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Expert discusses which diets are best, based on the evidence
according to a speaker at the annual meeting of the American College of Physicians.
“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
Predominantly plant‐based diets
Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).
The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.
“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.
A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.
“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.
For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
Time‐restricted feeding
There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.
Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.
These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
Low‐carbohydrate and ketogenic diets
Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.
The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
Rating the level of scientific evidence behind different diet options
Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.
In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
Getting to know patients is essential to help them maintain diet modifications
When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”
In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.
“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.
When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.
Dr. Hauser and Dr. Bittleman report no relevant financial relationships.
according to a speaker at the annual meeting of the American College of Physicians.
“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
Predominantly plant‐based diets
Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).
The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.
“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.
A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.
“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.
For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
Time‐restricted feeding
There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.
Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.
These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
Low‐carbohydrate and ketogenic diets
Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.
The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
Rating the level of scientific evidence behind different diet options
Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.
In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
Getting to know patients is essential to help them maintain diet modifications
When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”
In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.
“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.
When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.
Dr. Hauser and Dr. Bittleman report no relevant financial relationships.
according to a speaker at the annual meeting of the American College of Physicians.
“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
Predominantly plant‐based diets
Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).
The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.
“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.
A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.
“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.
For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
Time‐restricted feeding
There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.
Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.
These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
Low‐carbohydrate and ketogenic diets
Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.
The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
Rating the level of scientific evidence behind different diet options
Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.
In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
Getting to know patients is essential to help them maintain diet modifications
When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”
In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.
“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.
When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.
Dr. Hauser and Dr. Bittleman report no relevant financial relationships.
AT INTERNAL MEDICINE 2023
Statins tied to lower stroke risk in atrial fibrillation
Among patients with atrial fibrillation (AFib), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows.
Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications.
Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen (China) Hospital, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AFib.
“The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said.
The results were presented in a moderated poster session at the European Heart Rhythm Association 2023 Congress.
Widely prescribed
Anticoagulant drugs are prescribed to lower the fivefold increased risk of stroke among individuals with AFib, compared with those without AFib, but the therapy does not eliminate the higher risk, Ms. Huang explained. And although statins are widely prescribed to reduce the likelihood of myocardial infarction and stroke, “the benefit of statins for stroke prevention in patients with atrial fibrillation has been unclear.”
Ms. Huang and colleagues analyzed data from 51,472 patients newly diagnosed with AFib between 2010 and 2018. The population was divided into statin users (n = 11,866), defined as patients who had taken statins for at least 19 consecutive days in the first year after AFib diagnosis, and statin nonusers (n = 39,606), based on whether they were prescribed statin therapy after their first diagnosis of AFib.
The median age of the cohort was 74.9 years, and 47.7% were women. The investigators used statistical methods to balance baseline covariates between the two groups.
The primary outcomes were ischemic stroke or systemic embolism, hemorrhagic stroke, and TIA. Median follow-up was 5.1 years.
Statin use was associated with a significantly lower risk of all outcomes, compared with nonuse. Statin users had a 17% reduced risk of ischemic stroke or systemic embolism, a 7% reduced risk of hemorrhagic stroke, and a 15% rate of reduced risk of TIA, Ms. Huang reported.
“We also found long-term statin use was associated with greater protection than short-term use,” she said. For statin use of 6 years or longer, in comparison with use of 3 months to 2 years, the risk of ischemic stroke or systemic embolism was lowered by 43%; for hemorrhagic stroke, it was lowered by 44%, and for TIA, it was lowered by 42%.
These associations were consistent regardless of whether patients used anticoagulant medications or the type of anticoagulant.
Oussama Wazni, MD, MBA, section head of cardiac electrophysiology and pacing at the Cleveland Clinic, was a moderator of the poster session at which Ms. Huang presented her study. In an interview, he called the study “very important.”
“The message should be that all patients who have atrial fibrillation should be checked for cholesterol levels, and we should consider placing them on statins,” he said. “Is there an opportunity? Probably there is, and that’s why we’re seeing this effect in this group of patients.”
When asked about a possible mechanism by which statins produced the effects seen in the study, he pointed to LDL cholesterol lowering and possibly an effect on inflammation. “If a patient had a carotid atheroma, for example, maybe it helped with that,” he said. Previous work has shown that inflammation is related to or is associated with higher risk of thrombogenic effects, including MI or stroke.
It may be a bit less clear how statins reduced the incidence of hemorrhagic strokes, but Dr. Wazni proposed that some strokes could have started as an ischemic stroke “and then had hemorrhagic conversion, so we don’t have the granularity in here to know whether that was the case or not.”
Given the fact that the effect was stronger the longer a patient had been taking a statin, Dr. Wazni said that if a patient is tolerating the drug well, there should be no reason to discontinue it, regardless of age.
He said the study provides “welcome data and evidence because it’s pointing in the right direction,” but prospective studies would be useful “so that we can see what is driving what. Otherwise, this is just an association.”
The study was supported by Sanming Project Shenzhen. Ms. Huang and Dr. Wazni disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Among patients with atrial fibrillation (AFib), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows.
Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications.
Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen (China) Hospital, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AFib.
“The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said.
The results were presented in a moderated poster session at the European Heart Rhythm Association 2023 Congress.
Widely prescribed
Anticoagulant drugs are prescribed to lower the fivefold increased risk of stroke among individuals with AFib, compared with those without AFib, but the therapy does not eliminate the higher risk, Ms. Huang explained. And although statins are widely prescribed to reduce the likelihood of myocardial infarction and stroke, “the benefit of statins for stroke prevention in patients with atrial fibrillation has been unclear.”
Ms. Huang and colleagues analyzed data from 51,472 patients newly diagnosed with AFib between 2010 and 2018. The population was divided into statin users (n = 11,866), defined as patients who had taken statins for at least 19 consecutive days in the first year after AFib diagnosis, and statin nonusers (n = 39,606), based on whether they were prescribed statin therapy after their first diagnosis of AFib.
The median age of the cohort was 74.9 years, and 47.7% were women. The investigators used statistical methods to balance baseline covariates between the two groups.
The primary outcomes were ischemic stroke or systemic embolism, hemorrhagic stroke, and TIA. Median follow-up was 5.1 years.
Statin use was associated with a significantly lower risk of all outcomes, compared with nonuse. Statin users had a 17% reduced risk of ischemic stroke or systemic embolism, a 7% reduced risk of hemorrhagic stroke, and a 15% rate of reduced risk of TIA, Ms. Huang reported.
“We also found long-term statin use was associated with greater protection than short-term use,” she said. For statin use of 6 years or longer, in comparison with use of 3 months to 2 years, the risk of ischemic stroke or systemic embolism was lowered by 43%; for hemorrhagic stroke, it was lowered by 44%, and for TIA, it was lowered by 42%.
These associations were consistent regardless of whether patients used anticoagulant medications or the type of anticoagulant.
Oussama Wazni, MD, MBA, section head of cardiac electrophysiology and pacing at the Cleveland Clinic, was a moderator of the poster session at which Ms. Huang presented her study. In an interview, he called the study “very important.”
“The message should be that all patients who have atrial fibrillation should be checked for cholesterol levels, and we should consider placing them on statins,” he said. “Is there an opportunity? Probably there is, and that’s why we’re seeing this effect in this group of patients.”
When asked about a possible mechanism by which statins produced the effects seen in the study, he pointed to LDL cholesterol lowering and possibly an effect on inflammation. “If a patient had a carotid atheroma, for example, maybe it helped with that,” he said. Previous work has shown that inflammation is related to or is associated with higher risk of thrombogenic effects, including MI or stroke.
It may be a bit less clear how statins reduced the incidence of hemorrhagic strokes, but Dr. Wazni proposed that some strokes could have started as an ischemic stroke “and then had hemorrhagic conversion, so we don’t have the granularity in here to know whether that was the case or not.”
Given the fact that the effect was stronger the longer a patient had been taking a statin, Dr. Wazni said that if a patient is tolerating the drug well, there should be no reason to discontinue it, regardless of age.
He said the study provides “welcome data and evidence because it’s pointing in the right direction,” but prospective studies would be useful “so that we can see what is driving what. Otherwise, this is just an association.”
The study was supported by Sanming Project Shenzhen. Ms. Huang and Dr. Wazni disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Among patients with atrial fibrillation (AFib), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows.
Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications.
Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen (China) Hospital, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AFib.
“The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said.
The results were presented in a moderated poster session at the European Heart Rhythm Association 2023 Congress.
Widely prescribed
Anticoagulant drugs are prescribed to lower the fivefold increased risk of stroke among individuals with AFib, compared with those without AFib, but the therapy does not eliminate the higher risk, Ms. Huang explained. And although statins are widely prescribed to reduce the likelihood of myocardial infarction and stroke, “the benefit of statins for stroke prevention in patients with atrial fibrillation has been unclear.”
Ms. Huang and colleagues analyzed data from 51,472 patients newly diagnosed with AFib between 2010 and 2018. The population was divided into statin users (n = 11,866), defined as patients who had taken statins for at least 19 consecutive days in the first year after AFib diagnosis, and statin nonusers (n = 39,606), based on whether they were prescribed statin therapy after their first diagnosis of AFib.
The median age of the cohort was 74.9 years, and 47.7% were women. The investigators used statistical methods to balance baseline covariates between the two groups.
The primary outcomes were ischemic stroke or systemic embolism, hemorrhagic stroke, and TIA. Median follow-up was 5.1 years.
Statin use was associated with a significantly lower risk of all outcomes, compared with nonuse. Statin users had a 17% reduced risk of ischemic stroke or systemic embolism, a 7% reduced risk of hemorrhagic stroke, and a 15% rate of reduced risk of TIA, Ms. Huang reported.
“We also found long-term statin use was associated with greater protection than short-term use,” she said. For statin use of 6 years or longer, in comparison with use of 3 months to 2 years, the risk of ischemic stroke or systemic embolism was lowered by 43%; for hemorrhagic stroke, it was lowered by 44%, and for TIA, it was lowered by 42%.
These associations were consistent regardless of whether patients used anticoagulant medications or the type of anticoagulant.
Oussama Wazni, MD, MBA, section head of cardiac electrophysiology and pacing at the Cleveland Clinic, was a moderator of the poster session at which Ms. Huang presented her study. In an interview, he called the study “very important.”
“The message should be that all patients who have atrial fibrillation should be checked for cholesterol levels, and we should consider placing them on statins,” he said. “Is there an opportunity? Probably there is, and that’s why we’re seeing this effect in this group of patients.”
When asked about a possible mechanism by which statins produced the effects seen in the study, he pointed to LDL cholesterol lowering and possibly an effect on inflammation. “If a patient had a carotid atheroma, for example, maybe it helped with that,” he said. Previous work has shown that inflammation is related to or is associated with higher risk of thrombogenic effects, including MI or stroke.
It may be a bit less clear how statins reduced the incidence of hemorrhagic strokes, but Dr. Wazni proposed that some strokes could have started as an ischemic stroke “and then had hemorrhagic conversion, so we don’t have the granularity in here to know whether that was the case or not.”
Given the fact that the effect was stronger the longer a patient had been taking a statin, Dr. Wazni said that if a patient is tolerating the drug well, there should be no reason to discontinue it, regardless of age.
He said the study provides “welcome data and evidence because it’s pointing in the right direction,” but prospective studies would be useful “so that we can see what is driving what. Otherwise, this is just an association.”
The study was supported by Sanming Project Shenzhen. Ms. Huang and Dr. Wazni disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM EHRA 2023
10 popular diets for heart health ranked
An evidence-based analysis of 10 popular dietary patterns shows that some promote heart health better than others.
A new American Heart Association scientific statement concludes that the Mediterranean, Dietary Approach to Stop Hypertension (DASH), pescatarian, and vegetarian eating patterns most strongly align with heart-healthy eating guidelines issued by the AHA in 2021, whereas the popular paleolithic (paleo) and ketogenic (keto) diets fall short.
“The good news for the public and their clinicians is that there are several dietary patterns that allow for substantial flexibility for following a heart healthy diet – DASH, Mediterranean, vegetarian,” writing-group chair Christopher Gardner, PhD, with Stanford (Calif.) University, told this news organization.
“However, some of the popular diets – particularly paleo and keto – are so strictly restrictive of specific food groups that when these diets are followed as intended by their proponents, they are not aligned with the scientific evidence for a heart-healthy diet,” Dr. Gardner said.
The statement was published online in Circulation.
A tool for clinicians
“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” Dr. Gardner said in a news release.
“The public – and even many health care professionals – may rightfully be confused about heart-healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health,” he noted.
The writing group rated on a scale of 1-100 how well 10 popular diets or eating patterns align with AHA dietary advice for heart-healthy eating.
That advice includes consuming a wide variety of fruits and vegetables; choosing mostly whole grains instead of refined grains; using liquid plant oils rather than tropical oils; eating healthy sources of protein, such as from plants, seafood, or lean meats; minimizing added sugars and salt; limiting alcohol; choosing minimally processed foods instead of ultraprocessed foods; and following this guidance wherever food is prepared or consumed.
The 10 diets/dietary patterns were DASH, Mediterranean-style, pescatarian, ovo-lacto vegetarian, vegan, low-fat, very low–fat, low-carbohydrate, paleo, and very low–carbohydrate/keto patterns.
The diets were divided into four tiers on the basis of their scores, which ranged from a low of 31 to a high of 100.
Only the DASH eating plan got a perfect score of 100. This eating pattern is low in salt, added sugar, tropical oil, alcohol, and processed foods and high in nonstarchy vegetables, fruits, whole grains, and legumes. Proteins are mostly plant-based, such as legumes, beans, or nuts, along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.
The Mediterranean eating pattern achieved a slightly lower score of 89 because unlike DASH, it allows for moderate alcohol consumption and does not address added salt.
