mg doses, with decreases of 17.8%, 34.8%, and 39.9%, respectively.

Peak efficacy occurred in the range of 200-300 mg and was similar for patients with moderate or severe OSA, Dr. Hedner said in his presentation.

Notably, in a post hoc analysis, apnea improved by 47.1% at a 300-mg dose when the AHI4 measure (apnea/hypopnea with ≥ 4% O₂ desaturation) was used in a placebo-adjusted dose-dependent reduction, the researchers wrote. The changes in AHI4 from baseline in this analysis also were significant for 200 mg and 100 mg doses (36.8% and 26.2%, respectively).

Patients underwent polysomnography at baseline and at weeks 4 and 12.

Mean overnight oxygen saturation also improved significantly from baseline with doses of 200 mg and 300 mg, compared with placebo (P < .0001 for both).

In addition, scores on the Epworth Sleepiness Scale (ESS) improved from baseline to week 15 in all dosage groups, and the subgroup of patients with ESS scores of ≥ 11 at baseline showed even greater improvement in ESS, Dr. Hedner said in his presentation.

Total arousal index and sleep quality also improved from baseline compared with placebo, and no clinically relevant reduction in REM sleep was noted, Dr. Hedner added.

Treatment-emergent adverse events were in line with the known safety profile of sulthiame and included paresthesia, headache, fatigue, and nausea; these were mainly moderate and dose-dependent, with no evidence of cardiovascular safety issues, he said.

Although the study results were not surprising given previous research, the investigators were pleased with the potency of the therapy. “We are also happy about potential added values such as a blood pressure lowering effect, which is beneficial in this group of patients; however, we need to further study these mechanisms in detail,” Dr. Hedner noted.

The study findings were limited by the relatively small scale, and larger studies on long-term efficacy and tolerability are also needed, he said.

“The current study was a dose-finding study, and we now have useful information on most suitable dose,” he said.

However, the results support sulthiame as an effective, well-tolerated, and promising novel candidate for drug therapy in patients with OSA, worthy of phase 3 studies, Dr. Hedner said.
 

Oral Option Could Be Game-Changer, But Not Yet

The gold standard of treatment for OSA is a CPAP machine, but the effectiveness is limited by patient tolerance, Q. Afifa Shamim-Uzzaman, MD, an associate professor and a sleep medicine specialist at the University of Michigan, Ann Arbor, said in an interview.

“Presently, there are no effective pharmacological treatments for OSA — having a pill that treats OSA would be a total game changer and huge advance for the treatment of OSA and the field of sleep medicine,” said Dr. Shamim-Uzzaman, who was not involved in the study. “More patients may be able to obtain treatment for OSA and thereby reduce the potential complications of untreated OSA.

“Carbonic anhydrase inhibitors such as acetazolamide and sulthiame have been studied with limited success for the treatment of other forms of sleep disordered breathing such as central sleep apnea [CSA] but have shown less efficacy for OSA and are presently not recommended in the treatment of OSA by the American Academy of Sleep Medicine,” Dr. Shamim-Uzzaman said.

Recently, emerging evidence about different phenotypes of OSA suggests that nonanatomic features (such as high loop gain) may play a role in patients with OSA, not only in those with CSA, she said. Whether carbonic anhydrase inhibitors could play a greater role in treating sleep apnea in patients with predominantly nonanatomic pathophysiologic traits remains to be seen.

The sulthiame data are promising, but more research is needed, Dr. Shamim-Uzzaman said. Although patients in the highest dose group showed a reduction in AHI of nearly 40%, they still would have moderate OSA, and the OSA did not appear to decrease to a normal range in any of the treatment groups.

“More research is needed to identify which types of patients would be responders to this form of therapy, to understand if these effects are maintained long term (beyond 15 weeks), to evaluate patient-centered outcomes, especially in different sleep apnea subgroups (such as phenotypes with high loop gain vs those without), and to assess interactions with other therapies,” she said.

The study was supported by manufacturer Desitin. Dr. Hedner disclosed serving as a consultant to AstraZeneca, Bayer, CereusScience, Jazz Pharmaceuticals, MSD, Weinmann, Desitin, SomnoMed, and Itamar Medical; serving on the speakers’ bureau for Almirall, AstraZeneca, Jazz Pharmaceuticals, ResMed, Philips Respironics, and Weinmann; and receiving grants or research support from Bayer, ResMed, Philips Respironics, and SomnoMed. He also disclosed shared ownership of intellectual property related to sleep apnea therapy. Dr. Shamim-Uzzaman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

A case of locally acquired dengue fever has been confirmed in a resident of Baldwin Park, California, according to a press release from the Los Angeles County Department of Public Health. This locally acquired case of dengue is the third to be reported in California and the first to be reported by the Los Angeles County Department of Public Health; cases were confirmed in Pasadena and Long Beach, California, in the fall of 2023.

“Dengue is the most common insect-borne viral infection in the world, with a wide geographic spread; we know that we have mosquitoes capable of carrying and transmitting the virus in the United States already, and Los Angeles county is a major epicenter for international travel and trade,” James Lawler, MD, associate director for International Programs and Innovation at the Global Center for Health Security and professor in the Infectious Diseases Division at the University of Nebraska Medical Center, Omaha, Nebraska, said in an interview.

Although the patient had no known history of travel to a dengue-endemic area, the potential risk for widespread transmission of the virus in the Los Angeles County area remains low, and no additional suspected cases of locally acquired dengue have been identified, according to the release. However, the recent cases highlight the need for vigilance on the part of the public to reduce transmission of mosquito-borne infections, the public health department noted.

Most cases of dengue occur in people who have traveled to areas where the disease is more common, mainly tropical and subtropical areas, according to the press release. However, the types of mosquitoes that spread dengue exist in parts of the United States, so locally acquired infections can occur.

The Centers for Disease Control and Prevention (CDC) issued an official health advisory in June 2024 about an increased risk for dengue infections in the United States. According to the advisory, 745 cases of dengue were identified in US travelers to endemic areas between January 1, 2024, and June 24, 2024.

The CDC advises clinicians to maintain a high level of suspicion for dengue among individuals with fever and recent travel to areas with frequent dengue transmission, but also to consider locally acquired disease in areas of mosquito vectors.

In clinical practice, dengue may be difficult to differentiate from other febrile systemic infections, Dr. Lawler noted. “Joint pain, low back pain, and headache (often retro-orbital) are common and can be severe, and a rash often appears several days into illness,” he noted.

Do not delay treatment in suspected cases while waiting for test results, the CDC emphasized in the advisory. Food and Drug Administration–approved tests for dengue include RT-PCR and IgM antibody tests or NS1 and IgM antibody tests.

“Severe dengue can be life-threatening and progress to a hemorrhagic fever-like syndrome, and patients with severe dengue should be cared for on a high-acuity or intensive care setting, with close monitoring of labs and fluid status,” Dr. Lawler told this news organization.

The World Health Organization has published guidelines for the management of dengue, which Dr. Lawler strongly recommends to clinicians in the rare event that they are facing a severe case. The treatment for dengue is supportive care, according to the CDC; a vaccine that was deemed safe and effective is no longer being manufactured because of low demand.

Most symptoms last for 2-7 days, and most patients recover within a week, but approximately 1 in 20 may develop severe disease, according to the Los Angeles County Department of Public Health.

Approximately one quarter of dengue infections are symptomatic, and clinicians should know the signs of progression to severe disease, which include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and liver enlargement, according to the CDC.
 

Local Dengue Not Unexpected

“Sadly, I am not surprised at another locally acquired case of dengue fever in the United States,” said Dr. Lawler. “We also have seen a trend of more historically tropical, insect-borne diseases popping up with locally acquired cases in the United States,” he noted.

Dr. Lawler suggested that “the erosion of state and local public health” is a major contributor to the increase in dengue cases. For more than 100 years, activities of state and local public health officials had significantly curtailed mosquito-borne diseases through aggressive control programs, “but we seem to be losing ground over the last several years,” he said.

“Locally acquired dengue cases are still rare in the United States,” he added. “However, people can protect themselves against dengue and more common arthropod-borne infections by taking precautions to cover up and wear insect repellent while outdoors.”

In addition, the Los Angeles County Department of Public Health emphasized in its press release that local residents reduce their risk for contact with mosquitoes by removing areas of standing water on their property and ensuring well-fitted screens on doors and windows.

Dr. Lawler had no financial conflicts to disclose.
 

A version of this article first appeared on Medscape.com.

A case of locally acquired dengue fever has been confirmed in a resident of Baldwin Park, California, according to a press release from the Los Angeles County Department of Public Health. This locally acquired case of dengue is the third to be reported in California and the first to be reported by the Los Angeles County Department of Public Health; cases were confirmed in Pasadena and Long Beach, California, in the fall of 2023.

