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People really can get ‘hangry’ when hungry
The notion that people get ‘hangry’ – irritable and short-tempered when they’re hungry – is such an established part of modern folklore that the word has even been added to the Oxford English Dictionary. Although experimental studies in the past have shown that low blood glucose levels increase impulsivity, anger, and aggression, there has been little solid evidence that this translates to real-life settings.
Now new research has confirmed that the phenomenon does really exist in everyday life. The study, published in the journal PLOS ONE, is the first to investigate how hunger affects people’s emotions on a day-to-day level. Lead author Viren Swami, professor of social psychology at Anglia Ruskin University, Cambridge, England, said: “Many of us are aware that being hungry can influence our emotions, but surprisingly little scientific research has focused on being ‘hangry’.”
He and coauthors from Karl Landsteiner University of Health Sciences in Krems an der Donau, Austria, recruited 64 participants from Central Europe who completed a 21-day experience sampling phase, in which they were prompted to report their feelings on a smartphone app five times a day. At each prompt, they reported their levels of hunger, anger, irritability, pleasure, and arousal on a visual analog scale.
Participants were on average 29.9 years old (range = 18-60), predominantly (81.3%) women, and had a mean body mass index of 23.8 kg/m2 (range 15.8-36.5 kg/m2).
Anger was rated on a 5-point scale but the team explained that the effects of hunger are unlikely to be unique to anger per se, so they also asked about experiences of irritability and, in order to obtain a more holistic view of emotionality, also about pleasure and arousal, as indexed using Russell’s affect grid.
They also asked about eating behaviors over the previous 3 weeks, including frequency of main meals, snacking behavior, healthy eating, feeling hungry, and sense of satiety, and about dietary behaviors including restrictive eating, emotionally induced eating, and externally determined eating behavior.
Analysis of the resulting total of 9,142 responses showed that higher levels of self-reported hunger were associated with greater feelings of anger and irritability, and with lower levels of pleasure. These findings remained significant after accounting for participants’ sex, age, body mass index, dietary behaviors, and trait anger. However, associations with arousal were not significant.
The authors commented that the use of the app allowed data collection to take place in subjects’ everyday environments, such as their workplace and at home. “These results provide evidence that everyday levels of hunger are associated with negative emotionality and supports the notion of being ‘hangry.’ ”
‘Substantial’ effects
“The effects were substantial,” the team said, “even after taking into account demographic factors” such as age and sex, body mass index, dietary behavior, and individual personality traits. Hunger was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants.
The research also showed that the negative emotions – irritability, anger, and unpleasantness – were caused by both day-to-day fluctuations in hunger and residual levels of hunger measured by averages over the 3-week period.
The authors said their findings “suggest that the experience of being hangry is real, insofar as hunger was associated with greater anger and irritability, and lower pleasure, in our sample over a period of 3 weeks.
“These results may have important implications for understanding everyday experiences of emotions, and may also assist practitioners to more effectively ensure productive individual behaviors and interpersonal relationships (for example, by ensuring that no one goes hungry).”
Although the majority of participants (55%) said they paid attention to hunger pangs, only 23% said that they knew when they were full and then stopped eating, whereas 63% said they could tell when they were full but sometimes continued to eat. Few (4.7%) people said they could not tell when they were full and therefore oriented their eating based on the size of the meal, but 9% described frequent overeating because of not feeling satiated, and 13% stated they ate when they were stressed, upset, angry, or bored.
Professor Swami said: “Ours is the first study to examine being ‘hangry’ outside of a lab. By following people in their day-to-day lives, we found that hunger was related to levels of anger, irritability, and pleasure.
“Although our study doesn’t present ways to mitigate negative hunger-induced emotions, research suggests that being able to label an emotion can help people to regulate it, such as by recognizing that we feel angry simply because we are hungry. Therefore, greater awareness of being ‘hangry’ could reduce the likelihood that hunger results in negative emotions and behaviors in individuals.”
A version of this article first appeared on Medscape UK.
The notion that people get ‘hangry’ – irritable and short-tempered when they’re hungry – is such an established part of modern folklore that the word has even been added to the Oxford English Dictionary. Although experimental studies in the past have shown that low blood glucose levels increase impulsivity, anger, and aggression, there has been little solid evidence that this translates to real-life settings.
Now new research has confirmed that the phenomenon does really exist in everyday life. The study, published in the journal PLOS ONE, is the first to investigate how hunger affects people’s emotions on a day-to-day level. Lead author Viren Swami, professor of social psychology at Anglia Ruskin University, Cambridge, England, said: “Many of us are aware that being hungry can influence our emotions, but surprisingly little scientific research has focused on being ‘hangry’.”
He and coauthors from Karl Landsteiner University of Health Sciences in Krems an der Donau, Austria, recruited 64 participants from Central Europe who completed a 21-day experience sampling phase, in which they were prompted to report their feelings on a smartphone app five times a day. At each prompt, they reported their levels of hunger, anger, irritability, pleasure, and arousal on a visual analog scale.
Participants were on average 29.9 years old (range = 18-60), predominantly (81.3%) women, and had a mean body mass index of 23.8 kg/m2 (range 15.8-36.5 kg/m2).
Anger was rated on a 5-point scale but the team explained that the effects of hunger are unlikely to be unique to anger per se, so they also asked about experiences of irritability and, in order to obtain a more holistic view of emotionality, also about pleasure and arousal, as indexed using Russell’s affect grid.
They also asked about eating behaviors over the previous 3 weeks, including frequency of main meals, snacking behavior, healthy eating, feeling hungry, and sense of satiety, and about dietary behaviors including restrictive eating, emotionally induced eating, and externally determined eating behavior.
Analysis of the resulting total of 9,142 responses showed that higher levels of self-reported hunger were associated with greater feelings of anger and irritability, and with lower levels of pleasure. These findings remained significant after accounting for participants’ sex, age, body mass index, dietary behaviors, and trait anger. However, associations with arousal were not significant.
The authors commented that the use of the app allowed data collection to take place in subjects’ everyday environments, such as their workplace and at home. “These results provide evidence that everyday levels of hunger are associated with negative emotionality and supports the notion of being ‘hangry.’ ”
‘Substantial’ effects
“The effects were substantial,” the team said, “even after taking into account demographic factors” such as age and sex, body mass index, dietary behavior, and individual personality traits. Hunger was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants.
The research also showed that the negative emotions – irritability, anger, and unpleasantness – were caused by both day-to-day fluctuations in hunger and residual levels of hunger measured by averages over the 3-week period.
The authors said their findings “suggest that the experience of being hangry is real, insofar as hunger was associated with greater anger and irritability, and lower pleasure, in our sample over a period of 3 weeks.
“These results may have important implications for understanding everyday experiences of emotions, and may also assist practitioners to more effectively ensure productive individual behaviors and interpersonal relationships (for example, by ensuring that no one goes hungry).”
Although the majority of participants (55%) said they paid attention to hunger pangs, only 23% said that they knew when they were full and then stopped eating, whereas 63% said they could tell when they were full but sometimes continued to eat. Few (4.7%) people said they could not tell when they were full and therefore oriented their eating based on the size of the meal, but 9% described frequent overeating because of not feeling satiated, and 13% stated they ate when they were stressed, upset, angry, or bored.
Professor Swami said: “Ours is the first study to examine being ‘hangry’ outside of a lab. By following people in their day-to-day lives, we found that hunger was related to levels of anger, irritability, and pleasure.
“Although our study doesn’t present ways to mitigate negative hunger-induced emotions, research suggests that being able to label an emotion can help people to regulate it, such as by recognizing that we feel angry simply because we are hungry. Therefore, greater awareness of being ‘hangry’ could reduce the likelihood that hunger results in negative emotions and behaviors in individuals.”
A version of this article first appeared on Medscape UK.
The notion that people get ‘hangry’ – irritable and short-tempered when they’re hungry – is such an established part of modern folklore that the word has even been added to the Oxford English Dictionary. Although experimental studies in the past have shown that low blood glucose levels increase impulsivity, anger, and aggression, there has been little solid evidence that this translates to real-life settings.
Now new research has confirmed that the phenomenon does really exist in everyday life. The study, published in the journal PLOS ONE, is the first to investigate how hunger affects people’s emotions on a day-to-day level. Lead author Viren Swami, professor of social psychology at Anglia Ruskin University, Cambridge, England, said: “Many of us are aware that being hungry can influence our emotions, but surprisingly little scientific research has focused on being ‘hangry’.”
He and coauthors from Karl Landsteiner University of Health Sciences in Krems an der Donau, Austria, recruited 64 participants from Central Europe who completed a 21-day experience sampling phase, in which they were prompted to report their feelings on a smartphone app five times a day. At each prompt, they reported their levels of hunger, anger, irritability, pleasure, and arousal on a visual analog scale.
Participants were on average 29.9 years old (range = 18-60), predominantly (81.3%) women, and had a mean body mass index of 23.8 kg/m2 (range 15.8-36.5 kg/m2).
Anger was rated on a 5-point scale but the team explained that the effects of hunger are unlikely to be unique to anger per se, so they also asked about experiences of irritability and, in order to obtain a more holistic view of emotionality, also about pleasure and arousal, as indexed using Russell’s affect grid.
They also asked about eating behaviors over the previous 3 weeks, including frequency of main meals, snacking behavior, healthy eating, feeling hungry, and sense of satiety, and about dietary behaviors including restrictive eating, emotionally induced eating, and externally determined eating behavior.
Analysis of the resulting total of 9,142 responses showed that higher levels of self-reported hunger were associated with greater feelings of anger and irritability, and with lower levels of pleasure. These findings remained significant after accounting for participants’ sex, age, body mass index, dietary behaviors, and trait anger. However, associations with arousal were not significant.
The authors commented that the use of the app allowed data collection to take place in subjects’ everyday environments, such as their workplace and at home. “These results provide evidence that everyday levels of hunger are associated with negative emotionality and supports the notion of being ‘hangry.’ ”
‘Substantial’ effects
“The effects were substantial,” the team said, “even after taking into account demographic factors” such as age and sex, body mass index, dietary behavior, and individual personality traits. Hunger was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants.
The research also showed that the negative emotions – irritability, anger, and unpleasantness – were caused by both day-to-day fluctuations in hunger and residual levels of hunger measured by averages over the 3-week period.
The authors said their findings “suggest that the experience of being hangry is real, insofar as hunger was associated with greater anger and irritability, and lower pleasure, in our sample over a period of 3 weeks.
“These results may have important implications for understanding everyday experiences of emotions, and may also assist practitioners to more effectively ensure productive individual behaviors and interpersonal relationships (for example, by ensuring that no one goes hungry).”
Although the majority of participants (55%) said they paid attention to hunger pangs, only 23% said that they knew when they were full and then stopped eating, whereas 63% said they could tell when they were full but sometimes continued to eat. Few (4.7%) people said they could not tell when they were full and therefore oriented their eating based on the size of the meal, but 9% described frequent overeating because of not feeling satiated, and 13% stated they ate when they were stressed, upset, angry, or bored.
Professor Swami said: “Ours is the first study to examine being ‘hangry’ outside of a lab. By following people in their day-to-day lives, we found that hunger was related to levels of anger, irritability, and pleasure.
“Although our study doesn’t present ways to mitigate negative hunger-induced emotions, research suggests that being able to label an emotion can help people to regulate it, such as by recognizing that we feel angry simply because we are hungry. Therefore, greater awareness of being ‘hangry’ could reduce the likelihood that hunger results in negative emotions and behaviors in individuals.”
A version of this article first appeared on Medscape UK.
FROM PLOS ONE
Surprising ethnic difference in atherosclerosis burden in Harlem, N.Y.
Non-Hispanic Black young adults in a large, ethnically diverse underserved neighborhood in New York City have about twice the prevalence of subclinical atherosclerosis as Hispanic young adults, according to a new cross-sectional study. It was noteworthy for identifying subclinical cardiovascular (CV) disease in the cohorts using 3D intravascular ultrasound (3D IVUS).
The study’s 436 Black and Hispanic adults, 82% of them women, completed questionnaires regarding nutrition, lifestyle, medical history, weight, blood pressure, cholesterol levels, and other metrics.
(24.5% vs. 9.3%). Overall Framingham scores for 10-year risk for CV events were not statistically different, at 4.6 and 3.6, respectively.
The presence of atherosclerosis in either the carotid or femoral arteries was identified with 3D IVUS in 8.7% of participants. But its prevalence was about twofold greater in Black than in Hispanic participants (12.9% vs. 6.6%), a finding that persisted after multivariable adjustment and appeared driven by a greater prevalence of carotid disease among Black participants (12.9% vs. 4.8%).
“For the same predicted CV risk, non-Hispanic Black individuals appear to be more vulnerable than people of Hispanic origin to early subclinical atherosclerosis, particularly in the carotid arteries, potentially placing them at increased risk of clinical CV disease,” concludes the report published in the Journal of the American College of Cardiology, with lead author Josep Iglesies-Grau, MD, Montreal Heart Institute.
International program
The current analysis from the FAMILIA study is part of a large international project called Science, Health, and Education (SHE), which is designed to promote early intervention in the lives of children, their caretakers, and teachers so they can develop lifelong heart-healthy habits, senior author Valentin Fuster, MD, PhD, physician-in chief, Mount Sinai Hospital, New York, said in an interview.