The other two top tier eating patterns were pescatarian, with a score of 92, and vegetarian, with a score of 86.
“If implemented as intended, the top-tier dietary patterns align best with the American Heart Association’s guidance and may be adapted to respect cultural practices, food preferences and budgets to enable people to always eat this way, for the long term,” Dr. Gardner said in the release.
Vegan and low-fat diets (each with a score of 78) fell into the second tier.
Though these diets emphasize fruits, vegetables, whole grains, legumes, and nuts while limiting alcohol and added sugars, the vegan diet is so restrictive that it could be challenging to follow long-term or when eating out and may increase the risk for vitamin B12 deficiency, which can lead to anemia, the writing group notes.
There also are concerns that low-fat diets treat all fats equally, whereas the AHA guidance calls for replacing saturated fats with healthier fats, they point out.
The third tier includes the very low–fat diet (score 72) and low-carb diet (score 64), whereas the paleo and very low–carb/keto diets fall into the fourth tier, with the lowest scores of 53 and 31, respectively.
Dr. Gardner said that it’s important to note that all 10 diet patterns “share four positive characteristics: more veggies, more whole foods, less added sugars, less refined grains.”
“These are all areas for which Americans have substantial room for improvement, and these are all things that we could work on together. Progress across these aspects would make a large difference in the heart-healthiness of the U.S. diet,” he told this news organization.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, and the Council on Peripheral Vascular Disease.
A version of this article first appeared on Medscape.com.
An evidence-based analysis of 10 popular dietary patterns shows that some promote heart health better than others.
A new American Heart Association scientific statement concludes that the Mediterranean, Dietary Approach to Stop Hypertension (DASH), pescatarian, and vegetarian eating patterns most strongly align with heart-healthy eating guidelines issued by the AHA in 2021, whereas the popular paleolithic (paleo) and ketogenic (keto) diets fall short.
“The good news for the public and their clinicians is that there are several dietary patterns that allow for substantial flexibility for following a heart healthy diet – DASH, Mediterranean, vegetarian,” writing-group chair Christopher Gardner, PhD, with Stanford (Calif.) University, told this news organization.
“However, some of the popular diets – particularly paleo and keto – are so strictly restrictive of specific food groups that when these diets are followed as intended by their proponents, they are not aligned with the scientific evidence for a heart-healthy diet,” Dr. Gardner said.
The statement was published online in Circulation.
A tool for clinicians
“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” Dr. Gardner said in a news release.
“The public – and even many health care professionals – may rightfully be confused about heart-healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health,” he noted.
The writing group rated on a scale of 1-100 how well 10 popular diets or eating patterns align with AHA dietary advice for heart-healthy eating.
That advice includes consuming a wide variety of fruits and vegetables; choosing mostly whole grains instead of refined grains; using liquid plant oils rather than tropical oils; eating healthy sources of protein, such as from plants, seafood, or lean meats; minimizing added sugars and salt; limiting alcohol; choosing minimally processed foods instead of ultraprocessed foods; and following this guidance wherever food is prepared or consumed.
The 10 diets/dietary patterns were DASH, Mediterranean-style, pescatarian, ovo-lacto vegetarian, vegan, low-fat, very low–fat, low-carbohydrate, paleo, and very low–carbohydrate/keto patterns.
The diets were divided into four tiers on the basis of their scores, which ranged from a low of 31 to a high of 100.
Only the DASH eating plan got a perfect score of 100. This eating pattern is low in salt, added sugar, tropical oil, alcohol, and processed foods and high in nonstarchy vegetables, fruits, whole grains, and legumes. Proteins are mostly plant-based, such as legumes, beans, or nuts, along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.
The Mediterranean eating pattern achieved a slightly lower score of 89 because unlike DASH, it allows for moderate alcohol consumption and does not address added salt.
The other two top tier eating patterns were pescatarian, with a score of 92, and vegetarian, with a score of 86.
“If implemented as intended, the top-tier dietary patterns align best with the American Heart Association’s guidance and may be adapted to respect cultural practices, food preferences and budgets to enable people to always eat this way, for the long term,” Dr. Gardner said in the release.
Vegan and low-fat diets (each with a score of 78) fell into the second tier.
Though these diets emphasize fruits, vegetables, whole grains, legumes, and nuts while limiting alcohol and added sugars, the vegan diet is so restrictive that it could be challenging to follow long-term or when eating out and may increase the risk for vitamin B12 deficiency, which can lead to anemia, the writing group notes.
There also are concerns that low-fat diets treat all fats equally, whereas the AHA guidance calls for replacing saturated fats with healthier fats, they point out.
The third tier includes the very low–fat diet (score 72) and low-carb diet (score 64), whereas the paleo and very low–carb/keto diets fall into the fourth tier, with the lowest scores of 53 and 31, respectively.
Dr. Gardner said that it’s important to note that all 10 diet patterns “share four positive characteristics: more veggies, more whole foods, less added sugars, less refined grains.”
“These are all areas for which Americans have substantial room for improvement, and these are all things that we could work on together. Progress across these aspects would make a large difference in the heart-healthiness of the U.S. diet,” he told this news organization.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, and the Council on Peripheral Vascular Disease.
A version of this article first appeared on Medscape.com.
An evidence-based analysis of 10 popular dietary patterns shows that some promote heart health better than others.
A new American Heart Association scientific statement concludes that the Mediterranean, Dietary Approach to Stop Hypertension (DASH), pescatarian, and vegetarian eating patterns most strongly align with heart-healthy eating guidelines issued by the AHA in 2021, whereas the popular paleolithic (paleo) and ketogenic (keto) diets fall short.
“The good news for the public and their clinicians is that there are several dietary patterns that allow for substantial flexibility for following a heart healthy diet – DASH, Mediterranean, vegetarian,” writing-group chair Christopher Gardner, PhD, with Stanford (Calif.) University, told this news organization.
“However, some of the popular diets – particularly paleo and keto – are so strictly restrictive of specific food groups that when these diets are followed as intended by their proponents, they are not aligned with the scientific evidence for a heart-healthy diet,” Dr. Gardner said.
The statement was published online in Circulation.
A tool for clinicians
“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” Dr. Gardner said in a news release.
“The public – and even many health care professionals – may rightfully be confused about heart-healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health,” he noted.
The writing group rated on a scale of 1-100 how well 10 popular diets or eating patterns align with AHA dietary advice for heart-healthy eating.
That advice includes consuming a wide variety of fruits and vegetables; choosing mostly whole grains instead of refined grains; using liquid plant oils rather than tropical oils; eating healthy sources of protein, such as from plants, seafood, or lean meats; minimizing added sugars and salt; limiting alcohol; choosing minimally processed foods instead of ultraprocessed foods; and following this guidance wherever food is prepared or consumed.
The 10 diets/dietary patterns were DASH, Mediterranean-style, pescatarian, ovo-lacto vegetarian, vegan, low-fat, very low–fat, low-carbohydrate, paleo, and very low–carbohydrate/keto patterns.
The diets were divided into four tiers on the basis of their scores, which ranged from a low of 31 to a high of 100.
Only the DASH eating plan got a perfect score of 100. This eating pattern is low in salt, added sugar, tropical oil, alcohol, and processed foods and high in nonstarchy vegetables, fruits, whole grains, and legumes. Proteins are mostly plant-based, such as legumes, beans, or nuts, along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.
The Mediterranean eating pattern achieved a slightly lower score of 89 because unlike DASH, it allows for moderate alcohol consumption and does not address added salt.
The other two top tier eating patterns were pescatarian, with a score of 92, and vegetarian, with a score of 86.
“If implemented as intended, the top-tier dietary patterns align best with the American Heart Association’s guidance and may be adapted to respect cultural practices, food preferences and budgets to enable people to always eat this way, for the long term,” Dr. Gardner said in the release.
Vegan and low-fat diets (each with a score of 78) fell into the second tier.
Though these diets emphasize fruits, vegetables, whole grains, legumes, and nuts while limiting alcohol and added sugars, the vegan diet is so restrictive that it could be challenging to follow long-term or when eating out and may increase the risk for vitamin B12 deficiency, which can lead to anemia, the writing group notes.
There also are concerns that low-fat diets treat all fats equally, whereas the AHA guidance calls for replacing saturated fats with healthier fats, they point out.
The third tier includes the very low–fat diet (score 72) and low-carb diet (score 64), whereas the paleo and very low–carb/keto diets fall into the fourth tier, with the lowest scores of 53 and 31, respectively.
Dr. Gardner said that it’s important to note that all 10 diet patterns “share four positive characteristics: more veggies, more whole foods, less added sugars, less refined grains.”
“These are all areas for which Americans have substantial room for improvement, and these are all things that we could work on together. Progress across these aspects would make a large difference in the heart-healthiness of the U.S. diet,” he told this news organization.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, and the Council on Peripheral Vascular Disease.
A version of this article first appeared on Medscape.com.
Tirzepatide scores win in second obesity trial, SURMOUNT-2
The “twincretin” tirzepatide (Mounjaro) has proven successful in SURMOUNT-2, the second pivotal trial for the drug as an antiobesity agent, according to top-line results reported April 27 by tirzepatide’s manufacturer, Lilly, in a press release. The company reveals that tirzepatide achieved both of its primary endpoints in the trial, as well as all its key secondary endpoints.
The findings pave the way for tirzepatide to likely receive Food and Drug Administration approval as a treatment for obesity, perhaps before the end of 2023.
Tirzepatide received FDA approval in May 2022 for the treatment of type 2 diabetes in adults, under the brand name Mounjaro, and some people have already been using it off-label to treat obesity.
Tirzepatide is a dual glucagonlike peptide–1 (GLP-1) agonist and glucose-dependent insulinotropic polypeptide agonist. Several GLP-1 receptor agonists are already approved in the United States, including semaglutide, a once-weekly injection, which is approved as Wegovy for patients with obesity and as Ozempic for treatment of type 2 diabetes.
These agents have been incredibly popular among celebrity influencers, and with use of the #Ozempic hashtag and others on social media, this has led to unprecedented use of these products for weight loss, often among those who do not even have obesity or type 2 diabetes. Subsequently, patients with type 2 diabetes and obesity who need them have often struggled to obtain them, owing to shortages following this phenomenon.
SURMOUNT-2: Weight loss around 15%, less than seen in SURMOUNT-1
SURMOUNT-2 enrolled 938 adults with overweight or obesity and type 2 diabetes and had dual primary endpoints that both focused on weight loss, compared with placebo.
The first completed pivotal trial of tirzepatide for weight loss, SURMOUNT-1, enrolled people with overweight or obesity but no diabetes and had its main results reported in 2022. At the time, the weight loss achieved with tirzepatide, was described as “unprecedented,” with those given the highest dose in that trial (15 mg subcutaneously per week) losing an average of 20%-22% of body weight over 72 weeks, depending on the specific statistical analysis used.
For SURMOUNT-2’s first primary endpoint, 72 weeks of weekly subcutaneous injections with tirzepatide at dosages of 10 mg or 15 mg led to an average weight loss from baseline of 13.4% and 15.7%, respectively, compared with an average loss of 3.3% from baseline in the placebo-treated control arm.
For the second primary endpoint, 81.6% of people on the 10-mg dose and 86.4% on the 15-mg dose achieved at least 5% weight loss from baseline, compared with 30.5% of controls who had at least 5% weight loss from baseline.
In one key secondary endpoint, tirzepatide at dosages of 10 mg or 15 mg weekly produced at least a 15% cut in weight from baseline in 41.4% and 51.8% of participants, respectively, compared with a 2.6% rate of this endpoint in the placebo controls.
So the extent of weight loss seen in in SURMOUNT-2 was somewhat less than was reported in SURMOUNT-1, a finding consistent with many prior studies of incretin-based weight-loss agents, which seem to pack a more potent weight-loss punch in people without type 2 diabetes.
Lilly did not specifically report the treatment effect of tirzepatide on hemoglobin A1c in SURMOUNT-2, only saying that the effect was similar to what had been seen in the series of five SURPASS trials that led to the approval of tirzepatide for type 2 diabetes.
Lilly also reported that the safety profile of tirzepatide in SURMOUNT-2 generally matched what was seen in SURMOUNT-1 as well as in the SURPASS trials. The most common adverse events in SURMOUNT-2 involved gastrointestinal symptoms, such as nausea, diarrhea, and vomiting; these were generally mild to moderate in severity and clustered during the dose-escalation phase at the start of treatment. Treatment discontinuations caused by adverse effects were 3.8% on the 10-mg dosage, 7.4% on the 15-mg dosage, and 3.8% on placebo.
SURMOUNT-2 enrolled patients in the United States, Puerto Rico, and five other countries. All participants also received interventions designed to reduce their calorie intake and increase their physical activity.
More SURMOUNT-2 results at ADA in June
Lilly also announced that researchers would report more complete results from SURMOUNT-2 at the 2023 scientific sessions of the American Diabetes Association, being held in San Diego in late June, and publish the findings in a major medical journal.
Results from two additional phase 3 trials of tirzepatide in people with overweight or obesity, SURMOUNT-3 and SURMOUNT-4, are expected later in 2023.
Lilly started an application to the FDA for an indication for weight loss in October 2022 under a fast track designation by the agency, and the data collected in SURMOUNT-2 are expected to complete this application, which would then be subject to an FDA decision within about 6 months. Lilly said in its April 27 press release that it anticipates an FDA decision on this application may occur before the end of 2023.
SURMOUNT-2 and all of the other tirzepatide trials were sponsored by Lilly.
A version of this article first appeared on Medscape.com.