“Dengue is the most common insect-borne viral infection in the world, with a wide geographic spread; we know that we have mosquitoes capable of carrying and transmitting the virus in the United States already, and Los Angeles county is a major epicenter for international travel and trade,” James Lawler, MD, associate director for International Programs and Innovation at the Global Center for Health Security and professor in the Infectious Diseases Division at the University of Nebraska Medical Center, Omaha, Nebraska, said in an interview.

Although the patient had no known history of travel to a dengue-endemic area, the potential risk for widespread transmission of the virus in the Los Angeles County area remains low, and no additional suspected cases of locally acquired dengue have been identified, according to the release. However, the recent cases highlight the need for vigilance on the part of the public to reduce transmission of mosquito-borne infections, the public health department noted.

Most cases of dengue occur in people who have traveled to areas where the disease is more common, mainly tropical and subtropical areas, according to the press release. However, the types of mosquitoes that spread dengue exist in parts of the United States, so locally acquired infections can occur.

The Centers for Disease Control and Prevention (CDC) issued an official health advisory in June 2024 about an increased risk for dengue infections in the United States. According to the advisory, 745 cases of dengue were identified in US travelers to endemic areas between January 1, 2024, and June 24, 2024.

The CDC advises clinicians to maintain a high level of suspicion for dengue among individuals with fever and recent travel to areas with frequent dengue transmission, but also to consider locally acquired disease in areas of mosquito vectors.

In clinical practice, dengue may be difficult to differentiate from other febrile systemic infections, Dr. Lawler noted. “Joint pain, low back pain, and headache (often retro-orbital) are common and can be severe, and a rash often appears several days into illness,” he noted.

Do not delay treatment in suspected cases while waiting for test results, the CDC emphasized in the advisory. Food and Drug Administration–approved tests for dengue include RT-PCR and IgM antibody tests or NS1 and IgM antibody tests.

“Severe dengue can be life-threatening and progress to a hemorrhagic fever-like syndrome, and patients with severe dengue should be cared for on a high-acuity or intensive care setting, with close monitoring of labs and fluid status,” Dr. Lawler told this news organization.

The World Health Organization has published guidelines for the management of dengue, which Dr. Lawler strongly recommends to clinicians in the rare event that they are facing a severe case. The treatment for dengue is supportive care, according to the CDC; a vaccine that was deemed safe and effective is no longer being manufactured because of low demand.

Most symptoms last for 2-7 days, and most patients recover within a week, but approximately 1 in 20 may develop severe disease, according to the Los Angeles County Department of Public Health.

Approximately one quarter of dengue infections are symptomatic, and clinicians should know the signs of progression to severe disease, which include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and liver enlargement, according to the CDC.
 

Local Dengue Not Unexpected

“Sadly, I am not surprised at another locally acquired case of dengue fever in the United States,” said Dr. Lawler. “We also have seen a trend of more historically tropical, insect-borne diseases popping up with locally acquired cases in the United States,” he noted.

Dr. Lawler suggested that “the erosion of state and local public health” is a major contributor to the increase in dengue cases. For more than 100 years, activities of state and local public health officials had significantly curtailed mosquito-borne diseases through aggressive control programs, “but we seem to be losing ground over the last several years,” he said.

“Locally acquired dengue cases are still rare in the United States,” he added. “However, people can protect themselves against dengue and more common arthropod-borne infections by taking precautions to cover up and wear insect repellent while outdoors.”

In addition, the Los Angeles County Department of Public Health emphasized in its press release that local residents reduce their risk for contact with mosquitoes by removing areas of standing water on their property and ensuring well-fitted screens on doors and windows.

Dr. Lawler had no financial conflicts to disclose.
 

A version of this article first appeared on Medscape.com.

A case of locally acquired dengue fever has been confirmed in a resident of Baldwin Park, California, according to a press release from the Los Angeles County Department of Public Health. This locally acquired case of dengue is the third to be reported in California and the first to be reported by the Los Angeles County Department of Public Health; cases were confirmed in Pasadena and Long Beach, California, in the fall of 2023.

“Dengue is the most common insect-borne viral infection in the world, with a wide geographic spread; we know that we have mosquitoes capable of carrying and transmitting the virus in the United States already, and Los Angeles county is a major epicenter for international travel and trade,” James Lawler, MD, associate director for International Programs and Innovation at the Global Center for Health Security and professor in the Infectious Diseases Division at the University of Nebraska Medical Center, Omaha, Nebraska, said in an interview.

Although the patient had no known history of travel to a dengue-endemic area, the potential risk for widespread transmission of the virus in the Los Angeles County area remains low, and no additional suspected cases of locally acquired dengue have been identified, according to the release. However, the recent cases highlight the need for vigilance on the part of the public to reduce transmission of mosquito-borne infections, the public health department noted.

Most cases of dengue occur in people who have traveled to areas where the disease is more common, mainly tropical and subtropical areas, according to the press release. However, the types of mosquitoes that spread dengue exist in parts of the United States, so locally acquired infections can occur.

The Centers for Disease Control and Prevention (CDC) issued an official health advisory in June 2024 about an increased risk for dengue infections in the United States. According to the advisory, 745 cases of dengue were identified in US travelers to endemic areas between January 1, 2024, and June 24, 2024.

The CDC advises clinicians to maintain a high level of suspicion for dengue among individuals with fever and recent travel to areas with frequent dengue transmission, but also to consider locally acquired disease in areas of mosquito vectors.

In clinical practice, dengue may be difficult to differentiate from other febrile systemic infections, Dr. Lawler noted. “Joint pain, low back pain, and headache (often retro-orbital) are common and can be severe, and a rash often appears several days into illness,” he noted.

Do not delay treatment in suspected cases while waiting for test results, the CDC emphasized in the advisory. Food and Drug Administration–approved tests for dengue include RT-PCR and IgM antibody tests or NS1 and IgM antibody tests.

“Severe dengue can be life-threatening and progress to a hemorrhagic fever-like syndrome, and patients with severe dengue should be cared for on a high-acuity or intensive care setting, with close monitoring of labs and fluid status,” Dr. Lawler told this news organization.

The World Health Organization has published guidelines for the management of dengue, which Dr. Lawler strongly recommends to clinicians in the rare event that they are facing a severe case. The treatment for dengue is supportive care, according to the CDC; a vaccine that was deemed safe and effective is no longer being manufactured because of low demand.

Most symptoms last for 2-7 days, and most patients recover within a week, but approximately 1 in 20 may develop severe disease, according to the Los Angeles County Department of Public Health.

Approximately one quarter of dengue infections are symptomatic, and clinicians should know the signs of progression to severe disease, which include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and liver enlargement, according to the CDC.
 

Local Dengue Not Unexpected

“Sadly, I am not surprised at another locally acquired case of dengue fever in the United States,” said Dr. Lawler. “We also have seen a trend of more historically tropical, insect-borne diseases popping up with locally acquired cases in the United States,” he noted.

Dr. Lawler suggested that “the erosion of state and local public health” is a major contributor to the increase in dengue cases. For more than 100 years, activities of state and local public health officials had significantly curtailed mosquito-borne diseases through aggressive control programs, “but we seem to be losing ground over the last several years,” he said.

“Locally acquired dengue cases are still rare in the United States,” he added. “However, people can protect themselves against dengue and more common arthropod-borne infections by taking precautions to cover up and wear insect repellent while outdoors.”

In addition, the Los Angeles County Department of Public Health emphasized in its press release that local residents reduce their risk for contact with mosquitoes by removing areas of standing water on their property and ensuring well-fitted screens on doors and windows.

Dr. Lawler had no financial conflicts to disclose.
 

A version of this article first appeared on Medscape.com.

Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals.

“Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented,” said lead author Gaël Grandmaison, MD, of the University of Fribourg in Switzerland, in an interview.

“This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient’s specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs,” Dr. Grandmaison said.

To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique.

The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average.

The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors.

The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.

“The inhalation technique was classified as ‘non-teachable’ if the patient continued to exhibit critical errors despite receiving three repetitions of the instructions,” the researchers wrote. Factors associated with inhaler misuse included cognitive disorders, fine motor disorders, poor coordination between inhaler activation and aspiration, and the inability to hold one’s breath.

Overall, the proportion of misused inhalers did not vary by age or gender. In an analysis at the patient level, 79 patients used at least one misused inhaler, 78 used at least one inhaler with a critical error, and 21 used inhalers with insufficient PIF.

“This study is particularly timely because reasons for hospitalization, such as COPD exacerbations or confusional states, could exacerbate the problem, leading to a potentially higher prevalence of suboptimal inhaler use compared to outpatient settings,” Dr. Grandmaison said.

The researchers also examined secondary outcomes including the prevalence of inhalers that were not suited to them and the number of patients using at least one misused inhaler.

The study findings confirm that suboptimal inhaler use is a significant problem in the hospital setting and provide new insights into the specific reasons behind this suboptimal usage, Dr. Grandmaison said.

“In the majority of cases, poor inhalation technique is the primary cause, which can generally be corrected through targeted therapeutic education,” she said. However, the study also revealed that 20% of patients are unable to use at least one of their inhalers correctly because of insufficient inspiratory force. Another 10% struggle despite receiving proper instruction, often because of cognitive impairments or difficulty with fine motor skills.