The SHE program has been presented to more than 50,000 children worldwide, and FAMILIA has delivered successful interventions to more than 500 preschoolers, caretakers, and educators at Head Start schools in the Harlem neighborhood of New York, where the current study was conducted.
The analysis centered on the children’s adult caregivers, of whom one-third were non-Hispanic Black and two-thirds were Hispanic. “We wanted to know if this young population of parents and caregivers [would show] development or initiation of atherosclerotic disease,” Dr. Fuster said, “thinking that when we showed them that they had disease, it would further motivate them to change their lifestyle.”
Participants were assessed for seven basic CV risk factors – hypertension, smoking, body mass index, diabetes, dyslipidemia, low physical activity levels, and poor-quality diet – as well as socioeconomic descriptors. All participants also underwent 3D IVUS to evaluate the presence and extent of atherosclerosis in the carotid and femoral arteries.
‘Expected and unexpected’ findings
Black participants were considerably more likely than their Hispanic counterparts to be hypertensive, to be active smokers, and to have higher BMIs. The Black cohort reported higher consumption of fruits and vegetables (P < .001).
There were no between-group differences in the prevalence of diabetes or in mean fasting glucose or total cholesterol levels.
The mean 10-year Framingham CV risk score across the entire study population was 4.0%, with no significant differences between the two groups. In fact, 89% of participants were classified as low risk on the basis of the score.
The overall prevalence of subclinical atherosclerosis was 8.7%, with a mean global plaque burden of 5.0 mm3. But there were dramatic differences in atherosclerotic burden. Across all 10-year Framingham risk categories, Black participants had twice the odds of having subclinical atherosclerosis as Hispanic participants (odds ratio, 2.11; 95% confidence interval, 1.09-4.08; P = .026).
Black participants also had a greater atherosclerotic disease burden (9.0 mm3 vs. 2.9 mm3), mean total plaque volume (P = .028), and a higher prevalence of disease in both the carotid and femoral arteries (8.2% vs. 3.8%; P = .026).
“Our findings were both expected and completely unexpected,” Dr. Fuster commented. “It was expected that the non-Hispanic Black population would have more hypertension, obesity, and smoking, and might therefore have more [atherosclerotic] disease. But what was unexpected was when we adjusted for the seven risk factors and socioeconomic status, the Black population had three times the amount of disease,” he said.
“We need to take better care of the risk factors already known in the Black population, which is critical.” However, “our challenge today is to identify these new risk factors, which might be genetic or socioeconomic.” Dr. Fuster said his group is “already working with artificial intelligence to identify risk factors beyond the traditional risk factors that are already established.”
Socioeconomic differences?
“The fact that we’re uncovering and demonstrating that this is an issue – especially for African American women at a young age – and we could make a significant interdiction in terms of risk reduction if we have tools and invest the necessary time and effort, that is the important part of this paper,” Keith Churchwell, MD, Yale New Haven Hospital, and Yale School of Medicine, New Haven, Conn., said in an interview.
“If you’re going to evaluate African Americans in Harlem who are socially disadvantaged, I would want to know if there is a difference between them and other African Americans who have a different socioeconomic status, in terms of atherosclerotic disease,” added Dr. Churchwell, who was not involved with the study.
The Framingham 10-year risk score is “inadequate in assessing CV disease risk in all populations and is not generalizable to non-Whites,” contend Ramdas G. Pai, MD, and Vrinda Vyas, MBBS, of the University of California, Riverside, in an accompanying editorial.
“New data are emerging in favor of imaging-based classification of CV disease risk and has been shown to improve patient adherence to and compliance with risk-modifying interventions,” they write. “Subclinical atherosclerosis may help better stratify CV disease risk so that preventive measures can be instituted to reduce cardiovascular events at a population level.”
Dr. Fuster and coauthors, Dr. Ramdas and Dr. Pai, and Dr. Churchwell report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Non-Hispanic Black young adults in a large, ethnically diverse underserved neighborhood in New York City have about twice the prevalence of subclinical atherosclerosis as Hispanic young adults, according to a new cross-sectional study. It was noteworthy for identifying subclinical cardiovascular (CV) disease in the cohorts using 3D intravascular ultrasound (3D IVUS).
The study’s 436 Black and Hispanic adults, 82% of them women, completed questionnaires regarding nutrition, lifestyle, medical history, weight, blood pressure, cholesterol levels, and other metrics.
(24.5% vs. 9.3%). Overall Framingham scores for 10-year risk for CV events were not statistically different, at 4.6 and 3.6, respectively.
The presence of atherosclerosis in either the carotid or femoral arteries was identified with 3D IVUS in 8.7% of participants. But its prevalence was about twofold greater in Black than in Hispanic participants (12.9% vs. 6.6%), a finding that persisted after multivariable adjustment and appeared driven by a greater prevalence of carotid disease among Black participants (12.9% vs. 4.8%).
“For the same predicted CV risk, non-Hispanic Black individuals appear to be more vulnerable than people of Hispanic origin to early subclinical atherosclerosis, particularly in the carotid arteries, potentially placing them at increased risk of clinical CV disease,” concludes the report published in the Journal of the American College of Cardiology, with lead author Josep Iglesies-Grau, MD, Montreal Heart Institute.
International program
The current analysis from the FAMILIA study is part of a large international project called Science, Health, and Education (SHE), which is designed to promote early intervention in the lives of children, their caretakers, and teachers so they can develop lifelong heart-healthy habits, senior author Valentin Fuster, MD, PhD, physician-in chief, Mount Sinai Hospital, New York, said in an interview.
The SHE program has been presented to more than 50,000 children worldwide, and FAMILIA has delivered successful interventions to more than 500 preschoolers, caretakers, and educators at Head Start schools in the Harlem neighborhood of New York, where the current study was conducted.
The analysis centered on the children’s adult caregivers, of whom one-third were non-Hispanic Black and two-thirds were Hispanic. “We wanted to know if this young population of parents and caregivers [would show] development or initiation of atherosclerotic disease,” Dr. Fuster said, “thinking that when we showed them that they had disease, it would further motivate them to change their lifestyle.”
Participants were assessed for seven basic CV risk factors – hypertension, smoking, body mass index, diabetes, dyslipidemia, low physical activity levels, and poor-quality diet – as well as socioeconomic descriptors. All participants also underwent 3D IVUS to evaluate the presence and extent of atherosclerosis in the carotid and femoral arteries.
‘Expected and unexpected’ findings
Black participants were considerably more likely than their Hispanic counterparts to be hypertensive, to be active smokers, and to have higher BMIs. The Black cohort reported higher consumption of fruits and vegetables (P < .001).
There were no between-group differences in the prevalence of diabetes or in mean fasting glucose or total cholesterol levels.
The mean 10-year Framingham CV risk score across the entire study population was 4.0%, with no significant differences between the two groups. In fact, 89% of participants were classified as low risk on the basis of the score.
The overall prevalence of subclinical atherosclerosis was 8.7%, with a mean global plaque burden of 5.0 mm3. But there were dramatic differences in atherosclerotic burden. Across all 10-year Framingham risk categories, Black participants had twice the odds of having subclinical atherosclerosis as Hispanic participants (odds ratio, 2.11; 95% confidence interval, 1.09-4.08; P = .026).
Black participants also had a greater atherosclerotic disease burden (9.0 mm3 vs. 2.9 mm3), mean total plaque volume (P = .028), and a higher prevalence of disease in both the carotid and femoral arteries (8.2% vs. 3.8%; P = .026).
“Our findings were both expected and completely unexpected,” Dr. Fuster commented. “It was expected that the non-Hispanic Black population would have more hypertension, obesity, and smoking, and might therefore have more [atherosclerotic] disease. But what was unexpected was when we adjusted for the seven risk factors and socioeconomic status, the Black population had three times the amount of disease,” he said.
“We need to take better care of the risk factors already known in the Black population, which is critical.” However, “our challenge today is to identify these new risk factors, which might be genetic or socioeconomic.” Dr. Fuster said his group is “already working with artificial intelligence to identify risk factors beyond the traditional risk factors that are already established.”
Socioeconomic differences?
“The fact that we’re uncovering and demonstrating that this is an issue – especially for African American women at a young age – and we could make a significant interdiction in terms of risk reduction if we have tools and invest the necessary time and effort, that is the important part of this paper,” Keith Churchwell, MD, Yale New Haven Hospital, and Yale School of Medicine, New Haven, Conn., said in an interview.
“If you’re going to evaluate African Americans in Harlem who are socially disadvantaged, I would want to know if there is a difference between them and other African Americans who have a different socioeconomic status, in terms of atherosclerotic disease,” added Dr. Churchwell, who was not involved with the study.
The Framingham 10-year risk score is “inadequate in assessing CV disease risk in all populations and is not generalizable to non-Whites,” contend Ramdas G. Pai, MD, and Vrinda Vyas, MBBS, of the University of California, Riverside, in an accompanying editorial.
“New data are emerging in favor of imaging-based classification of CV disease risk and has been shown to improve patient adherence to and compliance with risk-modifying interventions,” they write. “Subclinical atherosclerosis may help better stratify CV disease risk so that preventive measures can be instituted to reduce cardiovascular events at a population level.”
Dr. Fuster and coauthors, Dr. Ramdas and Dr. Pai, and Dr. Churchwell report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Non-Hispanic Black young adults in a large, ethnically diverse underserved neighborhood in New York City have about twice the prevalence of subclinical atherosclerosis as Hispanic young adults, according to a new cross-sectional study. It was noteworthy for identifying subclinical cardiovascular (CV) disease in the cohorts using 3D intravascular ultrasound (3D IVUS).
The study’s 436 Black and Hispanic adults, 82% of them women, completed questionnaires regarding nutrition, lifestyle, medical history, weight, blood pressure, cholesterol levels, and other metrics.
(24.5% vs. 9.3%). Overall Framingham scores for 10-year risk for CV events were not statistically different, at 4.6 and 3.6, respectively.
The presence of atherosclerosis in either the carotid or femoral arteries was identified with 3D IVUS in 8.7% of participants. But its prevalence was about twofold greater in Black than in Hispanic participants (12.9% vs. 6.6%), a finding that persisted after multivariable adjustment and appeared driven by a greater prevalence of carotid disease among Black participants (12.9% vs. 4.8%).
“For the same predicted CV risk, non-Hispanic Black individuals appear to be more vulnerable than people of Hispanic origin to early subclinical atherosclerosis, particularly in the carotid arteries, potentially placing them at increased risk of clinical CV disease,” concludes the report published in the Journal of the American College of Cardiology, with lead author Josep Iglesies-Grau, MD, Montreal Heart Institute.
International program
The current analysis from the FAMILIA study is part of a large international project called Science, Health, and Education (SHE), which is designed to promote early intervention in the lives of children, their caretakers, and teachers so they can develop lifelong heart-healthy habits, senior author Valentin Fuster, MD, PhD, physician-in chief, Mount Sinai Hospital, New York, said in an interview.
The SHE program has been presented to more than 50,000 children worldwide, and FAMILIA has delivered successful interventions to more than 500 preschoolers, caretakers, and educators at Head Start schools in the Harlem neighborhood of New York, where the current study was conducted.
The analysis centered on the children’s adult caregivers, of whom one-third were non-Hispanic Black and two-thirds were Hispanic. “We wanted to know if this young population of parents and caregivers [would show] development or initiation of atherosclerotic disease,” Dr. Fuster said, “thinking that when we showed them that they had disease, it would further motivate them to change their lifestyle.”
Participants were assessed for seven basic CV risk factors – hypertension, smoking, body mass index, diabetes, dyslipidemia, low physical activity levels, and poor-quality diet – as well as socioeconomic descriptors. All participants also underwent 3D IVUS to evaluate the presence and extent of atherosclerosis in the carotid and femoral arteries.
‘Expected and unexpected’ findings
Black participants were considerably more likely than their Hispanic counterparts to be hypertensive, to be active smokers, and to have higher BMIs. The Black cohort reported higher consumption of fruits and vegetables (P < .001).
There were no between-group differences in the prevalence of diabetes or in mean fasting glucose or total cholesterol levels.
The mean 10-year Framingham CV risk score across the entire study population was 4.0%, with no significant differences between the two groups. In fact, 89% of participants were classified as low risk on the basis of the score.
The overall prevalence of subclinical atherosclerosis was 8.7%, with a mean global plaque burden of 5.0 mm3. But there were dramatic differences in atherosclerotic burden. Across all 10-year Framingham risk categories, Black participants had twice the odds of having subclinical atherosclerosis as Hispanic participants (odds ratio, 2.11; 95% confidence interval, 1.09-4.08; P = .026).
Black participants also had a greater atherosclerotic disease burden (9.0 mm3 vs. 2.9 mm3), mean total plaque volume (P = .028), and a higher prevalence of disease in both the carotid and femoral arteries (8.2% vs. 3.8%; P = .026).
“Our findings were both expected and completely unexpected,” Dr. Fuster commented. “It was expected that the non-Hispanic Black population would have more hypertension, obesity, and smoking, and might therefore have more [atherosclerotic] disease. But what was unexpected was when we adjusted for the seven risk factors and socioeconomic status, the Black population had three times the amount of disease,” he said.
“We need to take better care of the risk factors already known in the Black population, which is critical.” However, “our challenge today is to identify these new risk factors, which might be genetic or socioeconomic.” Dr. Fuster said his group is “already working with artificial intelligence to identify risk factors beyond the traditional risk factors that are already established.”
