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New outbreaks of Marburg virus disease: What clinicians need to know
What do green monkeys, fruit bats, and python caves all have in common? All have been implicated in outbreaks as transmission sources of the rare but deadly Marburg virus. Marburg virus is in the same Filoviridae family of highly pathogenic RNA viruses as Ebola virus, and similarly can cause a rapidly progressive and fatal viral hemorrhagic fever.
In the first reported Marburg outbreak in 1967, laboratory workers in Marburg and Frankfurt, Germany, and in Belgrade, Yugoslavia, developed severe febrile illnesses with massive hemorrhage and multiorgan system dysfunction after contact with infected African green monkeys imported from Uganda.
The majority of MVD outbreaks have occurred in sub-Saharan Africa, and primarily in three African countries: Angola, the Democratic Republic of Congo, and Uganda. In sub-Saharan Africa, these sporadic outbreaks have had high case fatality rates (up to 80%-90%) and been linked to human exposure to the oral secretions or urinary/fecal droppings of Egyptian fruit bats (Rousettus aegyptiacus), the animal reservoir for Marburg virus. These exposures have primarily occurred among miners or tourists frequenting bat-infested mines or caves, including Uganda’s python cave, where Centers for Disease Control and Prevention investigators have conducted ecological studies on Marburg-infected bats. Person-to-person transmission occurs from direct contact with the blood or bodily fluids of an infected person or contact with a contaminated object (for example, unsterilized needles and syringes in a large nosocomial outbreak in Angola).
On April 6, 2023, the CDC issued a Health Advisory for U.S. clinicians and public health departments regarding two separate MVD outbreaks in Equatorial Guinea and Tanzania. These first-ever MVD outbreaks in both West and East African countries appear to be epidemiologically unrelated. As of March 24, 2023, in Equatorial Guinea, a total of 15 confirmed cases, including 11 deaths, and 23 probable cases, all deceased, have been identified in multiple districts since the outbreak declaration in February 2023. In Tanzania, a total of eight cases, including five deaths, have been reported among villagers in a northwest region since the outbreak declaration in March 2023. While so far cases in the Tanzania MVD outbreak have been epidemiologically linked, in Equatorial Guinea some cases have no identified epidemiological links, raising concern for ongoing community spread.
To date, no cases in these outbreaks have been reported in the United States or outside the affected countries. Overall, the risk of MVD in nonendemic countries, like the United States, is low but there is still a risk of importation. As of May 2, 2023, CDC has issued a Level 2 travel alert (practice enhanced precautions) for Marburg in Equatorial Guinea and a Level 1 travel watch (practice usual precautions) for Marburg in Tanzania. Travelers to these countries are advised to avoid nonessential travel to areas with active outbreaks and practice preventative measures, including avoiding contact with sick people, blood and bodily fluids, dead bodies, fruit bats, and nonhuman primates. International travelers returning to the United States from these countries are advised to self-monitor for Marburg symptoms during travel and for 21 days after country departure. Travelers who develop signs or symptoms of MVD should immediately self-isolate and contact their local health department or clinician.
So, how should clinicians manage such return travelers? In the setting of these new MVD outbreaks in sub-Saharan Africa, what do U.S. clinicians need to know? Clinicians should consider MVD in the differential diagnosis of ill patients with a compatible exposure history and clinical presentation. A detailed exposure history should be obtained to determine if patients have been to an area with an active MVD outbreak during their incubation period (in the past 21 days), had concerning epidemiologic risk factors (for example, presence at funerals, health care facilities, in mines/caves) while in the affected area, and/or had contact with a suspected or confirmed MVD case.
Clinical diagnosis of MVD is challenging as the initial dry symptoms of infection are nonspecific (fever, influenza-like illness, malaise, anorexia, etc.) and can resemble other febrile infectious illnesses. Similarly, presenting alternative or concurrent infections, particularly in febrile return travelers, include malaria, Lassa fever, typhoid, and measles. From these nonspecific symptoms, patients with MVD can then progress to the more severe wet symptoms (for example, vomiting, diarrhea, and bleeding). Common clinical features of MVD have been described based on the clinical presentation and course of cases in MVD outbreaks. Notably, in the original Marburg outbreak, maculopapular rash and conjunctival injection were early patient symptoms and most patient deaths occurred during the second week of illness progression.
Supportive care, including aggressive fluid replacement, is the mainstay of therapy for MVD. Currently, there are no Food and Drug Administration–approved antiviral treatments or vaccines for Marburg virus. Despite their viral similarities, vaccines against Ebola virus have not been shown to be protective against Marburg virus. Marburg virus vaccine development is ongoing, with a few promising candidate vaccines in early phase 1 and 2 clinical trials. In 2022, in response to MVD outbreaks in Ghana and Guinea, the World Health Organization convened an international Marburg virus vaccine consortium which is working to promote global research collaboration for more rapid vaccine development.
In the absence of definitive therapies, early identification of patients with suspected MVD is critical for preventing the spread of infection to close contacts. Like Ebola virus–infected patients, only symptomatic MVD patients are infectious and all patients with suspected MVD should be isolated in a private room and cared for in accordance with infection control procedures. As MVD is a nationally notifiable disease, suspected cases should be reported to local or state health departments as per jurisdictional requirements. Clinicians should also consult with their local or state health department and CDC for guidance on testing patients with suspected MVD and consider prompt evaluation for other infectious etiologies in the patient’s differential diagnosis. Comprehensive guidance for clinicians on screening and diagnosing patients with MVD is available on the CDC website at https://www.cdc.gov/vhf/marburg/index.html.
Dr. Appiah (she/her) is a medical epidemiologist in the division of global migration and quarantine at the CDC. Dr. Appiah holds adjunct faculty appointment in the division of infectious diseases at Emory University, Atlanta. She also holds a commission in the U.S. Public Health Service and is a resident advisor, Uganda, U.S. President’s Malaria Initiative, at the CDC.
What do green monkeys, fruit bats, and python caves all have in common? All have been implicated in outbreaks as transmission sources of the rare but deadly Marburg virus. Marburg virus is in the same Filoviridae family of highly pathogenic RNA viruses as Ebola virus, and similarly can cause a rapidly progressive and fatal viral hemorrhagic fever.
In the first reported Marburg outbreak in 1967, laboratory workers in Marburg and Frankfurt, Germany, and in Belgrade, Yugoslavia, developed severe febrile illnesses with massive hemorrhage and multiorgan system dysfunction after contact with infected African green monkeys imported from Uganda.
The majority of MVD outbreaks have occurred in sub-Saharan Africa, and primarily in three African countries: Angola, the Democratic Republic of Congo, and Uganda. In sub-Saharan Africa, these sporadic outbreaks have had high case fatality rates (up to 80%-90%) and been linked to human exposure to the oral secretions or urinary/fecal droppings of Egyptian fruit bats (Rousettus aegyptiacus), the animal reservoir for Marburg virus. These exposures have primarily occurred among miners or tourists frequenting bat-infested mines or caves, including Uganda’s python cave, where Centers for Disease Control and Prevention investigators have conducted ecological studies on Marburg-infected bats. Person-to-person transmission occurs from direct contact with the blood or bodily fluids of an infected person or contact with a contaminated object (for example, unsterilized needles and syringes in a large nosocomial outbreak in Angola).
On April 6, 2023, the CDC issued a Health Advisory for U.S. clinicians and public health departments regarding two separate MVD outbreaks in Equatorial Guinea and Tanzania. These first-ever MVD outbreaks in both West and East African countries appear to be epidemiologically unrelated. As of March 24, 2023, in Equatorial Guinea, a total of 15 confirmed cases, including 11 deaths, and 23 probable cases, all deceased, have been identified in multiple districts since the outbreak declaration in February 2023. In Tanzania, a total of eight cases, including five deaths, have been reported among villagers in a northwest region since the outbreak declaration in March 2023. While so far cases in the Tanzania MVD outbreak have been epidemiologically linked, in Equatorial Guinea some cases have no identified epidemiological links, raising concern for ongoing community spread.
To date, no cases in these outbreaks have been reported in the United States or outside the affected countries. Overall, the risk of MVD in nonendemic countries, like the United States, is low but there is still a risk of importation. As of May 2, 2023, CDC has issued a Level 2 travel alert (practice enhanced precautions) for Marburg in Equatorial Guinea and a Level 1 travel watch (practice usual precautions) for Marburg in Tanzania. Travelers to these countries are advised to avoid nonessential travel to areas with active outbreaks and practice preventative measures, including avoiding contact with sick people, blood and bodily fluids, dead bodies, fruit bats, and nonhuman primates. International travelers returning to the United States from these countries are advised to self-monitor for Marburg symptoms during travel and for 21 days after country departure. Travelers who develop signs or symptoms of MVD should immediately self-isolate and contact their local health department or clinician.
So, how should clinicians manage such return travelers? In the setting of these new MVD outbreaks in sub-Saharan Africa, what do U.S. clinicians need to know? Clinicians should consider MVD in the differential diagnosis of ill patients with a compatible exposure history and clinical presentation. A detailed exposure history should be obtained to determine if patients have been to an area with an active MVD outbreak during their incubation period (in the past 21 days), had concerning epidemiologic risk factors (for example, presence at funerals, health care facilities, in mines/caves) while in the affected area, and/or had contact with a suspected or confirmed MVD case.
Clinical diagnosis of MVD is challenging as the initial dry symptoms of infection are nonspecific (fever, influenza-like illness, malaise, anorexia, etc.) and can resemble other febrile infectious illnesses. Similarly, presenting alternative or concurrent infections, particularly in febrile return travelers, include malaria, Lassa fever, typhoid, and measles. From these nonspecific symptoms, patients with MVD can then progress to the more severe wet symptoms (for example, vomiting, diarrhea, and bleeding). Common clinical features of MVD have been described based on the clinical presentation and course of cases in MVD outbreaks. Notably, in the original Marburg outbreak, maculopapular rash and conjunctival injection were early patient symptoms and most patient deaths occurred during the second week of illness progression.
Supportive care, including aggressive fluid replacement, is the mainstay of therapy for MVD. Currently, there are no Food and Drug Administration–approved antiviral treatments or vaccines for Marburg virus. Despite their viral similarities, vaccines against Ebola virus have not been shown to be protective against Marburg virus. Marburg virus vaccine development is ongoing, with a few promising candidate vaccines in early phase 1 and 2 clinical trials. In 2022, in response to MVD outbreaks in Ghana and Guinea, the World Health Organization convened an international Marburg virus vaccine consortium which is working to promote global research collaboration for more rapid vaccine development.
In the absence of definitive therapies, early identification of patients with suspected MVD is critical for preventing the spread of infection to close contacts. Like Ebola virus–infected patients, only symptomatic MVD patients are infectious and all patients with suspected MVD should be isolated in a private room and cared for in accordance with infection control procedures. As MVD is a nationally notifiable disease, suspected cases should be reported to local or state health departments as per jurisdictional requirements. Clinicians should also consult with their local or state health department and CDC for guidance on testing patients with suspected MVD and consider prompt evaluation for other infectious etiologies in the patient’s differential diagnosis. Comprehensive guidance for clinicians on screening and diagnosing patients with MVD is available on the CDC website at https://www.cdc.gov/vhf/marburg/index.html.
Dr. Appiah (she/her) is a medical epidemiologist in the division of global migration and quarantine at the CDC. Dr. Appiah holds adjunct faculty appointment in the division of infectious diseases at Emory University, Atlanta. She also holds a commission in the U.S. Public Health Service and is a resident advisor, Uganda, U.S. President’s Malaria Initiative, at the CDC.
What do green monkeys, fruit bats, and python caves all have in common? All have been implicated in outbreaks as transmission sources of the rare but deadly Marburg virus. Marburg virus is in the same Filoviridae family of highly pathogenic RNA viruses as Ebola virus, and similarly can cause a rapidly progressive and fatal viral hemorrhagic fever.
In the first reported Marburg outbreak in 1967, laboratory workers in Marburg and Frankfurt, Germany, and in Belgrade, Yugoslavia, developed severe febrile illnesses with massive hemorrhage and multiorgan system dysfunction after contact with infected African green monkeys imported from Uganda.
The majority of MVD outbreaks have occurred in sub-Saharan Africa, and primarily in three African countries: Angola, the Democratic Republic of Congo, and Uganda. In sub-Saharan Africa, these sporadic outbreaks have had high case fatality rates (up to 80%-90%) and been linked to human exposure to the oral secretions or urinary/fecal droppings of Egyptian fruit bats (Rousettus aegyptiacus), the animal reservoir for Marburg virus. These exposures have primarily occurred among miners or tourists frequenting bat-infested mines or caves, including Uganda’s python cave, where Centers for Disease Control and Prevention investigators have conducted ecological studies on Marburg-infected bats. Person-to-person transmission occurs from direct contact with the blood or bodily fluids of an infected person or contact with a contaminated object (for example, unsterilized needles and syringes in a large nosocomial outbreak in Angola).
On April 6, 2023, the CDC issued a Health Advisory for U.S. clinicians and public health departments regarding two separate MVD outbreaks in Equatorial Guinea and Tanzania. These first-ever MVD outbreaks in both West and East African countries appear to be epidemiologically unrelated. As of March 24, 2023, in Equatorial Guinea, a total of 15 confirmed cases, including 11 deaths, and 23 probable cases, all deceased, have been identified in multiple districts since the outbreak declaration in February 2023. In Tanzania, a total of eight cases, including five deaths, have been reported among villagers in a northwest region since the outbreak declaration in March 2023. While so far cases in the Tanzania MVD outbreak have been epidemiologically linked, in Equatorial Guinea some cases have no identified epidemiological links, raising concern for ongoing community spread.