The results underscore the need for a comprehensive approach to inhaler use in hospitalized patients that combines continuous therapeutic education with personalized assessment in order to improve technique and subsequently enhance patient outcomes, she said.
 

Changing Clinical Practice

“As hospital physicians, these findings have led us to systematically evaluate the inhalers used by COPD patients, regardless of their reason for hospitalization,” Dr. Grandmaison said. Consequently, the hospital has implemented an assessment of inhaler use among patients that includes a review of techniques, an evaluation of the appropriateness of the inhaler prescribed, and an algorithm to help clinicians choose the most appropriate inhaler. Since its inception, the targeted intervention has significantly reduced improper inhaler use at discharge.

Limitations and Next Steps

The findings were limited by several factors including the possible underreporting of misuse caused by inadequate PIF, a lack of consensus on what constitutes a critical error, and the small sample of patients from a single center.

Despite these limitations, the study adds to the understanding of improper inhaler use in the hospital setting, Dr. Grandmaison said. “Our subsequent research demonstrated that a systematic evaluation of inhalers, combined with therapeutic education and an algorithm to select an inhaler suited to the patient’s characteristics, significantly reduces the number of improperly used inhalers at hospital discharge.”

However, several areas require further investigation, said Dr. Grandmaison. The most effective methods and frequency for teaching inhalation techniques must be defined, and more research is needed to understand the factors influencing PIF and its progression over the course of disease. The next steps for the current research are to evaluate the impact of the intervention on long-term symptom control and disease progression.

“Moreover, adapting the strategy developed in our institution for use in outpatient care is a priority, and multicenter studies would be valuable in validating these findings across different hospital settings,” she added.
 

In-Hospital Inhaler Education Falls Short

“Poor inhaler technique can lead to ineffective inhaler use and suboptimal treatment of COPD,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview.

“The results from this study are consistent with prior studies showing a high prevalence of suboptimal inhaler use,” said Dr. Baldomero, who was not involved in the current study.

“The investigators also found that therapeutic education led to a significant reduction in the number of critical errors,” she said.

“What is surprising is that it can take up to three lessons to reduce this critical error down to 3.8%,” Dr. Baldomero said. “In most real-world clinic settings, many patients are not taught how to properly use inhalers, and many patients who receive inhaler technique education only receive instructions once.”

Dr. Baldomero’s takeaway from the study is that teaching patients to properly use their inhalers is critical, but that this education may need to be repeated multiple times. The findings also remind clinicians that some types of inhaler delivery are not suited for patients who cannot generate adequate respiratory flow.

Looking ahead, a larger sample size is needed to better identify which patients need additional teaching, Dr. Baldomero said. Also, the current study is limited by the focus on hospitalized patients. “I am interested in learning about the characteristics of patients in the outpatient settings who would benefit from additional inhaler teaching,” she noted.

The study was supported by a grant from the Hospital of Fribourg in Switzerland. The researchers had no financial conflicts to disclose. Dr. Baldomero had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals.

“Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented,” said lead author Gaël Grandmaison, MD, of the University of Fribourg in Switzerland, in an interview.

“This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient’s specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs,” Dr. Grandmaison said.

To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique.

The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average.

The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors.

The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.

“The inhalation technique was classified as ‘non-teachable’ if the patient continued to exhibit critical errors despite receiving three repetitions of the instructions,” the researchers wrote. Factors associated with inhaler misuse included cognitive disorders, fine motor disorders, poor coordination between inhaler activation and aspiration, and the inability to hold one’s breath.

Overall, the proportion of misused inhalers did not vary by age or gender. In an analysis at the patient level, 79 patients used at least one misused inhaler, 78 used at least one inhaler with a critical error, and 21 used inhalers with insufficient PIF.

“This study is particularly timely because reasons for hospitalization, such as COPD exacerbations or confusional states, could exacerbate the problem, leading to a potentially higher prevalence of suboptimal inhaler use compared to outpatient settings,” Dr. Grandmaison said.

The researchers also examined secondary outcomes including the prevalence of inhalers that were not suited to them and the number of patients using at least one misused inhaler.

The study findings confirm that suboptimal inhaler use is a significant problem in the hospital setting and provide new insights into the specific reasons behind this suboptimal usage, Dr. Grandmaison said.

“In the majority of cases, poor inhalation technique is the primary cause, which can generally be corrected through targeted therapeutic education,” she said. However, the study also revealed that 20% of patients are unable to use at least one of their inhalers correctly because of insufficient inspiratory force. Another 10% struggle despite receiving proper instruction, often because of cognitive impairments or difficulty with fine motor skills.

The results underscore the need for a comprehensive approach to inhaler use in hospitalized patients that combines continuous therapeutic education with personalized assessment in order to improve technique and subsequently enhance patient outcomes, she said.
 

Changing Clinical Practice

“As hospital physicians, these findings have led us to systematically evaluate the inhalers used by COPD patients, regardless of their reason for hospitalization,” Dr. Grandmaison said. Consequently, the hospital has implemented an assessment of inhaler use among patients that includes a review of techniques, an evaluation of the appropriateness of the inhaler prescribed, and an algorithm to help clinicians choose the most appropriate inhaler. Since its inception, the targeted intervention has significantly reduced improper inhaler use at discharge.

Limitations and Next Steps

The findings were limited by several factors including the possible underreporting of misuse caused by inadequate PIF, a lack of consensus on what constitutes a critical error, and the small sample of patients from a single center.

Despite these limitations, the study adds to the understanding of improper inhaler use in the hospital setting, Dr. Grandmaison said. “Our subsequent research demonstrated that a systematic evaluation of inhalers, combined with therapeutic education and an algorithm to select an inhaler suited to the patient’s characteristics, significantly reduces the number of improperly used inhalers at hospital discharge.”

However, several areas require further investigation, said Dr. Grandmaison. The most effective methods and frequency for teaching inhalation techniques must be defined, and more research is needed to understand the factors influencing PIF and its progression over the course of disease. The next steps for the current research are to evaluate the impact of the intervention on long-term symptom control and disease progression.

“Moreover, adapting the strategy developed in our institution for use in outpatient care is a priority, and multicenter studies would be valuable in validating these findings across different hospital settings,” she added.
 

In-Hospital Inhaler Education Falls Short

“Poor inhaler technique can lead to ineffective inhaler use and suboptimal treatment of COPD,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview.

“The results from this study are consistent with prior studies showing a high prevalence of suboptimal inhaler use,” said Dr. Baldomero, who was not involved in the current study.

“The investigators also found that therapeutic education led to a significant reduction in the number of critical errors,” she said.

“What is surprising is that it can take up to three lessons to reduce this critical error down to 3.8%,” Dr. Baldomero said. “In most real-world clinic settings, many patients are not taught how to properly use inhalers, and many patients who receive inhaler technique education only receive instructions once.”

Dr. Baldomero’s takeaway from the study is that teaching patients to properly use their inhalers is critical, but that this education may need to be repeated multiple times. The findings also remind clinicians that some types of inhaler delivery are not suited for patients who cannot generate adequate respiratory flow.

Looking ahead, a larger sample size is needed to better identify which patients need additional teaching, Dr. Baldomero said. Also, the current study is limited by the focus on hospitalized patients. “I am interested in learning about the characteristics of patients in the outpatient settings who would benefit from additional inhaler teaching,” she noted.

The study was supported by a grant from the Hospital of Fribourg in Switzerland. The researchers had no financial conflicts to disclose. Dr. Baldomero had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals.

“Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented,” said lead author Gaël Grandmaison, MD, of the University of Fribourg in Switzerland, in an interview.

“This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient’s specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs,” Dr. Grandmaison said.

To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique.

The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average.

The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors.

The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.

“The inhalation technique was classified as ‘non-teachable’ if the patient continued to exhibit critical errors despite receiving three repetitions of the instructions,” the researchers wrote. Factors associated with inhaler misuse included cognitive disorders, fine motor disorders, poor coordination between inhaler activation and aspiration, and the inability to hold one’s breath.

Overall, the proportion of misused inhalers did not vary by age or gender. In an analysis at the patient level, 79 patients used at least one misused inhaler, 78 used at least one inhaler with a critical error, and 21 used inhalers with insufficient PIF.

“This study is particularly timely because reasons for hospitalization, such as COPD exacerbations or confusional states, could exacerbate the problem, leading to a potentially higher prevalence of suboptimal inhaler use compared to outpatient settings,” Dr. Grandmaison said.

The researchers also examined secondary outcomes including the prevalence of inhalers that were not suited to them and the number of patients using at least one misused inhaler.

The study findings confirm that suboptimal inhaler use is a significant problem in the hospital setting and provide new insights into the specific reasons behind this suboptimal usage, Dr. Grandmaison said.