The “twincretin” tirzepatide (Mounjaro) has proven successful in SURMOUNT-2, the second pivotal trial for the drug as an antiobesity agent, according to top-line results reported April 27 by tirzepatide’s manufacturer, Lilly, in a press release. The company reveals that tirzepatide achieved both of its primary endpoints in the trial, as well as all its key secondary endpoints.
The findings pave the way for tirzepatide to likely receive Food and Drug Administration approval as a treatment for obesity, perhaps before the end of 2023.
Tirzepatide received FDA approval in May 2022 for the treatment of type 2 diabetes in adults, under the brand name Mounjaro, and some people have already been using it off-label to treat obesity.
Tirzepatide is a dual glucagonlike peptide–1 (GLP-1) agonist and glucose-dependent insulinotropic polypeptide agonist. Several GLP-1 receptor agonists are already approved in the United States, including semaglutide, a once-weekly injection, which is approved as Wegovy for patients with obesity and as Ozempic for treatment of type 2 diabetes.
These agents have been incredibly popular among celebrity influencers, and with use of the #Ozempic hashtag and others on social media, this has led to unprecedented use of these products for weight loss, often among those who do not even have obesity or type 2 diabetes. Subsequently, patients with type 2 diabetes and obesity who need them have often struggled to obtain them, owing to shortages following this phenomenon.
SURMOUNT-2: Weight loss around 15%, less than seen in SURMOUNT-1
SURMOUNT-2 enrolled 938 adults with overweight or obesity and type 2 diabetes and had dual primary endpoints that both focused on weight loss, compared with placebo.
The first completed pivotal trial of tirzepatide for weight loss, SURMOUNT-1, enrolled people with overweight or obesity but no diabetes and had its main results reported in 2022. At the time, the weight loss achieved with tirzepatide, was described as “unprecedented,” with those given the highest dose in that trial (15 mg subcutaneously per week) losing an average of 20%-22% of body weight over 72 weeks, depending on the specific statistical analysis used.
For SURMOUNT-2’s first primary endpoint, 72 weeks of weekly subcutaneous injections with tirzepatide at dosages of 10 mg or 15 mg led to an average weight loss from baseline of 13.4% and 15.7%, respectively, compared with an average loss of 3.3% from baseline in the placebo-treated control arm.
For the second primary endpoint, 81.6% of people on the 10-mg dose and 86.4% on the 15-mg dose achieved at least 5% weight loss from baseline, compared with 30.5% of controls who had at least 5% weight loss from baseline.
In one key secondary endpoint, tirzepatide at dosages of 10 mg or 15 mg weekly produced at least a 15% cut in weight from baseline in 41.4% and 51.8% of participants, respectively, compared with a 2.6% rate of this endpoint in the placebo controls.
So the extent of weight loss seen in in SURMOUNT-2 was somewhat less than was reported in SURMOUNT-1, a finding consistent with many prior studies of incretin-based weight-loss agents, which seem to pack a more potent weight-loss punch in people without type 2 diabetes.
Lilly did not specifically report the treatment effect of tirzepatide on hemoglobin A1c in SURMOUNT-2, only saying that the effect was similar to what had been seen in the series of five SURPASS trials that led to the approval of tirzepatide for type 2 diabetes.
Lilly also reported that the safety profile of tirzepatide in SURMOUNT-2 generally matched what was seen in SURMOUNT-1 as well as in the SURPASS trials. The most common adverse events in SURMOUNT-2 involved gastrointestinal symptoms, such as nausea, diarrhea, and vomiting; these were generally mild to moderate in severity and clustered during the dose-escalation phase at the start of treatment. Treatment discontinuations caused by adverse effects were 3.8% on the 10-mg dosage, 7.4% on the 15-mg dosage, and 3.8% on placebo.
SURMOUNT-2 enrolled patients in the United States, Puerto Rico, and five other countries. All participants also received interventions designed to reduce their calorie intake and increase their physical activity.
More SURMOUNT-2 results at ADA in June
Lilly also announced that researchers would report more complete results from SURMOUNT-2 at the 2023 scientific sessions of the American Diabetes Association, being held in San Diego in late June, and publish the findings in a major medical journal.
Results from two additional phase 3 trials of tirzepatide in people with overweight or obesity, SURMOUNT-3 and SURMOUNT-4, are expected later in 2023.
Lilly started an application to the FDA for an indication for weight loss in October 2022 under a fast track designation by the agency, and the data collected in SURMOUNT-2 are expected to complete this application, which would then be subject to an FDA decision within about 6 months. Lilly said in its April 27 press release that it anticipates an FDA decision on this application may occur before the end of 2023.
SURMOUNT-2 and all of the other tirzepatide trials were sponsored by Lilly.
A version of this article first appeared on Medscape.com.
The “twincretin” tirzepatide (Mounjaro) has proven successful in SURMOUNT-2, the second pivotal trial for the drug as an antiobesity agent, according to top-line results reported April 27 by tirzepatide’s manufacturer, Lilly, in a press release. The company reveals that tirzepatide achieved both of its primary endpoints in the trial, as well as all its key secondary endpoints.
The findings pave the way for tirzepatide to likely receive Food and Drug Administration approval as a treatment for obesity, perhaps before the end of 2023.
Tirzepatide received FDA approval in May 2022 for the treatment of type 2 diabetes in adults, under the brand name Mounjaro, and some people have already been using it off-label to treat obesity.
Tirzepatide is a dual glucagonlike peptide–1 (GLP-1) agonist and glucose-dependent insulinotropic polypeptide agonist. Several GLP-1 receptor agonists are already approved in the United States, including semaglutide, a once-weekly injection, which is approved as Wegovy for patients with obesity and as Ozempic for treatment of type 2 diabetes.
These agents have been incredibly popular among celebrity influencers, and with use of the #Ozempic hashtag and others on social media, this has led to unprecedented use of these products for weight loss, often among those who do not even have obesity or type 2 diabetes. Subsequently, patients with type 2 diabetes and obesity who need them have often struggled to obtain them, owing to shortages following this phenomenon.
SURMOUNT-2: Weight loss around 15%, less than seen in SURMOUNT-1
SURMOUNT-2 enrolled 938 adults with overweight or obesity and type 2 diabetes and had dual primary endpoints that both focused on weight loss, compared with placebo.
The first completed pivotal trial of tirzepatide for weight loss, SURMOUNT-1, enrolled people with overweight or obesity but no diabetes and had its main results reported in 2022. At the time, the weight loss achieved with tirzepatide, was described as “unprecedented,” with those given the highest dose in that trial (15 mg subcutaneously per week) losing an average of 20%-22% of body weight over 72 weeks, depending on the specific statistical analysis used.
For SURMOUNT-2’s first primary endpoint, 72 weeks of weekly subcutaneous injections with tirzepatide at dosages of 10 mg or 15 mg led to an average weight loss from baseline of 13.4% and 15.7%, respectively, compared with an average loss of 3.3% from baseline in the placebo-treated control arm.
For the second primary endpoint, 81.6% of people on the 10-mg dose and 86.4% on the 15-mg dose achieved at least 5% weight loss from baseline, compared with 30.5% of controls who had at least 5% weight loss from baseline.
In one key secondary endpoint, tirzepatide at dosages of 10 mg or 15 mg weekly produced at least a 15% cut in weight from baseline in 41.4% and 51.8% of participants, respectively, compared with a 2.6% rate of this endpoint in the placebo controls.
So the extent of weight loss seen in in SURMOUNT-2 was somewhat less than was reported in SURMOUNT-1, a finding consistent with many prior studies of incretin-based weight-loss agents, which seem to pack a more potent weight-loss punch in people without type 2 diabetes.
Lilly did not specifically report the treatment effect of tirzepatide on hemoglobin A1c in SURMOUNT-2, only saying that the effect was similar to what had been seen in the series of five SURPASS trials that led to the approval of tirzepatide for type 2 diabetes.
Lilly also reported that the safety profile of tirzepatide in SURMOUNT-2 generally matched what was seen in SURMOUNT-1 as well as in the SURPASS trials. The most common adverse events in SURMOUNT-2 involved gastrointestinal symptoms, such as nausea, diarrhea, and vomiting; these were generally mild to moderate in severity and clustered during the dose-escalation phase at the start of treatment. Treatment discontinuations caused by adverse effects were 3.8% on the 10-mg dosage, 7.4% on the 15-mg dosage, and 3.8% on placebo.
SURMOUNT-2 enrolled patients in the United States, Puerto Rico, and five other countries. All participants also received interventions designed to reduce their calorie intake and increase their physical activity.
More SURMOUNT-2 results at ADA in June
Lilly also announced that researchers would report more complete results from SURMOUNT-2 at the 2023 scientific sessions of the American Diabetes Association, being held in San Diego in late June, and publish the findings in a major medical journal.
Results from two additional phase 3 trials of tirzepatide in people with overweight or obesity, SURMOUNT-3 and SURMOUNT-4, are expected later in 2023.
Lilly started an application to the FDA for an indication for weight loss in October 2022 under a fast track designation by the agency, and the data collected in SURMOUNT-2 are expected to complete this application, which would then be subject to an FDA decision within about 6 months. Lilly said in its April 27 press release that it anticipates an FDA decision on this application may occur before the end of 2023.
SURMOUNT-2 and all of the other tirzepatide trials were sponsored by Lilly.
A version of this article first appeared on Medscape.com.
Meditation curbs stress, depression as adjunct to CAD rehab
Regular meditation reduced depression by roughly 44% in adults with coronary artery disease who were involved in a cardiovascular rehabilitation program.
An increasing body of research supports the impact of psychological risk factors including stress, personality type, anger, and hostility on conditions such as depression and anxiety, but also social isolation and low socioeconomic status, Ana Luisa Vitorino Monteiro, MD, of the University of Lisbon said in a presentation at the annual congress of the European Association of Preventive Cardiology. In addition, “stress, anxiety, and depression deteriorate the cardiovascular (CV) system through psycho-neuro-immunoendocrinology system and behavioral pathways.”
Meditation as a tool for stress management has been gaining popularity, but its use as part of a CV rehabilitation program as a complementary therapy has not been well studied, she added.
Dr. Monteiro and colleagues recruited 80 adults with CAD who were undergoing CV rehabilitation to join a meditation program. Of these, 48 accepted (60%) and 40% declined. Those who accepted were part of an exercise-based CV rehabilitation program that met three times a week for at least 6 months. The mean age of the participants was 65 years, and 80% were male.
Participants were randomized to an intervention group with a weekly 90-minute session that included breathing and meditation for 1 month in addition to usual care, or to usual care in the rehabilitation program. Over the next 3 months, the intervention patients were encouraged to practice daily meditation for 20 minutes alone or using video support material, with a weekly follow-up phone call. Assessments of stress, anxiety, and depression took place at baseline and after 4 months using the Perceived Stress Scale, Beck Anxiety Inventory, Beck Depression Inventory, and HeartQoL questionnaire.
At 4 months, individuals in the meditation group had reduced depression levels significantly, by 44%, compared with controls (P < .001). Anxiety and stress decreased significantly, by 30% (P = .04) and 31% (P = .05), respectively. After 4 months, individuals in the control group were offered the opportunity to follow the meditation protocol.
In addition, “the emotional dimension of quality of life increased by 60% in the intervention group,” Dr. Monteiro noted. However, physical QoL did not change between groups.
The study was limited by the small sample size, and more research is needed in larger and more diverse populations, Dr. Monteiro said. However, the results support the value of meditation as an adjunct component of care for CAD patients in a long-term rehabilitation program.
Motivation makes a difference
The current study is important as an exploration of “a straightforward, simple, low-risk approach that could be an adjunct to benefit patients with serious cardiovascular disease,” Brian Olshansky, MD, a cardiologist at the University of Iowa, Iowa City, said in an interview.
“We have moved into a time of polypharmacy and multiple interventions for patients with underlying cardiovascular disease which, in many cases, have proven benefit but also potential adverse effects,” he said. “Engaging patients to participate in their health care, when there is serious underlying cardiovascular disease, has potential beneficial impact in many ways. Meditation is a low-risk, low-cost, potentially beneficial adjunct to standard medical therapy that may enhance psychological outcomes as shown here in this small study.”
However, “patients often rely on high-cost, potentially high-risk therapeutic interventions, expecting complete control of their problems without their own collaborative intervention,” he noted.
Dr. Olshansky said he was not surprised by any of the findings, and would have been surprised if meditation had failed to show any benefit for the study population.
“I am very pleased to see these results and would encourage meditation practice to be part of cardiovascular rehabilitation for motivated individuals,” he said. “What did surprise me was the adherence to the meditation protocol for those who participated. This represents a highly motivated group and it may be difficult to expect the same results in less motivated individuals.”
The current study has several strengths, including the use of controls and high rates of adherence to the protocol, said Dr. Olshansky. Other strengths include the standardized approach and the reasonable quality of the outcome measures, which showed a substantial benefit.
However, “this is a small study of motivated individuals of whom 80% were male,” and generalizability to other populations is unclear, Dr. Olshansky said. In addition, the racial mix was not described, and the severity of the underlying coronary artery disease and the therapies provided to these individuals is not detailed. A sicker population may not fare as well.”
The reasons for the benefits of meditation remain uncertain, Dr. Olshansky said. “It could be, specifically, that the meditation itself has physiological effects that ultimately translate into psychosocial benefit. However, those who enrolled and were interested may have derived a placebo effect. In any case, benefit was achieved, but the crossover benefit to the control group is unclear.
“In other words, the statistical approach to benefit is uncertain as to when it was measured, but presumably before the control group was allowed to engage in a meditation practice,” and the follow-up was short term, said Dr. Olshansky.
Data support patient engagement
The message to clinicians and patients: “Patients should be engaged in their own health care when it comes to rehabilitation for cardiovascular disease,” said Dr. Olshansky. “Motivated individuals who are educated about a meditative practice performed in a standardized way will have improvement most likely in their quality of life, and when it comes to measurements of depression, stress and anxiety.”