Socioeconomic differences?
“The fact that we’re uncovering and demonstrating that this is an issue – especially for African American women at a young age – and we could make a significant interdiction in terms of risk reduction if we have tools and invest the necessary time and effort, that is the important part of this paper,” Keith Churchwell, MD, Yale New Haven Hospital, and Yale School of Medicine, New Haven, Conn., said in an interview.
“If you’re going to evaluate African Americans in Harlem who are socially disadvantaged, I would want to know if there is a difference between them and other African Americans who have a different socioeconomic status, in terms of atherosclerotic disease,” added Dr. Churchwell, who was not involved with the study.
The Framingham 10-year risk score is “inadequate in assessing CV disease risk in all populations and is not generalizable to non-Whites,” contend Ramdas G. Pai, MD, and Vrinda Vyas, MBBS, of the University of California, Riverside, in an accompanying editorial.
“New data are emerging in favor of imaging-based classification of CV disease risk and has been shown to improve patient adherence to and compliance with risk-modifying interventions,” they write. “Subclinical atherosclerosis may help better stratify CV disease risk so that preventive measures can be instituted to reduce cardiovascular events at a population level.”
Dr. Fuster and coauthors, Dr. Ramdas and Dr. Pai, and Dr. Churchwell report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
PCOS ups risk of heart complications during delivery period
Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.
An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.
But a study, published online in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.
“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”
Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.
Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
Solutions?
Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.
“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”
Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.
“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”
The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.
“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”
The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.
An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.
But a study, published online in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.
“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”
Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.
Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
Solutions?
Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.
“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”
Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.
“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”
The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.
“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”
The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.
An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.
But a study, published online in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.
“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”
Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.
Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
Solutions?
Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.
“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”
Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.
“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”
The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.
“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”
The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New European guidelines ‘drastically’ reduce statin eligibility
New risk thresholds used to guide statin therapy for primary prevention of atherosclerotic cardiovascular disease in the latest European guidelines dramatically reduce eligibility for statin use in low-risk countries, a new study has found.
The authors reported that
“We have guidelines in place to try to prevent cardiovascular disease but the risk threshold in this new guideline means that almost nobody qualifies for treatment in many countries, which will lead to almost no prevention of future cardiovascular disease in those countries,” lead author Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, commented in an interview.
“We argue that the risk thresholds need to be lowered to get the statin eligibility in European countries to be in line with thresholds in the U.K. and U.S., which are based on randomized, controlled trials,” he added.
The study was published online in JAMA Cardiology.
An accompanying editorial describes the results of the study as “alarming,” and, if confirmed, said the guidelines should be revisited to “prevent a step backwards in the use of statins in primary prevention.”
For the study, Dr. Mortensen and colleagues set out to compare the clinical performance of the new European prevention guidelines with American College of Cardiology/American Heart Association, United Kingdom–National Institute for Health and Care Excellence, and the 2019 European guidelines in a contemporary European cohort of 66,909 apparently healthy individuals from the Copenhagen General Population Study.
During the 9-year follow-up, a range of 2,962-4,277 nonfatal and fatal cardiovascular events was observed, as defined by the models in the various guidelines.
Results showed that although the new 2021 European guidelines introduced a new and improved risk model, known as SCORE2, the updated age-specific recommendations dramatically reduced eligibility for a class I recommendation for statin therapy to only 4% of individuals, aged 40-69 years, and less than 1% of women.
This is in sharp contrast to the previous 2019 European guidelines as well as current UK-NICE and US-ACC/AHA guidelines that provide class I/strong recommendations to 20%, 26%, and 34% of individuals, respectively, with better clinical performance in both men and women, the authors report.
The researchers also reported other analyses in which the sensitivity of the new European guidelines was improved considerably by lowering the treatment thresholds.
Dr. Mortensen explained to this news organization that the original SCORE risk model used in ESC guidelines was problematic as it only predicts the 10-year risk of fatal atherosclerotic cardiovascular events, whereas those from the United States and United Kingdom used both fatal and nonfatal cardiovascular events.
“Now the ESC has updated its model and the new model is much better in that it predicts both fatal and nonfatal events, and the predicted risk correlates well with the actual risk. So that’s a big step forward. However, the new thresholds for statin treatment are far too high for low-risk European countries because very few individuals will now qualify for statin therapy,” he said.
“The problem is that, if we use these guidelines, the vast majority of those individuals who will develop cardiovascular disease within 10 years will not be assigned statin therapy that can reduce this risk. There will be lots of individuals who are at high risk of cardiovascular disease, but these guidelines will not identify them as needing to take a statin,” Dr. Mortensen commented.
“If we use the U.K. or U.S. guidelines, far more people in these low-risk European countries would be eligible for statin therapy and we would prevent far more events than if we use the new ESC guidelines,” he added.
Dr. Mortensen explained that the problem arises from having four different risk score models in Europe for areas at different risk, but they all use the same risk thresholds for statin treatment.
“In general, Eastern European countries have higher risk than Western European countries, so these guidelines may work quite well in Eastern European countries but in low-risk Western European countries, where the low-risk score model is used, very few people will qualify for statin therapy,” he said.
While Dr. Mortensen is not against the idea of different risk models in areas that have different risks, he says this needs to be accompanied by different risk thresholds in the different risk areas.
Asked whether there is an argument that most individuals in low-risk countries may not need to take a statin, Dr. Mortensen countered: “One of the reasons the risk is low in many of these European countries is the high use of preventative medication. So, if a threshold that is too high is used most people will not take a statin anymore and the risk in these countries will increase again.”
Authors of the accompanying editorial, Ann Marie Navar, MD, PhD, University of Texas Southwestern Medical Center, Dallas; Gregg C. Fonarow, MD, University of California, Los Angeles; and Michael J. Pencina, PhD, Duke University Medical Center, Durham, N.C., agreed with Dr. Mortensen that the problems appear to arise from use of a risk score that is highly influenced by regional cardiovascular burden.
They point out that under the current guidelines, a 55-year-old woman (smoker; systolic blood pressure, 130 mm Hg; non–HDL cholesterol, 4.0 mmol/L) would have a 10-year predicted risk of having a cardiovascular event of 5% in Denmark but a predicted risk of 18% in Romania.
“While there may be regional differences in environmental risk factors, location alone should not cause a fourfold difference in an individual’s predicted cardiovascular risk,” they wrote.
The editorialists also elaborated on Dr. Mortensen’s point that the new guideline creates a system that eventually becomes a victim of its own success.
“As countries are successful in implementing statin therapy to lower CVD, CVD rates drop, and progressively fewer individuals are then eligible for the very therapy that contributed to the decline in CVD in the first place,” they noted.
The editorialists called for the analysis to be replicated in other low-risk countries and extended to higher-risk regions, with a focus on potential overtreatment of men and older adults.
“If confirmed, the present findings should be a catalyst for the ESC to revisit or augment their current guidelines to prevent a step backward in the use of statins in primary prevention,” they concluded.
This news organization asked the ESC for a response to the findings, but did not comment by press time.
This work was supported by the Lundbeck Foundation, Herlev and Gentofte Hospital, Copenhagen University Hospital, the Copenhagen County Foundation, and Aarhus University, Denmark. Dr. Mortensen reported no disclosures.
A version of this article first appeared on Medscape.com.
New risk thresholds used to guide statin therapy for primary prevention of atherosclerotic cardiovascular disease in the latest European guidelines dramatically reduce eligibility for statin use in low-risk countries, a new study has found.
The authors reported that
“We have guidelines in place to try to prevent cardiovascular disease but the risk threshold in this new guideline means that almost nobody qualifies for treatment in many countries, which will lead to almost no prevention of future cardiovascular disease in those countries,” lead author Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, commented in an interview.
“We argue that the risk thresholds need to be lowered to get the statin eligibility in European countries to be in line with thresholds in the U.K. and U.S., which are based on randomized, controlled trials,” he added.
The study was published online in JAMA Cardiology.
An accompanying editorial describes the results of the study as “alarming,” and, if confirmed, said the guidelines should be revisited to “prevent a step backwards in the use of statins in primary prevention.”
For the study, Dr. Mortensen and colleagues set out to compare the clinical performance of the new European prevention guidelines with American College of Cardiology/American Heart Association, United Kingdom–National Institute for Health and Care Excellence, and the 2019 European guidelines in a contemporary European cohort of 66,909 apparently healthy individuals from the Copenhagen General Population Study.
During the 9-year follow-up, a range of 2,962-4,277 nonfatal and fatal cardiovascular events was observed, as defined by the models in the various guidelines.
Results showed that although the new 2021 European guidelines introduced a new and improved risk model, known as SCORE2, the updated age-specific recommendations dramatically reduced eligibility for a class I recommendation for statin therapy to only 4% of individuals, aged 40-69 years, and less than 1% of women.
This is in sharp contrast to the previous 2019 European guidelines as well as current UK-NICE and US-ACC/AHA guidelines that provide class I/strong recommendations to 20%, 26%, and 34% of individuals, respectively, with better clinical performance in both men and women, the authors report.
The researchers also reported other analyses in which the sensitivity of the new European guidelines was improved considerably by lowering the treatment thresholds.
Dr. Mortensen explained to this news organization that the original SCORE risk model used in ESC guidelines was problematic as it only predicts the 10-year risk of fatal atherosclerotic cardiovascular events, whereas those from the United States and United Kingdom used both fatal and nonfatal cardiovascular events.
“Now the ESC has updated its model and the new model is much better in that it predicts both fatal and nonfatal events, and the predicted risk correlates well with the actual risk. So that’s a big step forward. However, the new thresholds for statin treatment are far too high for low-risk European countries because very few individuals will now qualify for statin therapy,” he said.
“The problem is that, if we use these guidelines, the vast majority of those individuals who will develop cardiovascular disease within 10 years will not be assigned statin therapy that can reduce this risk. There will be lots of individuals who are at high risk of cardiovascular disease, but these guidelines will not identify them as needing to take a statin,” Dr. Mortensen commented.
“If we use the U.K. or U.S. guidelines, far more people in these low-risk European countries would be eligible for statin therapy and we would prevent far more events than if we use the new ESC guidelines,” he added.
Dr. Mortensen explained that the problem arises from having four different risk score models in Europe for areas at different risk, but they all use the same risk thresholds for statin treatment.
“In general, Eastern European countries have higher risk than Western European countries, so these guidelines may work quite well in Eastern European countries but in low-risk Western European countries, where the low-risk score model is used, very few people will qualify for statin therapy,” he said.
While Dr. Mortensen is not against the idea of different risk models in areas that have different risks, he says this needs to be accompanied by different risk thresholds in the different risk areas.
Asked whether there is an argument that most individuals in low-risk countries may not need to take a statin, Dr. Mortensen countered: “One of the reasons the risk is low in many of these European countries is the high use of preventative medication. So, if a threshold that is too high is used most people will not take a statin anymore and the risk in these countries will increase again.”
Authors of the accompanying editorial, Ann Marie Navar, MD, PhD, University of Texas Southwestern Medical Center, Dallas; Gregg C. Fonarow, MD, University of California, Los Angeles; and Michael J. Pencina, PhD, Duke University Medical Center, Durham, N.C., agreed with Dr. Mortensen that the problems appear to arise from use of a risk score that is highly influenced by regional cardiovascular burden.
They point out that under the current guidelines, a 55-year-old woman (smoker; systolic blood pressure, 130 mm Hg; non–HDL cholesterol, 4.0 mmol/L) would have a 10-year predicted risk of having a cardiovascular event of 5% in Denmark but a predicted risk of 18% in Romania.
“While there may be regional differences in environmental risk factors, location alone should not cause a fourfold difference in an individual’s predicted cardiovascular risk,” they wrote.
The editorialists also elaborated on Dr. Mortensen’s point that the new guideline creates a system that eventually becomes a victim of its own success.
“As countries are successful in implementing statin therapy to lower CVD, CVD rates drop, and progressively fewer individuals are then eligible for the very therapy that contributed to the decline in CVD in the first place,” they noted.
The editorialists called for the analysis to be replicated in other low-risk countries and extended to higher-risk regions, with a focus on potential overtreatment of men and older adults.
“If confirmed, the present findings should be a catalyst for the ESC to revisit or augment their current guidelines to prevent a step backward in the use of statins in primary prevention,” they concluded.
This news organization asked the ESC for a response to the findings, but did not comment by press time.
This work was supported by the Lundbeck Foundation, Herlev and Gentofte Hospital, Copenhagen University Hospital, the Copenhagen County Foundation, and Aarhus University, Denmark. Dr. Mortensen reported no disclosures.
A version of this article first appeared on Medscape.com.
New risk thresholds used to guide statin therapy for primary prevention of atherosclerotic cardiovascular disease in the latest European guidelines dramatically reduce eligibility for statin use in low-risk countries, a new study has found.
The authors reported that
“We have guidelines in place to try to prevent cardiovascular disease but the risk threshold in this new guideline means that almost nobody qualifies for treatment in many countries, which will lead to almost no prevention of future cardiovascular disease in those countries,” lead author Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, commented in an interview.
“We argue that the risk thresholds need to be lowered to get the statin eligibility in European countries to be in line with thresholds in the U.K. and U.S., which are based on randomized, controlled trials,” he added.
The study was published online in JAMA Cardiology.
An accompanying editorial describes the results of the study as “alarming,” and, if confirmed, said the guidelines should be revisited to “prevent a step backwards in the use of statins in primary prevention.”