“In the majority of cases, poor inhalation technique is the primary cause, which can generally be corrected through targeted therapeutic education,” she said. However, the study also revealed that 20% of patients are unable to use at least one of their inhalers correctly because of insufficient inspiratory force. Another 10% struggle despite receiving proper instruction, often because of cognitive impairments or difficulty with fine motor skills.

The results underscore the need for a comprehensive approach to inhaler use in hospitalized patients that combines continuous therapeutic education with personalized assessment in order to improve technique and subsequently enhance patient outcomes, she said.
 

Changing Clinical Practice

“As hospital physicians, these findings have led us to systematically evaluate the inhalers used by COPD patients, regardless of their reason for hospitalization,” Dr. Grandmaison said. Consequently, the hospital has implemented an assessment of inhaler use among patients that includes a review of techniques, an evaluation of the appropriateness of the inhaler prescribed, and an algorithm to help clinicians choose the most appropriate inhaler. Since its inception, the targeted intervention has significantly reduced improper inhaler use at discharge.

Limitations and Next Steps

The findings were limited by several factors including the possible underreporting of misuse caused by inadequate PIF, a lack of consensus on what constitutes a critical error, and the small sample of patients from a single center.

Despite these limitations, the study adds to the understanding of improper inhaler use in the hospital setting, Dr. Grandmaison said. “Our subsequent research demonstrated that a systematic evaluation of inhalers, combined with therapeutic education and an algorithm to select an inhaler suited to the patient’s characteristics, significantly reduces the number of improperly used inhalers at hospital discharge.”

However, several areas require further investigation, said Dr. Grandmaison. The most effective methods and frequency for teaching inhalation techniques must be defined, and more research is needed to understand the factors influencing PIF and its progression over the course of disease. The next steps for the current research are to evaluate the impact of the intervention on long-term symptom control and disease progression.

“Moreover, adapting the strategy developed in our institution for use in outpatient care is a priority, and multicenter studies would be valuable in validating these findings across different hospital settings,” she added.
 

In-Hospital Inhaler Education Falls Short

“Poor inhaler technique can lead to ineffective inhaler use and suboptimal treatment of COPD,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview.

“The results from this study are consistent with prior studies showing a high prevalence of suboptimal inhaler use,” said Dr. Baldomero, who was not involved in the current study.

“The investigators also found that therapeutic education led to a significant reduction in the number of critical errors,” she said.

“What is surprising is that it can take up to three lessons to reduce this critical error down to 3.8%,” Dr. Baldomero said. “In most real-world clinic settings, many patients are not taught how to properly use inhalers, and many patients who receive inhaler technique education only receive instructions once.”

Dr. Baldomero’s takeaway from the study is that teaching patients to properly use their inhalers is critical, but that this education may need to be repeated multiple times. The findings also remind clinicians that some types of inhaler delivery are not suited for patients who cannot generate adequate respiratory flow.

Looking ahead, a larger sample size is needed to better identify which patients need additional teaching, Dr. Baldomero said. Also, the current study is limited by the focus on hospitalized patients. “I am interested in learning about the characteristics of patients in the outpatient settings who would benefit from additional inhaler teaching,” she noted.

The study was supported by a grant from the Hospital of Fribourg in Switzerland. The researchers had no financial conflicts to disclose. Dr. Baldomero had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

New COVID-19 vaccines formulated for better protection against the currently circulating variants have been approved by the US Food and Drug Administration.

The COVID vaccines available this fall have been updated to better match the currently circulating COVID strains, said William Schaffner, MD, professor of medicine in the Division of Infectious Diseases at Vanderbilt University, Nashville, Tennessee, in an interview.

“The Pfizer and Moderna vaccines — both mRNA vaccines — target the KP.2 variant, while the Novavax vaccine targets the JN.1 variant, which is a predecessor to KP.2,” said Dr. Schaffner, who also serves as a spokesperson for the National Foundation for Infectious Diseases. “The Novavax vaccine is a protein adjuvant vaccine made in a more traditional fashion and may appeal to those who remain hesitant about receiving an mRNA vaccine,” he explained. However, all three vaccines are designed to protect against severe COVID illness and reduce the likelihood of hospitalization, he said.
 

Who Needs It?

“The CDC’s Advisory Committee on Immunization Practices (ACIP) continues to recommend that everyone in the United States who is age 6 months and older receive the updated COVID vaccine this fall, along with influenza vaccine,” Dr. Schaffner said.

“This was not a surprise because COVID will produce a sizable winter outbreak,” he predicted. Although older people and those who have chronic medical conditions such as heart or lung disease, diabetes, or other immunocompromising conditions suffer the most serious impact of COVID, he said. “The virus can strike anyone, even the young and healthy.” The risk for long COVID persists as well, he pointed out.

The ACIP recommendation is endorsed by the American Academy of Pediatrics and other professional organizations, Dr. Shaffner said.

A frequently asked question is whether the COVID and flu vaccines can be given at the same time, and the answer is yes, according to a statement from the Centers for Disease Control and Prevention (CDC).

“The optimal time to be vaccinated is late September and anytime during October in order to get the benefit of protection through the winter,” Dr. Schaffner said.

As with earlier versions of the COVID-19 vaccine, side effects vary from person to person. Reported side effects of the updated vaccine are similar to those seen with earlier versions and may include injection site pain, redness and swelling, fatigue, headache, muscle pain, chills, nausea, and fever, but most of these are short-lived, according to the CDC.
 

Clinical Guidance

The CDC’s clinical guidance for COVID-19 vaccination outlines more specific guidance for vaccination based on age, vaccination history, and immunocompromised status and will be updated as needed.

A notable difference in the latest guidance is the recommendation of only one shot for adults aged 65 years and older who are NOT moderately or severely immunocompromised. For those who are moderately or severely immunocompromised, the CDC recommends two to three doses of the same brand of vaccine.

Dr. Schaffner strongly encouraged clinicians to recommend the COVID-19 vaccination for all eligible patients. “COVID is a nasty virus that can cause serious disease in anyone,” and protection from previous vaccination or prior infection has likely waned, he said.

Dr. Schaffner also encouraged healthcare professionals and their families to lead by example. “We should all be vaccinated and let our patients know that we are vaccinated and that we want all our patents to be protected,” he said.

The updated COVID-19 vaccination recommendations have become much simpler for clinicians and patients, with a single messenger RNA (mRNA) vaccine required for anyone older than 5 years, said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

“The recommendations are a bit more complex for children under 5 years old receiving their first vaccination; they require two to three doses depending on the brand,” he said. “It is important to review the latest recommendations to plan the doses with the correct interval timing. Considering the doses may be 3-4 weeks apart, start early,” he advised.
 

One-Time Dosing

Although the updated mRNA vaccine is currently recommended as a one-time dose, Dr. Cennimo said he can envision a scenario later in the season when a second dose is recommended for the elderly and those at high risk for severe illness. Dr. Cennimo said that he strongly agrees with the recommendations that everyone aged 6 months and older receive an updated COVID-19 vaccine. Older age remains the prime risk factor, but anyone can become infected, he said.

Predicting a prime time to get vaccinated is tricky because no one knows when the expected rise in winter cases will occur, said Dr. Cennimo.

“We know from years of flu vaccine data that some number of people who delay the vaccine will never return and will miss protection,” he said. Therefore, delaying vaccination is not recommended. Dr. Cennimo plans to follow his habit of getting vaccinated in early October. “I anticipate the maximal effectiveness of the vaccine will carry me through the winter,” he said.

Data support the safety and effectiveness for both flu and COVID vaccines if they are given together, and some research on earlier versions of COVID vaccines suggested that receiving flu and COVID vaccines together might increase the antibody response against COVID, but similar studies of the updated version have not been done, Dr. Cennimo said.

Clinicians may have to overcome the barrier of COVID fatigue to encourage vaccination, Dr. Cennimo said. Many people say they “want it to be over,” he said, but SARS-CoV-2, established as a viral respiratory infection, shows no signs of disappearing. In addition, new data continue to show higher mortality associated with COVID-19 than with influenza, he said.

“We need to explain to our patients that COVID-19 is still here and is still dangerous. The yearly influenza vaccination campaigns should have established and normalized the idea of an updated vaccine targeted for the season’s predicated strains is expected,” he emphasized. “We now have years of safety data behind these vaccines, and we need to make a strong recommendation for this protection,” he said.

COVID-19 vaccines are covered by private insurance, as well as by Medicare and Medicaid, according to the CDC. Vaccination for uninsured children is covered through the Vaccines for Children Program.

A version of this article first appeared on Medscape.com.

New COVID-19 vaccines formulated for better protection against the currently circulating variants have been approved by the US Food and Drug Administration.

The COVID vaccines available this fall have been updated to better match the currently circulating COVID strains, said William Schaffner, MD, professor of medicine in the Division of Infectious Diseases at Vanderbilt University, Nashville, Tennessee, in an interview.