Although the mechanisms behind the benefits remain unclear, “having a standardized credible prescription for which patients can become intimately engaged is beneficial,” he added.
The study received no outside funding. Neither Dr. Monteiro nor Dr. Olshansky had any financial conflicts to disclose.
Regular meditation reduced depression by roughly 44% in adults with coronary artery disease who were involved in a cardiovascular rehabilitation program.
An increasing body of research supports the impact of psychological risk factors including stress, personality type, anger, and hostility on conditions such as depression and anxiety, but also social isolation and low socioeconomic status, Ana Luisa Vitorino Monteiro, MD, of the University of Lisbon said in a presentation at the annual congress of the European Association of Preventive Cardiology. In addition, “stress, anxiety, and depression deteriorate the cardiovascular (CV) system through psycho-neuro-immunoendocrinology system and behavioral pathways.”
Meditation as a tool for stress management has been gaining popularity, but its use as part of a CV rehabilitation program as a complementary therapy has not been well studied, she added.
Dr. Monteiro and colleagues recruited 80 adults with CAD who were undergoing CV rehabilitation to join a meditation program. Of these, 48 accepted (60%) and 40% declined. Those who accepted were part of an exercise-based CV rehabilitation program that met three times a week for at least 6 months. The mean age of the participants was 65 years, and 80% were male.
Participants were randomized to an intervention group with a weekly 90-minute session that included breathing and meditation for 1 month in addition to usual care, or to usual care in the rehabilitation program. Over the next 3 months, the intervention patients were encouraged to practice daily meditation for 20 minutes alone or using video support material, with a weekly follow-up phone call. Assessments of stress, anxiety, and depression took place at baseline and after 4 months using the Perceived Stress Scale, Beck Anxiety Inventory, Beck Depression Inventory, and HeartQoL questionnaire.
At 4 months, individuals in the meditation group had reduced depression levels significantly, by 44%, compared with controls (P < .001). Anxiety and stress decreased significantly, by 30% (P = .04) and 31% (P = .05), respectively. After 4 months, individuals in the control group were offered the opportunity to follow the meditation protocol.
In addition, “the emotional dimension of quality of life increased by 60% in the intervention group,” Dr. Monteiro noted. However, physical QoL did not change between groups.
The study was limited by the small sample size, and more research is needed in larger and more diverse populations, Dr. Monteiro said. However, the results support the value of meditation as an adjunct component of care for CAD patients in a long-term rehabilitation program.
Motivation makes a difference
The current study is important as an exploration of “a straightforward, simple, low-risk approach that could be an adjunct to benefit patients with serious cardiovascular disease,” Brian Olshansky, MD, a cardiologist at the University of Iowa, Iowa City, said in an interview.
“We have moved into a time of polypharmacy and multiple interventions for patients with underlying cardiovascular disease which, in many cases, have proven benefit but also potential adverse effects,” he said. “Engaging patients to participate in their health care, when there is serious underlying cardiovascular disease, has potential beneficial impact in many ways. Meditation is a low-risk, low-cost, potentially beneficial adjunct to standard medical therapy that may enhance psychological outcomes as shown here in this small study.”
However, “patients often rely on high-cost, potentially high-risk therapeutic interventions, expecting complete control of their problems without their own collaborative intervention,” he noted.
Dr. Olshansky said he was not surprised by any of the findings, and would have been surprised if meditation had failed to show any benefit for the study population.
“I am very pleased to see these results and would encourage meditation practice to be part of cardiovascular rehabilitation for motivated individuals,” he said. “What did surprise me was the adherence to the meditation protocol for those who participated. This represents a highly motivated group and it may be difficult to expect the same results in less motivated individuals.”
The current study has several strengths, including the use of controls and high rates of adherence to the protocol, said Dr. Olshansky. Other strengths include the standardized approach and the reasonable quality of the outcome measures, which showed a substantial benefit.
However, “this is a small study of motivated individuals of whom 80% were male,” and generalizability to other populations is unclear, Dr. Olshansky said. In addition, the racial mix was not described, and the severity of the underlying coronary artery disease and the therapies provided to these individuals is not detailed. A sicker population may not fare as well.”
The reasons for the benefits of meditation remain uncertain, Dr. Olshansky said. “It could be, specifically, that the meditation itself has physiological effects that ultimately translate into psychosocial benefit. However, those who enrolled and were interested may have derived a placebo effect. In any case, benefit was achieved, but the crossover benefit to the control group is unclear.
“In other words, the statistical approach to benefit is uncertain as to when it was measured, but presumably before the control group was allowed to engage in a meditation practice,” and the follow-up was short term, said Dr. Olshansky.
Data support patient engagement
The message to clinicians and patients: “Patients should be engaged in their own health care when it comes to rehabilitation for cardiovascular disease,” said Dr. Olshansky. “Motivated individuals who are educated about a meditative practice performed in a standardized way will have improvement most likely in their quality of life, and when it comes to measurements of depression, stress and anxiety.”
Although the mechanisms behind the benefits remain unclear, “having a standardized credible prescription for which patients can become intimately engaged is beneficial,” he added.
The study received no outside funding. Neither Dr. Monteiro nor Dr. Olshansky had any financial conflicts to disclose.
Regular meditation reduced depression by roughly 44% in adults with coronary artery disease who were involved in a cardiovascular rehabilitation program.
An increasing body of research supports the impact of psychological risk factors including stress, personality type, anger, and hostility on conditions such as depression and anxiety, but also social isolation and low socioeconomic status, Ana Luisa Vitorino Monteiro, MD, of the University of Lisbon said in a presentation at the annual congress of the European Association of Preventive Cardiology. In addition, “stress, anxiety, and depression deteriorate the cardiovascular (CV) system through psycho-neuro-immunoendocrinology system and behavioral pathways.”
Meditation as a tool for stress management has been gaining popularity, but its use as part of a CV rehabilitation program as a complementary therapy has not been well studied, she added.
Dr. Monteiro and colleagues recruited 80 adults with CAD who were undergoing CV rehabilitation to join a meditation program. Of these, 48 accepted (60%) and 40% declined. Those who accepted were part of an exercise-based CV rehabilitation program that met three times a week for at least 6 months. The mean age of the participants was 65 years, and 80% were male.
Participants were randomized to an intervention group with a weekly 90-minute session that included breathing and meditation for 1 month in addition to usual care, or to usual care in the rehabilitation program. Over the next 3 months, the intervention patients were encouraged to practice daily meditation for 20 minutes alone or using video support material, with a weekly follow-up phone call. Assessments of stress, anxiety, and depression took place at baseline and after 4 months using the Perceived Stress Scale, Beck Anxiety Inventory, Beck Depression Inventory, and HeartQoL questionnaire.
At 4 months, individuals in the meditation group had reduced depression levels significantly, by 44%, compared with controls (P < .001). Anxiety and stress decreased significantly, by 30% (P = .04) and 31% (P = .05), respectively. After 4 months, individuals in the control group were offered the opportunity to follow the meditation protocol.
In addition, “the emotional dimension of quality of life increased by 60% in the intervention group,” Dr. Monteiro noted. However, physical QoL did not change between groups.
The study was limited by the small sample size, and more research is needed in larger and more diverse populations, Dr. Monteiro said. However, the results support the value of meditation as an adjunct component of care for CAD patients in a long-term rehabilitation program.
Motivation makes a difference
The current study is important as an exploration of “a straightforward, simple, low-risk approach that could be an adjunct to benefit patients with serious cardiovascular disease,” Brian Olshansky, MD, a cardiologist at the University of Iowa, Iowa City, said in an interview.
“We have moved into a time of polypharmacy and multiple interventions for patients with underlying cardiovascular disease which, in many cases, have proven benefit but also potential adverse effects,” he said. “Engaging patients to participate in their health care, when there is serious underlying cardiovascular disease, has potential beneficial impact in many ways. Meditation is a low-risk, low-cost, potentially beneficial adjunct to standard medical therapy that may enhance psychological outcomes as shown here in this small study.”
However, “patients often rely on high-cost, potentially high-risk therapeutic interventions, expecting complete control of their problems without their own collaborative intervention,” he noted.
Dr. Olshansky said he was not surprised by any of the findings, and would have been surprised if meditation had failed to show any benefit for the study population.
“I am very pleased to see these results and would encourage meditation practice to be part of cardiovascular rehabilitation for motivated individuals,” he said. “What did surprise me was the adherence to the meditation protocol for those who participated. This represents a highly motivated group and it may be difficult to expect the same results in less motivated individuals.”
The current study has several strengths, including the use of controls and high rates of adherence to the protocol, said Dr. Olshansky. Other strengths include the standardized approach and the reasonable quality of the outcome measures, which showed a substantial benefit.
However, “this is a small study of motivated individuals of whom 80% were male,” and generalizability to other populations is unclear, Dr. Olshansky said. In addition, the racial mix was not described, and the severity of the underlying coronary artery disease and the therapies provided to these individuals is not detailed. A sicker population may not fare as well.”
The reasons for the benefits of meditation remain uncertain, Dr. Olshansky said. “It could be, specifically, that the meditation itself has physiological effects that ultimately translate into psychosocial benefit. However, those who enrolled and were interested may have derived a placebo effect. In any case, benefit was achieved, but the crossover benefit to the control group is unclear.
“In other words, the statistical approach to benefit is uncertain as to when it was measured, but presumably before the control group was allowed to engage in a meditation practice,” and the follow-up was short term, said Dr. Olshansky.
Data support patient engagement
The message to clinicians and patients: “Patients should be engaged in their own health care when it comes to rehabilitation for cardiovascular disease,” said Dr. Olshansky. “Motivated individuals who are educated about a meditative practice performed in a standardized way will have improvement most likely in their quality of life, and when it comes to measurements of depression, stress and anxiety.”
Although the mechanisms behind the benefits remain unclear, “having a standardized credible prescription for which patients can become intimately engaged is beneficial,” he added.
The study received no outside funding. Neither Dr. Monteiro nor Dr. Olshansky had any financial conflicts to disclose.
FROM ESC PREVENTIVE CARDIOLOGY 2023
Green Mediterranean diet may relieve aortic stiffness
A green adaptation to the traditional Mediterranean diet improves proximal aortic stiffness (PAS), a distinct marker of vascular aging and increased cardiovascular risk, according to an exploratory post hoc analysis of the DIRECT-PLUS randomized clinical trial.
The green Mediterranean diet is distinct from the traditional Mediterranean diet because of its more abundant dietary polyphenols, from green tea and a Wolffia globosa (Mankai) plant green shake, and lower intake of red or processed meat.
Independent of weight loss, the modified green Mediterranean diet regressed PAS by 15%, the traditional Mediterranean diet by 7.3%, and the healthy dietary guideline–based diet by 4.8%, the study team observed.
“The DIRECT-PLUS trial research team was the first to introduce the concept of the green-Mediterranean/high polyphenols diet,” lead researcher Iris Shai, RD, PhD, with Ben-Gurion University of the Negev, Be’er-Sheva, Israel, told this news organization.
This diet promoted “dramatic proximal aortic de-stiffening” as assessed by MRI over 18 months in roughly 300 participants with abdominal obesity/dyslipidemia. “To date, no dietary strategies have been shown to impact vascular aging physiology,” Dr. Shai said.
The analysis was published online in the Journal of the American College of Cardiology.
Not all healthy diets are equal
Of the 294 participants, 281 had valid PAS measurements at baseline. The baseline PAS (6.1 m/s) was similar across intervention groups (P = .20). Increased PAS was associated with aging, hypertension, dyslipidemia, diabetes, and visceral adiposity (P < .05).
After 18 months’ intervention (retention rate 89.8%), all diet groups showed significant PAS reductions: –0.05 m/s with the standard healthy diet (4.8%), –0.08 m/s with the traditional Mediterranean diet (7.3%) and –0.15 the green Mediterranean diet (15%).
In the multivariable model, the green Mediterranean dieters had greater PAS reduction than did the healthy-diet and Mediterranean dieters (P = .003 and P = .032, respectively).
The researchers caution that DIRECT-PLUS had multiple endpoints and this exploratory post hoc analysis might be sensitive to type I statistical error and should be considered “hypothesis-generating.”
High-quality study, believable results
Reached for comment on the study, Deepak L. Bhatt, MD, MPH, director of Mount Sinai Heart in New York, said, “There is not a lot of high-quality research on diet, and I would call this high-quality research in as much as they used randomization which most dietary studies don’t do.
“The greener Mediterranean diet seemed to be the best one on the surrogate marker of MRI-defined aortic stiffness,” Dr. Bhatt, professor of cardiovascular medicine, Icahn School of Medicine at Mount Sinai, who wasn’t involved in the study, told this news organization.
“It makes sense that a diet that has more green in it, more polyphenols, would be healthier. This has been shown in some other studies, that these plant-based polyphenols might have various cardiovascular protective aspects to them,” Dr. Bhatt said.
Overall, he said the results are “quite believable, with the caveat that it would be nice to see the results reproduced in a more diverse and larger sample.”
“There is emerging evidence that diets that are higher in fresh fruits and vegetables and whole grains and lower in overall caloric intake, in general, seem to be good diets to reduce cardiovascular risk factors and maybe even reduce actual cardiovascular risk,” Dr. Bhatt added.
The study was funded by grants from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), the Rosetrees Trust, Israel Ministry of Health, Israel Ministry of Science and Technology, and the California Walnuts Commission. Dr. Shai and Dr. Bhatt have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A green adaptation to the traditional Mediterranean diet improves proximal aortic stiffness (PAS), a distinct marker of vascular aging and increased cardiovascular risk, according to an exploratory post hoc analysis of the DIRECT-PLUS randomized clinical trial.