To date, no cases in these outbreaks have been reported in the United States or outside the affected countries. Overall, the risk of MVD in nonendemic countries, like the United States, is low but there is still a risk of importation. As of May 2, 2023, CDC has issued a Level 2 travel alert (practice enhanced precautions) for Marburg in Equatorial Guinea and a Level 1 travel watch (practice usual precautions) for Marburg in Tanzania. Travelers to these countries are advised to avoid nonessential travel to areas with active outbreaks and practice preventative measures, including avoiding contact with sick people, blood and bodily fluids, dead bodies, fruit bats, and nonhuman primates. International travelers returning to the United States from these countries are advised to self-monitor for Marburg symptoms during travel and for 21 days after country departure. Travelers who develop signs or symptoms of MVD should immediately self-isolate and contact their local health department or clinician.
So, how should clinicians manage such return travelers? In the setting of these new MVD outbreaks in sub-Saharan Africa, what do U.S. clinicians need to know? Clinicians should consider MVD in the differential diagnosis of ill patients with a compatible exposure history and clinical presentation. A detailed exposure history should be obtained to determine if patients have been to an area with an active MVD outbreak during their incubation period (in the past 21 days), had concerning epidemiologic risk factors (for example, presence at funerals, health care facilities, in mines/caves) while in the affected area, and/or had contact with a suspected or confirmed MVD case.
Clinical diagnosis of MVD is challenging as the initial dry symptoms of infection are nonspecific (fever, influenza-like illness, malaise, anorexia, etc.) and can resemble other febrile infectious illnesses. Similarly, presenting alternative or concurrent infections, particularly in febrile return travelers, include malaria, Lassa fever, typhoid, and measles. From these nonspecific symptoms, patients with MVD can then progress to the more severe wet symptoms (for example, vomiting, diarrhea, and bleeding). Common clinical features of MVD have been described based on the clinical presentation and course of cases in MVD outbreaks. Notably, in the original Marburg outbreak, maculopapular rash and conjunctival injection were early patient symptoms and most patient deaths occurred during the second week of illness progression.
Supportive care, including aggressive fluid replacement, is the mainstay of therapy for MVD. Currently, there are no Food and Drug Administration–approved antiviral treatments or vaccines for Marburg virus. Despite their viral similarities, vaccines against Ebola virus have not been shown to be protective against Marburg virus. Marburg virus vaccine development is ongoing, with a few promising candidate vaccines in early phase 1 and 2 clinical trials. In 2022, in response to MVD outbreaks in Ghana and Guinea, the World Health Organization convened an international Marburg virus vaccine consortium which is working to promote global research collaboration for more rapid vaccine development.
In the absence of definitive therapies, early identification of patients with suspected MVD is critical for preventing the spread of infection to close contacts. Like Ebola virus–infected patients, only symptomatic MVD patients are infectious and all patients with suspected MVD should be isolated in a private room and cared for in accordance with infection control procedures. As MVD is a nationally notifiable disease, suspected cases should be reported to local or state health departments as per jurisdictional requirements. Clinicians should also consult with their local or state health department and CDC for guidance on testing patients with suspected MVD and consider prompt evaluation for other infectious etiologies in the patient’s differential diagnosis. Comprehensive guidance for clinicians on screening and diagnosing patients with MVD is available on the CDC website at https://www.cdc.gov/vhf/marburg/index.html.
Dr. Appiah (she/her) is a medical epidemiologist in the division of global migration and quarantine at the CDC. Dr. Appiah holds adjunct faculty appointment in the division of infectious diseases at Emory University, Atlanta. She also holds a commission in the U.S. Public Health Service and is a resident advisor, Uganda, U.S. President’s Malaria Initiative, at the CDC.
10 popular diets for heart health ranked
An evidence-based analysis of 10 popular dietary patterns shows that some promote heart health better than others.
A new American Heart Association scientific statement concludes that the Mediterranean, Dietary Approach to Stop Hypertension (DASH), pescatarian, and vegetarian eating patterns most strongly align with heart-healthy eating guidelines issued by the AHA in 2021, whereas the popular paleolithic (paleo) and ketogenic (keto) diets fall short.
“The good news for the public and their clinicians is that there are several dietary patterns that allow for substantial flexibility for following a heart healthy diet – DASH, Mediterranean, vegetarian,” writing-group chair Christopher Gardner, PhD, with Stanford (Calif.) University, told this news organization.
“However, some of the popular diets – particularly paleo and keto – are so strictly restrictive of specific food groups that when these diets are followed as intended by their proponents, they are not aligned with the scientific evidence for a heart-healthy diet,” Dr. Gardner said.
The statement was published online in Circulation.
A tool for clinicians
“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” Dr. Gardner said in a news release.
“The public – and even many health care professionals – may rightfully be confused about heart-healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health,” he noted.
The writing group rated on a scale of 1-100 how well 10 popular diets or eating patterns align with AHA dietary advice for heart-healthy eating.
That advice includes consuming a wide variety of fruits and vegetables; choosing mostly whole grains instead of refined grains; using liquid plant oils rather than tropical oils; eating healthy sources of protein, such as from plants, seafood, or lean meats; minimizing added sugars and salt; limiting alcohol; choosing minimally processed foods instead of ultraprocessed foods; and following this guidance wherever food is prepared or consumed.
The 10 diets/dietary patterns were DASH, Mediterranean-style, pescatarian, ovo-lacto vegetarian, vegan, low-fat, very low–fat, low-carbohydrate, paleo, and very low–carbohydrate/keto patterns.
The diets were divided into four tiers on the basis of their scores, which ranged from a low of 31 to a high of 100.
Only the DASH eating plan got a perfect score of 100. This eating pattern is low in salt, added sugar, tropical oil, alcohol, and processed foods and high in nonstarchy vegetables, fruits, whole grains, and legumes. Proteins are mostly plant-based, such as legumes, beans, or nuts, along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.
The Mediterranean eating pattern achieved a slightly lower score of 89 because unlike DASH, it allows for moderate alcohol consumption and does not address added salt.
The other two top tier eating patterns were pescatarian, with a score of 92, and vegetarian, with a score of 86.
“If implemented as intended, the top-tier dietary patterns align best with the American Heart Association’s guidance and may be adapted to respect cultural practices, food preferences and budgets to enable people to always eat this way, for the long term,” Dr. Gardner said in the release.
Vegan and low-fat diets (each with a score of 78) fell into the second tier.
Though these diets emphasize fruits, vegetables, whole grains, legumes, and nuts while limiting alcohol and added sugars, the vegan diet is so restrictive that it could be challenging to follow long-term or when eating out and may increase the risk for vitamin B12 deficiency, which can lead to anemia, the writing group notes.
There also are concerns that low-fat diets treat all fats equally, whereas the AHA guidance calls for replacing saturated fats with healthier fats, they point out.
The third tier includes the very low–fat diet (score 72) and low-carb diet (score 64), whereas the paleo and very low–carb/keto diets fall into the fourth tier, with the lowest scores of 53 and 31, respectively.
Dr. Gardner said that it’s important to note that all 10 diet patterns “share four positive characteristics: more veggies, more whole foods, less added sugars, less refined grains.”
“These are all areas for which Americans have substantial room for improvement, and these are all things that we could work on together. Progress across these aspects would make a large difference in the heart-healthiness of the U.S. diet,” he told this news organization.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, and the Council on Peripheral Vascular Disease.
A version of this article first appeared on Medscape.com.
An evidence-based analysis of 10 popular dietary patterns shows that some promote heart health better than others.
A new American Heart Association scientific statement concludes that the Mediterranean, Dietary Approach to Stop Hypertension (DASH), pescatarian, and vegetarian eating patterns most strongly align with heart-healthy eating guidelines issued by the AHA in 2021, whereas the popular paleolithic (paleo) and ketogenic (keto) diets fall short.
“The good news for the public and their clinicians is that there are several dietary patterns that allow for substantial flexibility for following a heart healthy diet – DASH, Mediterranean, vegetarian,” writing-group chair Christopher Gardner, PhD, with Stanford (Calif.) University, told this news organization.
“However, some of the popular diets – particularly paleo and keto – are so strictly restrictive of specific food groups that when these diets are followed as intended by their proponents, they are not aligned with the scientific evidence for a heart-healthy diet,” Dr. Gardner said.
The statement was published online in Circulation.
A tool for clinicians
“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” Dr. Gardner said in a news release.
“The public – and even many health care professionals – may rightfully be confused about heart-healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health,” he noted.
The writing group rated on a scale of 1-100 how well 10 popular diets or eating patterns align with AHA dietary advice for heart-healthy eating.
That advice includes consuming a wide variety of fruits and vegetables; choosing mostly whole grains instead of refined grains; using liquid plant oils rather than tropical oils; eating healthy sources of protein, such as from plants, seafood, or lean meats; minimizing added sugars and salt; limiting alcohol; choosing minimally processed foods instead of ultraprocessed foods; and following this guidance wherever food is prepared or consumed.
The 10 diets/dietary patterns were DASH, Mediterranean-style, pescatarian, ovo-lacto vegetarian, vegan, low-fat, very low–fat, low-carbohydrate, paleo, and very low–carbohydrate/keto patterns.
The diets were divided into four tiers on the basis of their scores, which ranged from a low of 31 to a high of 100.
Only the DASH eating plan got a perfect score of 100. This eating pattern is low in salt, added sugar, tropical oil, alcohol, and processed foods and high in nonstarchy vegetables, fruits, whole grains, and legumes. Proteins are mostly plant-based, such as legumes, beans, or nuts, along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.
The Mediterranean eating pattern achieved a slightly lower score of 89 because unlike DASH, it allows for moderate alcohol consumption and does not address added salt.
The other two top tier eating patterns were pescatarian, with a score of 92, and vegetarian, with a score of 86.
“If implemented as intended, the top-tier dietary patterns align best with the American Heart Association’s guidance and may be adapted to respect cultural practices, food preferences and budgets to enable people to always eat this way, for the long term,” Dr. Gardner said in the release.
Vegan and low-fat diets (each with a score of 78) fell into the second tier.
Though these diets emphasize fruits, vegetables, whole grains, legumes, and nuts while limiting alcohol and added sugars, the vegan diet is so restrictive that it could be challenging to follow long-term or when eating out and may increase the risk for vitamin B12 deficiency, which can lead to anemia, the writing group notes.
There also are concerns that low-fat diets treat all fats equally, whereas the AHA guidance calls for replacing saturated fats with healthier fats, they point out.
The third tier includes the very low–fat diet (score 72) and low-carb diet (score 64), whereas the paleo and very low–carb/keto diets fall into the fourth tier, with the lowest scores of 53 and 31, respectively.
Dr. Gardner said that it’s important to note that all 10 diet patterns “share four positive characteristics: more veggies, more whole foods, less added sugars, less refined grains.”
“These are all areas for which Americans have substantial room for improvement, and these are all things that we could work on together. Progress across these aspects would make a large difference in the heart-healthiness of the U.S. diet,” he told this news organization.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, and the Council on Peripheral Vascular Disease.
A version of this article first appeared on Medscape.com.
An evidence-based analysis of 10 popular dietary patterns shows that some promote heart health better than others.
A new American Heart Association scientific statement concludes that the Mediterranean, Dietary Approach to Stop Hypertension (DASH), pescatarian, and vegetarian eating patterns most strongly align with heart-healthy eating guidelines issued by the AHA in 2021, whereas the popular paleolithic (paleo) and ketogenic (keto) diets fall short.
“The good news for the public and their clinicians is that there are several dietary patterns that allow for substantial flexibility for following a heart healthy diet – DASH, Mediterranean, vegetarian,” writing-group chair Christopher Gardner, PhD, with Stanford (Calif.) University, told this news organization.
“However, some of the popular diets – particularly paleo and keto – are so strictly restrictive of specific food groups that when these diets are followed as intended by their proponents, they are not aligned with the scientific evidence for a heart-healthy diet,” Dr. Gardner said.
The statement was published online in Circulation.
A tool for clinicians
“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” Dr. Gardner said in a news release.
“The public – and even many health care professionals – may rightfully be confused about heart-healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health,” he noted.
The writing group rated on a scale of 1-100 how well 10 popular diets or eating patterns align with AHA dietary advice for heart-healthy eating.
That advice includes consuming a wide variety of fruits and vegetables; choosing mostly whole grains instead of refined grains; using liquid plant oils rather than tropical oils; eating healthy sources of protein, such as from plants, seafood, or lean meats; minimizing added sugars and salt; limiting alcohol; choosing minimally processed foods instead of ultraprocessed foods; and following this guidance wherever food is prepared or consumed.
The 10 diets/dietary patterns were DASH, Mediterranean-style, pescatarian, ovo-lacto vegetarian, vegan, low-fat, very low–fat, low-carbohydrate, paleo, and very low–carbohydrate/keto patterns.
The diets were divided into four tiers on the basis of their scores, which ranged from a low of 31 to a high of 100.
Only the DASH eating plan got a perfect score of 100. This eating pattern is low in salt, added sugar, tropical oil, alcohol, and processed foods and high in nonstarchy vegetables, fruits, whole grains, and legumes. Proteins are mostly plant-based, such as legumes, beans, or nuts, along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.