“The Pfizer and Moderna vaccines — both mRNA vaccines — target the KP.2 variant, while the Novavax vaccine targets the JN.1 variant, which is a predecessor to KP.2,” said Dr. Schaffner, who also serves as a spokesperson for the National Foundation for Infectious Diseases. “The Novavax vaccine is a protein adjuvant vaccine made in a more traditional fashion and may appeal to those who remain hesitant about receiving an mRNA vaccine,” he explained. However, all three vaccines are designed to protect against severe COVID illness and reduce the likelihood of hospitalization, he said.
 

Who Needs It?

“The CDC’s Advisory Committee on Immunization Practices (ACIP) continues to recommend that everyone in the United States who is age 6 months and older receive the updated COVID vaccine this fall, along with influenza vaccine,” Dr. Schaffner said.

“This was not a surprise because COVID will produce a sizable winter outbreak,” he predicted. Although older people and those who have chronic medical conditions such as heart or lung disease, diabetes, or other immunocompromising conditions suffer the most serious impact of COVID, he said. “The virus can strike anyone, even the young and healthy.” The risk for long COVID persists as well, he pointed out.

The ACIP recommendation is endorsed by the American Academy of Pediatrics and other professional organizations, Dr. Shaffner said.

A frequently asked question is whether the COVID and flu vaccines can be given at the same time, and the answer is yes, according to a statement from the Centers for Disease Control and Prevention (CDC).

“The optimal time to be vaccinated is late September and anytime during October in order to get the benefit of protection through the winter,” Dr. Schaffner said.

As with earlier versions of the COVID-19 vaccine, side effects vary from person to person. Reported side effects of the updated vaccine are similar to those seen with earlier versions and may include injection site pain, redness and swelling, fatigue, headache, muscle pain, chills, nausea, and fever, but most of these are short-lived, according to the CDC.
 

Clinical Guidance

The CDC’s clinical guidance for COVID-19 vaccination outlines more specific guidance for vaccination based on age, vaccination history, and immunocompromised status and will be updated as needed.

A notable difference in the latest guidance is the recommendation of only one shot for adults aged 65 years and older who are NOT moderately or severely immunocompromised. For those who are moderately or severely immunocompromised, the CDC recommends two to three doses of the same brand of vaccine.

Dr. Schaffner strongly encouraged clinicians to recommend the COVID-19 vaccination for all eligible patients. “COVID is a nasty virus that can cause serious disease in anyone,” and protection from previous vaccination or prior infection has likely waned, he said.

Dr. Schaffner also encouraged healthcare professionals and their families to lead by example. “We should all be vaccinated and let our patients know that we are vaccinated and that we want all our patents to be protected,” he said.

The updated COVID-19 vaccination recommendations have become much simpler for clinicians and patients, with a single messenger RNA (mRNA) vaccine required for anyone older than 5 years, said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

“The recommendations are a bit more complex for children under 5 years old receiving their first vaccination; they require two to three doses depending on the brand,” he said. “It is important to review the latest recommendations to plan the doses with the correct interval timing. Considering the doses may be 3-4 weeks apart, start early,” he advised.
 

One-Time Dosing

Although the updated mRNA vaccine is currently recommended as a one-time dose, Dr. Cennimo said he can envision a scenario later in the season when a second dose is recommended for the elderly and those at high risk for severe illness. Dr. Cennimo said that he strongly agrees with the recommendations that everyone aged 6 months and older receive an updated COVID-19 vaccine. Older age remains the prime risk factor, but anyone can become infected, he said.

Predicting a prime time to get vaccinated is tricky because no one knows when the expected rise in winter cases will occur, said Dr. Cennimo.

“We know from years of flu vaccine data that some number of people who delay the vaccine will never return and will miss protection,” he said. Therefore, delaying vaccination is not recommended. Dr. Cennimo plans to follow his habit of getting vaccinated in early October. “I anticipate the maximal effectiveness of the vaccine will carry me through the winter,” he said.

Data support the safety and effectiveness for both flu and COVID vaccines if they are given together, and some research on earlier versions of COVID vaccines suggested that receiving flu and COVID vaccines together might increase the antibody response against COVID, but similar studies of the updated version have not been done, Dr. Cennimo said.

Clinicians may have to overcome the barrier of COVID fatigue to encourage vaccination, Dr. Cennimo said. Many people say they “want it to be over,” he said, but SARS-CoV-2, established as a viral respiratory infection, shows no signs of disappearing. In addition, new data continue to show higher mortality associated with COVID-19 than with influenza, he said.

“We need to explain to our patients that COVID-19 is still here and is still dangerous. The yearly influenza vaccination campaigns should have established and normalized the idea of an updated vaccine targeted for the season’s predicated strains is expected,” he emphasized. “We now have years of safety data behind these vaccines, and we need to make a strong recommendation for this protection,” he said.

COVID-19 vaccines are covered by private insurance, as well as by Medicare and Medicaid, according to the CDC. Vaccination for uninsured children is covered through the Vaccines for Children Program.

A version of this article first appeared on Medscape.com.

New COVID-19 vaccines formulated for better protection against the currently circulating variants have been approved by the US Food and Drug Administration.

The COVID vaccines available this fall have been updated to better match the currently circulating COVID strains, said William Schaffner, MD, professor of medicine in the Division of Infectious Diseases at Vanderbilt University, Nashville, Tennessee, in an interview.

“The Pfizer and Moderna vaccines — both mRNA vaccines — target the KP.2 variant, while the Novavax vaccine targets the JN.1 variant, which is a predecessor to KP.2,” said Dr. Schaffner, who also serves as a spokesperson for the National Foundation for Infectious Diseases. “The Novavax vaccine is a protein adjuvant vaccine made in a more traditional fashion and may appeal to those who remain hesitant about receiving an mRNA vaccine,” he explained. However, all three vaccines are designed to protect against severe COVID illness and reduce the likelihood of hospitalization, he said.
 

Who Needs It?

“The CDC’s Advisory Committee on Immunization Practices (ACIP) continues to recommend that everyone in the United States who is age 6 months and older receive the updated COVID vaccine this fall, along with influenza vaccine,” Dr. Schaffner said.

“This was not a surprise because COVID will produce a sizable winter outbreak,” he predicted. Although older people and those who have chronic medical conditions such as heart or lung disease, diabetes, or other immunocompromising conditions suffer the most serious impact of COVID, he said. “The virus can strike anyone, even the young and healthy.” The risk for long COVID persists as well, he pointed out.

The ACIP recommendation is endorsed by the American Academy of Pediatrics and other professional organizations, Dr. Shaffner said.

A frequently asked question is whether the COVID and flu vaccines can be given at the same time, and the answer is yes, according to a statement from the Centers for Disease Control and Prevention (CDC).

“The optimal time to be vaccinated is late September and anytime during October in order to get the benefit of protection through the winter,” Dr. Schaffner said.

As with earlier versions of the COVID-19 vaccine, side effects vary from person to person. Reported side effects of the updated vaccine are similar to those seen with earlier versions and may include injection site pain, redness and swelling, fatigue, headache, muscle pain, chills, nausea, and fever, but most of these are short-lived, according to the CDC.
 

Clinical Guidance

The CDC’s clinical guidance for COVID-19 vaccination outlines more specific guidance for vaccination based on age, vaccination history, and immunocompromised status and will be updated as needed.

A notable difference in the latest guidance is the recommendation of only one shot for adults aged 65 years and older who are NOT moderately or severely immunocompromised. For those who are moderately or severely immunocompromised, the CDC recommends two to three doses of the same brand of vaccine.

Dr. Schaffner strongly encouraged clinicians to recommend the COVID-19 vaccination for all eligible patients. “COVID is a nasty virus that can cause serious disease in anyone,” and protection from previous vaccination or prior infection has likely waned, he said.

Dr. Schaffner also encouraged healthcare professionals and their families to lead by example. “We should all be vaccinated and let our patients know that we are vaccinated and that we want all our patents to be protected,” he said.

The updated COVID-19 vaccination recommendations have become much simpler for clinicians and patients, with a single messenger RNA (mRNA) vaccine required for anyone older than 5 years, said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

“The recommendations are a bit more complex for children under 5 years old receiving their first vaccination; they require two to three doses depending on the brand,” he said. “It is important to review the latest recommendations to plan the doses with the correct interval timing. Considering the doses may be 3-4 weeks apart, start early,” he advised.
 

One-Time Dosing

Although the updated mRNA vaccine is currently recommended as a one-time dose, Dr. Cennimo said he can envision a scenario later in the season when a second dose is recommended for the elderly and those at high risk for severe illness. Dr. Cennimo said that he strongly agrees with the recommendations that everyone aged 6 months and older receive an updated COVID-19 vaccine. Older age remains the prime risk factor, but anyone can become infected, he said.

Predicting a prime time to get vaccinated is tricky because no one knows when the expected rise in winter cases will occur, said Dr. Cennimo.

“We know from years of flu vaccine data that some number of people who delay the vaccine will never return and will miss protection,” he said. Therefore, delaying vaccination is not recommended. Dr. Cennimo plans to follow his habit of getting vaccinated in early October. “I anticipate the maximal effectiveness of the vaccine will carry me through the winter,” he said.