The green Mediterranean diet is distinct from the traditional Mediterranean diet because of its more abundant dietary polyphenols, from green tea and a Wolffia globosa (Mankai) plant green shake, and lower intake of red or processed meat.
Independent of weight loss, the modified green Mediterranean diet regressed PAS by 15%, the traditional Mediterranean diet by 7.3%, and the healthy dietary guideline–based diet by 4.8%, the study team observed.
“The DIRECT-PLUS trial research team was the first to introduce the concept of the green-Mediterranean/high polyphenols diet,” lead researcher Iris Shai, RD, PhD, with Ben-Gurion University of the Negev, Be’er-Sheva, Israel, told this news organization.
This diet promoted “dramatic proximal aortic de-stiffening” as assessed by MRI over 18 months in roughly 300 participants with abdominal obesity/dyslipidemia. “To date, no dietary strategies have been shown to impact vascular aging physiology,” Dr. Shai said.
The analysis was published online in the Journal of the American College of Cardiology.
Not all healthy diets are equal
Of the 294 participants, 281 had valid PAS measurements at baseline. The baseline PAS (6.1 m/s) was similar across intervention groups (P = .20). Increased PAS was associated with aging, hypertension, dyslipidemia, diabetes, and visceral adiposity (P < .05).
After 18 months’ intervention (retention rate 89.8%), all diet groups showed significant PAS reductions: –0.05 m/s with the standard healthy diet (4.8%), –0.08 m/s with the traditional Mediterranean diet (7.3%) and –0.15 the green Mediterranean diet (15%).
In the multivariable model, the green Mediterranean dieters had greater PAS reduction than did the healthy-diet and Mediterranean dieters (P = .003 and P = .032, respectively).
The researchers caution that DIRECT-PLUS had multiple endpoints and this exploratory post hoc analysis might be sensitive to type I statistical error and should be considered “hypothesis-generating.”
High-quality study, believable results
Reached for comment on the study, Deepak L. Bhatt, MD, MPH, director of Mount Sinai Heart in New York, said, “There is not a lot of high-quality research on diet, and I would call this high-quality research in as much as they used randomization which most dietary studies don’t do.
“The greener Mediterranean diet seemed to be the best one on the surrogate marker of MRI-defined aortic stiffness,” Dr. Bhatt, professor of cardiovascular medicine, Icahn School of Medicine at Mount Sinai, who wasn’t involved in the study, told this news organization.
“It makes sense that a diet that has more green in it, more polyphenols, would be healthier. This has been shown in some other studies, that these plant-based polyphenols might have various cardiovascular protective aspects to them,” Dr. Bhatt said.
Overall, he said the results are “quite believable, with the caveat that it would be nice to see the results reproduced in a more diverse and larger sample.”
“There is emerging evidence that diets that are higher in fresh fruits and vegetables and whole grains and lower in overall caloric intake, in general, seem to be good diets to reduce cardiovascular risk factors and maybe even reduce actual cardiovascular risk,” Dr. Bhatt added.
The study was funded by grants from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), the Rosetrees Trust, Israel Ministry of Health, Israel Ministry of Science and Technology, and the California Walnuts Commission. Dr. Shai and Dr. Bhatt have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A green adaptation to the traditional Mediterranean diet improves proximal aortic stiffness (PAS), a distinct marker of vascular aging and increased cardiovascular risk, according to an exploratory post hoc analysis of the DIRECT-PLUS randomized clinical trial.
The green Mediterranean diet is distinct from the traditional Mediterranean diet because of its more abundant dietary polyphenols, from green tea and a Wolffia globosa (Mankai) plant green shake, and lower intake of red or processed meat.
Independent of weight loss, the modified green Mediterranean diet regressed PAS by 15%, the traditional Mediterranean diet by 7.3%, and the healthy dietary guideline–based diet by 4.8%, the study team observed.
“The DIRECT-PLUS trial research team was the first to introduce the concept of the green-Mediterranean/high polyphenols diet,” lead researcher Iris Shai, RD, PhD, with Ben-Gurion University of the Negev, Be’er-Sheva, Israel, told this news organization.
This diet promoted “dramatic proximal aortic de-stiffening” as assessed by MRI over 18 months in roughly 300 participants with abdominal obesity/dyslipidemia. “To date, no dietary strategies have been shown to impact vascular aging physiology,” Dr. Shai said.
The analysis was published online in the Journal of the American College of Cardiology.
Not all healthy diets are equal
Of the 294 participants, 281 had valid PAS measurements at baseline. The baseline PAS (6.1 m/s) was similar across intervention groups (P = .20). Increased PAS was associated with aging, hypertension, dyslipidemia, diabetes, and visceral adiposity (P < .05).
After 18 months’ intervention (retention rate 89.8%), all diet groups showed significant PAS reductions: –0.05 m/s with the standard healthy diet (4.8%), –0.08 m/s with the traditional Mediterranean diet (7.3%) and –0.15 the green Mediterranean diet (15%).
In the multivariable model, the green Mediterranean dieters had greater PAS reduction than did the healthy-diet and Mediterranean dieters (P = .003 and P = .032, respectively).
The researchers caution that DIRECT-PLUS had multiple endpoints and this exploratory post hoc analysis might be sensitive to type I statistical error and should be considered “hypothesis-generating.”
High-quality study, believable results
Reached for comment on the study, Deepak L. Bhatt, MD, MPH, director of Mount Sinai Heart in New York, said, “There is not a lot of high-quality research on diet, and I would call this high-quality research in as much as they used randomization which most dietary studies don’t do.
“The greener Mediterranean diet seemed to be the best one on the surrogate marker of MRI-defined aortic stiffness,” Dr. Bhatt, professor of cardiovascular medicine, Icahn School of Medicine at Mount Sinai, who wasn’t involved in the study, told this news organization.
“It makes sense that a diet that has more green in it, more polyphenols, would be healthier. This has been shown in some other studies, that these plant-based polyphenols might have various cardiovascular protective aspects to them,” Dr. Bhatt said.
Overall, he said the results are “quite believable, with the caveat that it would be nice to see the results reproduced in a more diverse and larger sample.”
“There is emerging evidence that diets that are higher in fresh fruits and vegetables and whole grains and lower in overall caloric intake, in general, seem to be good diets to reduce cardiovascular risk factors and maybe even reduce actual cardiovascular risk,” Dr. Bhatt added.
The study was funded by grants from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), the Rosetrees Trust, Israel Ministry of Health, Israel Ministry of Science and Technology, and the California Walnuts Commission. Dr. Shai and Dr. Bhatt have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Napping and AFib risk: The long and the short of it
Napping for more than half an hour during the day was associated with a 90% increased risk of atrial fibrillation (AFib), but shorter naps were linked to a reduced risk, based on data from more than 20,000 individuals.
“Short daytime napping is a common, healthy habit, especially in Mediterranean countries,” Jesus Diaz-Gutierrez, MD, of Juan Ramon Jimenez University Hospital, Huelva, Spain, said in a presentation at the annual congress of the European Association of Preventive Cardiology (EAPC).
Previous studies have shown a potential link between sleep patterns and AFib risk, but the association between specific duration of daytime naps and AFib risk has not been explored, he said.
Dr. Diaz-Gutierrez and colleagues used data from the University of Navarra Follow-up (SUN) Project, a prospective cohort of Spanish university graduates, to explore the possible link between naps and AFib. The study population included 20,348 individuals without AFib at baseline who were followed for a median of 13.8 years. The average age of participants at baseline was 38 years; 61% were women.
Daytime napping patterns were assessed at baseline, and participants were divided into nap groups of short nappers (defined as less than 30 minutes per day), and longer nappers (30 minutes or more per day), and those who reported no napping.
The researchers identified 131 incident cases of AFib during the follow-up period. Overall, the relative risk of incident AFib was significantly higher for the long nappers (adjusted hazard ratio 1.90) compared with short nappers in a multivariate analysis, while no significant risk appeared among non-nappers compared to short nappers (aHR 1.26).
The researchers then excluded the non-nappers in a secondary analysis to explore the impact of more specific daily nap duration on AFib risk. In a multivariate analysis, they found a 42% reduced risk of AF among those who napped for less than 15 minutes, and a 56% reduced risk for those who napped for 15-30 minutes, compared with those who napped for more than 30 minutes (aHR 0.56 and 0.42, respectively).
Potential explanations for the associations include the role of circadian rhythms, Dr. Diaz-Gutierrez said in a press release accompanying the presentation at the meeting. “Long daytime naps may disrupt the body’s internal clock (circadian rhythm), leading to shorter nighttime sleep, more nocturnal awakening, and reduced physical activity. In contrast, short daytime napping may improve circadian rhythm, lower blood pressure levels, and reduce stress.” More research is needed to validate the findings and the optimum nap duration, and whether a short nap is more advantageous than not napping in terms of AFib risk reduction, he said.
The study results suggest that naps of 15-30 minutes represent “a potential novel healthy lifestyle habit in the primary prevention of AFib,” Dr. Diaz-Gutierrez said in his presentation. However, the results also suggest that daily naps be limited to less than 30 minutes, he concluded.
Sleep habits may serve as red flag
“As we age, most if not all of us will develop sleep disturbances, such as insomnia, obstructive sleep apnea (OSA), and other sleep issues,” Lawrence S. Rosenthal, MD, of the University of Massachusetts, Worcester, said in an interview.
Therefore, “this study is near and dear to most people, and most would agree that poor sleeping habits affect our health.” In particular, OSA has been linked to AFib, although that was not measured in the current study, he added.
Dr. Rosenthal said he was not surprised by the current study findings. “It seems that a quick recharge of your ‘battery’ during the day is healthier than a long, deep sleep daytime nap,” he said. In addition, “Longer naps may be a marker of OSA,” he noted.
For clinicians, the take-home message of the current study is the need to consider underlying medical conditions in patients who regularly take long afternoon naps, and to consider these longer naps as a potential marker for AFib, said Dr. Rosenthal.
Looking ahead, a “deeper dive into the makeup of the populations studied” would be useful as a foundation for additional research, he said.
The SUN Project disclosed funding from the Spanish Government-Instituto de Salud Carlos III and the European Regional Development Fund (FEDER), the Navarra Regional Government, Plan Nacional Sobre Drogas, the University of Navarra, and the European Research Council. The researchers, and Dr. Rosenthal, had no financial conflicts to disclose.
Napping for more than half an hour during the day was associated with a 90% increased risk of atrial fibrillation (AFib), but shorter naps were linked to a reduced risk, based on data from more than 20,000 individuals.
“Short daytime napping is a common, healthy habit, especially in Mediterranean countries,” Jesus Diaz-Gutierrez, MD, of Juan Ramon Jimenez University Hospital, Huelva, Spain, said in a presentation at the annual congress of the European Association of Preventive Cardiology (EAPC).
Previous studies have shown a potential link between sleep patterns and AFib risk, but the association between specific duration of daytime naps and AFib risk has not been explored, he said.
Dr. Diaz-Gutierrez and colleagues used data from the University of Navarra Follow-up (SUN) Project, a prospective cohort of Spanish university graduates, to explore the possible link between naps and AFib. The study population included 20,348 individuals without AFib at baseline who were followed for a median of 13.8 years. The average age of participants at baseline was 38 years; 61% were women.
Daytime napping patterns were assessed at baseline, and participants were divided into nap groups of short nappers (defined as less than 30 minutes per day), and longer nappers (30 minutes or more per day), and those who reported no napping.
The researchers identified 131 incident cases of AFib during the follow-up period. Overall, the relative risk of incident AFib was significantly higher for the long nappers (adjusted hazard ratio 1.90) compared with short nappers in a multivariate analysis, while no significant risk appeared among non-nappers compared to short nappers (aHR 1.26).
The researchers then excluded the non-nappers in a secondary analysis to explore the impact of more specific daily nap duration on AFib risk. In a multivariate analysis, they found a 42% reduced risk of AF among those who napped for less than 15 minutes, and a 56% reduced risk for those who napped for 15-30 minutes, compared with those who napped for more than 30 minutes (aHR 0.56 and 0.42, respectively).
Potential explanations for the associations include the role of circadian rhythms, Dr. Diaz-Gutierrez said in a press release accompanying the presentation at the meeting. “Long daytime naps may disrupt the body’s internal clock (circadian rhythm), leading to shorter nighttime sleep, more nocturnal awakening, and reduced physical activity. In contrast, short daytime napping may improve circadian rhythm, lower blood pressure levels, and reduce stress.” More research is needed to validate the findings and the optimum nap duration, and whether a short nap is more advantageous than not napping in terms of AFib risk reduction, he said.
The study results suggest that naps of 15-30 minutes represent “a potential novel healthy lifestyle habit in the primary prevention of AFib,” Dr. Diaz-Gutierrez said in his presentation. However, the results also suggest that daily naps be limited to less than 30 minutes, he concluded.
Sleep habits may serve as red flag
“As we age, most if not all of us will develop sleep disturbances, such as insomnia, obstructive sleep apnea (OSA), and other sleep issues,” Lawrence S. Rosenthal, MD, of the University of Massachusetts, Worcester, said in an interview.
Therefore, “this study is near and dear to most people, and most would agree that poor sleeping habits affect our health.” In particular, OSA has been linked to AFib, although that was not measured in the current study, he added.
Dr. Rosenthal said he was not surprised by the current study findings. “It seems that a quick recharge of your ‘battery’ during the day is healthier than a long, deep sleep daytime nap,” he said. In addition, “Longer naps may be a marker of OSA,” he noted.
For clinicians, the take-home message of the current study is the need to consider underlying medical conditions in patients who regularly take long afternoon naps, and to consider these longer naps as a potential marker for AFib, said Dr. Rosenthal.