For the study, Dr. Mortensen and colleagues set out to compare the clinical performance of the new European prevention guidelines with American College of Cardiology/American Heart Association, United Kingdom–National Institute for Health and Care Excellence, and the 2019 European guidelines in a contemporary European cohort of 66,909 apparently healthy individuals from the Copenhagen General Population Study.
During the 9-year follow-up, a range of 2,962-4,277 nonfatal and fatal cardiovascular events was observed, as defined by the models in the various guidelines.
Results showed that although the new 2021 European guidelines introduced a new and improved risk model, known as SCORE2, the updated age-specific recommendations dramatically reduced eligibility for a class I recommendation for statin therapy to only 4% of individuals, aged 40-69 years, and less than 1% of women.
This is in sharp contrast to the previous 2019 European guidelines as well as current UK-NICE and US-ACC/AHA guidelines that provide class I/strong recommendations to 20%, 26%, and 34% of individuals, respectively, with better clinical performance in both men and women, the authors report.
The researchers also reported other analyses in which the sensitivity of the new European guidelines was improved considerably by lowering the treatment thresholds.
Dr. Mortensen explained to this news organization that the original SCORE risk model used in ESC guidelines was problematic as it only predicts the 10-year risk of fatal atherosclerotic cardiovascular events, whereas those from the United States and United Kingdom used both fatal and nonfatal cardiovascular events.
“Now the ESC has updated its model and the new model is much better in that it predicts both fatal and nonfatal events, and the predicted risk correlates well with the actual risk. So that’s a big step forward. However, the new thresholds for statin treatment are far too high for low-risk European countries because very few individuals will now qualify for statin therapy,” he said.
“The problem is that, if we use these guidelines, the vast majority of those individuals who will develop cardiovascular disease within 10 years will not be assigned statin therapy that can reduce this risk. There will be lots of individuals who are at high risk of cardiovascular disease, but these guidelines will not identify them as needing to take a statin,” Dr. Mortensen commented.
“If we use the U.K. or U.S. guidelines, far more people in these low-risk European countries would be eligible for statin therapy and we would prevent far more events than if we use the new ESC guidelines,” he added.
Dr. Mortensen explained that the problem arises from having four different risk score models in Europe for areas at different risk, but they all use the same risk thresholds for statin treatment.
“In general, Eastern European countries have higher risk than Western European countries, so these guidelines may work quite well in Eastern European countries but in low-risk Western European countries, where the low-risk score model is used, very few people will qualify for statin therapy,” he said.
While Dr. Mortensen is not against the idea of different risk models in areas that have different risks, he says this needs to be accompanied by different risk thresholds in the different risk areas.
Asked whether there is an argument that most individuals in low-risk countries may not need to take a statin, Dr. Mortensen countered: “One of the reasons the risk is low in many of these European countries is the high use of preventative medication. So, if a threshold that is too high is used most people will not take a statin anymore and the risk in these countries will increase again.”
Authors of the accompanying editorial, Ann Marie Navar, MD, PhD, University of Texas Southwestern Medical Center, Dallas; Gregg C. Fonarow, MD, University of California, Los Angeles; and Michael J. Pencina, PhD, Duke University Medical Center, Durham, N.C., agreed with Dr. Mortensen that the problems appear to arise from use of a risk score that is highly influenced by regional cardiovascular burden.
They point out that under the current guidelines, a 55-year-old woman (smoker; systolic blood pressure, 130 mm Hg; non–HDL cholesterol, 4.0 mmol/L) would have a 10-year predicted risk of having a cardiovascular event of 5% in Denmark but a predicted risk of 18% in Romania.
“While there may be regional differences in environmental risk factors, location alone should not cause a fourfold difference in an individual’s predicted cardiovascular risk,” they wrote.
The editorialists also elaborated on Dr. Mortensen’s point that the new guideline creates a system that eventually becomes a victim of its own success.
“As countries are successful in implementing statin therapy to lower CVD, CVD rates drop, and progressively fewer individuals are then eligible for the very therapy that contributed to the decline in CVD in the first place,” they noted.
The editorialists called for the analysis to be replicated in other low-risk countries and extended to higher-risk regions, with a focus on potential overtreatment of men and older adults.
“If confirmed, the present findings should be a catalyst for the ESC to revisit or augment their current guidelines to prevent a step backward in the use of statins in primary prevention,” they concluded.
This news organization asked the ESC for a response to the findings, but did not comment by press time.
This work was supported by the Lundbeck Foundation, Herlev and Gentofte Hospital, Copenhagen University Hospital, the Copenhagen County Foundation, and Aarhus University, Denmark. Dr. Mortensen reported no disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA CARDIOLOGY
‘Not their fault:’ Obesity warrants long-term management
This transcript has been edited for clarity.
It’s important to remember and to think about the first time when patients with obesity come to see us: What have they faced? What have been their struggles? What shame and blame and bias have they faced?
One of the first things that I do when a patient comes to see me is invite them to share their weight journey with me. I ask them to tell me about their struggles, about what’s worked and what hasn’t worked, what they would like, and what their health goals are.
As they share their stories, I look for the opportunity to share with them that obesity is not their fault, but that it’s biology driving their body to carry extra weight and their body is super smart. Neither their body nor their brain want them to starve.
Our bodies evolved during a time where there was food scarcity and the potential of famine. We have a complex system that was designed to make sure that we always held on to extra weight, specifically extra fat, because that’s how we store energy. In the current obesogenic environment, what happens is our bodies carry extra weight, or specifically, extra fat.
Again, I say to them, this is biology. Your body’s doing exactly what it was designed to do. Your body’s very smart, but now we have to figure out how to help your body want to carry less fat because it is impacting your health. This is not your fault. Having obesity is not your fault any more than having diabetes or hypertension is anyone’s fault. Now it’s time for all of us to use highly effective tools that target the pathophysiology of obesity.
When a patient comes to me for weight management or to help them treat their obesity, I listen to them, and I look for clues as to what might help that specific patient. Every patient deserves to have individualized treatment. One medicine may be right for one person, another medicine may be right for another, and surgery may be right for another patient. I really try to listen and hear what that patient is telling me.
What we as providers really need is tools – different options – to be able to provide for our patients and basically present them with different options, and then guide them toward the best therapy for them. Whether it’s semaglutide or tirzepatide potentially in the future, these types of medications are excellent options for our patients. They’re highly effective tools with safe profiles.
A question that I often get from providers or patients is, “Well, Doctor, I’ve lost the weight now. How long should I take this medicine? Can I stop it now?”
Then, we have a conversation, and we actually usually have this conversation even before we start the medicine. Basically, we talk about the fact that obesity is a chronic disease. There’s no cure for obesity. Because it’s a chronic disease, we need to treat it like we would treat any other chronic disease.
The example that I often use is, if you have a patient who has hypertension and you start them on an antihypertensive medication, what happens? Their blood pressure goes down. It improves. Now, if their blood pressure is improved with a specific antihypertensive, would you stop that medicine? What would happen if you stopped that antihypertensive? Well, their blood pressure would go up, and we wouldn’t be surprised.
In the same way, if you have a patient who has obesity and you start that patient on an antiobesity medication, and their weight decreases, and their body fat mass at that point decreases, what would happen if you stop that medicine? They lost the weight, but you stop the medicine. Well, their weight gain comes back. They regain the weight.
We should not be surprised that weight gain occurs when we stop the treatment. That really underscores the fact that treatment needs to be continued. If a patient is started on an antiobesity medication and they lose weight, that medication needs to be continued to maintain that weight loss.
Basically, we eat food and our body responds by releasing these hormones. The hormones are made in our gut and in our pancreas and these hormones inform our brain. Are we hungry? Are we full? Where are we with our homeostatic set point of fat mass? Based on that, our brain is like the sensor or the thermostat.
Obesity is a chronic, treatable disease. We should treat obesity as we treat any other chronic disease, with effective and safe approaches that target underlying disease mechanisms. These results in the SURMOUNT-1 trial underscore that tirzepatide may be doing just that. Remarkably, 9 in 10 individuals with obesity lost weight while taking tirzepatide. These results are impressive. They’re an important step forward in potentially expanding effective therapeutic options for people with obesity.
Dr. Jastreboff is an associate professor of medicine and pediatrics at Yale University, New Haven, Conn., and director of weight management and obesity prevention at Yale Stress Center. She reported conducting trials with Eli Lilly, Novo Nordisk, and Rhythm Pharmaceuticals; serving on scientific advisory boards for Ely Lilly, Intellihealth, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, and WW; and consulting for Boehringer Ingelheim and Scholar Rock.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
It’s important to remember and to think about the first time when patients with obesity come to see us: What have they faced? What have been their struggles? What shame and blame and bias have they faced?
One of the first things that I do when a patient comes to see me is invite them to share their weight journey with me. I ask them to tell me about their struggles, about what’s worked and what hasn’t worked, what they would like, and what their health goals are.
As they share their stories, I look for the opportunity to share with them that obesity is not their fault, but that it’s biology driving their body to carry extra weight and their body is super smart. Neither their body nor their brain want them to starve.
Our bodies evolved during a time where there was food scarcity and the potential of famine. We have a complex system that was designed to make sure that we always held on to extra weight, specifically extra fat, because that’s how we store energy. In the current obesogenic environment, what happens is our bodies carry extra weight, or specifically, extra fat.
Again, I say to them, this is biology. Your body’s doing exactly what it was designed to do. Your body’s very smart, but now we have to figure out how to help your body want to carry less fat because it is impacting your health. This is not your fault. Having obesity is not your fault any more than having diabetes or hypertension is anyone’s fault. Now it’s time for all of us to use highly effective tools that target the pathophysiology of obesity.
When a patient comes to me for weight management or to help them treat their obesity, I listen to them, and I look for clues as to what might help that specific patient. Every patient deserves to have individualized treatment. One medicine may be right for one person, another medicine may be right for another, and surgery may be right for another patient. I really try to listen and hear what that patient is telling me.
What we as providers really need is tools – different options – to be able to provide for our patients and basically present them with different options, and then guide them toward the best therapy for them. Whether it’s semaglutide or tirzepatide potentially in the future, these types of medications are excellent options for our patients. They’re highly effective tools with safe profiles.
A question that I often get from providers or patients is, “Well, Doctor, I’ve lost the weight now. How long should I take this medicine? Can I stop it now?”
Then, we have a conversation, and we actually usually have this conversation even before we start the medicine. Basically, we talk about the fact that obesity is a chronic disease. There’s no cure for obesity. Because it’s a chronic disease, we need to treat it like we would treat any other chronic disease.
The example that I often use is, if you have a patient who has hypertension and you start them on an antihypertensive medication, what happens? Their blood pressure goes down. It improves. Now, if their blood pressure is improved with a specific antihypertensive, would you stop that medicine? What would happen if you stopped that antihypertensive? Well, their blood pressure would go up, and we wouldn’t be surprised.
In the same way, if you have a patient who has obesity and you start that patient on an antiobesity medication, and their weight decreases, and their body fat mass at that point decreases, what would happen if you stop that medicine? They lost the weight, but you stop the medicine. Well, their weight gain comes back. They regain the weight.
We should not be surprised that weight gain occurs when we stop the treatment. That really underscores the fact that treatment needs to be continued. If a patient is started on an antiobesity medication and they lose weight, that medication needs to be continued to maintain that weight loss.
Basically, we eat food and our body responds by releasing these hormones. The hormones are made in our gut and in our pancreas and these hormones inform our brain. Are we hungry? Are we full? Where are we with our homeostatic set point of fat mass? Based on that, our brain is like the sensor or the thermostat.
Obesity is a chronic, treatable disease. We should treat obesity as we treat any other chronic disease, with effective and safe approaches that target underlying disease mechanisms. These results in the SURMOUNT-1 trial underscore that tirzepatide may be doing just that. Remarkably, 9 in 10 individuals with obesity lost weight while taking tirzepatide. These results are impressive. They’re an important step forward in potentially expanding effective therapeutic options for people with obesity.
Dr. Jastreboff is an associate professor of medicine and pediatrics at Yale University, New Haven, Conn., and director of weight management and obesity prevention at Yale Stress Center. She reported conducting trials with Eli Lilly, Novo Nordisk, and Rhythm Pharmaceuticals; serving on scientific advisory boards for Ely Lilly, Intellihealth, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, and WW; and consulting for Boehringer Ingelheim and Scholar Rock.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
It’s important to remember and to think about the first time when patients with obesity come to see us: What have they faced? What have been their struggles? What shame and blame and bias have they faced?
One of the first things that I do when a patient comes to see me is invite them to share their weight journey with me. I ask them to tell me about their struggles, about what’s worked and what hasn’t worked, what they would like, and what their health goals are.
As they share their stories, I look for the opportunity to share with them that obesity is not their fault, but that it’s biology driving their body to carry extra weight and their body is super smart. Neither their body nor their brain want them to starve.
Our bodies evolved during a time where there was food scarcity and the potential of famine. We have a complex system that was designed to make sure that we always held on to extra weight, specifically extra fat, because that’s how we store energy. In the current obesogenic environment, what happens is our bodies carry extra weight, or specifically, extra fat.
Again, I say to them, this is biology. Your body’s doing exactly what it was designed to do. Your body’s very smart, but now we have to figure out how to help your body want to carry less fat because it is impacting your health. This is not your fault. Having obesity is not your fault any more than having diabetes or hypertension is anyone’s fault. Now it’s time for all of us to use highly effective tools that target the pathophysiology of obesity.