Data support the safety and effectiveness for both flu and COVID vaccines if they are given together, and some research on earlier versions of COVID vaccines suggested that receiving flu and COVID vaccines together might increase the antibody response against COVID, but similar studies of the updated version have not been done, Dr. Cennimo said.

Clinicians may have to overcome the barrier of COVID fatigue to encourage vaccination, Dr. Cennimo said. Many people say they “want it to be over,” he said, but SARS-CoV-2, established as a viral respiratory infection, shows no signs of disappearing. In addition, new data continue to show higher mortality associated with COVID-19 than with influenza, he said.

“We need to explain to our patients that COVID-19 is still here and is still dangerous. The yearly influenza vaccination campaigns should have established and normalized the idea of an updated vaccine targeted for the season’s predicated strains is expected,” he emphasized. “We now have years of safety data behind these vaccines, and we need to make a strong recommendation for this protection,” he said.

COVID-19 vaccines are covered by private insurance, as well as by Medicare and Medicaid, according to the CDC. Vaccination for uninsured children is covered through the Vaccines for Children Program.

A version of this article first appeared on Medscape.com.

Prophylactic placement of balloon catheters or sheaths prior to planned cesarean delivery may reduce blood loss in women with placenta accreta spectrum disorder, according to a new systematic review of more than 5,000 individuals.

Placenta accreta spectrum disorder occurs when the endometrial-myometrial interface of the uterus is damaged, wrote Lisanne R. Bonsen, MD, of Leiden University Medical Center, the Netherlands, and colleagues. As a result, the placenta fails to detach at the time of birth and can result in life-threatening postpartum hemorrhage, the researchers said.

The greater the depth of placental invasiveness, the more severe the maternal outcomes, the researchers noted. Previous cesarean delivery is the primary risk factor for placenta accreta spectrum disorder, and the incidence has increased along with the increased rates of cesarean delivery on a global level, they explained.

More research is needed on intrapartum strategies to improve maternal outcomes, and prophylactic radiologic intervention to reduce perioperative blood loss has been explored, the researchers wrote. However, placenta accreta spectrum disorder remains relatively rare in most pregnancy settings, and data on the effect of prophylactic radiologic interventions to reduce bleeding in this high-risk population are limited they said.

In the review published in Obstetrics & Gynecology, the researchers analyzed data from 50 studies of prophylactic radiologic interventions (48 observational studies and 2 randomized, controlled trials) including 5,962 women.

The primary outcome was perioperative blood loss; secondary outcomes included the number of red blood cells transferred within 24 hours after delivery, maternal mortality, adverse events related to the interventions, and surgical complications.

Blood loss was significantly lower in the intervention groups compared with the control groups for patients who underwent distal balloon occlusion (30 studies), proximal balloon occlusion (14 studies), or uterine artery embolization (5 studies), with mean differences in blood loss of 406 mL, 1,041 mL, and 936 mL, respectively.

Results were similar with lower blood loss for intervention patients compared with controls in subgroup analyses of different types of placenta accreta spectrum disorder and those with placenta accreta spectrum disorder confirmed post partum.

Across the 35 studies that included data on blood transfusions, women who underwent any prophylactic radiologic intervention averaged fewer red blood cell units transferred than women who had no radiologic intervention, with a mean difference of 1.13, 1.90, and 1.86 units for distal prophylactic balloon occlusion, proximal prophylactic balloon occlusion, and prophylactic uterine artery embolization, respectively.

Data on adverse events related to the interventions were limited, but noted in approximately 2% of patients who underwent distal or proximal prophylactic balloon occlusion, and 45% of patients who underwent prophylactic uterine artery embolization. One maternal death was reported and attributed to diffuse intravascular coagulation. Three cardiac arrests occurred in control patients across different studies and all were successfully resuscitated.

Most of the studies did not report data on the researchers’ predefined secondary outcomes, including shock, transfer to a higher level of care, coagulopathy, organ dysfunction, and patient-reported outcomes.
 

What Works Best

“Our main analysis reveals differences in outcomes among the three interventions, with proximal balloon occlusion demonstrating the strongest effect,” the researchers wrote. “Our results show a blood loss reduction of 406 mL by distal prophylactic balloon occlusion. An explanation for the differences between the results of prophylactic balloon occlusion–distal and prophylactic balloon occlusion–proximal could be that implementing occlusion at a distal level may be less effective because of bleeding from the collateral circulation,” they said.

The findings were limited by several factors including the observational design of most of the studies, variation in measurements of blood loss among studies and in inclusion criteria, and insufficient adverse event data to draw conclusions about safety, the researchers noted. More research is needed to examine efficacy and safety of the interventions according to different sensitivities of placenta accreta spectrum disorder, they added.

Results Support Judicious Intervention

“Although previous studies showed mixed results, our meta-analysis demonstrated that prophylactic radiologic interventions, particularly balloon occlusion (both distal and proximal), were associated with reduced perioperative blood loss and less red blood cell unit transfusion; this was most pronounced in women with confirmed placenta percreta,” Bonsen said in an interview. However, the heterogeneity across the included studies prevents generalizations about the overall effects of the interventions across different severities of placenta accreta spectrum disorder, she said.*

Despite these limitations, the overview of the currently available evidence provides insights for clinical decision making, said Bonsen. “Our study highlights that, if we were to be certain of the diagnosis of placenta accreta spectrum disorder antepartum, prophylactic radiologic intervention could help reduce peripartum blood loss,” she said.

Risks vs Benefits

“Given the challenges in performing randomized surgical trials in a pregnant patient population with an uncommon disorder, this level of evidence provides important data to assist with clinical decision making in patients with placenta accreta spectrum disorder,” despite the limitations of the observational studies, wrote Jocelyn S. Chapman, MD, and Arianna M. Cassidy, MD, both affiliated with the Multidisciplinary Approach to Placenta Accreta Spectrum Disorder Service (MAPS) at the University of California, San Francisco, in an accompanying editorial.

Previous research has shown an increased risk of severe maternal morbidity among women with placenta accreta spectrum disorder and previous intervention strategies have involved protocols, surgical techniques, and management strategies, they wrote.

Uterine artery embolization after cesarean delivery also has been associated with reduced hemorrhage and no adverse events, but this procedure was not included in the studies reviewed and is best conducted in a delivery setup not available in many hospital systems, the editorialists noted.

The current study illustrates the value of prophylactic balloon occlusion and placement of vascular sheaths to reduce blood loss and blood transfusion, but the risk of thrombosis and lumbosacral pain must be considered, they said. These risks may be a reasonable trade-off to avoid severe blood loss and ICU care, and to preserve the uterus, Chapman and Cassidy added.

“However, we would urge continued critical appraisal of each placenta accreta spectrum disorder case with a multidisciplinary team to evaluate the available evidence-based strategies most likely to mitigate clinically relevant complications while minimizing the introduction of new ones,” the editorialists concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Chapman and Dr. Cassidy had no financial conflicts to disclose.

*This story was updated on August 28, 2024.

Prophylactic placement of balloon catheters or sheaths prior to planned cesarean delivery may reduce blood loss in women with placenta accreta spectrum disorder, according to a new systematic review of more than 5,000 individuals.

Placenta accreta spectrum disorder occurs when the endometrial-myometrial interface of the uterus is damaged, wrote Lisanne R. Bonsen, MD, of Leiden University Medical Center, the Netherlands, and colleagues. As a result, the placenta fails to detach at the time of birth and can result in life-threatening postpartum hemorrhage, the researchers said.

The greater the depth of placental invasiveness, the more severe the maternal outcomes, the researchers noted. Previous cesarean delivery is the primary risk factor for placenta accreta spectrum disorder, and the incidence has increased along with the increased rates of cesarean delivery on a global level, they explained.

More research is needed on intrapartum strategies to improve maternal outcomes, and prophylactic radiologic intervention to reduce perioperative blood loss has been explored, the researchers wrote. However, placenta accreta spectrum disorder remains relatively rare in most pregnancy settings, and data on the effect of prophylactic radiologic interventions to reduce bleeding in this high-risk population are limited they said.

In the review published in Obstetrics & Gynecology, the researchers analyzed data from 50 studies of prophylactic radiologic interventions (48 observational studies and 2 randomized, controlled trials) including 5,962 women.

The primary outcome was perioperative blood loss; secondary outcomes included the number of red blood cells transferred within 24 hours after delivery, maternal mortality, adverse events related to the interventions, and surgical complications.

Blood loss was significantly lower in the intervention groups compared with the control groups for patients who underwent distal balloon occlusion (30 studies), proximal balloon occlusion (14 studies), or uterine artery embolization (5 studies), with mean differences in blood loss of 406 mL, 1,041 mL, and 936 mL, respectively.

Results were similar with lower blood loss for intervention patients compared with controls in subgroup analyses of different types of placenta accreta spectrum disorder and those with placenta accreta spectrum disorder confirmed post partum.