Looking ahead, a “deeper dive into the makeup of the populations studied” would be useful as a foundation for additional research, he said.
The SUN Project disclosed funding from the Spanish Government-Instituto de Salud Carlos III and the European Regional Development Fund (FEDER), the Navarra Regional Government, Plan Nacional Sobre Drogas, the University of Navarra, and the European Research Council. The researchers, and Dr. Rosenthal, had no financial conflicts to disclose.
Napping for more than half an hour during the day was associated with a 90% increased risk of atrial fibrillation (AFib), but shorter naps were linked to a reduced risk, based on data from more than 20,000 individuals.
“Short daytime napping is a common, healthy habit, especially in Mediterranean countries,” Jesus Diaz-Gutierrez, MD, of Juan Ramon Jimenez University Hospital, Huelva, Spain, said in a presentation at the annual congress of the European Association of Preventive Cardiology (EAPC).
Previous studies have shown a potential link between sleep patterns and AFib risk, but the association between specific duration of daytime naps and AFib risk has not been explored, he said.
Dr. Diaz-Gutierrez and colleagues used data from the University of Navarra Follow-up (SUN) Project, a prospective cohort of Spanish university graduates, to explore the possible link between naps and AFib. The study population included 20,348 individuals without AFib at baseline who were followed for a median of 13.8 years. The average age of participants at baseline was 38 years; 61% were women.
Daytime napping patterns were assessed at baseline, and participants were divided into nap groups of short nappers (defined as less than 30 minutes per day), and longer nappers (30 minutes or more per day), and those who reported no napping.
The researchers identified 131 incident cases of AFib during the follow-up period. Overall, the relative risk of incident AFib was significantly higher for the long nappers (adjusted hazard ratio 1.90) compared with short nappers in a multivariate analysis, while no significant risk appeared among non-nappers compared to short nappers (aHR 1.26).
The researchers then excluded the non-nappers in a secondary analysis to explore the impact of more specific daily nap duration on AFib risk. In a multivariate analysis, they found a 42% reduced risk of AF among those who napped for less than 15 minutes, and a 56% reduced risk for those who napped for 15-30 minutes, compared with those who napped for more than 30 minutes (aHR 0.56 and 0.42, respectively).
Potential explanations for the associations include the role of circadian rhythms, Dr. Diaz-Gutierrez said in a press release accompanying the presentation at the meeting. “Long daytime naps may disrupt the body’s internal clock (circadian rhythm), leading to shorter nighttime sleep, more nocturnal awakening, and reduced physical activity. In contrast, short daytime napping may improve circadian rhythm, lower blood pressure levels, and reduce stress.” More research is needed to validate the findings and the optimum nap duration, and whether a short nap is more advantageous than not napping in terms of AFib risk reduction, he said.
The study results suggest that naps of 15-30 minutes represent “a potential novel healthy lifestyle habit in the primary prevention of AFib,” Dr. Diaz-Gutierrez said in his presentation. However, the results also suggest that daily naps be limited to less than 30 minutes, he concluded.
Sleep habits may serve as red flag
“As we age, most if not all of us will develop sleep disturbances, such as insomnia, obstructive sleep apnea (OSA), and other sleep issues,” Lawrence S. Rosenthal, MD, of the University of Massachusetts, Worcester, said in an interview.
Therefore, “this study is near and dear to most people, and most would agree that poor sleeping habits affect our health.” In particular, OSA has been linked to AFib, although that was not measured in the current study, he added.
Dr. Rosenthal said he was not surprised by the current study findings. “It seems that a quick recharge of your ‘battery’ during the day is healthier than a long, deep sleep daytime nap,” he said. In addition, “Longer naps may be a marker of OSA,” he noted.
For clinicians, the take-home message of the current study is the need to consider underlying medical conditions in patients who regularly take long afternoon naps, and to consider these longer naps as a potential marker for AFib, said Dr. Rosenthal.
Looking ahead, a “deeper dive into the makeup of the populations studied” would be useful as a foundation for additional research, he said.
The SUN Project disclosed funding from the Spanish Government-Instituto de Salud Carlos III and the European Regional Development Fund (FEDER), the Navarra Regional Government, Plan Nacional Sobre Drogas, the University of Navarra, and the European Research Council. The researchers, and Dr. Rosenthal, had no financial conflicts to disclose.
FROM ESC PREVENTIVE CARDIOLOGY 2023
Cardiovascular disease deaths rise on and after high-pollution days
Cardiovascular disease deaths were significantly more common on days of high pollution and for the following 2 days, compared with other days, based on data from nearly 88,000 deaths over a 5-year period.
Previous research has shown the harmful effect of air pollution on human health in highly polluted areas, but Eastern Poland, a region with so-called “Polish smog” has exceptionally high levels of pollution. However, the specific impact of Polish smog, caused primarily by burning coal, on cardiovascular disease (CVD) mortality has not been well studied, said Michal Swieczkowski, MD, of the Medical University of Bialystok (Poland) in a presentation at the annual congress of the European Association of Preventive Cardiology.
Dr. Swieczkowski and colleagues reviewed all-cause deaths from five main cities in Eastern Poland during 2016-2020 for associations with pollution levels and days when deaths occurred. Mortality data were obtained from the Central Statistical Office. Air pollution concentrations for two types of particulate matter (PM2.5, PM10) and nitrogen oxide were collected from the Voivodeship Inspectorate for Environmental Protection. The main sources of the pollutants were road traffic and household heaters using coal or wood.
The final analysis included nearly 6 million person-years of follow-up. The researchers used a time-stratified case-crossover design. For each participant, the researchers compared levels of each pollutant on the day of the week a death occurred (such as a Wednesday) with pollutant levels on the same day of the week without any deaths in the same month (the remaining Wednesdays of that month). This design eliminated the potential confounding effects of participant characteristics, including other cardiovascular risk factors such as smoking and hyperlipidemia, and time trends. Essentially, participants “served as their own controls,” Dr. Swieczkowski said. The researchers conducted similar analyses for pollution levels 1 day and 2 days before a death occurred.
Overall, 87,990 deaths were identified during the study period; of these, 34,907 were from CVD, 9,688 from acute coronary syndromes, and 3,776 from ischemic stroke.
“Exposure to PM2.5 and PM10 was associated with increased mortality on the day of exposure, the next day, and up to 2 days after exposure,” said Dr. Swieczkowski.
Overall, an increase of 10 mcg/m3 in the three pollutants was significantly associated with increase in CVD mortality on the day of exposure to the increased pollution levels, with odds ratios of 1.034, 1.033, and 1.083 for PM2.5, PM10, and NO2, respectively (all P < .001).
The risks of dying from CVD were similar 1 and 2 days after the polluted day.
An increase in PM levels, but not NO2, was significantly associated with acute coronary syndrome (ACS) on the day of exposure to increased pollutants (ORs, 1.029 for PM2.5 [P = .002] and 1.015 [P = .049] for PM10). Both ischemic stroke and ACS mortality were significantly higher at 1 day after exposure, compared with other days. Ischemic stroke was associated with increases in PM2.5 and PM10, while ACS was associated with increases in PM2.5, PM10, and NO2.
When stratified by gender, the effects were more noticeable in women, Dr. Swieczkowski said. “Exposure to both types of particulate caused increased mortality due to acute coronary syndrome as well as ischemic stroke.” Among men, only death from acute coronary syndrome was significantly associated with exposure to increased particulate matter.
In a head-to-head comparison, women were more vulnerable to air pollution by up to 2.5%, he added.
When stratified by age, the effects of all three pollutants were associated with increased risk of death from ischemic stroke and ACS in participants older than 65 years. For those aged 65 years and younger, the only significant association was between ACS-associated mortality and ischemic stroke.
The results suggest “a special need for developing calculators to estimate the risk of CVD incidence depending on the place of residence that could be used for everyday practice,” said Dr. Swieczkowski. “Systemic changes should become a priority for policy makers, and, simultaneously, we as physicians should educate and protect our patients, especially those with high risk of cardiovascular disease,” he said.
Gender differences rooted in anatomy
When asked for an explanation of the difference in the impact of pollution on mortality between men and women, Dr. Swieczkowski explained that women are likely more vulnerable because of differences in anatomy of the pharynx and larynx, and breathing patterns. Previous studies have shown that air pollution causes more oxidative stress in women. Also, in the current study, the mean age of the women was 8 to 9 years older, he said.
The study design was an “elegant way to take away the impact of other cardiovascular risk factors,” noted session moderator Maryam Kavousi, MD, of Erasmus University Medical Center, Rotterdam, the Netherlands.
The study was supported by the National Science Centre, Poland. The researchers had no financial conflicts to disclose.
Cardiovascular disease deaths were significantly more common on days of high pollution and for the following 2 days, compared with other days, based on data from nearly 88,000 deaths over a 5-year period.
Previous research has shown the harmful effect of air pollution on human health in highly polluted areas, but Eastern Poland, a region with so-called “Polish smog” has exceptionally high levels of pollution. However, the specific impact of Polish smog, caused primarily by burning coal, on cardiovascular disease (CVD) mortality has not been well studied, said Michal Swieczkowski, MD, of the Medical University of Bialystok (Poland) in a presentation at the annual congress of the European Association of Preventive Cardiology.
Dr. Swieczkowski and colleagues reviewed all-cause deaths from five main cities in Eastern Poland during 2016-2020 for associations with pollution levels and days when deaths occurred. Mortality data were obtained from the Central Statistical Office. Air pollution concentrations for two types of particulate matter (PM2.5, PM10) and nitrogen oxide were collected from the Voivodeship Inspectorate for Environmental Protection. The main sources of the pollutants were road traffic and household heaters using coal or wood.
The final analysis included nearly 6 million person-years of follow-up. The researchers used a time-stratified case-crossover design. For each participant, the researchers compared levels of each pollutant on the day of the week a death occurred (such as a Wednesday) with pollutant levels on the same day of the week without any deaths in the same month (the remaining Wednesdays of that month). This design eliminated the potential confounding effects of participant characteristics, including other cardiovascular risk factors such as smoking and hyperlipidemia, and time trends. Essentially, participants “served as their own controls,” Dr. Swieczkowski said. The researchers conducted similar analyses for pollution levels 1 day and 2 days before a death occurred.
Overall, 87,990 deaths were identified during the study period; of these, 34,907 were from CVD, 9,688 from acute coronary syndromes, and 3,776 from ischemic stroke.
“Exposure to PM2.5 and PM10 was associated with increased mortality on the day of exposure, the next day, and up to 2 days after exposure,” said Dr. Swieczkowski.
Overall, an increase of 10 mcg/m3 in the three pollutants was significantly associated with increase in CVD mortality on the day of exposure to the increased pollution levels, with odds ratios of 1.034, 1.033, and 1.083 for PM2.5, PM10, and NO2, respectively (all P < .001).
The risks of dying from CVD were similar 1 and 2 days after the polluted day.
An increase in PM levels, but not NO2, was significantly associated with acute coronary syndrome (ACS) on the day of exposure to increased pollutants (ORs, 1.029 for PM2.5 [P = .002] and 1.015 [P = .049] for PM10). Both ischemic stroke and ACS mortality were significantly higher at 1 day after exposure, compared with other days. Ischemic stroke was associated with increases in PM2.5 and PM10, while ACS was associated with increases in PM2.5, PM10, and NO2.
When stratified by gender, the effects were more noticeable in women, Dr. Swieczkowski said. “Exposure to both types of particulate caused increased mortality due to acute coronary syndrome as well as ischemic stroke.” Among men, only death from acute coronary syndrome was significantly associated with exposure to increased particulate matter.
In a head-to-head comparison, women were more vulnerable to air pollution by up to 2.5%, he added.
When stratified by age, the effects of all three pollutants were associated with increased risk of death from ischemic stroke and ACS in participants older than 65 years. For those aged 65 years and younger, the only significant association was between ACS-associated mortality and ischemic stroke.
The results suggest “a special need for developing calculators to estimate the risk of CVD incidence depending on the place of residence that could be used for everyday practice,” said Dr. Swieczkowski. “Systemic changes should become a priority for policy makers, and, simultaneously, we as physicians should educate and protect our patients, especially those with high risk of cardiovascular disease,” he said.
Gender differences rooted in anatomy
When asked for an explanation of the difference in the impact of pollution on mortality between men and women, Dr. Swieczkowski explained that women are likely more vulnerable because of differences in anatomy of the pharynx and larynx, and breathing patterns. Previous studies have shown that air pollution causes more oxidative stress in women. Also, in the current study, the mean age of the women was 8 to 9 years older, he said.
The study design was an “elegant way to take away the impact of other cardiovascular risk factors,” noted session moderator Maryam Kavousi, MD, of Erasmus University Medical Center, Rotterdam, the Netherlands.
The study was supported by the National Science Centre, Poland. The researchers had no financial conflicts to disclose.
Cardiovascular disease deaths were significantly more common on days of high pollution and for the following 2 days, compared with other days, based on data from nearly 88,000 deaths over a 5-year period.
Previous research has shown the harmful effect of air pollution on human health in highly polluted areas, but Eastern Poland, a region with so-called “Polish smog” has exceptionally high levels of pollution. However, the specific impact of Polish smog, caused primarily by burning coal, on cardiovascular disease (CVD) mortality has not been well studied, said Michal Swieczkowski, MD, of the Medical University of Bialystok (Poland) in a presentation at the annual congress of the European Association of Preventive Cardiology.
Dr. Swieczkowski and colleagues reviewed all-cause deaths from five main cities in Eastern Poland during 2016-2020 for associations with pollution levels and days when deaths occurred. Mortality data were obtained from the Central Statistical Office. Air pollution concentrations for two types of particulate matter (PM2.5, PM10) and nitrogen oxide were collected from the Voivodeship Inspectorate for Environmental Protection. The main sources of the pollutants were road traffic and household heaters using coal or wood.