When a patient comes to me for weight management or to help them treat their obesity, I listen to them, and I look for clues as to what might help that specific patient. Every patient deserves to have individualized treatment. One medicine may be right for one person, another medicine may be right for another, and surgery may be right for another patient. I really try to listen and hear what that patient is telling me.
What we as providers really need is tools – different options – to be able to provide for our patients and basically present them with different options, and then guide them toward the best therapy for them. Whether it’s semaglutide or tirzepatide potentially in the future, these types of medications are excellent options for our patients. They’re highly effective tools with safe profiles.
A question that I often get from providers or patients is, “Well, Doctor, I’ve lost the weight now. How long should I take this medicine? Can I stop it now?”
Then, we have a conversation, and we actually usually have this conversation even before we start the medicine. Basically, we talk about the fact that obesity is a chronic disease. There’s no cure for obesity. Because it’s a chronic disease, we need to treat it like we would treat any other chronic disease.
The example that I often use is, if you have a patient who has hypertension and you start them on an antihypertensive medication, what happens? Their blood pressure goes down. It improves. Now, if their blood pressure is improved with a specific antihypertensive, would you stop that medicine? What would happen if you stopped that antihypertensive? Well, their blood pressure would go up, and we wouldn’t be surprised.
In the same way, if you have a patient who has obesity and you start that patient on an antiobesity medication, and their weight decreases, and their body fat mass at that point decreases, what would happen if you stop that medicine? They lost the weight, but you stop the medicine. Well, their weight gain comes back. They regain the weight.
We should not be surprised that weight gain occurs when we stop the treatment. That really underscores the fact that treatment needs to be continued. If a patient is started on an antiobesity medication and they lose weight, that medication needs to be continued to maintain that weight loss.
Basically, we eat food and our body responds by releasing these hormones. The hormones are made in our gut and in our pancreas and these hormones inform our brain. Are we hungry? Are we full? Where are we with our homeostatic set point of fat mass? Based on that, our brain is like the sensor or the thermostat.
Obesity is a chronic, treatable disease. We should treat obesity as we treat any other chronic disease, with effective and safe approaches that target underlying disease mechanisms. These results in the SURMOUNT-1 trial underscore that tirzepatide may be doing just that. Remarkably, 9 in 10 individuals with obesity lost weight while taking tirzepatide. These results are impressive. They’re an important step forward in potentially expanding effective therapeutic options for people with obesity.
Dr. Jastreboff is an associate professor of medicine and pediatrics at Yale University, New Haven, Conn., and director of weight management and obesity prevention at Yale Stress Center. She reported conducting trials with Eli Lilly, Novo Nordisk, and Rhythm Pharmaceuticals; serving on scientific advisory boards for Ely Lilly, Intellihealth, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, and WW; and consulting for Boehringer Ingelheim and Scholar Rock.
A version of this article first appeared on Medscape.com.
New AHA checklist: Only one in five adults has optimal heart health
About 80% of American adults have low to moderate cardiovascular (CV) health based on the American Heart Association checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health.
With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist.
“The new metric of sleep duration reflects the latest research findings: Sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure, or risk for type 2 diabetes more effectively,” AHA President Donald M. Lloyd-Jones, MD, said in a news release.
“In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home,” said Dr. Lloyd-Jones, chair of the department of preventive medicine at Northwestern University in Chicago.
The AHA Presidential Advisory – Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health – was published online in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the U.S. population is “suboptimal, and we see important differences across age and sociodemographic groups,” Dr. Lloyd-Jones said.
Refining Life’s Simple 7
The AHA first defined the seven metrics for optimal CV health in 2010. After 12 years and more than 2,400 scientific papers on the topic, new discoveries in CV health and ways to measure it provided an opportunity to revisit each health component in more detail and provide updates as needed, the AHA explains.
“We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people,” Dr. Lloyd-Jones said.
Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools, and the scoring system can now also be applied to anyone ages 2 and older. Here is a snapshot of Life’s Essential 8 metrics, including updates.
1. Diet (updated)
The tool includes a new guide to assess diet quality for adults and children at the individual and population level. At the population level, dietary assessment is based on daily intake of elements in the Dietary Approaches to Stop Hypertension (DASH) eating pattern. For individuals, the Mediterranean Eating Pattern for Americans (MEPA) is used to assess and monitor cardiovascular health.
2. Physical activity (no changes)
Physical activity continues to be measured by the total number of minutes of moderate or vigorous physical activity per week, as defined by the U.S. Physical Activity Guidelines for Americans (2nd edition). The optimal level is 150 minutes (2.5 hours) of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes (7 hours) or more per week for children ages 6 and older; and age-specific modifications for younger children.
3. Nicotine exposure (updated)
Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, has been added since the previous metric monitored only traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Second-hand smoke exposure for children and adults has also been added.
4. Sleep duration (new)
Sleep duration is associated with CV health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
5. Body mass index (no changes)
The AHA acknowledges that body mass index (BMI) is an imperfect metric. Yet, because it’s easily calculated and widely available, BMI continues as a “reasonable” gauge to assess weight categories that may lead to health problems. BMI of 18.5-24.9 is associated with the highest levels of CV health. The AHA notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as CVD or type 2 diabetes is higher at a lower BMI.
6. Blood lipids (updated)
The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
7. Blood glucose (updated)
This metric is expanded to include the option of hemoglobin A1c readings or blood glucose levels for people with or without type 1 or 2 diabetes or prediabetes.
8. Blood pressure (no changes)
Blood pressure criteria remain unchanged from 2017 guidance that established levels less than 120/80 mm Hg as optimal, and defined hypertension as 130-139 mm Hg systolic pressure or 80-89 mm Hg diastolic pressure.
‘Concerning’ new data
Results of the first study using Life’s Essential 8 show that the overall CV health of the U.S. population is “well below ideal,” with 80% of adults scoring at a low or moderate level, the researchers report.
Data for the analysis came from 2013-2018 U.S. National Health and Nutrition Examination surveys (NHANES) of more than 13,500 adults aged 20-79 years and nearly 9,900 children aged 2-19 years. Among the key findings:
- The average CV health score based on Life’s Essential 8 was 64.7 for adults and 65.5 for children – in the moderate range on the 0-100 scale.
- Only 0.45% of adults had a perfect score of 100; 20% had high CV health (score of 80 or higher), 63% moderate (score of 50-79), and 18% had low CV health (score of less than 50).
- Adult women had higher average CV health scores (67) compared with men (62.5).
- In general, adults scored lowest in the areas of diet, physical activity, and BMI.
- CV health scores were generally lower at older ages.
- Non-Hispanic Asian Americans had a higher average CV health score than other racial/ethnic groups. Non-Hispanic Whites had the second highest average CV health score, followed, in order, by Hispanic (other than Mexican), Mexican, and non-Hispanic Blacks.
- Children’s diet scores were low, at an average of 40.6.
- Adult sociodemographic groups varied notably in CV health scores for diet, nicotine exposure, blood glucose, and blood pressure.
“These data represent the first look at the cardiovascular health of the U.S. population using the AHA’s new Life’s Essential 8 scoring algorithm,” Dr. Lloyd-Jones said.
“Life’s Essential 8 is a major step forward in our ability to identify when cardiovascular health can be preserved and when it is suboptimal. It should energize efforts to improve cardiovascular health for all people and at every life stage,” Dr. Lloyd-Jones added.
“Analyses like this can help policymakers, communities, clinicians, and the public to understand the opportunities to intervene to improve and maintain optimal cardiovascular health across the life course,” he said.
This research had no commercial funding. The authors have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
About 80% of American adults have low to moderate cardiovascular (CV) health based on the American Heart Association checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health.
With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist.
“The new metric of sleep duration reflects the latest research findings: Sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure, or risk for type 2 diabetes more effectively,” AHA President Donald M. Lloyd-Jones, MD, said in a news release.
“In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home,” said Dr. Lloyd-Jones, chair of the department of preventive medicine at Northwestern University in Chicago.
The AHA Presidential Advisory – Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health – was published online in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the U.S. population is “suboptimal, and we see important differences across age and sociodemographic groups,” Dr. Lloyd-Jones said.
Refining Life’s Simple 7
The AHA first defined the seven metrics for optimal CV health in 2010. After 12 years and more than 2,400 scientific papers on the topic, new discoveries in CV health and ways to measure it provided an opportunity to revisit each health component in more detail and provide updates as needed, the AHA explains.
“We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people,” Dr. Lloyd-Jones said.
Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools, and the scoring system can now also be applied to anyone ages 2 and older. Here is a snapshot of Life’s Essential 8 metrics, including updates.
1. Diet (updated)
The tool includes a new guide to assess diet quality for adults and children at the individual and population level. At the population level, dietary assessment is based on daily intake of elements in the Dietary Approaches to Stop Hypertension (DASH) eating pattern. For individuals, the Mediterranean Eating Pattern for Americans (MEPA) is used to assess and monitor cardiovascular health.
2. Physical activity (no changes)
Physical activity continues to be measured by the total number of minutes of moderate or vigorous physical activity per week, as defined by the U.S. Physical Activity Guidelines for Americans (2nd edition). The optimal level is 150 minutes (2.5 hours) of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes (7 hours) or more per week for children ages 6 and older; and age-specific modifications for younger children.
3. Nicotine exposure (updated)
Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, has been added since the previous metric monitored only traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Second-hand smoke exposure for children and adults has also been added.
4. Sleep duration (new)
Sleep duration is associated with CV health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
5. Body mass index (no changes)
The AHA acknowledges that body mass index (BMI) is an imperfect metric. Yet, because it’s easily calculated and widely available, BMI continues as a “reasonable” gauge to assess weight categories that may lead to health problems. BMI of 18.5-24.9 is associated with the highest levels of CV health. The AHA notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as CVD or type 2 diabetes is higher at a lower BMI.
6. Blood lipids (updated)
The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
7. Blood glucose (updated)
This metric is expanded to include the option of hemoglobin A1c readings or blood glucose levels for people with or without type 1 or 2 diabetes or prediabetes.
8. Blood pressure (no changes)
Blood pressure criteria remain unchanged from 2017 guidance that established levels less than 120/80 mm Hg as optimal, and defined hypertension as 130-139 mm Hg systolic pressure or 80-89 mm Hg diastolic pressure.
‘Concerning’ new data
Results of the first study using Life’s Essential 8 show that the overall CV health of the U.S. population is “well below ideal,” with 80% of adults scoring at a low or moderate level, the researchers report.
Data for the analysis came from 2013-2018 U.S. National Health and Nutrition Examination surveys (NHANES) of more than 13,500 adults aged 20-79 years and nearly 9,900 children aged 2-19 years. Among the key findings:
- The average CV health score based on Life’s Essential 8 was 64.7 for adults and 65.5 for children – in the moderate range on the 0-100 scale.
- Only 0.45% of adults had a perfect score of 100; 20% had high CV health (score of 80 or higher), 63% moderate (score of 50-79), and 18% had low CV health (score of less than 50).
- Adult women had higher average CV health scores (67) compared with men (62.5).
- In general, adults scored lowest in the areas of diet, physical activity, and BMI.
- CV health scores were generally lower at older ages.
- Non-Hispanic Asian Americans had a higher average CV health score than other racial/ethnic groups. Non-Hispanic Whites had the second highest average CV health score, followed, in order, by Hispanic (other than Mexican), Mexican, and non-Hispanic Blacks.
- Children’s diet scores were low, at an average of 40.6.
- Adult sociodemographic groups varied notably in CV health scores for diet, nicotine exposure, blood glucose, and blood pressure.
“These data represent the first look at the cardiovascular health of the U.S. population using the AHA’s new Life’s Essential 8 scoring algorithm,” Dr. Lloyd-Jones said.
“Life’s Essential 8 is a major step forward in our ability to identify when cardiovascular health can be preserved and when it is suboptimal. It should energize efforts to improve cardiovascular health for all people and at every life stage,” Dr. Lloyd-Jones added.
“Analyses like this can help policymakers, communities, clinicians, and the public to understand the opportunities to intervene to improve and maintain optimal cardiovascular health across the life course,” he said.
This research had no commercial funding. The authors have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
About 80% of American adults have low to moderate cardiovascular (CV) health based on the American Heart Association checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health.
With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist.
“The new metric of sleep duration reflects the latest research findings: Sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure, or risk for type 2 diabetes more effectively,” AHA President Donald M. Lloyd-Jones, MD, said in a news release.
“In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home,” said Dr. Lloyd-Jones, chair of the department of preventive medicine at Northwestern University in Chicago.
The AHA Presidential Advisory – Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health – was published online in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the U.S. population is “suboptimal, and we see important differences across age and sociodemographic groups,” Dr. Lloyd-Jones said.
Refining Life’s Simple 7
The AHA first defined the seven metrics for optimal CV health in 2010. After 12 years and more than 2,400 scientific papers on the topic, new discoveries in CV health and ways to measure it provided an opportunity to revisit each health component in more detail and provide updates as needed, the AHA explains.
“We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people,” Dr. Lloyd-Jones said.
Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools, and the scoring system can now also be applied to anyone ages 2 and older. Here is a snapshot of Life’s Essential 8 metrics, including updates.