The Mediterranean eating pattern achieved a slightly lower score of 89 because unlike DASH, it allows for moderate alcohol consumption and does not address added salt.
The other two top tier eating patterns were pescatarian, with a score of 92, and vegetarian, with a score of 86.
“If implemented as intended, the top-tier dietary patterns align best with the American Heart Association’s guidance and may be adapted to respect cultural practices, food preferences and budgets to enable people to always eat this way, for the long term,” Dr. Gardner said in the release.
Vegan and low-fat diets (each with a score of 78) fell into the second tier.
Though these diets emphasize fruits, vegetables, whole grains, legumes, and nuts while limiting alcohol and added sugars, the vegan diet is so restrictive that it could be challenging to follow long-term or when eating out and may increase the risk for vitamin B12 deficiency, which can lead to anemia, the writing group notes.
There also are concerns that low-fat diets treat all fats equally, whereas the AHA guidance calls for replacing saturated fats with healthier fats, they point out.
The third tier includes the very low–fat diet (score 72) and low-carb diet (score 64), whereas the paleo and very low–carb/keto diets fall into the fourth tier, with the lowest scores of 53 and 31, respectively.
Dr. Gardner said that it’s important to note that all 10 diet patterns “share four positive characteristics: more veggies, more whole foods, less added sugars, less refined grains.”
“These are all areas for which Americans have substantial room for improvement, and these are all things that we could work on together. Progress across these aspects would make a large difference in the heart-healthiness of the U.S. diet,” he told this news organization.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, and the Council on Peripheral Vascular Disease.
A version of this article first appeared on Medscape.com.
Medications provide best risk-to-benefit ratio for weight loss, says expert
Lifestyle changes result in the least weight loss and may be safest, while surgery provides the most weight loss and has the greatest risk. Antiobesity medications, especially the newer ones used in combination with lifestyle changes, can provide significant and sustained weight loss with manageable side effects, said Daniel Bessesen, MD, a professor in the endocrinology, diabetes, and metabolism at University of Colorado at Denver, Aurora.
New and more effective antiobesity medications have given internists more potential options to discuss with their patients, Dr. Bessesen said. He reviewed the pros and cons of the different options.
Medications are indicated for patients with a body mass index greater than 30, including those with a weight-related comorbidity, Dr. Bessesen said. The average weight loss is 5%-15% over 3-6 months but may vary greatly. Insurance often does not cover the medication costs.
Older FDA-approved antiobesity medications
Phentermine is the most widely prescribed antiobesity medication, partly because it is the only option most people can afford out of pocket. Dr. Bessesen presented recent data showing that long-term use of phentermine was associated with greater weight loss and that patients continuously taking phentermine for 24 months lost 7.5% of their weight.
Phentermine suppresses appetite by increasing norepinephrine production. Dr. Bessesen warned that internists should be careful when prescribing it to patients with mental conditions, because it acts as a stimulant. Early studies raised concerns about the risk of cardiovascular disease (CVD) in patients taking phentermine. However, analysis of data from over 13,000 individuals showed no evidence of a relationship between phentermine exposure and CVD events.
“These data provide some reassurance that it could be used in patients with CVD risk,” he noted. Phentermine can also be combined with topiramate extended release, a combination that provides greater efficacy (up to 10% weight loss) with fewer side effects. However, this combination is less effective in patients with diabetes than in those without.
Additional treatment options included orlistat and naltrexone sustained release/bupropion SR. Orlistat is a good treatment alternative for patients with constipation and is the safest option among older anti-obesity medications, whereas naltrexone SR/bupropion SR may be useful in patients with food cravings. However, there is more variability in the individual-level benefit from these agents compared to phentermine and phentermine/topiramate ER, Dr. Bessesen said.
Newer anti‐obesity medications
Liraglutide, an agent used for the management of type 2 diabetes, has recently been approved for weight loss. Liraglutide causes moderate weight loss, and it may reduce the risk of CVD. However, there are tolerability issues, such as nausea and other risks, and Dr. Bessesen advises internists to “start at low doses and increase slowly.”
Semaglutide is the newest and most effective antiobesity drug approved by the Food and Drug Administration, providing sustained weight loss of 8% for up to 48 weeks after starting treatment. Although its efficacy is lower in patients with diabetes, Dr. Bessesen noted that “this is common for antiobesity agents, and clinicians should not refrain from prescribing it in this population.”
Setmelanotide is another new medication approved for chronic weight management in patients with monogenic obesity. This medication can be considered for patients with early-onset severe obesity with abnormal feeding behavior.
Commenting on barriers to access to new antiobesity medications, Dr. Bessesen said that “the high cost of these medications is a substantial problem, but as more companies become involved and products are on the market for a longer period of time, I am hopeful that prices will come down.”
Emerging antiobesity medications
Dr. Bessesen presented recent phase 3 data showing that treatment with tirzepatide provided sustained chronic loss and improved cardiometabolic measures with no diet. Tirzepatide, which targets receptors for glucagonlike peptide–1 and glucose-dependent insulinotropic polypeptide, is used for the management of type 2 diabetes and is expected to be reviewed soon by the FDA for its use in weight management.
A semaglutide/cagrilintide combination may also provide a new treatment option for patients with obesity. In a phase 1b trial, semaglutide/cagrilintide treatment resulted in up to 17% weight loss in patients with obesity who were otherwise healthy; however, phase 2 and 3 data are needed to confirm its efficacy.
A ‘holistic approach’
When deciding whether to prescribe antiobesity medications, Dr. Bessesen noted that medications are better than exercise alone. Factors to consider when deciding whether to prescribe drugs, as well as which ones, include costs, local regulatory guidelines, requirement for long-term use, and patient comorbidities.
He also stated that lifestyle changes, such as adopting healthy nutrition and exercising regularly, are also important and can enhance weight loss when combined with medications.
Richele Corrado, DO, MPH, agreed that lifestyle management in combination with medications may provide greater weight loss than each of these interventions alone.
“If you look at the data, exercise doesn’t help you lose much weight,” said Dr. Corrado, a staff internist and obesity medicine specialist at Walter Reed National Military Medical Center in Bethesda, Md., who spoke at the same session. She added that she has many patients who struggle to lose weight despite having a healthy lifestyle. “It’s important to discuss with these patients about medications and surgery.”
Dr. Bessesen noted that management of mental health and emotional well-being should also be an integral part of obesity management. “Treatment for obesity may be more successful when underlying psychological conditions such as depression, childhood sexual trauma, or anxiety are addressed and treated,” he said.
Dr. Bessesen was involved in the study of the efficacy of semaglutide/cagrilintide. He does not have any financial conflicts with the companies that make other mentioned medications. He has received research grants or contracts from Novo Nordisk, honoraria from Novo Nordisk, and consultantship from Eli Lilly. Dr. Corrado reported no relevant financial conflicts.
Lifestyle changes result in the least weight loss and may be safest, while surgery provides the most weight loss and has the greatest risk. Antiobesity medications, especially the newer ones used in combination with lifestyle changes, can provide significant and sustained weight loss with manageable side effects, said Daniel Bessesen, MD, a professor in the endocrinology, diabetes, and metabolism at University of Colorado at Denver, Aurora.
New and more effective antiobesity medications have given internists more potential options to discuss with their patients, Dr. Bessesen said. He reviewed the pros and cons of the different options.
Medications are indicated for patients with a body mass index greater than 30, including those with a weight-related comorbidity, Dr. Bessesen said. The average weight loss is 5%-15% over 3-6 months but may vary greatly. Insurance often does not cover the medication costs.
Older FDA-approved antiobesity medications
Phentermine is the most widely prescribed antiobesity medication, partly because it is the only option most people can afford out of pocket. Dr. Bessesen presented recent data showing that long-term use of phentermine was associated with greater weight loss and that patients continuously taking phentermine for 24 months lost 7.5% of their weight.
Phentermine suppresses appetite by increasing norepinephrine production. Dr. Bessesen warned that internists should be careful when prescribing it to patients with mental conditions, because it acts as a stimulant. Early studies raised concerns about the risk of cardiovascular disease (CVD) in patients taking phentermine. However, analysis of data from over 13,000 individuals showed no evidence of a relationship between phentermine exposure and CVD events.
“These data provide some reassurance that it could be used in patients with CVD risk,” he noted. Phentermine can also be combined with topiramate extended release, a combination that provides greater efficacy (up to 10% weight loss) with fewer side effects. However, this combination is less effective in patients with diabetes than in those without.
Additional treatment options included orlistat and naltrexone sustained release/bupropion SR. Orlistat is a good treatment alternative for patients with constipation and is the safest option among older anti-obesity medications, whereas naltrexone SR/bupropion SR may be useful in patients with food cravings. However, there is more variability in the individual-level benefit from these agents compared to phentermine and phentermine/topiramate ER, Dr. Bessesen said.
Newer anti‐obesity medications
Liraglutide, an agent used for the management of type 2 diabetes, has recently been approved for weight loss. Liraglutide causes moderate weight loss, and it may reduce the risk of CVD. However, there are tolerability issues, such as nausea and other risks, and Dr. Bessesen advises internists to “start at low doses and increase slowly.”
Semaglutide is the newest and most effective antiobesity drug approved by the Food and Drug Administration, providing sustained weight loss of 8% for up to 48 weeks after starting treatment. Although its efficacy is lower in patients with diabetes, Dr. Bessesen noted that “this is common for antiobesity agents, and clinicians should not refrain from prescribing it in this population.”
Setmelanotide is another new medication approved for chronic weight management in patients with monogenic obesity. This medication can be considered for patients with early-onset severe obesity with abnormal feeding behavior.
Commenting on barriers to access to new antiobesity medications, Dr. Bessesen said that “the high cost of these medications is a substantial problem, but as more companies become involved and products are on the market for a longer period of time, I am hopeful that prices will come down.”
Emerging antiobesity medications
Dr. Bessesen presented recent phase 3 data showing that treatment with tirzepatide provided sustained chronic loss and improved cardiometabolic measures with no diet. Tirzepatide, which targets receptors for glucagonlike peptide–1 and glucose-dependent insulinotropic polypeptide, is used for the management of type 2 diabetes and is expected to be reviewed soon by the FDA for its use in weight management.
A semaglutide/cagrilintide combination may also provide a new treatment option for patients with obesity. In a phase 1b trial, semaglutide/cagrilintide treatment resulted in up to 17% weight loss in patients with obesity who were otherwise healthy; however, phase 2 and 3 data are needed to confirm its efficacy.
A ‘holistic approach’
When deciding whether to prescribe antiobesity medications, Dr. Bessesen noted that medications are better than exercise alone. Factors to consider when deciding whether to prescribe drugs, as well as which ones, include costs, local regulatory guidelines, requirement for long-term use, and patient comorbidities.
He also stated that lifestyle changes, such as adopting healthy nutrition and exercising regularly, are also important and can enhance weight loss when combined with medications.
Richele Corrado, DO, MPH, agreed that lifestyle management in combination with medications may provide greater weight loss than each of these interventions alone.
“If you look at the data, exercise doesn’t help you lose much weight,” said Dr. Corrado, a staff internist and obesity medicine specialist at Walter Reed National Military Medical Center in Bethesda, Md., who spoke at the same session. She added that she has many patients who struggle to lose weight despite having a healthy lifestyle. “It’s important to discuss with these patients about medications and surgery.”
Dr. Bessesen noted that management of mental health and emotional well-being should also be an integral part of obesity management. “Treatment for obesity may be more successful when underlying psychological conditions such as depression, childhood sexual trauma, or anxiety are addressed and treated,” he said.
Dr. Bessesen was involved in the study of the efficacy of semaglutide/cagrilintide. He does not have any financial conflicts with the companies that make other mentioned medications. He has received research grants or contracts from Novo Nordisk, honoraria from Novo Nordisk, and consultantship from Eli Lilly. Dr. Corrado reported no relevant financial conflicts.
Lifestyle changes result in the least weight loss and may be safest, while surgery provides the most weight loss and has the greatest risk. Antiobesity medications, especially the newer ones used in combination with lifestyle changes, can provide significant and sustained weight loss with manageable side effects, said Daniel Bessesen, MD, a professor in the endocrinology, diabetes, and metabolism at University of Colorado at Denver, Aurora.
New and more effective antiobesity medications have given internists more potential options to discuss with their patients, Dr. Bessesen said. He reviewed the pros and cons of the different options.
Medications are indicated for patients with a body mass index greater than 30, including those with a weight-related comorbidity, Dr. Bessesen said. The average weight loss is 5%-15% over 3-6 months but may vary greatly. Insurance often does not cover the medication costs.
Older FDA-approved antiobesity medications
Phentermine is the most widely prescribed antiobesity medication, partly because it is the only option most people can afford out of pocket. Dr. Bessesen presented recent data showing that long-term use of phentermine was associated with greater weight loss and that patients continuously taking phentermine for 24 months lost 7.5% of their weight.
Phentermine suppresses appetite by increasing norepinephrine production. Dr. Bessesen warned that internists should be careful when prescribing it to patients with mental conditions, because it acts as a stimulant. Early studies raised concerns about the risk of cardiovascular disease (CVD) in patients taking phentermine. However, analysis of data from over 13,000 individuals showed no evidence of a relationship between phentermine exposure and CVD events.
“These data provide some reassurance that it could be used in patients with CVD risk,” he noted. Phentermine can also be combined with topiramate extended release, a combination that provides greater efficacy (up to 10% weight loss) with fewer side effects. However, this combination is less effective in patients with diabetes than in those without.
Additional treatment options included orlistat and naltrexone sustained release/bupropion SR. Orlistat is a good treatment alternative for patients with constipation and is the safest option among older anti-obesity medications, whereas naltrexone SR/bupropion SR may be useful in patients with food cravings. However, there is more variability in the individual-level benefit from these agents compared to phentermine and phentermine/topiramate ER, Dr. Bessesen said.
Newer anti‐obesity medications
Liraglutide, an agent used for the management of type 2 diabetes, has recently been approved for weight loss. Liraglutide causes moderate weight loss, and it may reduce the risk of CVD. However, there are tolerability issues, such as nausea and other risks, and Dr. Bessesen advises internists to “start at low doses and increase slowly.”
Semaglutide is the newest and most effective antiobesity drug approved by the Food and Drug Administration, providing sustained weight loss of 8% for up to 48 weeks after starting treatment. Although its efficacy is lower in patients with diabetes, Dr. Bessesen noted that “this is common for antiobesity agents, and clinicians should not refrain from prescribing it in this population.”
Setmelanotide is another new medication approved for chronic weight management in patients with monogenic obesity. This medication can be considered for patients with early-onset severe obesity with abnormal feeding behavior.
Commenting on barriers to access to new antiobesity medications, Dr. Bessesen said that “the high cost of these medications is a substantial problem, but as more companies become involved and products are on the market for a longer period of time, I am hopeful that prices will come down.”
Emerging antiobesity medications
Dr. Bessesen presented recent phase 3 data showing that treatment with tirzepatide provided sustained chronic loss and improved cardiometabolic measures with no diet. Tirzepatide, which targets receptors for glucagonlike peptide–1 and glucose-dependent insulinotropic polypeptide, is used for the management of type 2 diabetes and is expected to be reviewed soon by the FDA for its use in weight management.
A semaglutide/cagrilintide combination may also provide a new treatment option for patients with obesity. In a phase 1b trial, semaglutide/cagrilintide treatment resulted in up to 17% weight loss in patients with obesity who were otherwise healthy; however, phase 2 and 3 data are needed to confirm its efficacy.
A ‘holistic approach’
When deciding whether to prescribe antiobesity medications, Dr. Bessesen noted that medications are better than exercise alone. Factors to consider when deciding whether to prescribe drugs, as well as which ones, include costs, local regulatory guidelines, requirement for long-term use, and patient comorbidities.
He also stated that lifestyle changes, such as adopting healthy nutrition and exercising regularly, are also important and can enhance weight loss when combined with medications.
Richele Corrado, DO, MPH, agreed that lifestyle management in combination with medications may provide greater weight loss than each of these interventions alone.
“If you look at the data, exercise doesn’t help you lose much weight,” said Dr. Corrado, a staff internist and obesity medicine specialist at Walter Reed National Military Medical Center in Bethesda, Md., who spoke at the same session. She added that she has many patients who struggle to lose weight despite having a healthy lifestyle. “It’s important to discuss with these patients about medications and surgery.”
Dr. Bessesen noted that management of mental health and emotional well-being should also be an integral part of obesity management. “Treatment for obesity may be more successful when underlying psychological conditions such as depression, childhood sexual trauma, or anxiety are addressed and treated,” he said.
Dr. Bessesen was involved in the study of the efficacy of semaglutide/cagrilintide. He does not have any financial conflicts with the companies that make other mentioned medications. He has received research grants or contracts from Novo Nordisk, honoraria from Novo Nordisk, and consultantship from Eli Lilly. Dr. Corrado reported no relevant financial conflicts.
AT INTERNAL MEDICINE 2023
AHA backs screening for cognitive impairment after stroke
Screening for cognitive impairment should be part of multidisciplinary care for stroke survivors, the American Heart Association says in a new scientific statement.
“Cognitive impairment after stroke is very common, is associated with other post-stroke outcomes, and often has significant impact on the quality of life,” Nada El Husseini, MD, MHSc, chair of the scientific statement writing group, told this news organization.
“It is important to screen stroke survivors for cognitive impairment as well as for associated comorbidities such as mood and sleep disorders,” said Dr. El Husseini, associate professor of neurology at Duke University Medical Center in Durham, N.C.
The scientific statement was published online in Stroke. It’s the first to specifically focus on the cognitive impairment resulting from an overt stroke (ischemic or hemorrhagic).
‘Actionable’ considerations for care
The writing group performed a “scoping” review of the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) to provide a framework for “actionable considerations” for clinical practice as well as to highlight gaps needing additional studies, Dr. El Husseini explained.
PSCI, ranging from mild to severe, occurs in up to 60% of stroke survivors in the first year after stroke; yet, it is often underreported and underdiagnosed, the writing group notes.
Up to 20% of stroke survivors who experience mild cognitive impairment fully recover cognitive function, and cognitive recovery is most likely within the first 6 months after a stroke.
However, improvement in cognitive impairment without return to prestroke levels is more frequent than is complete recovery. As many as one in three stroke survivors may develop dementia within 5 years of stroke.
The writing group also notes that PSCI is often associated with other conditions, including physical disability, sleep disorders, behavioral and personality changes, depression, and other neuropsychological changes – each of which may contribute to lower quality of life.
Currently, there is no “gold standard” for cognitive screening following stroke, but several brief cognitive screening tests, including the Mini–Mental State Examination and the Montreal Cognitive Assessment, are widely used to identify cognitive impairment after stroke.
The statement also highlights the importance of assessing cognitive changes over time after stroke. Stroke survivors who experience unexplained difficulties with cognitive-related activities of daily living, following care instructions, or providing a reliable health history may be candidates for additional cognitive screening.
Manage risk factors to prevent repeat stroke
“Anticipatory guidance regarding home and driving safety and, return to work (if applicable) along with interdisciplinary collaboration among different medical and ancillary specialists in the diagnosis and management of cognitive impairment is key for the holistic care of stroke survivors,” Dr. El Husseini told this news organization.
The multidisciplinary poststroke health care team could include neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists, and primary care providers.
“Because recurrent stroke is strongly associated with the development of cognitive impairment and dementia, prevention of recurrent strokes should be sought to decrease that risk,” Dr. El Husseini said. This includes addressing stroke risk factors, including high blood pressure, high cholesterol, type 2 diabetes, and atrial fibrillation.
The writing group says research is needed in the future to determine how cognitive impairment develops after stroke and the impact of nonbrain factors, including infection, frailty, and social factors.
Further research is also needed to determine best practices for cognitive screening after stroke, including the development and use of screening instruments that consider demographic, cultural, and linguistic factors in determining “normal” function.
“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for poststroke cognitive impairment,” Dr. El Husseini said in a news release.
“We hope to see big enough clinical trials that assess various techniques, medications, and lifestyle changes in diverse groups of patients that may help improve cognitive function,” she added.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular Radiology and Intervention, the Council on Hypertension, and the Council on Lifestyle and Cardiometabolic Health.
Screening for cognitive impairment should be part of multidisciplinary care for stroke survivors, the American Heart Association says in a new scientific statement.
“Cognitive impairment after stroke is very common, is associated with other post-stroke outcomes, and often has significant impact on the quality of life,” Nada El Husseini, MD, MHSc, chair of the scientific statement writing group, told this news organization.
“It is important to screen stroke survivors for cognitive impairment as well as for associated comorbidities such as mood and sleep disorders,” said Dr. El Husseini, associate professor of neurology at Duke University Medical Center in Durham, N.C.
The scientific statement was published online in Stroke. It’s the first to specifically focus on the cognitive impairment resulting from an overt stroke (ischemic or hemorrhagic).
‘Actionable’ considerations for care
The writing group performed a “scoping” review of the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) to provide a framework for “actionable considerations” for clinical practice as well as to highlight gaps needing additional studies, Dr. El Husseini explained.
PSCI, ranging from mild to severe, occurs in up to 60% of stroke survivors in the first year after stroke; yet, it is often underreported and underdiagnosed, the writing group notes.
Up to 20% of stroke survivors who experience mild cognitive impairment fully recover cognitive function, and cognitive recovery is most likely within the first 6 months after a stroke.
However, improvement in cognitive impairment without return to prestroke levels is more frequent than is complete recovery. As many as one in three stroke survivors may develop dementia within 5 years of stroke.
The writing group also notes that PSCI is often associated with other conditions, including physical disability, sleep disorders, behavioral and personality changes, depression, and other neuropsychological changes – each of which may contribute to lower quality of life.
Currently, there is no “gold standard” for cognitive screening following stroke, but several brief cognitive screening tests, including the Mini–Mental State Examination and the Montreal Cognitive Assessment, are widely used to identify cognitive impairment after stroke.
The statement also highlights the importance of assessing cognitive changes over time after stroke. Stroke survivors who experience unexplained difficulties with cognitive-related activities of daily living, following care instructions, or providing a reliable health history may be candidates for additional cognitive screening.
Manage risk factors to prevent repeat stroke
“Anticipatory guidance regarding home and driving safety and, return to work (if applicable) along with interdisciplinary collaboration among different medical and ancillary specialists in the diagnosis and management of cognitive impairment is key for the holistic care of stroke survivors,” Dr. El Husseini told this news organization.
The multidisciplinary poststroke health care team could include neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists, and primary care providers.
“Because recurrent stroke is strongly associated with the development of cognitive impairment and dementia, prevention of recurrent strokes should be sought to decrease that risk,” Dr. El Husseini said. This includes addressing stroke risk factors, including high blood pressure, high cholesterol, type 2 diabetes, and atrial fibrillation.
The writing group says research is needed in the future to determine how cognitive impairment develops after stroke and the impact of nonbrain factors, including infection, frailty, and social factors.
Further research is also needed to determine best practices for cognitive screening after stroke, including the development and use of screening instruments that consider demographic, cultural, and linguistic factors in determining “normal” function.
“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for poststroke cognitive impairment,” Dr. El Husseini said in a news release.
“We hope to see big enough clinical trials that assess various techniques, medications, and lifestyle changes in diverse groups of patients that may help improve cognitive function,” she added.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular Radiology and Intervention, the Council on Hypertension, and the Council on Lifestyle and Cardiometabolic Health.
Screening for cognitive impairment should be part of multidisciplinary care for stroke survivors, the American Heart Association says in a new scientific statement.
“Cognitive impairment after stroke is very common, is associated with other post-stroke outcomes, and often has significant impact on the quality of life,” Nada El Husseini, MD, MHSc, chair of the scientific statement writing group, told this news organization.
“It is important to screen stroke survivors for cognitive impairment as well as for associated comorbidities such as mood and sleep disorders,” said Dr. El Husseini, associate professor of neurology at Duke University Medical Center in Durham, N.C.
The scientific statement was published online in Stroke. It’s the first to specifically focus on the cognitive impairment resulting from an overt stroke (ischemic or hemorrhagic).
‘Actionable’ considerations for care
The writing group performed a “scoping” review of the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) to provide a framework for “actionable considerations” for clinical practice as well as to highlight gaps needing additional studies, Dr. El Husseini explained.
PSCI, ranging from mild to severe, occurs in up to 60% of stroke survivors in the first year after stroke; yet, it is often underreported and underdiagnosed, the writing group notes.
Up to 20% of stroke survivors who experience mild cognitive impairment fully recover cognitive function, and cognitive recovery is most likely within the first 6 months after a stroke.
However, improvement in cognitive impairment without return to prestroke levels is more frequent than is complete recovery. As many as one in three stroke survivors may develop dementia within 5 years of stroke.
The writing group also notes that PSCI is often associated with other conditions, including physical disability, sleep disorders, behavioral and personality changes, depression, and other neuropsychological changes – each of which may contribute to lower quality of life.
Currently, there is no “gold standard” for cognitive screening following stroke, but several brief cognitive screening tests, including the Mini–Mental State Examination and the Montreal Cognitive Assessment, are widely used to identify cognitive impairment after stroke.
The statement also highlights the importance of assessing cognitive changes over time after stroke. Stroke survivors who experience unexplained difficulties with cognitive-related activities of daily living, following care instructions, or providing a reliable health history may be candidates for additional cognitive screening.
Manage risk factors to prevent repeat stroke
“Anticipatory guidance regarding home and driving safety and, return to work (if applicable) along with interdisciplinary collaboration among different medical and ancillary specialists in the diagnosis and management of cognitive impairment is key for the holistic care of stroke survivors,” Dr. El Husseini told this news organization.
The multidisciplinary poststroke health care team could include neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists, and primary care providers.
“Because recurrent stroke is strongly associated with the development of cognitive impairment and dementia, prevention of recurrent strokes should be sought to decrease that risk,” Dr. El Husseini said. This includes addressing stroke risk factors, including high blood pressure, high cholesterol, type 2 diabetes, and atrial fibrillation.
The writing group says research is needed in the future to determine how cognitive impairment develops after stroke and the impact of nonbrain factors, including infection, frailty, and social factors.
Further research is also needed to determine best practices for cognitive screening after stroke, including the development and use of screening instruments that consider demographic, cultural, and linguistic factors in determining “normal” function.
“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for poststroke cognitive impairment,” Dr. El Husseini said in a news release.
“We hope to see big enough clinical trials that assess various techniques, medications, and lifestyle changes in diverse groups of patients that may help improve cognitive function,” she added.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular Radiology and Intervention, the Council on Hypertension, and the Council on Lifestyle and Cardiometabolic Health.
New tool accurately predicts suicide risk in serious mental illness
The 17-question Oxford Mental Illness and Suicide Tool (OxMIS) assessment is designed to predict 12-month suicide risk in people with schizophrenia spectrum disorders and bipolar disorder based on risk factors such as familial traits, antisocial traits, and information about self-harm.
“We have demonstrated the clinical utility of OxMIS in two separate studies and countries. As with any clinical risk prediction tool, it will not improve outcomes unless coupled with effective interventions,” lead investigator Amir Sariaslan, PhD, a senior research fellow in psychiatric epidemiology at the University of Oxford, England, told this news organization.
The findings were published online in Translational Psychiatry.
Twice validated
Dr. Sariaslan and his team originally developed and validated the OxMIS in a cohort of 75,000 people with SMI in Sweden. Recognizing the lack of externally validated prognostic models in the mental health field, the team wanted to validate the instrument in a new, population-based sample in Finland.
The investigators accessed information about patient diagnosis and treatment from the Finnish Care Register for Health Care, which contains de-identified information for all individuals between ages 15 and 65 years diagnosed with an SMI between Jan. 1, 1996, and Dec. 31, 2017.
They included 137,000 patients with somatic symptom disorder or bipolar disorder for a total of more than 5 million episodes of inpatient or outpatient treatment. Investigators linked the cohort to the Causes of Death Register to identify those who had died by suicide within 12 months of an index treatment episode, which investigators randomly selected for each person.
The investigators found that 1,475 individuals in the sample died by suicide within 1 year of their index episode (1.1%).
Each patient was assigned a clinical suicide risk score based on their clinical information, familial traits, prescription information, and comorbid conditions. Using OxMIS, the investigators found that the instrument accurately predicted suicide with an area under the curve of 0.70.
In other words, in 70% of the instances where the investigators randomly selected two people from the sample, one of whom died by suicide and the other of whom did not, the individual who died by suicide had a higher OxMIS risk score.
The investigators note the model overestimated the risk for patients who were at extremely high risk for suicide (those with a predicted suicide risk of > 5%). “In our complementary sensitivity analysis, we observed improved calibration in these patients when we assigned them a suicide risk prediction of no more than 5%,” they write.
Dr. Sariaslan said that the findings highlight the importance of safety planning interventions. “It is also essential to remember that OxMIS is not intended to replace clinical decision-making, but rather to support it,” he said.
As to whether the tool could be used in other populations, such as in the United States, Dr. Sariaslan said, “there is no good evidence that the contribution of risk factors to suicide in this population is different in the U.S. than in northern Europe, so there is no a priori reason to have to do multiple external validations before it can be used for research or clinical purposes.”
One size does not fit all
Commenting on the study, Ronald Kessler, PhD, McNeil Family Professor, department of health care policy at Harvard Medical School, Boston, said that he’d be “surprised” if OxMIS was adopted in the United States because there is already an existing tool that is “slightly more accurate,” which he helped develop.
“In addition, when we start thinking about uses for such scales, it becomes clear that different scales should be used for different segments of the population, depending on intervention options,” Dr. Kessler said.
“So, for example, a different scale would probably be optimal in deciding how to manage psychiatric inpatients in the transition back to the community after hospital discharge than [it would be], say, in deciding how to respond to suicidality among patients presenting at an emergency department. No one scale will fit for all the scenarios in which prediction is desired,” he added.
The study was funded by the Academy of Finland. Dr. Kessler receives funding from the National Institute of Mental Health, Department of Defense, and Veterans Administration to develop suicide prediction models. Dr. Sariaslan has no disclosures to report.
A version of this article first appeared on Medscape.com.
The 17-question Oxford Mental Illness and Suicide Tool (OxMIS) assessment is designed to predict 12-month suicide risk in people with schizophrenia spectrum disorders and bipolar disorder based on risk factors such as familial traits, antisocial traits, and information about self-harm.
“We have demonstrated the clinical utility of OxMIS in two separate studies and countries. As with any clinical risk prediction tool, it will not improve outcomes unless coupled with effective interventions,” lead investigator Amir Sariaslan, PhD, a senior research fellow in psychiatric epidemiology at the University of Oxford, England, told this news organization.
The findings were published online in Translational Psychiatry.
Twice validated
Dr. Sariaslan and his team originally developed and validated the OxMIS in a cohort of 75,000 people with SMI in Sweden. Recognizing the lack of externally validated prognostic models in the mental health field, the team wanted to validate the instrument in a new, population-based sample in Finland.
The investigators accessed information about patient diagnosis and treatment from the Finnish Care Register for Health Care, which contains de-identified information for all individuals between ages 15 and 65 years diagnosed with an SMI between Jan. 1, 1996, and Dec. 31, 2017.
They included 137,000 patients with somatic symptom disorder or bipolar disorder for a total of more than 5 million episodes of inpatient or outpatient treatment. Investigators linked the cohort to the Causes of Death Register to identify those who had died by suicide within 12 months of an index treatment episode, which investigators randomly selected for each person.
The investigators found that 1,475 individuals in the sample died by suicide within 1 year of their index episode (1.1%).
Each patient was assigned a clinical suicide risk score based on their clinical information, familial traits, prescription information, and comorbid conditions. Using OxMIS, the investigators found that the instrument accurately predicted suicide with an area under the curve of 0.70.
In other words, in 70% of the instances where the investigators randomly selected two people from the sample, one of whom died by suicide and the other of whom did not, the individual who died by suicide had a higher OxMIS risk score.
The investigators note the model overestimated the risk for patients who were at extremely high risk for suicide (those with a predicted suicide risk of > 5%). “In our complementary sensitivity analysis, we observed improved calibration in these patients when we assigned them a suicide risk prediction of no more than 5%,” they write.
Dr. Sariaslan said that the findings highlight the importance of safety planning interventions. “It is also essential to remember that OxMIS is not intended to replace clinical decision-making, but rather to support it,” he said.
As to whether the tool could be used in other populations, such as in the United States, Dr. Sariaslan said, “there is no good evidence that the contribution of risk factors to suicide in this population is different in the U.S. than in northern Europe, so there is no a priori reason to have to do multiple external validations before it can be used for research or clinical purposes.”
One size does not fit all
Commenting on the study, Ronald Kessler, PhD, McNeil Family Professor, department of health care policy at Harvard Medical School, Boston, said that he’d be “surprised” if OxMIS was adopted in the United States because there is already an existing tool that is “slightly more accurate,” which he helped develop.
“In addition, when we start thinking about uses for such scales, it becomes clear that different scales should be used for different segments of the population, depending on intervention options,” Dr. Kessler said.
“So, for example, a different scale would probably be optimal in deciding how to manage psychiatric inpatients in the transition back to the community after hospital discharge than [it would be], say, in deciding how to respond to suicidality among patients presenting at an emergency department. No one scale will fit for all the scenarios in which prediction is desired,” he added.
The study was funded by the Academy of Finland. Dr. Kessler receives funding from the National Institute of Mental Health, Department of Defense, and Veterans Administration to develop suicide prediction models. Dr. Sariaslan has no disclosures to report.
A version of this article first appeared on Medscape.com.
The 17-question Oxford Mental Illness and Suicide Tool (OxMIS) assessment is designed to predict 12-month suicide risk in people with schizophrenia spectrum disorders and bipolar disorder based on risk factors such as familial traits, antisocial traits, and information about self-harm.
“We have demonstrated the clinical utility of OxMIS in two separate studies and countries. As with any clinical risk prediction tool, it will not improve outcomes unless coupled with effective interventions,” lead investigator Amir Sariaslan, PhD, a senior research fellow in psychiatric epidemiology at the University of Oxford, England, told this news organization.
The findings were published online in Translational Psychiatry.
Twice validated
Dr. Sariaslan and his team originally developed and validated the OxMIS in a cohort of 75,000 people with SMI in Sweden. Recognizing the lack of externally validated prognostic models in the mental health field, the team wanted to validate the instrument in a new, population-based sample in Finland.
The investigators accessed information about patient diagnosis and treatment from the Finnish Care Register for Health Care, which contains de-identified information for all individuals between ages 15 and 65 years diagnosed with an SMI between Jan. 1, 1996, and Dec. 31, 2017.
They included 137,000 patients with somatic symptom disorder or bipolar disorder for a total of more than 5 million episodes of inpatient or outpatient treatment. Investigators linked the cohort to the Causes of Death Register to identify those who had died by suicide within 12 months of an index treatment episode, which investigators randomly selected for each person.
The investigators found that 1,475 individuals in the sample died by suicide within 1 year of their index episode (1.1%).
Each patient was assigned a clinical suicide risk score based on their clinical information, familial traits, prescription information, and comorbid conditions. Using OxMIS, the investigators found that the instrument accurately predicted suicide with an area under the curve of 0.70.
In other words, in 70% of the instances where the investigators randomly selected two people from the sample, one of whom died by suicide and the other of whom did not, the individual who died by suicide had a higher OxMIS risk score.
The investigators note the model overestimated the risk for patients who were at extremely high risk for suicide (those with a predicted suicide risk of > 5%). “In our complementary sensitivity analysis, we observed improved calibration in these patients when we assigned them a suicide risk prediction of no more than 5%,” they write.
Dr. Sariaslan said that the findings highlight the importance of safety planning interventions. “It is also essential to remember that OxMIS is not intended to replace clinical decision-making, but rather to support it,” he said.
As to whether the tool could be used in other populations, such as in the United States, Dr. Sariaslan said, “there is no good evidence that the contribution of risk factors to suicide in this population is different in the U.S. than in northern Europe, so there is no a priori reason to have to do multiple external validations before it can be used for research or clinical purposes.”
One size does not fit all
Commenting on the study, Ronald Kessler, PhD, McNeil Family Professor, department of health care policy at Harvard Medical School, Boston, said that he’d be “surprised” if OxMIS was adopted in the United States because there is already an existing tool that is “slightly more accurate,” which he helped develop.
“In addition, when we start thinking about uses for such scales, it becomes clear that different scales should be used for different segments of the population, depending on intervention options,” Dr. Kessler said.
“So, for example, a different scale would probably be optimal in deciding how to manage psychiatric inpatients in the transition back to the community after hospital discharge than [it would be], say, in deciding how to respond to suicidality among patients presenting at an emergency department. No one scale will fit for all the scenarios in which prediction is desired,” he added.
The study was funded by the Academy of Finland. Dr. Kessler receives funding from the National Institute of Mental Health, Department of Defense, and Veterans Administration to develop suicide prediction models. Dr. Sariaslan has no disclosures to report.
A version of this article first appeared on Medscape.com.
FROM TRANSLATIONAL PSYCHIATRY
Experts debate reducing ASCT for multiple myeloma
NEW YORK –
Hematologist-oncologists whose top priority is ensuring that patients have the best chance of progression-free survival (PFS) will continue to choose ASCT as a best practice, argued Amrita Krishnan, MD, hematologist at the Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope Comprehensive Cancer Center, Duarte, Calif.
A differing perspective was presented by C. Ola Landgren, MD, PhD, hematologist at the Sylvester Comprehensive Cancer Center at the University of Miami. Dr. Landgren cited evidence that, for newly diagnosed MM patients treated successfully with modern combination therapies, ASCT is not a mandatory treatment step before starting maintenance therapy.
Making a case for ASCT as the SoC, Dr. Krishnan noted, “based on the DETERMINATION trial [DT], there is far superior rate of PFS with patients who get ASCT up front, compared patients who got only conventional chemotherapy with lenalidomide, bortezomib, and dexamethasone [RVd]. PFS is the endpoint we look for in our treatment regimens.
“If you don’t use ASCT up front, you may lose the opportunity at later relapse. This is not to say that transplant is the only tool at our disposal. It is just an indispensable one. The GRIFFIN trial [GT] has shown us that robust combinations of drugs [both RVd and dexamethasone +RVd] can improve patient outcomes both before and after ASCT,” Dr. Krishnan concluded.
In his presentation, Dr. Landgren stated that, in the DT, while PFS is prolonged by the addition of ASCT to RVd, adding ASCT did not significantly increase overall survival (OS) rates. He added that treatment-related AEs of grade 3+ occurred in only 78.2% of patients on RVd versus 94.2% of RVd + ASCT patients.
“ASCT should not be the SoC frontline treatment in MM because it does not prolong OS. The IFM trial and the DT both show that there is no difference in OS between drug combination therapy followed by transplant and maintenance versus combination therapy alone, followed by transplant and maintenance. Furthermore, patients who get ASCT have higher risk of developing secondary malignancies, worse quality of life, and higher long-term morbidity with other conditions,” Dr. Landgren said.
He cited the MAIA trial administered daratumumab and lenalidomide plus dexamethasone (DRd) to patients who were too old or too frail to qualify for ASCT. Over half of patients in the DRd arm of MAIA had an estimated progression-free survival rate at 60 months.
“Furthermore, GT and the MANHATTAN clinical trials showed that we can safely add CD38-targeted monoclonal antibodies to standard combination therapies [lenalidomide, bortezomib, and dexamethasone (KRd)], resulting in higher rates of minimal-residual-disease (MRD) negativity. That means modern four-drug combination therapies [DR-RVd and DR-KRd] will allow more [and more newly diagnosed] MM patients to achieve MRD negativity in the absence of ASCT,” Dr. Landgren concluded.
Asked to comment on the two viewpoints, Joshua Richter, MD, director of myeloma treatment at the Blavatnik Family Center at Chelsea Mount Sinai, New York, said: “With some patients, we can get similar outcomes, whether or not we do a transplant. Doctors need to be better at choosing who really needs ASCT. Older people with standard-risk disease or people who achieve MRD-negative status after pharmacological treatment might not need to receive a transplant as much as those who have bulk disease or high-risk cytogenetics.
“Although ASCT might not be the best frontline option for everyone, collecting cells from most patients and storing them has many advantages. It allows us to do have the option of ASCT in later lines of therapy. In some patients with low blood counts, we can use stored cells to reboot their marrow and make them eligible for trials of promising new drugs,” Dr. Richter said.
Dr. Krishnan disclosed relationships with Takeda, Amgen, GlaxoSmithKline, Bristol-Myers Squibb, Sanofi, Pfizer, Adaptive, Regeneron, Janssen, AstraZeneca, Artiva, and Sutro. Dr. Landgren reported ties with Amgen, BMS, Celgene, Janssen, Takedam Glenmark, Juno, Pfizer, Merck, and others. Dr. Richter disclosed relationships with Janssen, BMS, and Takeda.
NEW YORK –
Hematologist-oncologists whose top priority is ensuring that patients have the best chance of progression-free survival (PFS) will continue to choose ASCT as a best practice, argued Amrita Krishnan, MD, hematologist at the Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope Comprehensive Cancer Center, Duarte, Calif.
A differing perspective was presented by C. Ola Landgren, MD, PhD, hematologist at the Sylvester Comprehensive Cancer Center at the University of Miami. Dr. Landgren cited evidence that, for newly diagnosed MM patients treated successfully with modern combination therapies, ASCT is not a mandatory treatment step before starting maintenance therapy.
Making a case for ASCT as the SoC, Dr. Krishnan noted, “based on the DETERMINATION trial [DT], there is far superior rate of PFS with patients who get ASCT up front, compared patients who got only conventional chemotherapy with lenalidomide, bortezomib, and dexamethasone [RVd]. PFS is the endpoint we look for in our treatment regimens.
“If you don’t use ASCT up front, you may lose the opportunity at later relapse. This is not to say that transplant is the only tool at our disposal. It is just an indispensable one. The GRIFFIN trial [GT] has shown us that robust combinations of drugs [both RVd and dexamethasone +RVd] can improve patient outcomes both before and after ASCT,” Dr. Krishnan concluded.
In his presentation, Dr. Landgren stated that, in the DT, while PFS is prolonged by the addition of ASCT to RVd, adding ASCT did not significantly increase overall survival (OS) rates. He added that treatment-related AEs of grade 3+ occurred in only 78.2% of patients on RVd versus 94.2% of RVd + ASCT patients.
“ASCT should not be the SoC frontline treatment in MM because it does not prolong OS. The IFM trial and the DT both show that there is no difference in OS between drug combination therapy followed by transplant and maintenance versus combination therapy alone, followed by transplant and maintenance. Furthermore, patients who get ASCT have higher risk of developing secondary malignancies, worse quality of life, and higher long-term morbidity with other conditions,” Dr. Landgren said.
He cited the MAIA trial administered daratumumab and lenalidomide plus dexamethasone (DRd) to patients who were too old or too frail to qualify for ASCT. Over half of patients in the DRd arm of MAIA had an estimated progression-free survival rate at 60 months.
“Furthermore, GT and the MANHATTAN clinical trials showed that we can safely add CD38-targeted monoclonal antibodies to standard combination therapies [lenalidomide, bortezomib, and dexamethasone (KRd)], resulting in higher rates of minimal-residual-disease (MRD) negativity. That means modern four-drug combination therapies [DR-RVd and DR-KRd] will allow more [and more newly diagnosed] MM patients to achieve MRD negativity in the absence of ASCT,” Dr. Landgren concluded.
Asked to comment on the two viewpoints, Joshua Richter, MD, director of myeloma treatment at the Blavatnik Family Center at Chelsea Mount Sinai, New York, said: “With some patients, we can get similar outcomes, whether or not we do a transplant. Doctors need to be better at choosing who really needs ASCT. Older people with standard-risk disease or people who achieve MRD-negative status after pharmacological treatment might not need to receive a transplant as much as those who have bulk disease or high-risk cytogenetics.
“Although ASCT might not be the best frontline option for everyone, collecting cells from most patients and storing them has many advantages. It allows us to do have the option of ASCT in later lines of therapy. In some patients with low blood counts, we can use stored cells to reboot their marrow and make them eligible for trials of promising new drugs,” Dr. Richter said.
Dr. Krishnan disclosed relationships with Takeda, Amgen, GlaxoSmithKline, Bristol-Myers Squibb, Sanofi, Pfizer, Adaptive, Regeneron, Janssen, AstraZeneca, Artiva, and Sutro. Dr. Landgren reported ties with Amgen, BMS, Celgene, Janssen, Takedam Glenmark, Juno, Pfizer, Merck, and others. Dr. Richter disclosed relationships with Janssen, BMS, and Takeda.
NEW YORK –
Hematologist-oncologists whose top priority is ensuring that patients have the best chance of progression-free survival (PFS) will continue to choose ASCT as a best practice, argued Amrita Krishnan, MD, hematologist at the Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope Comprehensive Cancer Center, Duarte, Calif.
A differing perspective was presented by C. Ola Landgren, MD, PhD, hematologist at the Sylvester Comprehensive Cancer Center at the University of Miami. Dr. Landgren cited evidence that, for newly diagnosed MM patients treated successfully with modern combination therapies, ASCT is not a mandatory treatment step before starting maintenance therapy.
Making a case for ASCT as the SoC, Dr. Krishnan noted, “based on the DETERMINATION trial [DT], there is far superior rate of PFS with patients who get ASCT up front, compared patients who got only conventional chemotherapy with lenalidomide, bortezomib, and dexamethasone [RVd]. PFS is the endpoint we look for in our treatment regimens.
“If you don’t use ASCT up front, you may lose the opportunity at later relapse. This is not to say that transplant is the only tool at our disposal. It is just an indispensable one. The GRIFFIN trial [GT] has shown us that robust combinations of drugs [both RVd and dexamethasone +RVd] can improve patient outcomes both before and after ASCT,” Dr. Krishnan concluded.
In his presentation, Dr. Landgren stated that, in the DT, while PFS is prolonged by the addition of ASCT to RVd, adding ASCT did not significantly increase overall survival (OS) rates. He added that treatment-related AEs of grade 3+ occurred in only 78.2% of patients on RVd versus 94.2% of RVd + ASCT patients.
“ASCT should not be the SoC frontline treatment in MM because it does not prolong OS. The IFM trial and the DT both show that there is no difference in OS between drug combination therapy followed by transplant and maintenance versus combination therapy alone, followed by transplant and maintenance. Furthermore, patients who get ASCT have higher risk of developing secondary malignancies, worse quality of life, and higher long-term morbidity with other conditions,” Dr. Landgren said.
He cited the MAIA trial administered daratumumab and lenalidomide plus dexamethasone (DRd) to patients who were too old or too frail to qualify for ASCT. Over half of patients in the DRd arm of MAIA had an estimated progression-free survival rate at 60 months.
“Furthermore, GT and the MANHATTAN clinical trials showed that we can safely add CD38-targeted monoclonal antibodies to standard combination therapies [lenalidomide, bortezomib, and dexamethasone (KRd)], resulting in higher rates of minimal-residual-disease (MRD) negativity. That means modern four-drug combination therapies [DR-RVd and DR-KRd] will allow more [and more newly diagnosed] MM patients to achieve MRD negativity in the absence of ASCT,” Dr. Landgren concluded.
Asked to comment on the two viewpoints, Joshua Richter, MD, director of myeloma treatment at the Blavatnik Family Center at Chelsea Mount Sinai, New York, said: “With some patients, we can get similar outcomes, whether or not we do a transplant. Doctors need to be better at choosing who really needs ASCT. Older people with standard-risk disease or people who achieve MRD-negative status after pharmacological treatment might not need to receive a transplant as much as those who have bulk disease or high-risk cytogenetics.
“Although ASCT might not be the best frontline option for everyone, collecting cells from most patients and storing them has many advantages. It allows us to do have the option of ASCT in later lines of therapy. In some patients with low blood counts, we can use stored cells to reboot their marrow and make them eligible for trials of promising new drugs,” Dr. Richter said.
Dr. Krishnan disclosed relationships with Takeda, Amgen, GlaxoSmithKline, Bristol-Myers Squibb, Sanofi, Pfizer, Adaptive, Regeneron, Janssen, AstraZeneca, Artiva, and Sutro. Dr. Landgren reported ties with Amgen, BMS, Celgene, Janssen, Takedam Glenmark, Juno, Pfizer, Merck, and others. Dr. Richter disclosed relationships with Janssen, BMS, and Takeda.
AT 2023 GREAT DEBATES AND UPDATES HEMATOLOGIC MALIGNANCIES CONFERENCE
White House to end COVID vaccine mandate for federal workers
The move means vaccines will no longer be required for workers who are federal employees, federal contractors, Head Start early education employees, workers at Medicare-certified health care facilities, and those who work at U.S. borders. International air travelers will no longer be required to prove their vaccination status. The requirement will be lifted at the end of the day on May 11, which is also when the federal public health emergency declaration ends.
“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” an announcement from the White House stated.
White House officials credited vaccine requirements with saving millions of lives, noting that the rules ensured “the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations.”
More than 100 million people were subject to the vaccine requirement, The Associated Press reported. All but 2% of those covered by the mandate had received at least one dose or had a pending or approved exception on file by January 2022, the Biden administration said, noting that COVID deaths have dropped 95% since January 2021 and hospitalizations are down nearly 91%.
In January, vaccine requirements were lifted for U.S. military members.
On the government-run website Safer Federal Workforce, which helped affected organizations put federal COVID rules into place, agencies were told to “take no action to implement or enforce the COVID-19 vaccination requirement” at this time.
A version of this article first appeared on WebMD.com.
The move means vaccines will no longer be required for workers who are federal employees, federal contractors, Head Start early education employees, workers at Medicare-certified health care facilities, and those who work at U.S. borders. International air travelers will no longer be required to prove their vaccination status. The requirement will be lifted at the end of the day on May 11, which is also when the federal public health emergency declaration ends.
“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” an announcement from the White House stated.
White House officials credited vaccine requirements with saving millions of lives, noting that the rules ensured “the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations.”
More than 100 million people were subject to the vaccine requirement, The Associated Press reported. All but 2% of those covered by the mandate had received at least one dose or had a pending or approved exception on file by January 2022, the Biden administration said, noting that COVID deaths have dropped 95% since January 2021 and hospitalizations are down nearly 91%.
In January, vaccine requirements were lifted for U.S. military members.
On the government-run website Safer Federal Workforce, which helped affected organizations put federal COVID rules into place, agencies were told to “take no action to implement or enforce the COVID-19 vaccination requirement” at this time.
A version of this article first appeared on WebMD.com.
The move means vaccines will no longer be required for workers who are federal employees, federal contractors, Head Start early education employees, workers at Medicare-certified health care facilities, and those who work at U.S. borders. International air travelers will no longer be required to prove their vaccination status. The requirement will be lifted at the end of the day on May 11, which is also when the federal public health emergency declaration ends.
“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” an announcement from the White House stated.
White House officials credited vaccine requirements with saving millions of lives, noting that the rules ensured “the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations.”
More than 100 million people were subject to the vaccine requirement, The Associated Press reported. All but 2% of those covered by the mandate had received at least one dose or had a pending or approved exception on file by January 2022, the Biden administration said, noting that COVID deaths have dropped 95% since January 2021 and hospitalizations are down nearly 91%.
In January, vaccine requirements were lifted for U.S. military members.
On the government-run website Safer Federal Workforce, which helped affected organizations put federal COVID rules into place, agencies were told to “take no action to implement or enforce the COVID-19 vaccination requirement” at this time.
A version of this article first appeared on WebMD.com.
U.S. incidence, prevalence of myasthenia gravis is rising
, an analysis of new claims data shows. Investigators speculate the rise of this rare disorder may be due to “increased diagnosis and more awareness of the disease over time, which has been shown in several studies,” study investigator Ema Rodrigues, DSc, MPH, with Alexion Pharmaceuticals, Boston.
Dr. Rodrigues presented her research at the 2023 annual meeting of the American Academy of Neurology.
Myasthenia gravis is a rare neuromuscular disease characterized by muscle weakness and fatigue caused by the binding of autoantibodies at the neuromuscular junction. It affects the voluntary muscles of the body, especially those that control the eyes, mouth, throat, and limbs.
In Europe, the incidence and prevalence of myasthenia gravis has increased for the past several decades. In the United States, increasing prevalence has also been observed, but recent estimates are lacking, making it tough to gauge the true burden of disease, Dr. Rodrigues explained.
Claims-based analysis
To investigate, Dr. Rodrigues and colleagues analyzed claims data (commercial, Medicare, and Medicaid) and electronic health records representing over 300 million patients in the United States from 2011 to present.
They calculated sex- and age-specific incidence and prevalence of myasthenia gravis for the year 2021 using U.S. Census data.
Prevalent patients were identified as having one or more myasthenia gravis records in 2021 and two or more myasthenia gravis records, at least 30 days apart, from 2016 to 2021. This cohort had 78,225 patients.
Incident patients were identified as those with a myasthenia gravis record in 2021 and no previous myasthenia gravis record from 2019 to 2020. This cohort had 4,214 patients.
For both the prevalent and incident cohort, the distribution of male and female patients was roughly 50/50, with a slightly higher proportion of females in the incident cohort, Dr. Rodrigues reported.
When looking at age groups, there were “very few pediatric patients,” she noted, with less than 1% of the patients under the age of 12. The highest proportion of patients were 65 years or older. The mean age was 67 in the prevalent cohort and 68 in the incident cohort.
In 2021, the overall incidence of myasthenia gravis was 3.2 per 100,000 with similar estimates for males and females (3.2 vs. 3.1 per 100,000, respectively).
Total prevalence was estimated to be 37.0 per 100,000 with sex-specific estimates being comparable at 37.3 and 36.7 per 100,000 for males and females, respectively.
The incidence and prevalence of myasthenia gravis increased with age, ranging from 0.3 and 0.4 per 100,000, respectively, in children younger than age 2 years, to 10.2 and 116.8 per 100,000, respectively, in people 65 and older.
These estimates are “significantly higher” than those from a prior U.S. analysis from 2003, Dr. Rodrigues told attendees, but they are quite similar to the estimates that were reported in Sweden in 2020.
A limitation of the analysis is that patients who do not seek care regularly may have not been identified due to inclusion criteria, potentially leading to underestimates. Also, no information was available on the myasthenia gravis subtype (ocular vs. generalized).
Underestimated burden
Reached for comment, Richard J. Nowak, MD, MS, director of the Yale Myasthenia Gravis Clinic, Yale School of Medicine, New Haven, Conn., noted that the new report, “albeit limited as a claims-based analysis, presents modern data on incidence and prevalence of myasthenia gravis in the United States.”
“It suggests that the current estimates of myasthenia gravis in the United States are too low and that the true impact/burden of myasthenia gravis is greater. While we are unable to verify the accuracy of the diagnosis, the total myasthenia gravis population is likely to be about 100,000, which is higher than prior estimates.”
“This, in fact, might be driven by greater disease awareness and increased diagnosis along with decreased mortality and longer life expectancy,” Dr. Nowak said.
“Anecdotally, we are most certainly seeing patients with new-onset myasthenia gravis in their 70s, 80s, and even 90s in recent years. The EXPLORE-MG registry published data from a tertiary center on age of onset breakdown showing myasthenia gravis can present at any age,” Dr. Nowak added.
Funding for the study was provided by Alexion, AstraZeneca Rare Disease. Dr. Rodrigues receives compensation and owns stock as an employee of Alexion, AstraZeneca Rare Diseases. Dr. Nowak has no relevant disclosures.
A version of this article originally appeared on Medscape.com.
, an analysis of new claims data shows. Investigators speculate the rise of this rare disorder may be due to “increased diagnosis and more awareness of the disease over time, which has been shown in several studies,” study investigator Ema Rodrigues, DSc, MPH, with Alexion Pharmaceuticals, Boston.
Dr. Rodrigues presented her research at the 2023 annual meeting of the American Academy of Neurology.
Myasthenia gravis is a rare neuromuscular disease characterized by muscle weakness and fatigue caused by the binding of autoantibodies at the neuromuscular junction. It affects the voluntary muscles of the body, especially those that control the eyes, mouth, throat, and limbs.
In Europe, the incidence and prevalence of myasthenia gravis has increased for the past several decades. In the United States, increasing prevalence has also been observed, but recent estimates are lacking, making it tough to gauge the true burden of disease, Dr. Rodrigues explained.
Claims-based analysis
To investigate, Dr. Rodrigues and colleagues analyzed claims data (commercial, Medicare, and Medicaid) and electronic health records representing over 300 million patients in the United States from 2011 to present.
They calculated sex- and age-specific incidence and prevalence of myasthenia gravis for the year 2021 using U.S. Census data.
Prevalent patients were identified as having one or more myasthenia gravis records in 2021 and two or more myasthenia gravis records, at least 30 days apart, from 2016 to 2021. This cohort had 78,225 patients.
Incident patients were identified as those with a myasthenia gravis record in 2021 and no previous myasthenia gravis record from 2019 to 2020. This cohort had 4,214 patients.
For both the prevalent and incident cohort, the distribution of male and female patients was roughly 50/50, with a slightly higher proportion of females in the incident cohort, Dr. Rodrigues reported.
When looking at age groups, there were “very few pediatric patients,” she noted, with less than 1% of the patients under the age of 12. The highest proportion of patients were 65 years or older. The mean age was 67 in the prevalent cohort and 68 in the incident cohort.
In 2021, the overall incidence of myasthenia gravis was 3.2 per 100,000 with similar estimates for males and females (3.2 vs. 3.1 per 100,000, respectively).
Total prevalence was estimated to be 37.0 per 100,000 with sex-specific estimates being comparable at 37.3 and 36.7 per 100,000 for males and females, respectively.
The incidence and prevalence of myasthenia gravis increased with age, ranging from 0.3 and 0.4 per 100,000, respectively, in children younger than age 2 years, to 10.2 and 116.8 per 100,000, respectively, in people 65 and older.
These estimates are “significantly higher” than those from a prior U.S. analysis from 2003, Dr. Rodrigues told attendees, but they are quite similar to the estimates that were reported in Sweden in 2020.
A limitation of the analysis is that patients who do not seek care regularly may have not been identified due to inclusion criteria, potentially leading to underestimates. Also, no information was available on the myasthenia gravis subtype (ocular vs. generalized).
Underestimated burden
Reached for comment, Richard J. Nowak, MD, MS, director of the Yale Myasthenia Gravis Clinic, Yale School of Medicine, New Haven, Conn., noted that the new report, “albeit limited as a claims-based analysis, presents modern data on incidence and prevalence of myasthenia gravis in the United States.”
“It suggests that the current estimates of myasthenia gravis in the United States are too low and that the true impact/burden of myasthenia gravis is greater. While we are unable to verify the accuracy of the diagnosis, the total myasthenia gravis population is likely to be about 100,000, which is higher than prior estimates.”
“This, in fact, might be driven by greater disease awareness and increased diagnosis along with decreased mortality and longer life expectancy,” Dr. Nowak said.
“Anecdotally, we are most certainly seeing patients with new-onset myasthenia gravis in their 70s, 80s, and even 90s in recent years. The EXPLORE-MG registry published data from a tertiary center on age of onset breakdown showing myasthenia gravis can present at any age,” Dr. Nowak added.
Funding for the study was provided by Alexion, AstraZeneca Rare Disease. Dr. Rodrigues receives compensation and owns stock as an employee of Alexion, AstraZeneca Rare Diseases. Dr. Nowak has no relevant disclosures.
A version of this article originally appeared on Medscape.com.
, an analysis of new claims data shows. Investigators speculate the rise of this rare disorder may be due to “increased diagnosis and more awareness of the disease over time, which has been shown in several studies,” study investigator Ema Rodrigues, DSc, MPH, with Alexion Pharmaceuticals, Boston.
Dr. Rodrigues presented her research at the 2023 annual meeting of the American Academy of Neurology.
Myasthenia gravis is a rare neuromuscular disease characterized by muscle weakness and fatigue caused by the binding of autoantibodies at the neuromuscular junction. It affects the voluntary muscles of the body, especially those that control the eyes, mouth, throat, and limbs.
In Europe, the incidence and prevalence of myasthenia gravis has increased for the past several decades. In the United States, increasing prevalence has also been observed, but recent estimates are lacking, making it tough to gauge the true burden of disease, Dr. Rodrigues explained.
Claims-based analysis
To investigate, Dr. Rodrigues and colleagues analyzed claims data (commercial, Medicare, and Medicaid) and electronic health records representing over 300 million patients in the United States from 2011 to present.
They calculated sex- and age-specific incidence and prevalence of myasthenia gravis for the year 2021 using U.S. Census data.
Prevalent patients were identified as having one or more myasthenia gravis records in 2021 and two or more myasthenia gravis records, at least 30 days apart, from 2016 to 2021. This cohort had 78,225 patients.
Incident patients were identified as those with a myasthenia gravis record in 2021 and no previous myasthenia gravis record from 2019 to 2020. This cohort had 4,214 patients.
For both the prevalent and incident cohort, the distribution of male and female patients was roughly 50/50, with a slightly higher proportion of females in the incident cohort, Dr. Rodrigues reported.
When looking at age groups, there were “very few pediatric patients,” she noted, with less than 1% of the patients under the age of 12. The highest proportion of patients were 65 years or older. The mean age was 67 in the prevalent cohort and 68 in the incident cohort.
In 2021, the overall incidence of myasthenia gravis was 3.2 per 100,000 with similar estimates for males and females (3.2 vs. 3.1 per 100,000, respectively).
Total prevalence was estimated to be 37.0 per 100,000 with sex-specific estimates being comparable at 37.3 and 36.7 per 100,000 for males and females, respectively.
The incidence and prevalence of myasthenia gravis increased with age, ranging from 0.3 and 0.4 per 100,000, respectively, in children younger than age 2 years, to 10.2 and 116.8 per 100,000, respectively, in people 65 and older.
These estimates are “significantly higher” than those from a prior U.S. analysis from 2003, Dr. Rodrigues told attendees, but they are quite similar to the estimates that were reported in Sweden in 2020.
A limitation of the analysis is that patients who do not seek care regularly may have not been identified due to inclusion criteria, potentially leading to underestimates. Also, no information was available on the myasthenia gravis subtype (ocular vs. generalized).
Underestimated burden
Reached for comment, Richard J. Nowak, MD, MS, director of the Yale Myasthenia Gravis Clinic, Yale School of Medicine, New Haven, Conn., noted that the new report, “albeit limited as a claims-based analysis, presents modern data on incidence and prevalence of myasthenia gravis in the United States.”
“It suggests that the current estimates of myasthenia gravis in the United States are too low and that the true impact/burden of myasthenia gravis is greater. While we are unable to verify the accuracy of the diagnosis, the total myasthenia gravis population is likely to be about 100,000, which is higher than prior estimates.”
“This, in fact, might be driven by greater disease awareness and increased diagnosis along with decreased mortality and longer life expectancy,” Dr. Nowak said.
“Anecdotally, we are most certainly seeing patients with new-onset myasthenia gravis in their 70s, 80s, and even 90s in recent years. The EXPLORE-MG registry published data from a tertiary center on age of onset breakdown showing myasthenia gravis can present at any age,” Dr. Nowak added.
Funding for the study was provided by Alexion, AstraZeneca Rare Disease. Dr. Rodrigues receives compensation and owns stock as an employee of Alexion, AstraZeneca Rare Diseases. Dr. Nowak has no relevant disclosures.
A version of this article originally appeared on Medscape.com.
From AAN 2023
Step count–heart rate link confirmed in children
, according to a study presented at the Pediatric Academic Societies annual meeting.
The new findings provide a new means for pediatricians to measure physical fitness, the researchers said.
“It really changes the way we evaluate kids’ fitness and gives us a new method of judging physical fitness other than body mass index,” said Susan Gasparino, MD, an instructor in pediatrics at the University of Rochester (N.Y.) Medical Center, who led the study.
Using data from the 2005 to 2006 National Health and Nutrition Examination Survey, Dr. Gasparino and her colleagues examined the association between resting heart rate (RHR) and step count among 899 children and 1,640 adolescents aged 6-19 years.
In the adolescent group, the mean RHR was 74.9 among those who walked more than 10,000 steps per day (n = 414) and 79.3 for those whose step counts fell below that cutoff (n = 1,226) (P < .001). For each additional 1,000 steps per day, RHR decreased by an average of 0.7 beats per minute in this group (P < .001).
In the younger age group, mean RHR was 85.3 among children who took more than 10,000 steps per day (n = 447) and 86.3 among those who did not reach that threshold (n = 452) (P = .29). For each additional 1,000 steps per day, RHR decreased by an average of 0.3 bpm in this group (P = .02)
Dr. Gasparino said next steps in research could include controlling for confounders, such as baseline anxiety and medications that could blunt the heart rate.
Broader implications
If similar results bear out in future studies, monitoring RHR could be incorporated into fitness programs for children and adolescents. Doing so could obviate “the need for intensive treadmill assessments using VO2max, time-consuming and emotionally fraught school-based physical fitness tests, and the fear and potential shame of the scale,” the researchers said.
Dr. Gasparino said measuring RHR during a 3-minute step test could help organizations and governments determine whether fitness programs are improving cardiovascular and overall health and could help them direct “funding and resources to the programs that are effective.” Such a test could also be incorporated into pediatrician wellness checks, she noted.
“It’s an exciting development, and [RHR measurement] holds a lot of promise as a clinical tool that can be applicable in a lot of settings,” said Nicholas M. Edwards, MD, MPH, a sports medicine pediatrician and an associate professor of orthopedics at the University of Minnesota in Minneapolis.
Dr. Edwards said that, because measurement of fitness in clinical settings is difficult, finding ways to “assess fitness in the office with the equipment already at hand would be a superb development.”
If use of RHR to measure fitness “is validated in a clinical setting,” Dr. Edwards said, “I think adoption would be a natural next step.”
Dr. Edwards has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
, according to a study presented at the Pediatric Academic Societies annual meeting.
The new findings provide a new means for pediatricians to measure physical fitness, the researchers said.
“It really changes the way we evaluate kids’ fitness and gives us a new method of judging physical fitness other than body mass index,” said Susan Gasparino, MD, an instructor in pediatrics at the University of Rochester (N.Y.) Medical Center, who led the study.
Using data from the 2005 to 2006 National Health and Nutrition Examination Survey, Dr. Gasparino and her colleagues examined the association between resting heart rate (RHR) and step count among 899 children and 1,640 adolescents aged 6-19 years.
In the adolescent group, the mean RHR was 74.9 among those who walked more than 10,000 steps per day (n = 414) and 79.3 for those whose step counts fell below that cutoff (n = 1,226) (P < .001). For each additional 1,000 steps per day, RHR decreased by an average of 0.7 beats per minute in this group (P < .001).
In the younger age group, mean RHR was 85.3 among children who took more than 10,000 steps per day (n = 447) and 86.3 among those who did not reach that threshold (n = 452) (P = .29). For each additional 1,000 steps per day, RHR decreased by an average of 0.3 bpm in this group (P = .02)
Dr. Gasparino said next steps in research could include controlling for confounders, such as baseline anxiety and medications that could blunt the heart rate.
Broader implications
If similar results bear out in future studies, monitoring RHR could be incorporated into fitness programs for children and adolescents. Doing so could obviate “the need for intensive treadmill assessments using VO2max, time-consuming and emotionally fraught school-based physical fitness tests, and the fear and potential shame of the scale,” the researchers said.
Dr. Gasparino said measuring RHR during a 3-minute step test could help organizations and governments determine whether fitness programs are improving cardiovascular and overall health and could help them direct “funding and resources to the programs that are effective.” Such a test could also be incorporated into pediatrician wellness checks, she noted.
“It’s an exciting development, and [RHR measurement] holds a lot of promise as a clinical tool that can be applicable in a lot of settings,” said Nicholas M. Edwards, MD, MPH, a sports medicine pediatrician and an associate professor of orthopedics at the University of Minnesota in Minneapolis.
Dr. Edwards said that, because measurement of fitness in clinical settings is difficult, finding ways to “assess fitness in the office with the equipment already at hand would be a superb development.”
If use of RHR to measure fitness “is validated in a clinical setting,” Dr. Edwards said, “I think adoption would be a natural next step.”
Dr. Edwards has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
, according to a study presented at the Pediatric Academic Societies annual meeting.
The new findings provide a new means for pediatricians to measure physical fitness, the researchers said.
“It really changes the way we evaluate kids’ fitness and gives us a new method of judging physical fitness other than body mass index,” said Susan Gasparino, MD, an instructor in pediatrics at the University of Rochester (N.Y.) Medical Center, who led the study.
Using data from the 2005 to 2006 National Health and Nutrition Examination Survey, Dr. Gasparino and her colleagues examined the association between resting heart rate (RHR) and step count among 899 children and 1,640 adolescents aged 6-19 years.
In the adolescent group, the mean RHR was 74.9 among those who walked more than 10,000 steps per day (n = 414) and 79.3 for those whose step counts fell below that cutoff (n = 1,226) (P < .001). For each additional 1,000 steps per day, RHR decreased by an average of 0.7 beats per minute in this group (P < .001).
In the younger age group, mean RHR was 85.3 among children who took more than 10,000 steps per day (n = 447) and 86.3 among those who did not reach that threshold (n = 452) (P = .29). For each additional 1,000 steps per day, RHR decreased by an average of 0.3 bpm in this group (P = .02)
Dr. Gasparino said next steps in research could include controlling for confounders, such as baseline anxiety and medications that could blunt the heart rate.
Broader implications
If similar results bear out in future studies, monitoring RHR could be incorporated into fitness programs for children and adolescents. Doing so could obviate “the need for intensive treadmill assessments using VO2max, time-consuming and emotionally fraught school-based physical fitness tests, and the fear and potential shame of the scale,” the researchers said.
Dr. Gasparino said measuring RHR during a 3-minute step test could help organizations and governments determine whether fitness programs are improving cardiovascular and overall health and could help them direct “funding and resources to the programs that are effective.” Such a test could also be incorporated into pediatrician wellness checks, she noted.
“It’s an exciting development, and [RHR measurement] holds a lot of promise as a clinical tool that can be applicable in a lot of settings,” said Nicholas M. Edwards, MD, MPH, a sports medicine pediatrician and an associate professor of orthopedics at the University of Minnesota in Minneapolis.
Dr. Edwards said that, because measurement of fitness in clinical settings is difficult, finding ways to “assess fitness in the office with the equipment already at hand would be a superb development.”
If use of RHR to measure fitness “is validated in a clinical setting,” Dr. Edwards said, “I think adoption would be a natural next step.”
Dr. Edwards has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM PAS 2023
Head-to-head comparison of migraine meds reveals top options
BOSTON – , a new real-world analysis of data on more than 3 million migraine attacks shows.
The findings “align with results of clinical trials and recommendations from clinical treatment guidelines” and provide insights to complement clinical practice, said study investigator Chia-Chun Chiang, MD, a neurologist with Mayo Clinic, Rochester, Minn.
The findings were presented at the 2023 annual meeting of the American Academy of Neurology.
The power of big data
Despite a wide variety of acute migraine medications that are available, large-scale, head-to-head comparisons of treatment effectiveness from real-world patient experience reports are lacking, Dr. Chiang explained.
“To the best of our knowledge, this is the first study that simultaneously compared multiple acute migraine medications using a Big Data analysis approach based on real-world patient-provided data,” she said.
The researchers extracted more than 10 million self-reported migraine attack records from a migraine smartphone app called Migraine Buddy, where users can document whether a treatment was helpful, somewhat helpful, unsure, or unhelpful.
They analyzed 25 acute medications among seven classes: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, combination analgesics (acetaminophen/aspirin/caffeine), ergots, antiemetics, and opioids. The newer gepants and ditan medication classes of medications were not included because of the relatively lower numbers of usage when data was extracted (2014-2020).
The researchers employed a two-level nested logistic regression model to analyze the odds of treatment effectiveness of each medication by adjusting concurrent medications and the covariance within the same user.
The final analysis included more than 3.1 million migraine attacks among 278,000 users globally.
Using ibuprofen as the reference, triptans, ergots, and antiemetics had the highest efficacy with mean odds ratios of 4.8, 3.02, and 2.67, respectively, followed by opioids (OR, 2.49), NSAIDs (OR, 1.94), combination analgesics (OR, 1.69), others (OR, 1.49), and acetaminophen (OR, 0.83).
Individual medications with the highest patient-reported effectiveness were eletriptan (Relpax; OR, 6.1), zolmitriptan (Zomig; OR, 5.7) and sumatriptan (Zecuity; OR, 5.2).
This migraine medication comparative effectiveness analysis, based on patient-reported outcomes, “supports and complements the treatment recommendations from national headache societies based on randomized controlled trials and meta-analyses and strongly supports the use of triptans,” Dr. Chiang said.
End of trial-and-error?
Commenting on this research, Shaheen Lakhan, MD, PhD, a neurologist and researcher in Boston, said “This is a great study of Big Data in that it shows the power of the smartphone to collect real-world data and smart researchers like at Mayo Clinic to analyze them.”
“The study sheds light on how different therapeutics compare with each other. The next iteration of this line of research, I would hope, would be to determine if particular medications are effective for a particular migraine population, and even down to individuals with migraine,” said Dr. Lakhan, who wasn’t involved in the study.
“Once those models are appropriately built, long gone will be the era of trial-and-error medicine,” Dr. Lakhan added.
The study had no specific funding. Dr. Chiang has served as a consultant for Satsuma. Dr. Lakhan reports no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
BOSTON – , a new real-world analysis of data on more than 3 million migraine attacks shows.
The findings “align with results of clinical trials and recommendations from clinical treatment guidelines” and provide insights to complement clinical practice, said study investigator Chia-Chun Chiang, MD, a neurologist with Mayo Clinic, Rochester, Minn.
The findings were presented at the 2023 annual meeting of the American Academy of Neurology.
The power of big data
Despite a wide variety of acute migraine medications that are available, large-scale, head-to-head comparisons of treatment effectiveness from real-world patient experience reports are lacking, Dr. Chiang explained.
“To the best of our knowledge, this is the first study that simultaneously compared multiple acute migraine medications using a Big Data analysis approach based on real-world patient-provided data,” she said.
The researchers extracted more than 10 million self-reported migraine attack records from a migraine smartphone app called Migraine Buddy, where users can document whether a treatment was helpful, somewhat helpful, unsure, or unhelpful.
They analyzed 25 acute medications among seven classes: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, combination analgesics (acetaminophen/aspirin/caffeine), ergots, antiemetics, and opioids. The newer gepants and ditan medication classes of medications were not included because of the relatively lower numbers of usage when data was extracted (2014-2020).
The researchers employed a two-level nested logistic regression model to analyze the odds of treatment effectiveness of each medication by adjusting concurrent medications and the covariance within the same user.
The final analysis included more than 3.1 million migraine attacks among 278,000 users globally.
Using ibuprofen as the reference, triptans, ergots, and antiemetics had the highest efficacy with mean odds ratios of 4.8, 3.02, and 2.67, respectively, followed by opioids (OR, 2.49), NSAIDs (OR, 1.94), combination analgesics (OR, 1.69), others (OR, 1.49), and acetaminophen (OR, 0.83).
Individual medications with the highest patient-reported effectiveness were eletriptan (Relpax; OR, 6.1), zolmitriptan (Zomig; OR, 5.7) and sumatriptan (Zecuity; OR, 5.2).
This migraine medication comparative effectiveness analysis, based on patient-reported outcomes, “supports and complements the treatment recommendations from national headache societies based on randomized controlled trials and meta-analyses and strongly supports the use of triptans,” Dr. Chiang said.
End of trial-and-error?
Commenting on this research, Shaheen Lakhan, MD, PhD, a neurologist and researcher in Boston, said “This is a great study of Big Data in that it shows the power of the smartphone to collect real-world data and smart researchers like at Mayo Clinic to analyze them.”
“The study sheds light on how different therapeutics compare with each other. The next iteration of this line of research, I would hope, would be to determine if particular medications are effective for a particular migraine population, and even down to individuals with migraine,” said Dr. Lakhan, who wasn’t involved in the study.
“Once those models are appropriately built, long gone will be the era of trial-and-error medicine,” Dr. Lakhan added.
The study had no specific funding. Dr. Chiang has served as a consultant for Satsuma. Dr. Lakhan reports no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
BOSTON – , a new real-world analysis of data on more than 3 million migraine attacks shows.
The findings “align with results of clinical trials and recommendations from clinical treatment guidelines” and provide insights to complement clinical practice, said study investigator Chia-Chun Chiang, MD, a neurologist with Mayo Clinic, Rochester, Minn.
The findings were presented at the 2023 annual meeting of the American Academy of Neurology.
The power of big data
Despite a wide variety of acute migraine medications that are available, large-scale, head-to-head comparisons of treatment effectiveness from real-world patient experience reports are lacking, Dr. Chiang explained.
“To the best of our knowledge, this is the first study that simultaneously compared multiple acute migraine medications using a Big Data analysis approach based on real-world patient-provided data,” she said.
The researchers extracted more than 10 million self-reported migraine attack records from a migraine smartphone app called Migraine Buddy, where users can document whether a treatment was helpful, somewhat helpful, unsure, or unhelpful.
They analyzed 25 acute medications among seven classes: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, combination analgesics (acetaminophen/aspirin/caffeine), ergots, antiemetics, and opioids. The newer gepants and ditan medication classes of medications were not included because of the relatively lower numbers of usage when data was extracted (2014-2020).
The researchers employed a two-level nested logistic regression model to analyze the odds of treatment effectiveness of each medication by adjusting concurrent medications and the covariance within the same user.
The final analysis included more than 3.1 million migraine attacks among 278,000 users globally.
Using ibuprofen as the reference, triptans, ergots, and antiemetics had the highest efficacy with mean odds ratios of 4.8, 3.02, and 2.67, respectively, followed by opioids (OR, 2.49), NSAIDs (OR, 1.94), combination analgesics (OR, 1.69), others (OR, 1.49), and acetaminophen (OR, 0.83).
Individual medications with the highest patient-reported effectiveness were eletriptan (Relpax; OR, 6.1), zolmitriptan (Zomig; OR, 5.7) and sumatriptan (Zecuity; OR, 5.2).
This migraine medication comparative effectiveness analysis, based on patient-reported outcomes, “supports and complements the treatment recommendations from national headache societies based on randomized controlled trials and meta-analyses and strongly supports the use of triptans,” Dr. Chiang said.
End of trial-and-error?
Commenting on this research, Shaheen Lakhan, MD, PhD, a neurologist and researcher in Boston, said “This is a great study of Big Data in that it shows the power of the smartphone to collect real-world data and smart researchers like at Mayo Clinic to analyze them.”
“The study sheds light on how different therapeutics compare with each other. The next iteration of this line of research, I would hope, would be to determine if particular medications are effective for a particular migraine population, and even down to individuals with migraine,” said Dr. Lakhan, who wasn’t involved in the study.
“Once those models are appropriately built, long gone will be the era of trial-and-error medicine,” Dr. Lakhan added.
The study had no specific funding. Dr. Chiang has served as a consultant for Satsuma. Dr. Lakhan reports no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT AAN 2023