The final analysis included nearly 6 million person-years of follow-up. The researchers used a time-stratified case-crossover design. For each participant, the researchers compared levels of each pollutant on the day of the week a death occurred (such as a Wednesday) with pollutant levels on the same day of the week without any deaths in the same month (the remaining Wednesdays of that month). This design eliminated the potential confounding effects of participant characteristics, including other cardiovascular risk factors such as smoking and hyperlipidemia, and time trends. Essentially, participants “served as their own controls,” Dr. Swieczkowski said. The researchers conducted similar analyses for pollution levels 1 day and 2 days before a death occurred.
Overall, 87,990 deaths were identified during the study period; of these, 34,907 were from CVD, 9,688 from acute coronary syndromes, and 3,776 from ischemic stroke.
“Exposure to PM2.5 and PM10 was associated with increased mortality on the day of exposure, the next day, and up to 2 days after exposure,” said Dr. Swieczkowski.
Overall, an increase of 10 mcg/m3 in the three pollutants was significantly associated with increase in CVD mortality on the day of exposure to the increased pollution levels, with odds ratios of 1.034, 1.033, and 1.083 for PM2.5, PM10, and NO2, respectively (all P < .001).
The risks of dying from CVD were similar 1 and 2 days after the polluted day.
An increase in PM levels, but not NO2, was significantly associated with acute coronary syndrome (ACS) on the day of exposure to increased pollutants (ORs, 1.029 for PM2.5 [P = .002] and 1.015 [P = .049] for PM10). Both ischemic stroke and ACS mortality were significantly higher at 1 day after exposure, compared with other days. Ischemic stroke was associated with increases in PM2.5 and PM10, while ACS was associated with increases in PM2.5, PM10, and NO2.
When stratified by gender, the effects were more noticeable in women, Dr. Swieczkowski said. “Exposure to both types of particulate caused increased mortality due to acute coronary syndrome as well as ischemic stroke.” Among men, only death from acute coronary syndrome was significantly associated with exposure to increased particulate matter.
In a head-to-head comparison, women were more vulnerable to air pollution by up to 2.5%, he added.
When stratified by age, the effects of all three pollutants were associated with increased risk of death from ischemic stroke and ACS in participants older than 65 years. For those aged 65 years and younger, the only significant association was between ACS-associated mortality and ischemic stroke.
The results suggest “a special need for developing calculators to estimate the risk of CVD incidence depending on the place of residence that could be used for everyday practice,” said Dr. Swieczkowski. “Systemic changes should become a priority for policy makers, and, simultaneously, we as physicians should educate and protect our patients, especially those with high risk of cardiovascular disease,” he said.
Gender differences rooted in anatomy
When asked for an explanation of the difference in the impact of pollution on mortality between men and women, Dr. Swieczkowski explained that women are likely more vulnerable because of differences in anatomy of the pharynx and larynx, and breathing patterns. Previous studies have shown that air pollution causes more oxidative stress in women. Also, in the current study, the mean age of the women was 8 to 9 years older, he said.
The study design was an “elegant way to take away the impact of other cardiovascular risk factors,” noted session moderator Maryam Kavousi, MD, of Erasmus University Medical Center, Rotterdam, the Netherlands.
The study was supported by the National Science Centre, Poland. The researchers had no financial conflicts to disclose.
FROM ESC CONGRESS 2023
AHA statement targets nuance in CVD risk assessment of women
In a new scientific statement, the American Heart Association highlighted the importance of incorporating nonbiological risk factors and social determinants of health in cardiovascular disease (CVD) risk assessment for women, particularly women from different racial and ethnic backgrounds.
CVD risk assessment in women is multifaceted and goes well beyond traditional risk factors to include sex-specific biological risk factors, as well as social, behavioral, and environmental factors, the writing group noted.
They said a greater focus on addressing all CVD risk factors among women from underrepresented races and ethnicities is warranted to avert future CVD.
The scientific statement was published online in Circulation.
Look beyond traditional risk factors
“Risk assessment is the first step in preventing heart disease, yet there are many limitations to traditional risk factors and their ability to comprehensively estimate a woman’s risk for cardiovascular disease,” Jennifer H. Mieres, MD, vice chair of the writing group and professor of cardiology at Hofstra University, Hempstead, N.Y., said in a news release.
“The delivery of equitable cardiovascular health care for women depends on improving the knowledge and awareness of all members of the healthcare team about the full spectrum of cardiovascular risk factors for women, including female-specific and female-predominant risk factors,” Dr. Mieres added.
Female-specific factors that should be included in CVD risk assessment include pregnancy-related conditions such as preeclampsia, preterm delivery, and gestational diabetes, the writing group said.
Other factors include menstrual cycle history; types of birth control and/or hormone replacement therapy used; polycystic ovarian syndrome (PCOS), which affects 10% of women of reproductive age and is associated with increased CVD risk; and autoimmune disorders, depression, and PTSD, all of which are more common in women and are also associated with higher risk for CVD.
The statement also highlights the key role that social determinants of health (SDOH) play in the development of CVD in women, particularly women from diverse racial and ethnic backgrounds. SDOH include education level, economic stability, neighborhood safety, working conditions, environmental hazards, and access to quality health care.
“It is critical that risk assessment be expanded to include [SDOH] as risk factors if we are to improve health outcomes in all women,” Laxmi Mehta, MD, chair of the writing group and director of preventative cardiology and women’s cardiovascular health at Ohio State University Wexner Medical Center, Columbus, said in the news release.
“It is also important for the health care team to consider [SDOH] when working with women on shared decisions about cardiovascular disease prevention and treatment,” Dr. Mehta noted.
No one-size-fits-all approach
The statement highlighted significant differences in CVD risk among women of different racial and ethnic backgrounds and provides detailed CV risk factor profiles for non-Hispanic Black, Hispanic/Latinx, Asian and American Indian/Alaska Native women.
It noted that language barriers, discrimination, acculturation, and health care access disproportionately affect women of underrepresented racial and ethnic groups. These factors result in a higher prevalence of CVD and significant challenges in CVD diagnosis and treatment.
“When customizing CVD prevention and treatment strategies to improve cardiovascular health for women, a one-size-fits-all approach is unlikely to be successful,” Dr. Mieres said.
“We must be cognizant of the complex interplay of sex, race and ethnicity, as well as social determinants of health, and how they impact the risk of cardiovascular disease and adverse outcomes in order to avert future CVD morbidity and mortality,” Dr. Mieres added.
Looking ahead, the writing group said future CVD prevention guidelines could be strengthened by including culturally-specific lifestyle recommendations.
They also said community-based approaches, faith-based community partnerships, and peer support to encourage a healthy lifestyle could play a key role in preventing CVD among all women.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Cardiovascular Disease and Stroke in Women and Underrepresented Populations Committee of the Council on Clinical Cardiology, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.
A version of this article first appeared on Medscape.com.
In a new scientific statement, the American Heart Association highlighted the importance of incorporating nonbiological risk factors and social determinants of health in cardiovascular disease (CVD) risk assessment for women, particularly women from different racial and ethnic backgrounds.
CVD risk assessment in women is multifaceted and goes well beyond traditional risk factors to include sex-specific biological risk factors, as well as social, behavioral, and environmental factors, the writing group noted.
They said a greater focus on addressing all CVD risk factors among women from underrepresented races and ethnicities is warranted to avert future CVD.
The scientific statement was published online in Circulation.
Look beyond traditional risk factors
“Risk assessment is the first step in preventing heart disease, yet there are many limitations to traditional risk factors and their ability to comprehensively estimate a woman’s risk for cardiovascular disease,” Jennifer H. Mieres, MD, vice chair of the writing group and professor of cardiology at Hofstra University, Hempstead, N.Y., said in a news release.
“The delivery of equitable cardiovascular health care for women depends on improving the knowledge and awareness of all members of the healthcare team about the full spectrum of cardiovascular risk factors for women, including female-specific and female-predominant risk factors,” Dr. Mieres added.
Female-specific factors that should be included in CVD risk assessment include pregnancy-related conditions such as preeclampsia, preterm delivery, and gestational diabetes, the writing group said.
Other factors include menstrual cycle history; types of birth control and/or hormone replacement therapy used; polycystic ovarian syndrome (PCOS), which affects 10% of women of reproductive age and is associated with increased CVD risk; and autoimmune disorders, depression, and PTSD, all of which are more common in women and are also associated with higher risk for CVD.
The statement also highlights the key role that social determinants of health (SDOH) play in the development of CVD in women, particularly women from diverse racial and ethnic backgrounds. SDOH include education level, economic stability, neighborhood safety, working conditions, environmental hazards, and access to quality health care.
“It is critical that risk assessment be expanded to include [SDOH] as risk factors if we are to improve health outcomes in all women,” Laxmi Mehta, MD, chair of the writing group and director of preventative cardiology and women’s cardiovascular health at Ohio State University Wexner Medical Center, Columbus, said in the news release.
“It is also important for the health care team to consider [SDOH] when working with women on shared decisions about cardiovascular disease prevention and treatment,” Dr. Mehta noted.
No one-size-fits-all approach
The statement highlighted significant differences in CVD risk among women of different racial and ethnic backgrounds and provides detailed CV risk factor profiles for non-Hispanic Black, Hispanic/Latinx, Asian and American Indian/Alaska Native women.
It noted that language barriers, discrimination, acculturation, and health care access disproportionately affect women of underrepresented racial and ethnic groups. These factors result in a higher prevalence of CVD and significant challenges in CVD diagnosis and treatment.
“When customizing CVD prevention and treatment strategies to improve cardiovascular health for women, a one-size-fits-all approach is unlikely to be successful,” Dr. Mieres said.
“We must be cognizant of the complex interplay of sex, race and ethnicity, as well as social determinants of health, and how they impact the risk of cardiovascular disease and adverse outcomes in order to avert future CVD morbidity and mortality,” Dr. Mieres added.
Looking ahead, the writing group said future CVD prevention guidelines could be strengthened by including culturally-specific lifestyle recommendations.
They also said community-based approaches, faith-based community partnerships, and peer support to encourage a healthy lifestyle could play a key role in preventing CVD among all women.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Cardiovascular Disease and Stroke in Women and Underrepresented Populations Committee of the Council on Clinical Cardiology, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.
A version of this article first appeared on Medscape.com.
In a new scientific statement, the American Heart Association highlighted the importance of incorporating nonbiological risk factors and social determinants of health in cardiovascular disease (CVD) risk assessment for women, particularly women from different racial and ethnic backgrounds.
CVD risk assessment in women is multifaceted and goes well beyond traditional risk factors to include sex-specific biological risk factors, as well as social, behavioral, and environmental factors, the writing group noted.
They said a greater focus on addressing all CVD risk factors among women from underrepresented races and ethnicities is warranted to avert future CVD.
The scientific statement was published online in Circulation.
Look beyond traditional risk factors
“Risk assessment is the first step in preventing heart disease, yet there are many limitations to traditional risk factors and their ability to comprehensively estimate a woman’s risk for cardiovascular disease,” Jennifer H. Mieres, MD, vice chair of the writing group and professor of cardiology at Hofstra University, Hempstead, N.Y., said in a news release.
“The delivery of equitable cardiovascular health care for women depends on improving the knowledge and awareness of all members of the healthcare team about the full spectrum of cardiovascular risk factors for women, including female-specific and female-predominant risk factors,” Dr. Mieres added.
Female-specific factors that should be included in CVD risk assessment include pregnancy-related conditions such as preeclampsia, preterm delivery, and gestational diabetes, the writing group said.
Other factors include menstrual cycle history; types of birth control and/or hormone replacement therapy used; polycystic ovarian syndrome (PCOS), which affects 10% of women of reproductive age and is associated with increased CVD risk; and autoimmune disorders, depression, and PTSD, all of which are more common in women and are also associated with higher risk for CVD.
The statement also highlights the key role that social determinants of health (SDOH) play in the development of CVD in women, particularly women from diverse racial and ethnic backgrounds. SDOH include education level, economic stability, neighborhood safety, working conditions, environmental hazards, and access to quality health care.
“It is critical that risk assessment be expanded to include [SDOH] as risk factors if we are to improve health outcomes in all women,” Laxmi Mehta, MD, chair of the writing group and director of preventative cardiology and women’s cardiovascular health at Ohio State University Wexner Medical Center, Columbus, said in the news release.
“It is also important for the health care team to consider [SDOH] when working with women on shared decisions about cardiovascular disease prevention and treatment,” Dr. Mehta noted.
No one-size-fits-all approach
The statement highlighted significant differences in CVD risk among women of different racial and ethnic backgrounds and provides detailed CV risk factor profiles for non-Hispanic Black, Hispanic/Latinx, Asian and American Indian/Alaska Native women.
It noted that language barriers, discrimination, acculturation, and health care access disproportionately affect women of underrepresented racial and ethnic groups. These factors result in a higher prevalence of CVD and significant challenges in CVD diagnosis and treatment.
“When customizing CVD prevention and treatment strategies to improve cardiovascular health for women, a one-size-fits-all approach is unlikely to be successful,” Dr. Mieres said.
“We must be cognizant of the complex interplay of sex, race and ethnicity, as well as social determinants of health, and how they impact the risk of cardiovascular disease and adverse outcomes in order to avert future CVD morbidity and mortality,” Dr. Mieres added.
Looking ahead, the writing group said future CVD prevention guidelines could be strengthened by including culturally-specific lifestyle recommendations.