Across the 35 studies that included data on blood transfusions, women who underwent any prophylactic radiologic intervention averaged fewer red blood cell units transferred than women who had no radiologic intervention, with a mean difference of 1.13, 1.90, and 1.86 units for distal prophylactic balloon occlusion, proximal prophylactic balloon occlusion, and prophylactic uterine artery embolization, respectively.

Data on adverse events related to the interventions were limited, but noted in approximately 2% of patients who underwent distal or proximal prophylactic balloon occlusion, and 45% of patients who underwent prophylactic uterine artery embolization. One maternal death was reported and attributed to diffuse intravascular coagulation. Three cardiac arrests occurred in control patients across different studies and all were successfully resuscitated.

Most of the studies did not report data on the researchers’ predefined secondary outcomes, including shock, transfer to a higher level of care, coagulopathy, organ dysfunction, and patient-reported outcomes.
 

What Works Best

“Our main analysis reveals differences in outcomes among the three interventions, with proximal balloon occlusion demonstrating the strongest effect,” the researchers wrote. “Our results show a blood loss reduction of 406 mL by distal prophylactic balloon occlusion. An explanation for the differences between the results of prophylactic balloon occlusion–distal and prophylactic balloon occlusion–proximal could be that implementing occlusion at a distal level may be less effective because of bleeding from the collateral circulation,” they said.

The findings were limited by several factors including the observational design of most of the studies, variation in measurements of blood loss among studies and in inclusion criteria, and insufficient adverse event data to draw conclusions about safety, the researchers noted. More research is needed to examine efficacy and safety of the interventions according to different sensitivities of placenta accreta spectrum disorder, they added.

Results Support Judicious Intervention

“Although previous studies showed mixed results, our meta-analysis demonstrated that prophylactic radiologic interventions, particularly balloon occlusion (both distal and proximal), were associated with reduced perioperative blood loss and less red blood cell unit transfusion; this was most pronounced in women with confirmed placenta percreta,” Bonsen said in an interview. However, the heterogeneity across the included studies prevents generalizations about the overall effects of the interventions across different severities of placenta accreta spectrum disorder, she said.*

Despite these limitations, the overview of the currently available evidence provides insights for clinical decision making, said Bonsen. “Our study highlights that, if we were to be certain of the diagnosis of placenta accreta spectrum disorder antepartum, prophylactic radiologic intervention could help reduce peripartum blood loss,” she said.

Risks vs Benefits

“Given the challenges in performing randomized surgical trials in a pregnant patient population with an uncommon disorder, this level of evidence provides important data to assist with clinical decision making in patients with placenta accreta spectrum disorder,” despite the limitations of the observational studies, wrote Jocelyn S. Chapman, MD, and Arianna M. Cassidy, MD, both affiliated with the Multidisciplinary Approach to Placenta Accreta Spectrum Disorder Service (MAPS) at the University of California, San Francisco, in an accompanying editorial.

Previous research has shown an increased risk of severe maternal morbidity among women with placenta accreta spectrum disorder and previous intervention strategies have involved protocols, surgical techniques, and management strategies, they wrote.

Uterine artery embolization after cesarean delivery also has been associated with reduced hemorrhage and no adverse events, but this procedure was not included in the studies reviewed and is best conducted in a delivery setup not available in many hospital systems, the editorialists noted.

The current study illustrates the value of prophylactic balloon occlusion and placement of vascular sheaths to reduce blood loss and blood transfusion, but the risk of thrombosis and lumbosacral pain must be considered, they said. These risks may be a reasonable trade-off to avoid severe blood loss and ICU care, and to preserve the uterus, Chapman and Cassidy added.

“However, we would urge continued critical appraisal of each placenta accreta spectrum disorder case with a multidisciplinary team to evaluate the available evidence-based strategies most likely to mitigate clinically relevant complications while minimizing the introduction of new ones,” the editorialists concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Chapman and Dr. Cassidy had no financial conflicts to disclose.

*This story was updated on August 28, 2024.

Prophylactic placement of balloon catheters or sheaths prior to planned cesarean delivery may reduce blood loss in women with placenta accreta spectrum disorder, according to a new systematic review of more than 5,000 individuals.

Placenta accreta spectrum disorder occurs when the endometrial-myometrial interface of the uterus is damaged, wrote Lisanne R. Bonsen, MD, of Leiden University Medical Center, the Netherlands, and colleagues. As a result, the placenta fails to detach at the time of birth and can result in life-threatening postpartum hemorrhage, the researchers said.

The greater the depth of placental invasiveness, the more severe the maternal outcomes, the researchers noted. Previous cesarean delivery is the primary risk factor for placenta accreta spectrum disorder, and the incidence has increased along with the increased rates of cesarean delivery on a global level, they explained.

More research is needed on intrapartum strategies to improve maternal outcomes, and prophylactic radiologic intervention to reduce perioperative blood loss has been explored, the researchers wrote. However, placenta accreta spectrum disorder remains relatively rare in most pregnancy settings, and data on the effect of prophylactic radiologic interventions to reduce bleeding in this high-risk population are limited they said.

In the review published in Obstetrics & Gynecology, the researchers analyzed data from 50 studies of prophylactic radiologic interventions (48 observational studies and 2 randomized, controlled trials) including 5,962 women.

The primary outcome was perioperative blood loss; secondary outcomes included the number of red blood cells transferred within 24 hours after delivery, maternal mortality, adverse events related to the interventions, and surgical complications.

Blood loss was significantly lower in the intervention groups compared with the control groups for patients who underwent distal balloon occlusion (30 studies), proximal balloon occlusion (14 studies), or uterine artery embolization (5 studies), with mean differences in blood loss of 406 mL, 1,041 mL, and 936 mL, respectively.

Results were similar with lower blood loss for intervention patients compared with controls in subgroup analyses of different types of placenta accreta spectrum disorder and those with placenta accreta spectrum disorder confirmed post partum.

Across the 35 studies that included data on blood transfusions, women who underwent any prophylactic radiologic intervention averaged fewer red blood cell units transferred than women who had no radiologic intervention, with a mean difference of 1.13, 1.90, and 1.86 units for distal prophylactic balloon occlusion, proximal prophylactic balloon occlusion, and prophylactic uterine artery embolization, respectively.

Data on adverse events related to the interventions were limited, but noted in approximately 2% of patients who underwent distal or proximal prophylactic balloon occlusion, and 45% of patients who underwent prophylactic uterine artery embolization. One maternal death was reported and attributed to diffuse intravascular coagulation. Three cardiac arrests occurred in control patients across different studies and all were successfully resuscitated.

Most of the studies did not report data on the researchers’ predefined secondary outcomes, including shock, transfer to a higher level of care, coagulopathy, organ dysfunction, and patient-reported outcomes.
 

What Works Best

“Our main analysis reveals differences in outcomes among the three interventions, with proximal balloon occlusion demonstrating the strongest effect,” the researchers wrote. “Our results show a blood loss reduction of 406 mL by distal prophylactic balloon occlusion. An explanation for the differences between the results of prophylactic balloon occlusion–distal and prophylactic balloon occlusion–proximal could be that implementing occlusion at a distal level may be less effective because of bleeding from the collateral circulation,” they said.

The findings were limited by several factors including the observational design of most of the studies, variation in measurements of blood loss among studies and in inclusion criteria, and insufficient adverse event data to draw conclusions about safety, the researchers noted. More research is needed to examine efficacy and safety of the interventions according to different sensitivities of placenta accreta spectrum disorder, they added.

Results Support Judicious Intervention

“Although previous studies showed mixed results, our meta-analysis demonstrated that prophylactic radiologic interventions, particularly balloon occlusion (both distal and proximal), were associated with reduced perioperative blood loss and less red blood cell unit transfusion; this was most pronounced in women with confirmed placenta percreta,” Bonsen said in an interview. However, the heterogeneity across the included studies prevents generalizations about the overall effects of the interventions across different severities of placenta accreta spectrum disorder, she said.*

Despite these limitations, the overview of the currently available evidence provides insights for clinical decision making, said Bonsen. “Our study highlights that, if we were to be certain of the diagnosis of placenta accreta spectrum disorder antepartum, prophylactic radiologic intervention could help reduce peripartum blood loss,” she said.

Risks vs Benefits

“Given the challenges in performing randomized surgical trials in a pregnant patient population with an uncommon disorder, this level of evidence provides important data to assist with clinical decision making in patients with placenta accreta spectrum disorder,” despite the limitations of the observational studies, wrote Jocelyn S. Chapman, MD, and Arianna M. Cassidy, MD, both affiliated with the Multidisciplinary Approach to Placenta Accreta Spectrum Disorder Service (MAPS) at the University of California, San Francisco, in an accompanying editorial.

Previous research has shown an increased risk of severe maternal morbidity among women with placenta accreta spectrum disorder and previous intervention strategies have involved protocols, surgical techniques, and management strategies, they wrote.

Uterine artery embolization after cesarean delivery also has been associated with reduced hemorrhage and no adverse events, but this procedure was not included in the studies reviewed and is best conducted in a delivery setup not available in many hospital systems, the editorialists noted.

The current study illustrates the value of prophylactic balloon occlusion and placement of vascular sheaths to reduce blood loss and blood transfusion, but the risk of thrombosis and lumbosacral pain must be considered, they said. These risks may be a reasonable trade-off to avoid severe blood loss and ICU care, and to preserve the uterus, Chapman and Cassidy added.

“However, we would urge continued critical appraisal of each placenta accreta spectrum disorder case with a multidisciplinary team to evaluate the available evidence-based strategies most likely to mitigate clinically relevant complications while minimizing the introduction of new ones,” the editorialists concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Chapman and Dr. Cassidy had no financial conflicts to disclose.

*This story was updated on August 28, 2024.

A single night of sleep deprivation had a significant impact on human blood serum, based on new data from an analysis of nearly 500 proteins. Compromised sleep has demonstrated negative effects on cardiovascular, immune, and neuronal systems, and previous studies have shown human serum proteome changes after a simulation of night shift work, wrote Alvhild Alette Bjørkum, MD, of Western Norway University of Applied Sciences, Bergen, and colleagues.

In a pilot study published in Sleep Advances, the researchers recruited eight healthy adult women aged 22-57 years with no history of neurologic or psychiatric problems to participate in a study of the effect of compromised sleep on protein profiles, with implications for effects on cells, tissues, and organ systems. Each of the participants served as their own controls, and blood samples were taken after 6 hours of sleep at night, and again after 6 hours of sleep deprivation the following night.

The researchers identified analyzed 494 proteins using mass spectrometry. Of these, 66 were differentially expressed after 6 hours of sleep deprivation. The top enriched biologic processes of these significantly changed proteins were protein activation cascade, platelet degranulation, blood coagulation, and hemostasis.

Further analysis using gene ontology showed changes in response to sleep deprivation in biologic process, molecular function, and immune system process categories, including specific associations related to wound healing, cholesterol transport, high-density lipoprotein particle receptor binding, and granulocyte chemotaxis.

The findings were limited by several factors including the small sample size, inclusion only of adult females, and the use of data from only 1 night of sleep deprivation, the researchers noted. However, the results support previous studies showing a negative impact of sleep deprivation on biologic functions, they said.

“Our study was able to reveal another set of human serum proteins that were altered by sleep deprivation and could connect similar biological processes to sleep deprivation that have been identified before with slightly different methods,” the researchers concluded. The study findings add to the knowledge base for the protein profiling of sleep deprivation, which may inform the development of tools to manage lack of sleep and mistimed sleep, particularly in shift workers.
 

Too Soon for Clinical Implications

“The adverse impact of poor sleep across many organ systems is gaining recognition, but the mechanisms underlying sleep-related pathology are not well understood,” Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. “Studies like this begin to shed light on the mechanisms by which poor or reduced sleep affects specific bodily functions,” added Dr. Brittain, who was not involved in the study.

“The effects of other acute physiologic stressor such as exercise on the circulating proteome are well described. In that regard, it is not surprising that a brief episode of sleep deprivation would lead to detectable changes in the circulation,” Dr. Brittain said.

However, the specific changes reported in this study are difficult to interpret because of methodological and analytical concerns, particularly the small sample size, lack of an external validation cohort, and absence of appropriate statistical adjustments in the results, Dr. Brittain noted. These limitations prevent consideration of clinical implications without further study.

The study received no outside funding. Neither the researchers nor Dr. Brittain disclosed any conflicts of interest.

A version of this article first appeared on Medscape.com.

A single night of sleep deprivation had a significant impact on human blood serum, based on new data from an analysis of nearly 500 proteins. Compromised sleep has demonstrated negative effects on cardiovascular, immune, and neuronal systems, and previous studies have shown human serum proteome changes after a simulation of night shift work, wrote Alvhild Alette Bjørkum, MD, of Western Norway University of Applied Sciences, Bergen, and colleagues.

In a pilot study published in Sleep Advances, the researchers recruited eight healthy adult women aged 22-57 years with no history of neurologic or psychiatric problems to participate in a study of the effect of compromised sleep on protein profiles, with implications for effects on cells, tissues, and organ systems. Each of the participants served as their own controls, and blood samples were taken after 6 hours of sleep at night, and again after 6 hours of sleep deprivation the following night.

The researchers identified analyzed 494 proteins using mass spectrometry. Of these, 66 were differentially expressed after 6 hours of sleep deprivation. The top enriched biologic processes of these significantly changed proteins were protein activation cascade, platelet degranulation, blood coagulation, and hemostasis.

Further analysis using gene ontology showed changes in response to sleep deprivation in biologic process, molecular function, and immune system process categories, including specific associations related to wound healing, cholesterol transport, high-density lipoprotein particle receptor binding, and granulocyte chemotaxis.

The findings were limited by several factors including the small sample size, inclusion only of adult females, and the use of data from only 1 night of sleep deprivation, the researchers noted. However, the results support previous studies showing a negative impact of sleep deprivation on biologic functions, they said.

“Our study was able to reveal another set of human serum proteins that were altered by sleep deprivation and could connect similar biological processes to sleep deprivation that have been identified before with slightly different methods,” the researchers concluded. The study findings add to the knowledge base for the protein profiling of sleep deprivation, which may inform the development of tools to manage lack of sleep and mistimed sleep, particularly in shift workers.
 

Too Soon for Clinical Implications

“The adverse impact of poor sleep across many organ systems is gaining recognition, but the mechanisms underlying sleep-related pathology are not well understood,” Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. “Studies like this begin to shed light on the mechanisms by which poor or reduced sleep affects specific bodily functions,” added Dr. Brittain, who was not involved in the study.

“The effects of other acute physiologic stressor such as exercise on the circulating proteome are well described. In that regard, it is not surprising that a brief episode of sleep deprivation would lead to detectable changes in the circulation,” Dr. Brittain said.

However, the specific changes reported in this study are difficult to interpret because of methodological and analytical concerns, particularly the small sample size, lack of an external validation cohort, and absence of appropriate statistical adjustments in the results, Dr. Brittain noted. These limitations prevent consideration of clinical implications without further study.

The study received no outside funding. Neither the researchers nor Dr. Brittain disclosed any conflicts of interest.

A version of this article first appeared on Medscape.com.

A single night of sleep deprivation had a significant impact on human blood serum, based on new data from an analysis of nearly 500 proteins. Compromised sleep has demonstrated negative effects on cardiovascular, immune, and neuronal systems, and previous studies have shown human serum proteome changes after a simulation of night shift work, wrote Alvhild Alette Bjørkum, MD, of Western Norway University of Applied Sciences, Bergen, and colleagues.

In a pilot study published in Sleep Advances, the researchers recruited eight healthy adult women aged 22-57 years with no history of neurologic or psychiatric problems to participate in a study of the effect of compromised sleep on protein profiles, with implications for effects on cells, tissues, and organ systems. Each of the participants served as their own controls, and blood samples were taken after 6 hours of sleep at night, and again after 6 hours of sleep deprivation the following night.

The researchers identified analyzed 494 proteins using mass spectrometry. Of these, 66 were differentially expressed after 6 hours of sleep deprivation. The top enriched biologic processes of these significantly changed proteins were protein activation cascade, platelet degranulation, blood coagulation, and hemostasis.

Further analysis using gene ontology showed changes in response to sleep deprivation in biologic process, molecular function, and immune system process categories, including specific associations related to wound healing, cholesterol transport, high-density lipoprotein particle receptor binding, and granulocyte chemotaxis.

The findings were limited by several factors including the small sample size, inclusion only of adult females, and the use of data from only 1 night of sleep deprivation, the researchers noted. However, the results support previous studies showing a negative impact of sleep deprivation on biologic functions, they said.

“Our study was able to reveal another set of human serum proteins that were altered by sleep deprivation and could connect similar biological processes to sleep deprivation that have been identified before with slightly different methods,” the researchers concluded. The study findings add to the knowledge base for the protein profiling of sleep deprivation, which may inform the development of tools to manage lack of sleep and mistimed sleep, particularly in shift workers.
 

Too Soon for Clinical Implications

“The adverse impact of poor sleep across many organ systems is gaining recognition, but the mechanisms underlying sleep-related pathology are not well understood,” Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview. “Studies like this begin to shed light on the mechanisms by which poor or reduced sleep affects specific bodily functions,” added Dr. Brittain, who was not involved in the study.

“The effects of other acute physiologic stressor such as exercise on the circulating proteome are well described. In that regard, it is not surprising that a brief episode of sleep deprivation would lead to detectable changes in the circulation,” Dr. Brittain said.

However, the specific changes reported in this study are difficult to interpret because of methodological and analytical concerns, particularly the small sample size, lack of an external validation cohort, and absence of appropriate statistical adjustments in the results, Dr. Brittain noted. These limitations prevent consideration of clinical implications without further study.

The study received no outside funding. Neither the researchers nor Dr. Brittain disclosed any conflicts of interest.

A version of this article first appeared on Medscape.com.