1. Diet (updated)
The tool includes a new guide to assess diet quality for adults and children at the individual and population level. At the population level, dietary assessment is based on daily intake of elements in the Dietary Approaches to Stop Hypertension (DASH) eating pattern. For individuals, the Mediterranean Eating Pattern for Americans (MEPA) is used to assess and monitor cardiovascular health.
2. Physical activity (no changes)
Physical activity continues to be measured by the total number of minutes of moderate or vigorous physical activity per week, as defined by the U.S. Physical Activity Guidelines for Americans (2nd edition). The optimal level is 150 minutes (2.5 hours) of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes (7 hours) or more per week for children ages 6 and older; and age-specific modifications for younger children.
3. Nicotine exposure (updated)
Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, has been added since the previous metric monitored only traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Second-hand smoke exposure for children and adults has also been added.
4. Sleep duration (new)
Sleep duration is associated with CV health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
5. Body mass index (no changes)
The AHA acknowledges that body mass index (BMI) is an imperfect metric. Yet, because it’s easily calculated and widely available, BMI continues as a “reasonable” gauge to assess weight categories that may lead to health problems. BMI of 18.5-24.9 is associated with the highest levels of CV health. The AHA notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as CVD or type 2 diabetes is higher at a lower BMI.
6. Blood lipids (updated)
The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
7. Blood glucose (updated)
This metric is expanded to include the option of hemoglobin A1c readings or blood glucose levels for people with or without type 1 or 2 diabetes or prediabetes.
8. Blood pressure (no changes)
Blood pressure criteria remain unchanged from 2017 guidance that established levels less than 120/80 mm Hg as optimal, and defined hypertension as 130-139 mm Hg systolic pressure or 80-89 mm Hg diastolic pressure.
‘Concerning’ new data
Results of the first study using Life’s Essential 8 show that the overall CV health of the U.S. population is “well below ideal,” with 80% of adults scoring at a low or moderate level, the researchers report.
Data for the analysis came from 2013-2018 U.S. National Health and Nutrition Examination surveys (NHANES) of more than 13,500 adults aged 20-79 years and nearly 9,900 children aged 2-19 years. Among the key findings:
- The average CV health score based on Life’s Essential 8 was 64.7 for adults and 65.5 for children – in the moderate range on the 0-100 scale.
- Only 0.45% of adults had a perfect score of 100; 20% had high CV health (score of 80 or higher), 63% moderate (score of 50-79), and 18% had low CV health (score of less than 50).
- Adult women had higher average CV health scores (67) compared with men (62.5).
- In general, adults scored lowest in the areas of diet, physical activity, and BMI.
- CV health scores were generally lower at older ages.
- Non-Hispanic Asian Americans had a higher average CV health score than other racial/ethnic groups. Non-Hispanic Whites had the second highest average CV health score, followed, in order, by Hispanic (other than Mexican), Mexican, and non-Hispanic Blacks.
- Children’s diet scores were low, at an average of 40.6.
- Adult sociodemographic groups varied notably in CV health scores for diet, nicotine exposure, blood glucose, and blood pressure.
“These data represent the first look at the cardiovascular health of the U.S. population using the AHA’s new Life’s Essential 8 scoring algorithm,” Dr. Lloyd-Jones said.
“Life’s Essential 8 is a major step forward in our ability to identify when cardiovascular health can be preserved and when it is suboptimal. It should energize efforts to improve cardiovascular health for all people and at every life stage,” Dr. Lloyd-Jones added.
“Analyses like this can help policymakers, communities, clinicians, and the public to understand the opportunities to intervene to improve and maintain optimal cardiovascular health across the life course,” he said.
This research had no commercial funding. The authors have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Heart attack care not equal for women and people of color
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF EMERGENCY MEDICINE
New biomarker data add to concerns over REDUCE-IT trial
A new analysis of the REDUCE-IT study has reignited concerns that the benefit shown by the high-dose fish oil product in the study, icosapent ethyl (Vascepa, Amarin), may have been related to harms caused by the placebo mineral oil.
Results show that allocation to icosapent ethyl had minimal effects on a series of biomarkers associated with atherosclerotic disease, whereas levels of these biomarkers increased among those allocated to mineral oil.
At 12 months, the median percent increases from baseline in the mineral oil group were 1.5% for homocysteine, 2.2% for lipoprotein(a), 10.9% for oxidized low-density-lipoprotein (LDL) cholesterol, 16.2% for interleukin (IL)-6, 18.5% for lipoprotein-associated phospholipase A2, 21.9% for high-sensitivity C-reactive protein (hsCRP), and 28.9% for IL-1β. The changes were similar at 24 months. However, in the icosapent ethyl group, there were minimal changes in these biomarkers at 12 and 24 months.
The study was published online in Circulation.
The authors, led by Paul Ridker, MD, Brigham & Women’s Hospital, Boston, do not voice much opinion on what the results mean, concluding that “the effect of these findings on the interpretation of the REDUCE-IT trial results remains unclear and will require further investigation.”
They also say that a second icosapent ethyl trial using a nonmineral oil comparator “would help resolve ongoing controversy.”
However, the authors are a mixed group; Dr. Ridker and some of his coauthors were not part of the original REDUCE-IT trial, whereas other coauthors were members of the REDUCE-IT steering committee, and one was an employee of Amarin.
Lead investigator of the REDUCE-IT trial, Deepak Bhatt, MD, also from Brigham & Women’s Hospital, who is the senior author of the current study, played down the new findings, saying they did not offer much new incremental information on mechanistic insight.
“These are small degrees of biomarker increases on an absolute level we are seeing with the placebo that would not be expected to produce harm,” Dr. Bhatt told this news organization. He also said the Circulation peer-review process had removed some of the discussion, which could lead to some “misinterpretation” of the authors’ views.
Dr. Ridker was unavailable for further comment.
The publication of this study has inevitably poured fuel on the fire regarding the controversy that has long dogged the REDUCE-IT trial, with questions about the large reduction in event rates seen with icosapent ethyl without an obvious mechanistic explanation.
‘Smoking gun’
One of the loudest critics of the study, Steve Nissen, MD, Cleveland Clinic, described the new findings as “the closest thing I’ve seen to a smoking gun in medicine for a long, long time.”
“The result of this new analysis shows that mineral oil increases virtually every inflammatory and lipid marker that they measured,” he commented.
“There are a lot of theories, but the bottom line is that something really bad happened in the mineral-oil group, which makes icosapent ethyl look efficacious. In my view, this needs to be reviewed by the FDA for consideration of removing the label claim for cardiovascular benefit.”
Other experts in the field not directly involved in the study voiced concern about these new findings, adding to calls for another trial.
In a Twitter thread on the issue, Harlan Krumholz, MD, describes the Circulation publication as “an exceptionally important article,” adding that it is “time to rethink this drug.”
“My point is ... once you know you have non-neutral comparator and the effect on risk biomarkers is far from trivial ... then you have introduced substantial uncertainty about the trial result, as conveyed by the authors ... and no one can say what would happen with a neutral comparator,” Dr. Krumholz writes.
In an accompanying editorial in Circulation, Robert Harrington, MD, professor of medicine at Stanford (Calif.) University, concludes that “the hard reality is that we are left with uncertainties and the questions raised by use of the mineral oil as placebo can only be answered by another randomized controlled trial.”
“My main points are that the chosen placebo was not inert (an essential characteristic for an active control–placebo comparison), that the biomarker data show elevations in multiple markers involved with inflammatory pathways associated with atherosclerosis, and that these data create enough uncertainty in the trial interpretation that the best recourse to answer the criticisms is to do another trial with a truly inert placebo,” Dr. Harrington said in an interview.
He added that Dr. Bhatt’s point that the changes in biomarkers are too small to really matter clinically may be right. “But for me, the uncertainties mean that I have less confidence in the true magnitude of the treatment effect than I would have if there were no changes in the inflammatory markers.”
In Circulation, the authors say it is unclear why multiple biomarkers increased over time among REDUCE-IT participants allocated to mineral oil. They note that no substantive changes in these biomarkers were observed in the placebo groups over periods of 3-5 years in other trials, including JUPITER, CIRT, CANTOS, SPIRE, and the STRENGTH trials, which evaluated a different high-dose omega-3 oil product but used corn oil as the placebo.
“The core design of REDUCE-IT does not make it possible to resolve convincingly whether any adverse effects associated with mineral oil use as a comparator may have affected clinical outcomes,” they write.
They point out that regulatory agencies evaluating REDUCE-IT estimated that approximately 3% of the net clinical benefit observed with icosapent ethyl might have been a consequence of adverse biomarker effects on LDL cholesterol and hsCRP attributable to mineral oil. But in the context of an overall 25% relative risk reduction in first events and a 30% reduction in total ischemic events observed, a potential bias of this magnitude, even if doubled in size, would be unlikely to fully attenuate the overall benefit of icosapent ethyl observed.
They add that they are not aware of a method to assess what the potential magnitude might be of a combination of the multiple effects.
New data do not change the debate
“We did a large, well-powered randomized trial, and this paper shouldn’t change anything in how that trial should be interpreted,” Dr. Bhatt said in an interview.
He claims the new biomarkers evaluated in the study are correlated with LDL and CRP, data which have already been reported and analyzed so have limited relevance.
“It’s not really independent biomarker information; this is what we would expect to see when we see small increases in LDL and CRP. So, I don’t think this new information fundamentally changes the debate,” he said.
Dr. Bhatt also pointed out that the study highlights relative increases rather than absolute increases in the biomarkers, making it seem more alarming than is actually the case.
“The paper makes it seem like that there are large increases in these other biomarkers, but the values reported are relative increases and the absolute increases were actually rather small. In many cases, the changes reported are less than the lower limit of quantification of the assay used,” he noted.
He added: “Even if one is unable to get around the placebo issue in the REDUCE-IT trial, there will always be the JELIS trial – a randomized trial with no placebo showing a 19% relative risk reduction. While the biomarker data may be interesting, what really matters in the end is clinical events. And significant reductions in two independent trials should be enough.”
Dr. Bhatt says the REDUCE-IT steering committee does not believe another trial is needed. “Maybe a different population would be good – such as primary prevention, patients without elevated triglycerides – but just repeating REDUCE- IT with a different placebo would be a waste of resources,” he commented.
But Dr. Nissen refuted Dr. Bhatt’s claims.
“These biomarkers are not in the same pathways as LDL and CRP, and these are not small increases. In the CANTOS trial, a monoclonal antibody against interleukin-1β beta showed a significant benefit. The increase in interleukin-1β now reported in REDUCE-IT is exactly the opposite of CANTOS,” he pointed out.
“The FDA did not know about these additional biomarkers when it reviewed the data on LDL and CRP. Now we have new information. It needs to be looked at again,” Dr. Nissen added.
Funding for the study was provided by Amarin Pharma. Dr. Bhatt was the lead investigator of the REDUCE-IT trial. Dr. Nissen was the lead investigator the STRENGTH trial. Further disclosures of the authors can be found in Circulation.
A version of this article first appeared on Medscape.com.
A new analysis of the REDUCE-IT study has reignited concerns that the benefit shown by the high-dose fish oil product in the study, icosapent ethyl (Vascepa, Amarin), may have been related to harms caused by the placebo mineral oil.
Results show that allocation to icosapent ethyl had minimal effects on a series of biomarkers associated with atherosclerotic disease, whereas levels of these biomarkers increased among those allocated to mineral oil.
At 12 months, the median percent increases from baseline in the mineral oil group were 1.5% for homocysteine, 2.2% for lipoprotein(a), 10.9% for oxidized low-density-lipoprotein (LDL) cholesterol, 16.2% for interleukin (IL)-6, 18.5% for lipoprotein-associated phospholipase A2, 21.9% for high-sensitivity C-reactive protein (hsCRP), and 28.9% for IL-1β. The changes were similar at 24 months. However, in the icosapent ethyl group, there were minimal changes in these biomarkers at 12 and 24 months.
The study was published online in Circulation.
The authors, led by Paul Ridker, MD, Brigham & Women’s Hospital, Boston, do not voice much opinion on what the results mean, concluding that “the effect of these findings on the interpretation of the REDUCE-IT trial results remains unclear and will require further investigation.”
They also say that a second icosapent ethyl trial using a nonmineral oil comparator “would help resolve ongoing controversy.”
However, the authors are a mixed group; Dr. Ridker and some of his coauthors were not part of the original REDUCE-IT trial, whereas other coauthors were members of the REDUCE-IT steering committee, and one was an employee of Amarin.
Lead investigator of the REDUCE-IT trial, Deepak Bhatt, MD, also from Brigham & Women’s Hospital, who is the senior author of the current study, played down the new findings, saying they did not offer much new incremental information on mechanistic insight.
“These are small degrees of biomarker increases on an absolute level we are seeing with the placebo that would not be expected to produce harm,” Dr. Bhatt told this news organization. He also said the Circulation peer-review process had removed some of the discussion, which could lead to some “misinterpretation” of the authors’ views.
Dr. Ridker was unavailable for further comment.
The publication of this study has inevitably poured fuel on the fire regarding the controversy that has long dogged the REDUCE-IT trial, with questions about the large reduction in event rates seen with icosapent ethyl without an obvious mechanistic explanation.
‘Smoking gun’
One of the loudest critics of the study, Steve Nissen, MD, Cleveland Clinic, described the new findings as “the closest thing I’ve seen to a smoking gun in medicine for a long, long time.”
“The result of this new analysis shows that mineral oil increases virtually every inflammatory and lipid marker that they measured,” he commented.
“There are a lot of theories, but the bottom line is that something really bad happened in the mineral-oil group, which makes icosapent ethyl look efficacious. In my view, this needs to be reviewed by the FDA for consideration of removing the label claim for cardiovascular benefit.”
Other experts in the field not directly involved in the study voiced concern about these new findings, adding to calls for another trial.
In a Twitter thread on the issue, Harlan Krumholz, MD, describes the Circulation publication as “an exceptionally important article,” adding that it is “time to rethink this drug.”
“My point is ... once you know you have non-neutral comparator and the effect on risk biomarkers is far from trivial ... then you have introduced substantial uncertainty about the trial result, as conveyed by the authors ... and no one can say what would happen with a neutral comparator,” Dr. Krumholz writes.
In an accompanying editorial in Circulation, Robert Harrington, MD, professor of medicine at Stanford (Calif.) University, concludes that “the hard reality is that we are left with uncertainties and the questions raised by use of the mineral oil as placebo can only be answered by another randomized controlled trial.”
“My main points are that the chosen placebo was not inert (an essential characteristic for an active control–placebo comparison), that the biomarker data show elevations in multiple markers involved with inflammatory pathways associated with atherosclerosis, and that these data create enough uncertainty in the trial interpretation that the best recourse to answer the criticisms is to do another trial with a truly inert placebo,” Dr. Harrington said in an interview.
He added that Dr. Bhatt’s point that the changes in biomarkers are too small to really matter clinically may be right. “But for me, the uncertainties mean that I have less confidence in the true magnitude of the treatment effect than I would have if there were no changes in the inflammatory markers.”
In Circulation, the authors say it is unclear why multiple biomarkers increased over time among REDUCE-IT participants allocated to mineral oil. They note that no substantive changes in these biomarkers were observed in the placebo groups over periods of 3-5 years in other trials, including JUPITER, CIRT, CANTOS, SPIRE, and the STRENGTH trials, which evaluated a different high-dose omega-3 oil product but used corn oil as the placebo.
“The core design of REDUCE-IT does not make it possible to resolve convincingly whether any adverse effects associated with mineral oil use as a comparator may have affected clinical outcomes,” they write.
They point out that regulatory agencies evaluating REDUCE-IT estimated that approximately 3% of the net clinical benefit observed with icosapent ethyl might have been a consequence of adverse biomarker effects on LDL cholesterol and hsCRP attributable to mineral oil. But in the context of an overall 25% relative risk reduction in first events and a 30% reduction in total ischemic events observed, a potential bias of this magnitude, even if doubled in size, would be unlikely to fully attenuate the overall benefit of icosapent ethyl observed.
They add that they are not aware of a method to assess what the potential magnitude might be of a combination of the multiple effects.
New data do not change the debate
“We did a large, well-powered randomized trial, and this paper shouldn’t change anything in how that trial should be interpreted,” Dr. Bhatt said in an interview.
He claims the new biomarkers evaluated in the study are correlated with LDL and CRP, data which have already been reported and analyzed so have limited relevance.
“It’s not really independent biomarker information; this is what we would expect to see when we see small increases in LDL and CRP. So, I don’t think this new information fundamentally changes the debate,” he said.
Dr. Bhatt also pointed out that the study highlights relative increases rather than absolute increases in the biomarkers, making it seem more alarming than is actually the case.
“The paper makes it seem like that there are large increases in these other biomarkers, but the values reported are relative increases and the absolute increases were actually rather small. In many cases, the changes reported are less than the lower limit of quantification of the assay used,” he noted.
He added: “Even if one is unable to get around the placebo issue in the REDUCE-IT trial, there will always be the JELIS trial – a randomized trial with no placebo showing a 19% relative risk reduction. While the biomarker data may be interesting, what really matters in the end is clinical events. And significant reductions in two independent trials should be enough.”
Dr. Bhatt says the REDUCE-IT steering committee does not believe another trial is needed. “Maybe a different population would be good – such as primary prevention, patients without elevated triglycerides – but just repeating REDUCE- IT with a different placebo would be a waste of resources,” he commented.
But Dr. Nissen refuted Dr. Bhatt’s claims.
“These biomarkers are not in the same pathways as LDL and CRP, and these are not small increases. In the CANTOS trial, a monoclonal antibody against interleukin-1β beta showed a significant benefit. The increase in interleukin-1β now reported in REDUCE-IT is exactly the opposite of CANTOS,” he pointed out.
“The FDA did not know about these additional biomarkers when it reviewed the data on LDL and CRP. Now we have new information. It needs to be looked at again,” Dr. Nissen added.
Funding for the study was provided by Amarin Pharma. Dr. Bhatt was the lead investigator of the REDUCE-IT trial. Dr. Nissen was the lead investigator the STRENGTH trial. Further disclosures of the authors can be found in Circulation.
A version of this article first appeared on Medscape.com.
A new analysis of the REDUCE-IT study has reignited concerns that the benefit shown by the high-dose fish oil product in the study, icosapent ethyl (Vascepa, Amarin), may have been related to harms caused by the placebo mineral oil.
Results show that allocation to icosapent ethyl had minimal effects on a series of biomarkers associated with atherosclerotic disease, whereas levels of these biomarkers increased among those allocated to mineral oil.
At 12 months, the median percent increases from baseline in the mineral oil group were 1.5% for homocysteine, 2.2% for lipoprotein(a), 10.9% for oxidized low-density-lipoprotein (LDL) cholesterol, 16.2% for interleukin (IL)-6, 18.5% for lipoprotein-associated phospholipase A2, 21.9% for high-sensitivity C-reactive protein (hsCRP), and 28.9% for IL-1β. The changes were similar at 24 months. However, in the icosapent ethyl group, there were minimal changes in these biomarkers at 12 and 24 months.
The study was published online in Circulation.
The authors, led by Paul Ridker, MD, Brigham & Women’s Hospital, Boston, do not voice much opinion on what the results mean, concluding that “the effect of these findings on the interpretation of the REDUCE-IT trial results remains unclear and will require further investigation.”
They also say that a second icosapent ethyl trial using a nonmineral oil comparator “would help resolve ongoing controversy.”
However, the authors are a mixed group; Dr. Ridker and some of his coauthors were not part of the original REDUCE-IT trial, whereas other coauthors were members of the REDUCE-IT steering committee, and one was an employee of Amarin.
Lead investigator of the REDUCE-IT trial, Deepak Bhatt, MD, also from Brigham & Women’s Hospital, who is the senior author of the current study, played down the new findings, saying they did not offer much new incremental information on mechanistic insight.
“These are small degrees of biomarker increases on an absolute level we are seeing with the placebo that would not be expected to produce harm,” Dr. Bhatt told this news organization. He also said the Circulation peer-review process had removed some of the discussion, which could lead to some “misinterpretation” of the authors’ views.
Dr. Ridker was unavailable for further comment.
The publication of this study has inevitably poured fuel on the fire regarding the controversy that has long dogged the REDUCE-IT trial, with questions about the large reduction in event rates seen with icosapent ethyl without an obvious mechanistic explanation.
‘Smoking gun’
One of the loudest critics of the study, Steve Nissen, MD, Cleveland Clinic, described the new findings as “the closest thing I’ve seen to a smoking gun in medicine for a long, long time.”
“The result of this new analysis shows that mineral oil increases virtually every inflammatory and lipid marker that they measured,” he commented.
“There are a lot of theories, but the bottom line is that something really bad happened in the mineral-oil group, which makes icosapent ethyl look efficacious. In my view, this needs to be reviewed by the FDA for consideration of removing the label claim for cardiovascular benefit.”
Other experts in the field not directly involved in the study voiced concern about these new findings, adding to calls for another trial.
In a Twitter thread on the issue, Harlan Krumholz, MD, describes the Circulation publication as “an exceptionally important article,” adding that it is “time to rethink this drug.”
“My point is ... once you know you have non-neutral comparator and the effect on risk biomarkers is far from trivial ... then you have introduced substantial uncertainty about the trial result, as conveyed by the authors ... and no one can say what would happen with a neutral comparator,” Dr. Krumholz writes.
In an accompanying editorial in Circulation, Robert Harrington, MD, professor of medicine at Stanford (Calif.) University, concludes that “the hard reality is that we are left with uncertainties and the questions raised by use of the mineral oil as placebo can only be answered by another randomized controlled trial.”
“My main points are that the chosen placebo was not inert (an essential characteristic for an active control–placebo comparison), that the biomarker data show elevations in multiple markers involved with inflammatory pathways associated with atherosclerosis, and that these data create enough uncertainty in the trial interpretation that the best recourse to answer the criticisms is to do another trial with a truly inert placebo,” Dr. Harrington said in an interview.
He added that Dr. Bhatt’s point that the changes in biomarkers are too small to really matter clinically may be right. “But for me, the uncertainties mean that I have less confidence in the true magnitude of the treatment effect than I would have if there were no changes in the inflammatory markers.”
In Circulation, the authors say it is unclear why multiple biomarkers increased over time among REDUCE-IT participants allocated to mineral oil. They note that no substantive changes in these biomarkers were observed in the placebo groups over periods of 3-5 years in other trials, including JUPITER, CIRT, CANTOS, SPIRE, and the STRENGTH trials, which evaluated a different high-dose omega-3 oil product but used corn oil as the placebo.
“The core design of REDUCE-IT does not make it possible to resolve convincingly whether any adverse effects associated with mineral oil use as a comparator may have affected clinical outcomes,” they write.
They point out that regulatory agencies evaluating REDUCE-IT estimated that approximately 3% of the net clinical benefit observed with icosapent ethyl might have been a consequence of adverse biomarker effects on LDL cholesterol and hsCRP attributable to mineral oil. But in the context of an overall 25% relative risk reduction in first events and a 30% reduction in total ischemic events observed, a potential bias of this magnitude, even if doubled in size, would be unlikely to fully attenuate the overall benefit of icosapent ethyl observed.
They add that they are not aware of a method to assess what the potential magnitude might be of a combination of the multiple effects.
New data do not change the debate
“We did a large, well-powered randomized trial, and this paper shouldn’t change anything in how that trial should be interpreted,” Dr. Bhatt said in an interview.
He claims the new biomarkers evaluated in the study are correlated with LDL and CRP, data which have already been reported and analyzed so have limited relevance.
“It’s not really independent biomarker information; this is what we would expect to see when we see small increases in LDL and CRP. So, I don’t think this new information fundamentally changes the debate,” he said.
Dr. Bhatt also pointed out that the study highlights relative increases rather than absolute increases in the biomarkers, making it seem more alarming than is actually the case.
“The paper makes it seem like that there are large increases in these other biomarkers, but the values reported are relative increases and the absolute increases were actually rather small. In many cases, the changes reported are less than the lower limit of quantification of the assay used,” he noted.
He added: “Even if one is unable to get around the placebo issue in the REDUCE-IT trial, there will always be the JELIS trial – a randomized trial with no placebo showing a 19% relative risk reduction. While the biomarker data may be interesting, what really matters in the end is clinical events. And significant reductions in two independent trials should be enough.”
Dr. Bhatt says the REDUCE-IT steering committee does not believe another trial is needed. “Maybe a different population would be good – such as primary prevention, patients without elevated triglycerides – but just repeating REDUCE- IT with a different placebo would be a waste of resources,” he commented.
But Dr. Nissen refuted Dr. Bhatt’s claims.
“These biomarkers are not in the same pathways as LDL and CRP, and these are not small increases. In the CANTOS trial, a monoclonal antibody against interleukin-1β beta showed a significant benefit. The increase in interleukin-1β now reported in REDUCE-IT is exactly the opposite of CANTOS,” he pointed out.
“The FDA did not know about these additional biomarkers when it reviewed the data on LDL and CRP. Now we have new information. It needs to be looked at again,” Dr. Nissen added.
Funding for the study was provided by Amarin Pharma. Dr. Bhatt was the lead investigator of the REDUCE-IT trial. Dr. Nissen was the lead investigator the STRENGTH trial. Further disclosures of the authors can be found in Circulation.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Nordic walking bests other workouts on functional outcome in CVD
Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.
Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).
From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.
Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.
“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.
“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.
Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”
The results were published online in the Canadian Journal of Cardiology.
“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.
“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.
Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.
“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.
Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
Cardiac rehabilitation
The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.
Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.
The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.
Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.
From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).
Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).
Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.
Other data indicated the following:
- From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
- During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
- After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
- Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.
Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.
“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.
Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.
Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).
From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.
Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.
“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.
“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.
Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”
The results were published online in the Canadian Journal of Cardiology.
“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.
“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.
Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.
“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.
Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
Cardiac rehabilitation
The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.
Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.
The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.
Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.
From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).
Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).
Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.
Other data indicated the following:
- From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
- During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
- After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
- Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.
Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.
“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.
Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.
Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).
From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.
Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.
“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.
“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.
Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”
The results were published online in the Canadian Journal of Cardiology.
“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.
“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.
Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.
“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.
Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
Cardiac rehabilitation
The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.
Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.
The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.
Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.
From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).
Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).
Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.
Other data indicated the following:
- From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
- During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
- After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
- Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.
Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.
“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.
Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN JOURNAL OF CARDIOLOGY
Mobile devices ‘addictive by design’: Obesity is one of many health effects
Wireless devices, like smart phones and tablets, appear to induce compulsive or even addictive use in many individuals, leading to adverse health consequences that are likely to be curtailed only through often difficult behavior modification, according to a pediatric endocrinologist’s take on the problem.
While the summary was based in part on the analysis of 234 published papers drawn from the medical literature, the lead author, Nidhi Gupta, MD, said the data reinforce her own clinical experience.
“As a pediatric endocrinologist, the trend in smartphone-associated health disorders, such as obesity, sleep, and behavior issues, worries me,” Dr. Gupta, director of KAP Pediatric Endocrinology, Nashville, Tenn., said at the annual meeting of the Endocrine Society.
Based on her search of the medical literature, the available data raise concern. In one study she cited, for example, each hour per day of screen time was found to translate into a body mass index increase of 0.5 to 0.7 kg/m2 (P < .001).
With this type of progressive rise in BMI comes prediabetes, dyslipidemia, and other metabolic disorders associated with major health risks, including cardiovascular disease. And there are others. Dr. Gupta cited data suggesting screen time before bed disturbs sleep, which has its own set of health risks.
“When I say health, it includes physical health, mental health, and emotional health,” said Dr. Gupta.
In the U.S. and other countries with a growing obesity epidemic, lack of physical activity and unhealthy eating are widely considered the major culprits. Excessive screen time contributes to both.
“When we are engaged with our devices, we are often snacking subconsciously and not very mindful that we are making unhealthy choices,” Dr. Gupta said.
The problem is that there is a vicious circle. Compulsive use of devices follows the same loop as other types of addictive behaviors, according to Dr. Gupta. She traced overuse of wireless devices to the dopaminergic system, which is a powerful neuroendocrine-mediated process of craving, response, and reward.
Like fat, sugar, and salt, which provoke a neuroendocrine reward signal, the chimes and buzzes of a cell phone provide their own cues for reward in the form of a dopamine surge. As a result, these become the “triggers of an irresistible and irrational urge to check our device that makes the dopamine go high in our brain,” Dr. Gupta explained.
Although the vicious cycle can be thwarted by turning off the device, Dr. Gupta characterized this as “impractical” when smartphones are so vital to daily communication. Rather, Dr. Gupta advocated a program of moderation, reserving the phone for useful tasks without succumbing to the siren song of apps that waste time.
The most conspicuous culprit is social media, which Dr. Gupta considers to be among the most Pavlovian triggers of cell phone addiction. However, she acknowledged that participation in social media has its justifications.
“I, myself, use social media for my own branding and marketing,” Dr. Gupta said.
The problem that users have is distinguishing between screen time that does and does not have value, according to Dr. Gupta. She indicated that many of those overusing their smart devices are being driven by the dopaminergic reward system, which is generally divorced from the real goals of life, such as personal satisfaction and activity that is rewarding monetarily or in other ways.
“I am not asking for these devices to be thrown out the window. I am advocating for moderation, balance, and real-life engagement,” Dr. Gupta said at the meeting, held in Atlanta and virtually.
She outlined a long list of practical suggestions, including turning off the alarms, chimes, and messages that engage the user into the vicious dopaminergic-reward system loop. She suggested mindfulness so that the user can distinguish between valuable device use and activity that is simply procrastination.
“The devices are designed to be addictive. They are designed to manipulate our brain,” she said. “Eliminate the reward. Let’s try to make our devices boring, unappealing, or enticing so that they only work as tools.”
The medical literature is filled with data that support the potential harms of excessive screen use, leading many others to make some of the same points. In 2017, Thomas N. Robinson, MD, professor of child health at Stanford (Calif.) University, reviewed data showing an association between screen media exposure and obesity in children and adolescents.
“This is an area crying out for more research,” Dr. Robinson said in an interview. The problem of screen time, sedentary behavior, and weight gain has been an issue since the television was invented, which was the point he made in his 2017 paper, but he agreed that the problem is only getting worse.
“Digital technology has become ubiquitous, touching nearly every aspect of people’s lives,” he said. Yet, as evidence grows that overuse of this technology can be harmful, it is creating a problem without a clear solution.
“There are few data about the efficacy of specific strategies to reduce harmful impacts of digital screen use,” he said.
While some of the solutions that Dr. Gupta described make sense, they are more easily described than executed. The dopaminergic reward system is strong and largely experienced subconsciously. Recruiting patients to recognize that dopaminergic rewards are not rewards in any true sense is already a challenge. Enlisting patients to take the difficult steps to avoid the behavioral cues might be even more difficult.
Dr. Gupta and Dr. Robinson report no potential conflicts of interest.
Wireless devices, like smart phones and tablets, appear to induce compulsive or even addictive use in many individuals, leading to adverse health consequences that are likely to be curtailed only through often difficult behavior modification, according to a pediatric endocrinologist’s take on the problem.
While the summary was based in part on the analysis of 234 published papers drawn from the medical literature, the lead author, Nidhi Gupta, MD, said the data reinforce her own clinical experience.
“As a pediatric endocrinologist, the trend in smartphone-associated health disorders, such as obesity, sleep, and behavior issues, worries me,” Dr. Gupta, director of KAP Pediatric Endocrinology, Nashville, Tenn., said at the annual meeting of the Endocrine Society.
Based on her search of the medical literature, the available data raise concern. In one study she cited, for example, each hour per day of screen time was found to translate into a body mass index increase of 0.5 to 0.7 kg/m2 (P < .001).
With this type of progressive rise in BMI comes prediabetes, dyslipidemia, and other metabolic disorders associated with major health risks, including cardiovascular disease. And there are others. Dr. Gupta cited data suggesting screen time before bed disturbs sleep, which has its own set of health risks.
“When I say health, it includes physical health, mental health, and emotional health,” said Dr. Gupta.
In the U.S. and other countries with a growing obesity epidemic, lack of physical activity and unhealthy eating are widely considered the major culprits. Excessive screen time contributes to both.
“When we are engaged with our devices, we are often snacking subconsciously and not very mindful that we are making unhealthy choices,” Dr. Gupta said.
The problem is that there is a vicious circle. Compulsive use of devices follows the same loop as other types of addictive behaviors, according to Dr. Gupta. She traced overuse of wireless devices to the dopaminergic system, which is a powerful neuroendocrine-mediated process of craving, response, and reward.
Like fat, sugar, and salt, which provoke a neuroendocrine reward signal, the chimes and buzzes of a cell phone provide their own cues for reward in the form of a dopamine surge. As a result, these become the “triggers of an irresistible and irrational urge to check our device that makes the dopamine go high in our brain,” Dr. Gupta explained.
Although the vicious cycle can be thwarted by turning off the device, Dr. Gupta characterized this as “impractical” when smartphones are so vital to daily communication. Rather, Dr. Gupta advocated a program of moderation, reserving the phone for useful tasks without succumbing to the siren song of apps that waste time.
The most conspicuous culprit is social media, which Dr. Gupta considers to be among the most Pavlovian triggers of cell phone addiction. However, she acknowledged that participation in social media has its justifications.
“I, myself, use social media for my own branding and marketing,” Dr. Gupta said.
The problem that users have is distinguishing between screen time that does and does not have value, according to Dr. Gupta. She indicated that many of those overusing their smart devices are being driven by the dopaminergic reward system, which is generally divorced from the real goals of life, such as personal satisfaction and activity that is rewarding monetarily or in other ways.
“I am not asking for these devices to be thrown out the window. I am advocating for moderation, balance, and real-life engagement,” Dr. Gupta said at the meeting, held in Atlanta and virtually.
She outlined a long list of practical suggestions, including turning off the alarms, chimes, and messages that engage the user into the vicious dopaminergic-reward system loop. She suggested mindfulness so that the user can distinguish between valuable device use and activity that is simply procrastination.
“The devices are designed to be addictive. They are designed to manipulate our brain,” she said. “Eliminate the reward. Let’s try to make our devices boring, unappealing, or enticing so that they only work as tools.”
The medical literature is filled with data that support the potential harms of excessive screen use, leading many others to make some of the same points. In 2017, Thomas N. Robinson, MD, professor of child health at Stanford (Calif.) University, reviewed data showing an association between screen media exposure and obesity in children and adolescents.
“This is an area crying out for more research,” Dr. Robinson said in an interview. The problem of screen time, sedentary behavior, and weight gain has been an issue since the television was invented, which was the point he made in his 2017 paper, but he agreed that the problem is only getting worse.
“Digital technology has become ubiquitous, touching nearly every aspect of people’s lives,” he said. Yet, as evidence grows that overuse of this technology can be harmful, it is creating a problem without a clear solution.
“There are few data about the efficacy of specific strategies to reduce harmful impacts of digital screen use,” he said.
While some of the solutions that Dr. Gupta described make sense, they are more easily described than executed. The dopaminergic reward system is strong and largely experienced subconsciously. Recruiting patients to recognize that dopaminergic rewards are not rewards in any true sense is already a challenge. Enlisting patients to take the difficult steps to avoid the behavioral cues might be even more difficult.
Dr. Gupta and Dr. Robinson report no potential conflicts of interest.
Wireless devices, like smart phones and tablets, appear to induce compulsive or even addictive use in many individuals, leading to adverse health consequences that are likely to be curtailed only through often difficult behavior modification, according to a pediatric endocrinologist’s take on the problem.
While the summary was based in part on the analysis of 234 published papers drawn from the medical literature, the lead author, Nidhi Gupta, MD, said the data reinforce her own clinical experience.
“As a pediatric endocrinologist, the trend in smartphone-associated health disorders, such as obesity, sleep, and behavior issues, worries me,” Dr. Gupta, director of KAP Pediatric Endocrinology, Nashville, Tenn., said at the annual meeting of the Endocrine Society.
Based on her search of the medical literature, the available data raise concern. In one study she cited, for example, each hour per day of screen time was found to translate into a body mass index increase of 0.5 to 0.7 kg/m2 (P < .001).
With this type of progressive rise in BMI comes prediabetes, dyslipidemia, and other metabolic disorders associated with major health risks, including cardiovascular disease. And there are others. Dr. Gupta cited data suggesting screen time before bed disturbs sleep, which has its own set of health risks.
“When I say health, it includes physical health, mental health, and emotional health,” said Dr. Gupta.
In the U.S. and other countries with a growing obesity epidemic, lack of physical activity and unhealthy eating are widely considered the major culprits. Excessive screen time contributes to both.
“When we are engaged with our devices, we are often snacking subconsciously and not very mindful that we are making unhealthy choices,” Dr. Gupta said.
The problem is that there is a vicious circle. Compulsive use of devices follows the same loop as other types of addictive behaviors, according to Dr. Gupta. She traced overuse of wireless devices to the dopaminergic system, which is a powerful neuroendocrine-mediated process of craving, response, and reward.
Like fat, sugar, and salt, which provoke a neuroendocrine reward signal, the chimes and buzzes of a cell phone provide their own cues for reward in the form of a dopamine surge. As a result, these become the “triggers of an irresistible and irrational urge to check our device that makes the dopamine go high in our brain,” Dr. Gupta explained.
Although the vicious cycle can be thwarted by turning off the device, Dr. Gupta characterized this as “impractical” when smartphones are so vital to daily communication. Rather, Dr. Gupta advocated a program of moderation, reserving the phone for useful tasks without succumbing to the siren song of apps that waste time.
The most conspicuous culprit is social media, which Dr. Gupta considers to be among the most Pavlovian triggers of cell phone addiction. However, she acknowledged that participation in social media has its justifications.
“I, myself, use social media for my own branding and marketing,” Dr. Gupta said.
The problem that users have is distinguishing between screen time that does and does not have value, according to Dr. Gupta. She indicated that many of those overusing their smart devices are being driven by the dopaminergic reward system, which is generally divorced from the real goals of life, such as personal satisfaction and activity that is rewarding monetarily or in other ways.
“I am not asking for these devices to be thrown out the window. I am advocating for moderation, balance, and real-life engagement,” Dr. Gupta said at the meeting, held in Atlanta and virtually.
She outlined a long list of practical suggestions, including turning off the alarms, chimes, and messages that engage the user into the vicious dopaminergic-reward system loop. She suggested mindfulness so that the user can distinguish between valuable device use and activity that is simply procrastination.
“The devices are designed to be addictive. They are designed to manipulate our brain,” she said. “Eliminate the reward. Let’s try to make our devices boring, unappealing, or enticing so that they only work as tools.”
The medical literature is filled with data that support the potential harms of excessive screen use, leading many others to make some of the same points. In 2017, Thomas N. Robinson, MD, professor of child health at Stanford (Calif.) University, reviewed data showing an association between screen media exposure and obesity in children and adolescents.
“This is an area crying out for more research,” Dr. Robinson said in an interview. The problem of screen time, sedentary behavior, and weight gain has been an issue since the television was invented, which was the point he made in his 2017 paper, but he agreed that the problem is only getting worse.
“Digital technology has become ubiquitous, touching nearly every aspect of people’s lives,” he said. Yet, as evidence grows that overuse of this technology can be harmful, it is creating a problem without a clear solution.
“There are few data about the efficacy of specific strategies to reduce harmful impacts of digital screen use,” he said.
While some of the solutions that Dr. Gupta described make sense, they are more easily described than executed. The dopaminergic reward system is strong and largely experienced subconsciously. Recruiting patients to recognize that dopaminergic rewards are not rewards in any true sense is already a challenge. Enlisting patients to take the difficult steps to avoid the behavioral cues might be even more difficult.
Dr. Gupta and Dr. Robinson report no potential conflicts of interest.
FROM ENDO 2022