They also said community-based approaches, faith-based community partnerships, and peer support to encourage a healthy lifestyle could play a key role in preventing CVD among all women.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Cardiovascular Disease and Stroke in Women and Underrepresented Populations Committee of the Council on Clinical Cardiology, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Statins don’t worsen muscle injury from moderately intense exercise
People who are physically active and on statins may have one less potential concern about the drugs. Despite their reputation for causing muscle injury, a study suggests statins won’t worsen the toll that sustained, moderately intensive exercise already takes on patients’ muscles.
Statin therapy in this prospective, controlled study wasn’t seen to aggravate normal muscle fatigue or pain from sustained exercise or adversely affect enzymes or other biomarkers associated with muscle injury.
The findings come from 100 individuals, of whom about two-thirds were on statins, participating in a public, 4-day, long-distance walking event held annually in the Netherlands. Results were published in the Journal of the American College of Cardiology with Neeltje A.E. Allard, MD, Radboud University Medical Center, Nijmegen, the Netherlands, as lead author.
For all of statins’ common use in adults with cardiovascular (CV) risk factors, the drugs are often blamed for causing excessive muscle pain or injury as a side effect. Yet there is a predominance of evidence to the contrary based on meta-analyses and clinical trials, suggesting that the drugs are taking the rap for many entirely unrelated muscle symptoms.
The new findings, from people ranging widely in fitness levels, suggest that “exercise of moderate intensity is feasible and safe” in statin users, that the drugs won’t exacerbate normal muscle symptoms from exercise, Dr. Allard told this news organization.
And that exercise doesn’t have to be on an unusual scale. Regular exercise in statin users can simply be consistent with broader guidelines, say 30 minutes of walking per day, she noted.
The study has such broad applicability, Dr. Allard said, because participants represented the spectrum of the thousands who signed up for the walking event, who varied in age, level of physical fitness, and number of CV risk factors. They included CV patients, the physically fit, “recreational walkers who didn’t really exercise regularly,” and “habitual nonexercisers.”
It enrolled three groups of participants in the Four Days Marches in Nijmegen, which in a typical year attracts tens of thousands of participants who walk up to 30 km, 40 km, or 50 km per day for 4 consecutive days.
They included 35 statin users who walked the event despite muscle symptoms, 34 on statins but without such symptoms, and 31 non–statin-using controls. Their mean ages ranged from 65 to 68 years.
Statin users were overwhelmingly on simvastatin or atorvastatin. The average statin therapy durations were 60 months and 96 months for those with and without symptoms, respectively.
Assessments were performed several days before the event, at baseline, and after the end of walking on days 1, 2, and 3.
Scores for muscle pain on the Brief Pain Inventory were higher at baseline for the symptomatic-on-statins group (P < .001) compared with the other two groups, and went up (P < .001) similarly across the three groups during each of the 3 days, the report notes. Fatigue scores on the Brief Fatigue Inventory followed the same pattern.
All biomarkers of muscle injury or stress were at comparable levels at baseline in the three groups and went up similarly (P < .001) with no significant differences at the end of day 3. Biomarkers included lactate dehydrogenase, creatine kinase, myoglobin, cardiac troponin I, and N-terminal pro-brain natriuretic peptide.
Statin-related reductions in levels of coenzyme Q 10 (CoQ10) have been thought to exacerbate muscle injury, the authors note. But levels of CoQ10 weren’t significantly different across the three groups at any point in the study, and they did not show any significant associations with measures of muscle injury, symptoms, or fatigue.
Patients with statin-associated muscle symptoms (SAMS) often limit physical activity because of muscle pain or weakness, but also “concerns that exercise will exacerbate muscle injury,” an accompanying editorial notes. “Therefore, exercise, a foundation of improving and maintaining cardiometabolic health, is often avoided or limited.”
But the current study, writes Robert S. Rosenson, MD, of Mount Sinai Heart, New York, indeed suggests that “many patients who develop SAMS may engage in a moderately intensive walking program without concern for worsened muscle biomarkers or performance.”
The exercise didn’t seem to improve muscle function in symptomatic statin users, compared with the other groups over the study’s very short follow-up, Dr. Rosenson observes. But “it remains uncertain from this study whether sustained exercise in SAMS patients will effectuate improved metabolic biomarkers or exercise capacity in the long term.”
Dr. Allard is supported by a grant from the Radboud Institute for Health Sciences; the other authors have disclosed no relevant financial relationships. Dr. Rosenson disclosed receiving research funding to his institution from Amgen, Arrowhead, Lilly, Novartis, and Regeneron; consulting fees from Amgen, Arrowhead, Lilly, Lipigon, Novartis, CRISPR Therapeutics, Precision BioSciences, Verve, Ultragenyx Pharmaceutical, and Regeneron; speaking fees from Amgen, Kowa, and Regeneron; and royalties from Wolters Kluwer (UpToDate); and that he holds stock in MediMergent.
A version of this article first appeared on Medscape.com.
People who are physically active and on statins may have one less potential concern about the drugs. Despite their reputation for causing muscle injury, a study suggests statins won’t worsen the toll that sustained, moderately intensive exercise already takes on patients’ muscles.
Statin therapy in this prospective, controlled study wasn’t seen to aggravate normal muscle fatigue or pain from sustained exercise or adversely affect enzymes or other biomarkers associated with muscle injury.
The findings come from 100 individuals, of whom about two-thirds were on statins, participating in a public, 4-day, long-distance walking event held annually in the Netherlands. Results were published in the Journal of the American College of Cardiology with Neeltje A.E. Allard, MD, Radboud University Medical Center, Nijmegen, the Netherlands, as lead author.
For all of statins’ common use in adults with cardiovascular (CV) risk factors, the drugs are often blamed for causing excessive muscle pain or injury as a side effect. Yet there is a predominance of evidence to the contrary based on meta-analyses and clinical trials, suggesting that the drugs are taking the rap for many entirely unrelated muscle symptoms.
The new findings, from people ranging widely in fitness levels, suggest that “exercise of moderate intensity is feasible and safe” in statin users, that the drugs won’t exacerbate normal muscle symptoms from exercise, Dr. Allard told this news organization.
And that exercise doesn’t have to be on an unusual scale. Regular exercise in statin users can simply be consistent with broader guidelines, say 30 minutes of walking per day, she noted.
The study has such broad applicability, Dr. Allard said, because participants represented the spectrum of the thousands who signed up for the walking event, who varied in age, level of physical fitness, and number of CV risk factors. They included CV patients, the physically fit, “recreational walkers who didn’t really exercise regularly,” and “habitual nonexercisers.”
It enrolled three groups of participants in the Four Days Marches in Nijmegen, which in a typical year attracts tens of thousands of participants who walk up to 30 km, 40 km, or 50 km per day for 4 consecutive days.
They included 35 statin users who walked the event despite muscle symptoms, 34 on statins but without such symptoms, and 31 non–statin-using controls. Their mean ages ranged from 65 to 68 years.
Statin users were overwhelmingly on simvastatin or atorvastatin. The average statin therapy durations were 60 months and 96 months for those with and without symptoms, respectively.
Assessments were performed several days before the event, at baseline, and after the end of walking on days 1, 2, and 3.
Scores for muscle pain on the Brief Pain Inventory were higher at baseline for the symptomatic-on-statins group (P < .001) compared with the other two groups, and went up (P < .001) similarly across the three groups during each of the 3 days, the report notes. Fatigue scores on the Brief Fatigue Inventory followed the same pattern.
All biomarkers of muscle injury or stress were at comparable levels at baseline in the three groups and went up similarly (P < .001) with no significant differences at the end of day 3. Biomarkers included lactate dehydrogenase, creatine kinase, myoglobin, cardiac troponin I, and N-terminal pro-brain natriuretic peptide.
Statin-related reductions in levels of coenzyme Q 10 (CoQ10) have been thought to exacerbate muscle injury, the authors note. But levels of CoQ10 weren’t significantly different across the three groups at any point in the study, and they did not show any significant associations with measures of muscle injury, symptoms, or fatigue.
Patients with statin-associated muscle symptoms (SAMS) often limit physical activity because of muscle pain or weakness, but also “concerns that exercise will exacerbate muscle injury,” an accompanying editorial notes. “Therefore, exercise, a foundation of improving and maintaining cardiometabolic health, is often avoided or limited.”
But the current study, writes Robert S. Rosenson, MD, of Mount Sinai Heart, New York, indeed suggests that “many patients who develop SAMS may engage in a moderately intensive walking program without concern for worsened muscle biomarkers or performance.”
The exercise didn’t seem to improve muscle function in symptomatic statin users, compared with the other groups over the study’s very short follow-up, Dr. Rosenson observes. But “it remains uncertain from this study whether sustained exercise in SAMS patients will effectuate improved metabolic biomarkers or exercise capacity in the long term.”
Dr. Allard is supported by a grant from the Radboud Institute for Health Sciences; the other authors have disclosed no relevant financial relationships. Dr. Rosenson disclosed receiving research funding to his institution from Amgen, Arrowhead, Lilly, Novartis, and Regeneron; consulting fees from Amgen, Arrowhead, Lilly, Lipigon, Novartis, CRISPR Therapeutics, Precision BioSciences, Verve, Ultragenyx Pharmaceutical, and Regeneron; speaking fees from Amgen, Kowa, and Regeneron; and royalties from Wolters Kluwer (UpToDate); and that he holds stock in MediMergent.
A version of this article first appeared on Medscape.com.
People who are physically active and on statins may have one less potential concern about the drugs. Despite their reputation for causing muscle injury, a study suggests statins won’t worsen the toll that sustained, moderately intensive exercise already takes on patients’ muscles.
Statin therapy in this prospective, controlled study wasn’t seen to aggravate normal muscle fatigue or pain from sustained exercise or adversely affect enzymes or other biomarkers associated with muscle injury.
The findings come from 100 individuals, of whom about two-thirds were on statins, participating in a public, 4-day, long-distance walking event held annually in the Netherlands. Results were published in the Journal of the American College of Cardiology with Neeltje A.E. Allard, MD, Radboud University Medical Center, Nijmegen, the Netherlands, as lead author.
For all of statins’ common use in adults with cardiovascular (CV) risk factors, the drugs are often blamed for causing excessive muscle pain or injury as a side effect. Yet there is a predominance of evidence to the contrary based on meta-analyses and clinical trials, suggesting that the drugs are taking the rap for many entirely unrelated muscle symptoms.
The new findings, from people ranging widely in fitness levels, suggest that “exercise of moderate intensity is feasible and safe” in statin users, that the drugs won’t exacerbate normal muscle symptoms from exercise, Dr. Allard told this news organization.
And that exercise doesn’t have to be on an unusual scale. Regular exercise in statin users can simply be consistent with broader guidelines, say 30 minutes of walking per day, she noted.
The study has such broad applicability, Dr. Allard said, because participants represented the spectrum of the thousands who signed up for the walking event, who varied in age, level of physical fitness, and number of CV risk factors. They included CV patients, the physically fit, “recreational walkers who didn’t really exercise regularly,” and “habitual nonexercisers.”
It enrolled three groups of participants in the Four Days Marches in Nijmegen, which in a typical year attracts tens of thousands of participants who walk up to 30 km, 40 km, or 50 km per day for 4 consecutive days.
They included 35 statin users who walked the event despite muscle symptoms, 34 on statins but without such symptoms, and 31 non–statin-using controls. Their mean ages ranged from 65 to 68 years.
Statin users were overwhelmingly on simvastatin or atorvastatin. The average statin therapy durations were 60 months and 96 months for those with and without symptoms, respectively.
Assessments were performed several days before the event, at baseline, and after the end of walking on days 1, 2, and 3.
Scores for muscle pain on the Brief Pain Inventory were higher at baseline for the symptomatic-on-statins group (P < .001) compared with the other two groups, and went up (P < .001) similarly across the three groups during each of the 3 days, the report notes. Fatigue scores on the Brief Fatigue Inventory followed the same pattern.
All biomarkers of muscle injury or stress were at comparable levels at baseline in the three groups and went up similarly (P < .001) with no significant differences at the end of day 3. Biomarkers included lactate dehydrogenase, creatine kinase, myoglobin, cardiac troponin I, and N-terminal pro-brain natriuretic peptide.
Statin-related reductions in levels of coenzyme Q 10 (CoQ10) have been thought to exacerbate muscle injury, the authors note. But levels of CoQ10 weren’t significantly different across the three groups at any point in the study, and they did not show any significant associations with measures of muscle injury, symptoms, or fatigue.
Patients with statin-associated muscle symptoms (SAMS) often limit physical activity because of muscle pain or weakness, but also “concerns that exercise will exacerbate muscle injury,” an accompanying editorial notes. “Therefore, exercise, a foundation of improving and maintaining cardiometabolic health, is often avoided or limited.”
But the current study, writes Robert S. Rosenson, MD, of Mount Sinai Heart, New York, indeed suggests that “many patients who develop SAMS may engage in a moderately intensive walking program without concern for worsened muscle biomarkers or performance.”
The exercise didn’t seem to improve muscle function in symptomatic statin users, compared with the other groups over the study’s very short follow-up, Dr. Rosenson observes. But “it remains uncertain from this study whether sustained exercise in SAMS patients will effectuate improved metabolic biomarkers or exercise capacity in the long term.”
Dr. Allard is supported by a grant from the Radboud Institute for Health Sciences; the other authors have disclosed no relevant financial relationships. Dr. Rosenson disclosed receiving research funding to his institution from Amgen, Arrowhead, Lilly, Novartis, and Regeneron; consulting fees from Amgen, Arrowhead, Lilly, Lipigon, Novartis, CRISPR Therapeutics, Precision BioSciences, Verve, Ultragenyx Pharmaceutical, and Regeneron; speaking fees from Amgen, Kowa, and Regeneron; and royalties from Wolters Kluwer (UpToDate); and that he holds stock in MediMergent.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY