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Moderate drinking shows more benefit for older vs. younger adults
The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.
“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.
“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.
“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
Methods and results
In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.
One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.
Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.
For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.
The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).
The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.
However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.
“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
Consider individual factors when counseling patients
The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.
“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
Health and alcohol interaction is complicated
“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.
However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.
“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.
In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”
Data can guide clinical practice
No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.
“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.
“This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.
As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.
The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.
The study was supported by the Bill and Melinda Gates Foundation.
The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.
“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.
“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.
“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
Methods and results
In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.
One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.
Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.
For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.
The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).
The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.
However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.
“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
Consider individual factors when counseling patients
The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.
“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
Health and alcohol interaction is complicated
“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.
However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.
“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.
In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”
Data can guide clinical practice
No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.
“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.
“This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.
As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.
The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.
The study was supported by the Bill and Melinda Gates Foundation.
The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.
“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.
“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.
“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
Methods and results
In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.
One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.
Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.
For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.
The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).
The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.
However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.
“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
Consider individual factors when counseling patients
The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.
“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
Health and alcohol interaction is complicated
“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.
However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.
“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.
In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”
Data can guide clinical practice
No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.
“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.
“This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.
As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.
The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.
The study was supported by the Bill and Melinda Gates Foundation.
FROM THE LANCET
The heartache of bereavement can be fatal in heart failure
that points to the need for greater integration of psychosocial risk factors in the treatment of HF.
The adjusted relative risk of dying was nearly 30% higher among bereaved patients with HF (1.29; 95% confidence interval, 1.27-1.30) and slightly higher for those grieving the loss of more than one family member (RR, 1.35).
The highest risk was in the first week after the loss (RR, 1.78) but persisted after 5 years of follow-up (RR, 1.30).
“Heart failure is a very difficult condition and has a very poor prognosis comparable to many, many cancers,” senior author Krisztina László, PhD, Karolinska Institutet, Stockholm, said in an interview. “So it’s important for us to be aware of these increased risks and to understand them better.”
The early risk for death could be related to stress-induced cardiomyopathy, or Takotsubo syndrome, as well as activation of the hypothalamic-pituitary-adrenal axis, the renin-angiotensin-aldosterone system, and sympathetic nervous system, she explained. Higher long-term risks may reflect chronic stress, leading to poorly managed disease and an unhealthy lifestyle.
“If we understand better the underlying mechanisms maybe we can give more specific advice,” Dr. László said. “At this stage, I think having an awareness of the risk and trying to follow patients or at least not let them fall out of usual care, asking questions, trying to understand what their needs are, maybe that is what we can do well.”
A recent position paper by the European Association of Preventive Cardiology pointed out that psychosocial risk factors, like depression and social isolation, can exacerbate heart failure and calls for better integration of psychosocial factors in the treatment of patients with chronic HF.
“We don’t do a very good job of it, but I think they are very important,” observed Stuart D. Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., and was not involved in the study.
“When we hear about a spouse dying, we might call and give condolences, but it’s probably a group of patients that for the next 6 months or so we need to watch more closely and see if there are things we can impact both medically as well as socially to perhaps prevent some of this increase in mortality,” he told this news organization.
Although several studies have linked bereavement with adverse health outcomes, this is just one of two studies to look specifically at its role in HF prognosis, Dr. László noted. A 2013 study of 66,000 male veterans reported that widowers had nearly a 38% higher all-cause mortality risk than did married veterans.
The present study extends those findings to 490,527 patients in the Swedish Heart Failure Registry between 2000 and 2018 and/or in the Swedish Patient Register with a primary diagnosis of HF between 1987 and 2018. During a mean follow-up of 3.7 years, 12% of participants had a family member die, and 383,674 participants died.
Results showed the HF mortality risk increased 10% after the death of a child, 20% with the death of a spouse/partner, 13% with a sibling’s death, and 5% with the death of a grandchild.
No increased risk was seen after the death of a parent, which is likely owed to a median patient age of about 75 years and “is in line with our expectations of the life cycle,” Dr. László said.
An association between bereavement and mortality risk was observed in cases of loss caused by cardiovascular disease (RR, 1.34) and other natural causes (RR, 1.27) but also in cases of unnatural deaths, such as suicide (RR, 1.13).
The overall findings were similar regardless of left ventricular ejection fraction and New York Heart Association functional class and were not affected by sex or country of birth.
Dr. Russell agreed that the death of a parent would be expected among these older patients with HF but said that “if the mechanism of this truly is kind of this increased stress hormones and Takotsubo-type mechanism, you’d think it would be worse if it was your kid that died. That shocked me a bit.”
The strong association between mortality and the loss of a spouse or partner was not surprising, given that they’re an important source of mutual social support, he added.
“If it’s a 75-year-old whose spouse dies, we need to make sure that we have the children’s phone number or other people that we can reach out to and say: ‘Can you check on them?’ ” he said. “And we need to make sure that somebody else is coming in with them because I would guess that probably at least half of what patients hear in a clinic visit goes in one ear and out the other and it’s going to make that much better. So we need to find who that new support person is for the patient.”
Asked whether there are efforts underway to incorporate psychosocial factors into current U.S. guidelines, Dr. Russell replied, “certainly within heart failure, I don’t think we’re really discussing it and, that may be the best part of this paper. It really makes us think about a different way of approaching these older patients.”
Dr. László said that future studies are needed to investigate whether less severe sources of stress may also contribute to poor HF prognosis.
“In our population, 12% of patients were affected, which is quite high, but there are patients with heart failure who experience on a daily basis other sources of stress, which are less severe but chronic and affect large numbers,” she said. “This may also have important public health implications and will be an important next step.”
The authors noted that they were unable to eliminate residual confounding by genetic factors or unmeasured socioeconomic-, lifestyle-, or health-related factors shared by family members. Other limitations are limited power to detect a modest effect in some of the subanalyses and that the findings may be generalizable only to countries with social and cultural contexts and health-related factors similar to those of Sweden.
The study was supported by grants from the Swedish Council for Working Life and Social Research, the Karolinska Institutet’s Research Foundation, and the China Scholarship Council. Dr. László is also supported by a grant from the Heart and Lung Foundation. All other authors and Dr. Russell reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
that points to the need for greater integration of psychosocial risk factors in the treatment of HF.
The adjusted relative risk of dying was nearly 30% higher among bereaved patients with HF (1.29; 95% confidence interval, 1.27-1.30) and slightly higher for those grieving the loss of more than one family member (RR, 1.35).
The highest risk was in the first week after the loss (RR, 1.78) but persisted after 5 years of follow-up (RR, 1.30).
“Heart failure is a very difficult condition and has a very poor prognosis comparable to many, many cancers,” senior author Krisztina László, PhD, Karolinska Institutet, Stockholm, said in an interview. “So it’s important for us to be aware of these increased risks and to understand them better.”
The early risk for death could be related to stress-induced cardiomyopathy, or Takotsubo syndrome, as well as activation of the hypothalamic-pituitary-adrenal axis, the renin-angiotensin-aldosterone system, and sympathetic nervous system, she explained. Higher long-term risks may reflect chronic stress, leading to poorly managed disease and an unhealthy lifestyle.
“If we understand better the underlying mechanisms maybe we can give more specific advice,” Dr. László said. “At this stage, I think having an awareness of the risk and trying to follow patients or at least not let them fall out of usual care, asking questions, trying to understand what their needs are, maybe that is what we can do well.”
A recent position paper by the European Association of Preventive Cardiology pointed out that psychosocial risk factors, like depression and social isolation, can exacerbate heart failure and calls for better integration of psychosocial factors in the treatment of patients with chronic HF.
“We don’t do a very good job of it, but I think they are very important,” observed Stuart D. Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., and was not involved in the study.
“When we hear about a spouse dying, we might call and give condolences, but it’s probably a group of patients that for the next 6 months or so we need to watch more closely and see if there are things we can impact both medically as well as socially to perhaps prevent some of this increase in mortality,” he told this news organization.
Although several studies have linked bereavement with adverse health outcomes, this is just one of two studies to look specifically at its role in HF prognosis, Dr. László noted. A 2013 study of 66,000 male veterans reported that widowers had nearly a 38% higher all-cause mortality risk than did married veterans.
The present study extends those findings to 490,527 patients in the Swedish Heart Failure Registry between 2000 and 2018 and/or in the Swedish Patient Register with a primary diagnosis of HF between 1987 and 2018. During a mean follow-up of 3.7 years, 12% of participants had a family member die, and 383,674 participants died.
Results showed the HF mortality risk increased 10% after the death of a child, 20% with the death of a spouse/partner, 13% with a sibling’s death, and 5% with the death of a grandchild.
No increased risk was seen after the death of a parent, which is likely owed to a median patient age of about 75 years and “is in line with our expectations of the life cycle,” Dr. László said.
An association between bereavement and mortality risk was observed in cases of loss caused by cardiovascular disease (RR, 1.34) and other natural causes (RR, 1.27) but also in cases of unnatural deaths, such as suicide (RR, 1.13).
The overall findings were similar regardless of left ventricular ejection fraction and New York Heart Association functional class and were not affected by sex or country of birth.
Dr. Russell agreed that the death of a parent would be expected among these older patients with HF but said that “if the mechanism of this truly is kind of this increased stress hormones and Takotsubo-type mechanism, you’d think it would be worse if it was your kid that died. That shocked me a bit.”
The strong association between mortality and the loss of a spouse or partner was not surprising, given that they’re an important source of mutual social support, he added.
“If it’s a 75-year-old whose spouse dies, we need to make sure that we have the children’s phone number or other people that we can reach out to and say: ‘Can you check on them?’ ” he said. “And we need to make sure that somebody else is coming in with them because I would guess that probably at least half of what patients hear in a clinic visit goes in one ear and out the other and it’s going to make that much better. So we need to find who that new support person is for the patient.”
Asked whether there are efforts underway to incorporate psychosocial factors into current U.S. guidelines, Dr. Russell replied, “certainly within heart failure, I don’t think we’re really discussing it and, that may be the best part of this paper. It really makes us think about a different way of approaching these older patients.”
Dr. László said that future studies are needed to investigate whether less severe sources of stress may also contribute to poor HF prognosis.
“In our population, 12% of patients were affected, which is quite high, but there are patients with heart failure who experience on a daily basis other sources of stress, which are less severe but chronic and affect large numbers,” she said. “This may also have important public health implications and will be an important next step.”
The authors noted that they were unable to eliminate residual confounding by genetic factors or unmeasured socioeconomic-, lifestyle-, or health-related factors shared by family members. Other limitations are limited power to detect a modest effect in some of the subanalyses and that the findings may be generalizable only to countries with social and cultural contexts and health-related factors similar to those of Sweden.
The study was supported by grants from the Swedish Council for Working Life and Social Research, the Karolinska Institutet’s Research Foundation, and the China Scholarship Council. Dr. László is also supported by a grant from the Heart and Lung Foundation. All other authors and Dr. Russell reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
that points to the need for greater integration of psychosocial risk factors in the treatment of HF.
The adjusted relative risk of dying was nearly 30% higher among bereaved patients with HF (1.29; 95% confidence interval, 1.27-1.30) and slightly higher for those grieving the loss of more than one family member (RR, 1.35).
The highest risk was in the first week after the loss (RR, 1.78) but persisted after 5 years of follow-up (RR, 1.30).
“Heart failure is a very difficult condition and has a very poor prognosis comparable to many, many cancers,” senior author Krisztina László, PhD, Karolinska Institutet, Stockholm, said in an interview. “So it’s important for us to be aware of these increased risks and to understand them better.”
The early risk for death could be related to stress-induced cardiomyopathy, or Takotsubo syndrome, as well as activation of the hypothalamic-pituitary-adrenal axis, the renin-angiotensin-aldosterone system, and sympathetic nervous system, she explained. Higher long-term risks may reflect chronic stress, leading to poorly managed disease and an unhealthy lifestyle.
“If we understand better the underlying mechanisms maybe we can give more specific advice,” Dr. László said. “At this stage, I think having an awareness of the risk and trying to follow patients or at least not let them fall out of usual care, asking questions, trying to understand what their needs are, maybe that is what we can do well.”
A recent position paper by the European Association of Preventive Cardiology pointed out that psychosocial risk factors, like depression and social isolation, can exacerbate heart failure and calls for better integration of psychosocial factors in the treatment of patients with chronic HF.
“We don’t do a very good job of it, but I think they are very important,” observed Stuart D. Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., and was not involved in the study.
“When we hear about a spouse dying, we might call and give condolences, but it’s probably a group of patients that for the next 6 months or so we need to watch more closely and see if there are things we can impact both medically as well as socially to perhaps prevent some of this increase in mortality,” he told this news organization.
Although several studies have linked bereavement with adverse health outcomes, this is just one of two studies to look specifically at its role in HF prognosis, Dr. László noted. A 2013 study of 66,000 male veterans reported that widowers had nearly a 38% higher all-cause mortality risk than did married veterans.
The present study extends those findings to 490,527 patients in the Swedish Heart Failure Registry between 2000 and 2018 and/or in the Swedish Patient Register with a primary diagnosis of HF between 1987 and 2018. During a mean follow-up of 3.7 years, 12% of participants had a family member die, and 383,674 participants died.
Results showed the HF mortality risk increased 10% after the death of a child, 20% with the death of a spouse/partner, 13% with a sibling’s death, and 5% with the death of a grandchild.
No increased risk was seen after the death of a parent, which is likely owed to a median patient age of about 75 years and “is in line with our expectations of the life cycle,” Dr. László said.
An association between bereavement and mortality risk was observed in cases of loss caused by cardiovascular disease (RR, 1.34) and other natural causes (RR, 1.27) but also in cases of unnatural deaths, such as suicide (RR, 1.13).
The overall findings were similar regardless of left ventricular ejection fraction and New York Heart Association functional class and were not affected by sex or country of birth.
Dr. Russell agreed that the death of a parent would be expected among these older patients with HF but said that “if the mechanism of this truly is kind of this increased stress hormones and Takotsubo-type mechanism, you’d think it would be worse if it was your kid that died. That shocked me a bit.”
The strong association between mortality and the loss of a spouse or partner was not surprising, given that they’re an important source of mutual social support, he added.
“If it’s a 75-year-old whose spouse dies, we need to make sure that we have the children’s phone number or other people that we can reach out to and say: ‘Can you check on them?’ ” he said. “And we need to make sure that somebody else is coming in with them because I would guess that probably at least half of what patients hear in a clinic visit goes in one ear and out the other and it’s going to make that much better. So we need to find who that new support person is for the patient.”
Asked whether there are efforts underway to incorporate psychosocial factors into current U.S. guidelines, Dr. Russell replied, “certainly within heart failure, I don’t think we’re really discussing it and, that may be the best part of this paper. It really makes us think about a different way of approaching these older patients.”
Dr. László said that future studies are needed to investigate whether less severe sources of stress may also contribute to poor HF prognosis.
“In our population, 12% of patients were affected, which is quite high, but there are patients with heart failure who experience on a daily basis other sources of stress, which are less severe but chronic and affect large numbers,” she said. “This may also have important public health implications and will be an important next step.”
The authors noted that they were unable to eliminate residual confounding by genetic factors or unmeasured socioeconomic-, lifestyle-, or health-related factors shared by family members. Other limitations are limited power to detect a modest effect in some of the subanalyses and that the findings may be generalizable only to countries with social and cultural contexts and health-related factors similar to those of Sweden.
The study was supported by grants from the Swedish Council for Working Life and Social Research, the Karolinska Institutet’s Research Foundation, and the China Scholarship Council. Dr. László is also supported by a grant from the Heart and Lung Foundation. All other authors and Dr. Russell reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JACC: HEART FAILURE
Pulse oximeters lead to less oxygen supplementation for people of color
The new research suggests that skin color–related differences in pulse oximeter readings are in fact impacting clinical decision-making, lead author Eric R. Gottlieb, MD, of Brigham and Women’s Hospital and Massachusetts Institute of Technology, both in Boston, and colleagues wrote. This suggests that technology needs to updated to improve health equity, they continued, in their paper published in JAMA Internal Medicine.
“It has been known for decades that these readings are affected by various surface pigmentations, including nail polish and skin melanin, which may affect light absorption and scattering,” the investigators wrote. “This increases the risk of hidden hypoxemia [among patients with darker skin], in which patients have falsely elevated SpO2 readings, usually defined as 92% or greater, with a blood hemoglobin oxygen saturation less than 88%.”
Although published reports on this phenomenon date back to the 1980s, clinical significance has been largely discounted, they said, citing a 2008 paper on the topic, which stated that “oximetry need not have exact accuracy” to determine if a patient needs oxygen supplementation.
‘We’re not providing equal care’
Questioning the validity of this statement, Dr. Gottlieb and colleagues conducted a retrospective cohort study involving 3,069 patients admitted to intensive care at the Beth Israel Deaconess Medical Center in Boston between 2008 and 2019, thereby excluding patients treated during the COVID-19 pandemic. The population consisted of four races/ethnicities: White (87%), Black (7%), Hispanic (4%), and Asian (3%).
Aligning with previous studies, multivariable linear regression analyses showed that Asian, Black, and Hispanic patients had significantly higher SpO2 readings than White patients in relation to hemoglobin oxygen saturation values, suggesting falsely elevated readings.
Further modeling showed that these same patient groups also received lower oxygen delivery rates, which were not explained directly by race/ethnicity, but instead were mediated by the discrepancy between SpO2 and hemoglobin oxygen saturation values. In other words, physicians were responding consistently to pulse oximetry readings, rather than exhibiting a direct racial/ethnic bias in their clinical decision-making.
“We’re not providing equal care,” Dr. Gottlieb said in an interview. “It’s not that the patients are sicker, or have other socioeconomic explanations for why this happens to them. It’s us. It’s our technology. And that’s something that really has to be fixed.”
The investigators offered a cautionary view of corrective algorithms, as these “have exacerbated disparities and are subject to ethical concerns;” for example, with glomerular filtration rate estimations in Black patients.
Dr. Gottlieb also cautioned against action by individual physicians, who may now be inclined to change how they interpret pulse oximeter readings based on a patient’s race or ethnicity.
“I don’t think that we can expect physicians, every time they see a patient, to be second guessing whether the number basically reflects the truth,” he said.
Instead, Dr. Gottlieb suggested that the burden of change rests upon the shoulders of institutions, including hospitals and device manufacturers, both of which “really need to take the responsibility” for making sure that pulse oximeters are “equitable and have similar performance across races.”
While Dr. Gottlieb said that skin color likely plays the greatest role in measurement discrepancies, he encouraged stakeholders “to think broadly about this, and not just assume that it’s entirely skin color,” noting a small amount of evidence indicating that blood chemistry may also play a role. Still, he predicted that colorimetry – the direct measurement of skin color – will probably be incorporated into pulse oximeters of the future.
Black patients 3X more likely to have hidden hypoxia than White patients
Michael Sjoding, MD, of the University of Michigan, Ann Arbor, was one of the first to raise awareness of skin color–related issues with pulse oximeters during the throes of the COVID-19 pandemic. His study, which involved more than 10,000 patients, showed that Black patients were threefold more likely to have hidden hypoxia than White patients.
The present study shows that such discrepancies are indeed clinically significant, Dr. Sjoding said in an interview. And these data are needed, he added, to bring about change.
“What is being asked is potentially a big deal,” Dr. Sjoding said. “Pulse oximeters are everywhere, and it would be a big undertaking to redesign pulse oximeters and purchase new pulse oximeters. You need a compelling body of evidence to do that. I think it’s there now, clearly. So I’m hopeful that we’re going to finally move forward, towards having devices that we are confident work accurately in everyone.”
Why it has taken so long to gather this evidence, however, is a thornier topic, considering race-related discrepancies in pulse oximeter readings were first documented more than 3 decades ago.
“We sort of rediscovered something that had been known and had been described in the past,” Dr. Sjoding said. He explained how he and many of his colleagues had completed pulmonary fellowships, yet none of them knew of these potential issues with pulse oximeters until they began to observe differences in their own patients during the pandemic.
“I’ll give previous generations of researchers the benefit of the doubt,” Dr. Sjoding said, pointing out that techniques in data gathering and analysis have advanced considerably over the years. “The types of studies that were done before were very different than what we did.”
Yet Dr. Sjoding entertained the possibility that other factors may have been at play.
“I think definitely there’s a social commentary on prioritization of research,” he said.
The study was supported by grants from the National Institutes of Health. The investigators and Dr. Sjoding reported no conflicts of interest.
The new research suggests that skin color–related differences in pulse oximeter readings are in fact impacting clinical decision-making, lead author Eric R. Gottlieb, MD, of Brigham and Women’s Hospital and Massachusetts Institute of Technology, both in Boston, and colleagues wrote. This suggests that technology needs to updated to improve health equity, they continued, in their paper published in JAMA Internal Medicine.
“It has been known for decades that these readings are affected by various surface pigmentations, including nail polish and skin melanin, which may affect light absorption and scattering,” the investigators wrote. “This increases the risk of hidden hypoxemia [among patients with darker skin], in which patients have falsely elevated SpO2 readings, usually defined as 92% or greater, with a blood hemoglobin oxygen saturation less than 88%.”
Although published reports on this phenomenon date back to the 1980s, clinical significance has been largely discounted, they said, citing a 2008 paper on the topic, which stated that “oximetry need not have exact accuracy” to determine if a patient needs oxygen supplementation.
‘We’re not providing equal care’
Questioning the validity of this statement, Dr. Gottlieb and colleagues conducted a retrospective cohort study involving 3,069 patients admitted to intensive care at the Beth Israel Deaconess Medical Center in Boston between 2008 and 2019, thereby excluding patients treated during the COVID-19 pandemic. The population consisted of four races/ethnicities: White (87%), Black (7%), Hispanic (4%), and Asian (3%).
Aligning with previous studies, multivariable linear regression analyses showed that Asian, Black, and Hispanic patients had significantly higher SpO2 readings than White patients in relation to hemoglobin oxygen saturation values, suggesting falsely elevated readings.
Further modeling showed that these same patient groups also received lower oxygen delivery rates, which were not explained directly by race/ethnicity, but instead were mediated by the discrepancy between SpO2 and hemoglobin oxygen saturation values. In other words, physicians were responding consistently to pulse oximetry readings, rather than exhibiting a direct racial/ethnic bias in their clinical decision-making.
“We’re not providing equal care,” Dr. Gottlieb said in an interview. “It’s not that the patients are sicker, or have other socioeconomic explanations for why this happens to them. It’s us. It’s our technology. And that’s something that really has to be fixed.”
The investigators offered a cautionary view of corrective algorithms, as these “have exacerbated disparities and are subject to ethical concerns;” for example, with glomerular filtration rate estimations in Black patients.
Dr. Gottlieb also cautioned against action by individual physicians, who may now be inclined to change how they interpret pulse oximeter readings based on a patient’s race or ethnicity.
“I don’t think that we can expect physicians, every time they see a patient, to be second guessing whether the number basically reflects the truth,” he said.
Instead, Dr. Gottlieb suggested that the burden of change rests upon the shoulders of institutions, including hospitals and device manufacturers, both of which “really need to take the responsibility” for making sure that pulse oximeters are “equitable and have similar performance across races.”
While Dr. Gottlieb said that skin color likely plays the greatest role in measurement discrepancies, he encouraged stakeholders “to think broadly about this, and not just assume that it’s entirely skin color,” noting a small amount of evidence indicating that blood chemistry may also play a role. Still, he predicted that colorimetry – the direct measurement of skin color – will probably be incorporated into pulse oximeters of the future.
Black patients 3X more likely to have hidden hypoxia than White patients
Michael Sjoding, MD, of the University of Michigan, Ann Arbor, was one of the first to raise awareness of skin color–related issues with pulse oximeters during the throes of the COVID-19 pandemic. His study, which involved more than 10,000 patients, showed that Black patients were threefold more likely to have hidden hypoxia than White patients.
The present study shows that such discrepancies are indeed clinically significant, Dr. Sjoding said in an interview. And these data are needed, he added, to bring about change.
“What is being asked is potentially a big deal,” Dr. Sjoding said. “Pulse oximeters are everywhere, and it would be a big undertaking to redesign pulse oximeters and purchase new pulse oximeters. You need a compelling body of evidence to do that. I think it’s there now, clearly. So I’m hopeful that we’re going to finally move forward, towards having devices that we are confident work accurately in everyone.”
Why it has taken so long to gather this evidence, however, is a thornier topic, considering race-related discrepancies in pulse oximeter readings were first documented more than 3 decades ago.
“We sort of rediscovered something that had been known and had been described in the past,” Dr. Sjoding said. He explained how he and many of his colleagues had completed pulmonary fellowships, yet none of them knew of these potential issues with pulse oximeters until they began to observe differences in their own patients during the pandemic.
“I’ll give previous generations of researchers the benefit of the doubt,” Dr. Sjoding said, pointing out that techniques in data gathering and analysis have advanced considerably over the years. “The types of studies that were done before were very different than what we did.”
Yet Dr. Sjoding entertained the possibility that other factors may have been at play.
“I think definitely there’s a social commentary on prioritization of research,” he said.
The study was supported by grants from the National Institutes of Health. The investigators and Dr. Sjoding reported no conflicts of interest.
The new research suggests that skin color–related differences in pulse oximeter readings are in fact impacting clinical decision-making, lead author Eric R. Gottlieb, MD, of Brigham and Women’s Hospital and Massachusetts Institute of Technology, both in Boston, and colleagues wrote. This suggests that technology needs to updated to improve health equity, they continued, in their paper published in JAMA Internal Medicine.
“It has been known for decades that these readings are affected by various surface pigmentations, including nail polish and skin melanin, which may affect light absorption and scattering,” the investigators wrote. “This increases the risk of hidden hypoxemia [among patients with darker skin], in which patients have falsely elevated SpO2 readings, usually defined as 92% or greater, with a blood hemoglobin oxygen saturation less than 88%.”
Although published reports on this phenomenon date back to the 1980s, clinical significance has been largely discounted, they said, citing a 2008 paper on the topic, which stated that “oximetry need not have exact accuracy” to determine if a patient needs oxygen supplementation.
‘We’re not providing equal care’
Questioning the validity of this statement, Dr. Gottlieb and colleagues conducted a retrospective cohort study involving 3,069 patients admitted to intensive care at the Beth Israel Deaconess Medical Center in Boston between 2008 and 2019, thereby excluding patients treated during the COVID-19 pandemic. The population consisted of four races/ethnicities: White (87%), Black (7%), Hispanic (4%), and Asian (3%).
Aligning with previous studies, multivariable linear regression analyses showed that Asian, Black, and Hispanic patients had significantly higher SpO2 readings than White patients in relation to hemoglobin oxygen saturation values, suggesting falsely elevated readings.
Further modeling showed that these same patient groups also received lower oxygen delivery rates, which were not explained directly by race/ethnicity, but instead were mediated by the discrepancy between SpO2 and hemoglobin oxygen saturation values. In other words, physicians were responding consistently to pulse oximetry readings, rather than exhibiting a direct racial/ethnic bias in their clinical decision-making.
“We’re not providing equal care,” Dr. Gottlieb said in an interview. “It’s not that the patients are sicker, or have other socioeconomic explanations for why this happens to them. It’s us. It’s our technology. And that’s something that really has to be fixed.”
The investigators offered a cautionary view of corrective algorithms, as these “have exacerbated disparities and are subject to ethical concerns;” for example, with glomerular filtration rate estimations in Black patients.
Dr. Gottlieb also cautioned against action by individual physicians, who may now be inclined to change how they interpret pulse oximeter readings based on a patient’s race or ethnicity.
“I don’t think that we can expect physicians, every time they see a patient, to be second guessing whether the number basically reflects the truth,” he said.
Instead, Dr. Gottlieb suggested that the burden of change rests upon the shoulders of institutions, including hospitals and device manufacturers, both of which “really need to take the responsibility” for making sure that pulse oximeters are “equitable and have similar performance across races.”
While Dr. Gottlieb said that skin color likely plays the greatest role in measurement discrepancies, he encouraged stakeholders “to think broadly about this, and not just assume that it’s entirely skin color,” noting a small amount of evidence indicating that blood chemistry may also play a role. Still, he predicted that colorimetry – the direct measurement of skin color – will probably be incorporated into pulse oximeters of the future.
Black patients 3X more likely to have hidden hypoxia than White patients
Michael Sjoding, MD, of the University of Michigan, Ann Arbor, was one of the first to raise awareness of skin color–related issues with pulse oximeters during the throes of the COVID-19 pandemic. His study, which involved more than 10,000 patients, showed that Black patients were threefold more likely to have hidden hypoxia than White patients.
The present study shows that such discrepancies are indeed clinically significant, Dr. Sjoding said in an interview. And these data are needed, he added, to bring about change.
“What is being asked is potentially a big deal,” Dr. Sjoding said. “Pulse oximeters are everywhere, and it would be a big undertaking to redesign pulse oximeters and purchase new pulse oximeters. You need a compelling body of evidence to do that. I think it’s there now, clearly. So I’m hopeful that we’re going to finally move forward, towards having devices that we are confident work accurately in everyone.”
Why it has taken so long to gather this evidence, however, is a thornier topic, considering race-related discrepancies in pulse oximeter readings were first documented more than 3 decades ago.
“We sort of rediscovered something that had been known and had been described in the past,” Dr. Sjoding said. He explained how he and many of his colleagues had completed pulmonary fellowships, yet none of them knew of these potential issues with pulse oximeters until they began to observe differences in their own patients during the pandemic.
“I’ll give previous generations of researchers the benefit of the doubt,” Dr. Sjoding said, pointing out that techniques in data gathering and analysis have advanced considerably over the years. “The types of studies that were done before were very different than what we did.”
Yet Dr. Sjoding entertained the possibility that other factors may have been at play.
“I think definitely there’s a social commentary on prioritization of research,” he said.
The study was supported by grants from the National Institutes of Health. The investigators and Dr. Sjoding reported no conflicts of interest.
FROM JAMA INTERNAL MEDICINE
Transplanted pig hearts functioned normally in deceased persons on ventilator support
A team of surgeons successfully transplanted genetically engineered pig hearts into two recently deceased people whose bodies were being maintained on ventilatory support – not in the hope of restoring life, but as a proof-of-concept experiment in xenotransplantation that could eventually help to ease the critical shortage of donor organs.
The surgeries were performed on June 16 and July 6, 2022, using porcine hearts from animals genetically engineered to prevent organ rejection and promote adaptive immunity by human recipients
without utilizing unapproved devices or techniques or medications,” said Nader Moazami, MD, surgical director of heart transplantation and chief of the division of heart and lung transplantation and mechanical circulatory support at NYU Langone Health, New York.
Through 72 hours of postoperative monitoring “we evaluated the heart for functionality and the heart function was completely normal with excellent contractility,” he said at a press briefing announcing early results of the experimental program.
He acknowledged that for the first of the two procedures some surgical modification of the pig heart was required, primarily because of size differences between the donor and recipient.
“Nevertheless, we learned a tremendous amount from the first operation, and when that experience was translated into the second operation it even performed better,” he said.
Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone advanced heart failure program noted that “there are 6 million individuals with heart failure in the United States. About 100,000 of those individuals have end-stage heart failure, and we only do about 3,500 heart transplants a year in the United States, so we have a tremendous deficiency in organs, and there are many people dying waiting for a heart.”
Infection protocols
To date there has been only one xenotransplant of a genetically modified pig heart into a living human recipient, David Bennett Sr., age 57. The surgery, performed at the University of Maryland in January 2022, was initially successful, with the patient able to sit up in bed a few days after the procedure, and the heart performing like a “rock star” according to transplant surgeon Bartley Griffith, MD.
However, Mr. Bennett died 2 months after the procedure from compromise of the organ by an as yet undetermined cause, of which one may have been the heart's infection by porcine cytomegalovirus (CMV).
The NYU team, mindful of this potential setback, used more sensitive assays to screen the donor organs for porcine CMV, and implemented protocols to prevent and to monitor for potential zoonotic transmission of porcine endogenous retrovirus.
The procedure used a dedicated operating room and equipment that will not be used for clinical procedures, the team emphasized.
An organ transplant specialist who was not involved in the study commented that there can be unwelcome surprises even with the most rigorous infection prophylaxis protocols.
“I think these are important steps, but they don’t resolve the question of infectious risk. Sometimes viruses or latent infections are only manifested later,” said Jay A. Fishman, MD, associate director of the Massachusetts General Hospital Transplant Center and director of the transplant infectious diseases and compromised host program at the hospital, which is in Boston.
“I think these are important steps, but as you may recall from the Maryland heart transplant experience, when porcine cytomegalovirus was activated, it was a long way into that patient’s course, and so we just don’t know whether something would have been reactivated later,” he said in an interview.
Dr. Fishman noted that experience with xenotransplantation at the University of Maryland and other centers has suggested that immunosuppressive regimens used for human-to-human transplants may not be suited for animal-to-human grafts.
The hearts were taken from pigs genetically modified with knockouts of four porcine genes to prevent rejection – including a gene for a growth hormone that would otherwise cause the heart to continue to expand in the recipient’s chest – and with the addition of six human transgenes encoding for expression of proteins regulating biologic pathways that might be disrupted by incompatibilities across species.
Vietnam veteran
The organ recipients were recently deceased patients who had expressed the clear wish to be organ donors but whose organs were for clinical reasons unsuitable for transplant.
The first recipient was Lawrence Kelly, a Vietnam War veteran and welder who died from heart failure at the age of 72.
“He was an organ donor, and would be so happy to know how much his contribution to this research will help people like him with this heart disease. He was a hero his whole life, and he went out a hero,” said Alice Michael, Mr. Kelly’s partner of 33 years, who also spoke at the briefing.
“It was, I think, one of the most incredible things to see a pig heart pounding away and beating inside the chest of a human being,” said Robert A. Montgomery, MD, DPhil, director of the NYU Transplant Institute, and himself a heart transplant recipient.
Dr. Fishman said he had no relevant conflicts of interest.
This article was updated on 7/12/22 and 7/14/22.
A team of surgeons successfully transplanted genetically engineered pig hearts into two recently deceased people whose bodies were being maintained on ventilatory support – not in the hope of restoring life, but as a proof-of-concept experiment in xenotransplantation that could eventually help to ease the critical shortage of donor organs.
The surgeries were performed on June 16 and July 6, 2022, using porcine hearts from animals genetically engineered to prevent organ rejection and promote adaptive immunity by human recipients
without utilizing unapproved devices or techniques or medications,” said Nader Moazami, MD, surgical director of heart transplantation and chief of the division of heart and lung transplantation and mechanical circulatory support at NYU Langone Health, New York.
Through 72 hours of postoperative monitoring “we evaluated the heart for functionality and the heart function was completely normal with excellent contractility,” he said at a press briefing announcing early results of the experimental program.
He acknowledged that for the first of the two procedures some surgical modification of the pig heart was required, primarily because of size differences between the donor and recipient.
“Nevertheless, we learned a tremendous amount from the first operation, and when that experience was translated into the second operation it even performed better,” he said.
Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone advanced heart failure program noted that “there are 6 million individuals with heart failure in the United States. About 100,000 of those individuals have end-stage heart failure, and we only do about 3,500 heart transplants a year in the United States, so we have a tremendous deficiency in organs, and there are many people dying waiting for a heart.”
Infection protocols
To date there has been only one xenotransplant of a genetically modified pig heart into a living human recipient, David Bennett Sr., age 57. The surgery, performed at the University of Maryland in January 2022, was initially successful, with the patient able to sit up in bed a few days after the procedure, and the heart performing like a “rock star” according to transplant surgeon Bartley Griffith, MD.
However, Mr. Bennett died 2 months after the procedure from compromise of the organ by an as yet undetermined cause, of which one may have been the heart's infection by porcine cytomegalovirus (CMV).
The NYU team, mindful of this potential setback, used more sensitive assays to screen the donor organs for porcine CMV, and implemented protocols to prevent and to monitor for potential zoonotic transmission of porcine endogenous retrovirus.
The procedure used a dedicated operating room and equipment that will not be used for clinical procedures, the team emphasized.
An organ transplant specialist who was not involved in the study commented that there can be unwelcome surprises even with the most rigorous infection prophylaxis protocols.
“I think these are important steps, but they don’t resolve the question of infectious risk. Sometimes viruses or latent infections are only manifested later,” said Jay A. Fishman, MD, associate director of the Massachusetts General Hospital Transplant Center and director of the transplant infectious diseases and compromised host program at the hospital, which is in Boston.
“I think these are important steps, but as you may recall from the Maryland heart transplant experience, when porcine cytomegalovirus was activated, it was a long way into that patient’s course, and so we just don’t know whether something would have been reactivated later,” he said in an interview.
Dr. Fishman noted that experience with xenotransplantation at the University of Maryland and other centers has suggested that immunosuppressive regimens used for human-to-human transplants may not be suited for animal-to-human grafts.
The hearts were taken from pigs genetically modified with knockouts of four porcine genes to prevent rejection – including a gene for a growth hormone that would otherwise cause the heart to continue to expand in the recipient’s chest – and with the addition of six human transgenes encoding for expression of proteins regulating biologic pathways that might be disrupted by incompatibilities across species.
Vietnam veteran
The organ recipients were recently deceased patients who had expressed the clear wish to be organ donors but whose organs were for clinical reasons unsuitable for transplant.
The first recipient was Lawrence Kelly, a Vietnam War veteran and welder who died from heart failure at the age of 72.
“He was an organ donor, and would be so happy to know how much his contribution to this research will help people like him with this heart disease. He was a hero his whole life, and he went out a hero,” said Alice Michael, Mr. Kelly’s partner of 33 years, who also spoke at the briefing.
“It was, I think, one of the most incredible things to see a pig heart pounding away and beating inside the chest of a human being,” said Robert A. Montgomery, MD, DPhil, director of the NYU Transplant Institute, and himself a heart transplant recipient.
Dr. Fishman said he had no relevant conflicts of interest.
This article was updated on 7/12/22 and 7/14/22.
A team of surgeons successfully transplanted genetically engineered pig hearts into two recently deceased people whose bodies were being maintained on ventilatory support – not in the hope of restoring life, but as a proof-of-concept experiment in xenotransplantation that could eventually help to ease the critical shortage of donor organs.
The surgeries were performed on June 16 and July 6, 2022, using porcine hearts from animals genetically engineered to prevent organ rejection and promote adaptive immunity by human recipients
without utilizing unapproved devices or techniques or medications,” said Nader Moazami, MD, surgical director of heart transplantation and chief of the division of heart and lung transplantation and mechanical circulatory support at NYU Langone Health, New York.
Through 72 hours of postoperative monitoring “we evaluated the heart for functionality and the heart function was completely normal with excellent contractility,” he said at a press briefing announcing early results of the experimental program.
He acknowledged that for the first of the two procedures some surgical modification of the pig heart was required, primarily because of size differences between the donor and recipient.
“Nevertheless, we learned a tremendous amount from the first operation, and when that experience was translated into the second operation it even performed better,” he said.
Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone advanced heart failure program noted that “there are 6 million individuals with heart failure in the United States. About 100,000 of those individuals have end-stage heart failure, and we only do about 3,500 heart transplants a year in the United States, so we have a tremendous deficiency in organs, and there are many people dying waiting for a heart.”
Infection protocols
To date there has been only one xenotransplant of a genetically modified pig heart into a living human recipient, David Bennett Sr., age 57. The surgery, performed at the University of Maryland in January 2022, was initially successful, with the patient able to sit up in bed a few days after the procedure, and the heart performing like a “rock star” according to transplant surgeon Bartley Griffith, MD.
However, Mr. Bennett died 2 months after the procedure from compromise of the organ by an as yet undetermined cause, of which one may have been the heart's infection by porcine cytomegalovirus (CMV).
The NYU team, mindful of this potential setback, used more sensitive assays to screen the donor organs for porcine CMV, and implemented protocols to prevent and to monitor for potential zoonotic transmission of porcine endogenous retrovirus.
The procedure used a dedicated operating room and equipment that will not be used for clinical procedures, the team emphasized.
An organ transplant specialist who was not involved in the study commented that there can be unwelcome surprises even with the most rigorous infection prophylaxis protocols.
“I think these are important steps, but they don’t resolve the question of infectious risk. Sometimes viruses or latent infections are only manifested later,” said Jay A. Fishman, MD, associate director of the Massachusetts General Hospital Transplant Center and director of the transplant infectious diseases and compromised host program at the hospital, which is in Boston.
“I think these are important steps, but as you may recall from the Maryland heart transplant experience, when porcine cytomegalovirus was activated, it was a long way into that patient’s course, and so we just don’t know whether something would have been reactivated later,” he said in an interview.
Dr. Fishman noted that experience with xenotransplantation at the University of Maryland and other centers has suggested that immunosuppressive regimens used for human-to-human transplants may not be suited for animal-to-human grafts.
The hearts were taken from pigs genetically modified with knockouts of four porcine genes to prevent rejection – including a gene for a growth hormone that would otherwise cause the heart to continue to expand in the recipient’s chest – and with the addition of six human transgenes encoding for expression of proteins regulating biologic pathways that might be disrupted by incompatibilities across species.
Vietnam veteran
The organ recipients were recently deceased patients who had expressed the clear wish to be organ donors but whose organs were for clinical reasons unsuitable for transplant.
The first recipient was Lawrence Kelly, a Vietnam War veteran and welder who died from heart failure at the age of 72.
“He was an organ donor, and would be so happy to know how much his contribution to this research will help people like him with this heart disease. He was a hero his whole life, and he went out a hero,” said Alice Michael, Mr. Kelly’s partner of 33 years, who also spoke at the briefing.
“It was, I think, one of the most incredible things to see a pig heart pounding away and beating inside the chest of a human being,” said Robert A. Montgomery, MD, DPhil, director of the NYU Transplant Institute, and himself a heart transplant recipient.
Dr. Fishman said he had no relevant conflicts of interest.
This article was updated on 7/12/22 and 7/14/22.
PCOS ups risk of heart complications during delivery period
Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.
An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.
But a study, published online in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.
“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”
Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.
Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
Solutions?
Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.
“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”
Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.
“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”
The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.
“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”
The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.
An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.
But a study, published online in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.
“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”
Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.
Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
Solutions?
Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.
“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”
Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.
“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”
The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.
“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”
The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.
An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.
But a study, published online in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.
“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”
Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.
Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
Solutions?
Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.
“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”
Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.
“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”
The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.
“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”
The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adding salt to food linked to higher risk of premature death
in a new study.
In the study of more than 500,000 people, compared with those who never or rarely added salt, those who always added salt to their food had a 28% increased risk of dying prematurely (defined as death before the age of 75 years).
Results also showed that adding salt to food was linked to a lower life expectancy. At the age of 50 years, life expectancy was reduced by 1.5 years in women and by 2.28 years in men who always added salt to their food, compared with those who never or rarely did.
However, these increased risks appeared to be attenuated with increasing intakes of high-potassium foods (vegetables and fruits).
The study was published online in the European Heart Journal.
“As far as we are aware, this is the first study to analyze adding salt to meals as a unique measurement for dietary sodium intake. Such a measure is less likely affected by other dietary components, especially potassium intake,” senior author Lu Qi, MD, Tulane University, New Orleans, told this news organization.
“Our study provides supportive evidence from a novel perspective to show the adverse effects of high sodium intake on human health, which is still a controversial topic. Our findings support the advice that reduction of salt intake by reducing the salt added to meals may benefit health and improve life expectancy. Our results also suggest that high intakes of fruits and vegetables are beneficial regarding lowering the adverse effects of salt,” he added.
Link between dietary salt and health is subject of longstanding debate
The researchers explained that the relationship between dietary salt intake and health remains a subject of longstanding debate, with previous studies on the association between sodium intake and mortality having shown conflicting results.
They attributed the inconsistent results to the low accuracy of sodium measurement, noting that sodium intake varies widely from day to day, but the majority of previous studies have largely relied on a single day’s urine collection or dietary survey for estimating the sodium intake, which is inadequate to assess an individual’s usual consumption levels.
They also pointed out that it is difficult to separate the contributions of intakes of sodium and potassium to health based on current methods for measuring dietary sodium and potassium, and this may confound the association between sodium intake and health outcomes.
They noted that the hypothesis that a high-potassium intake may attenuate the adverse association of high-sodium intake with health outcomes has been proposed for many years, but studies assessing the interaction between sodium intake and potassium intake on the risk of mortality are scarce.
Adding salt to food at the table is a common eating behavior directly related to an individual’s long-term preference for salty tasting foods and habitual salt intake, the authors said, adding that commonly used table salt contains 97%-99% sodium chloride, minimizing the potential confounding effects of other dietary factors including potassium. “Therefore, adding salt to foods provides a unique assessment to evaluate the association between habitual sodium intake and mortality.”
UK Biobank study
For the current study Dr. Qi and colleagues analyzed data from 501,379 people taking part in the UK Biobank study. When joining the study between 2006 and 2010, the participants were asked whether they added salt to their foods never/rarely, sometimes, usually or always. Participants were then followed for a median of 9 years.
After adjustment for sex, age, race, smoking, moderate drinking, body mass index, physical activity, Townsend deprivation index, high cholesterol, chronic kidney disease, diabetes, cardiovascular disease, and cancer, results showed an increasing risk of all-cause premature mortality rose with increasing frequency of adding salt to foods.
The adjusted hazard ratios, compared with those who never or rarely added salt, were 1.02 (95% CI, 0.99-1.06) for those who added salt sometimes, 1.07 (95% CI, 1.02-1.11) for those who usually added salt, and 1.28 (95% CI, 1.20-1.35) for those who always added salt.
The researchers also estimated the lower survival time caused by the high frequency of adding salt to foods. At age 50, women who always added salt to foods had an average 1.50 fewer years of life expectancy, and men who always added salt had an average 2.28 fewer years of life expectancy, as compared with their counterparts who never/rarely added salt to foods.
For cause-specific premature mortality, results showed that higher frequency of adding salt to foods was significantly associated with a higher risk of cardiovascular mortality and cancer mortality, but not for dementia mortality or respiratory mortality. For the subtypes of cardiovascular mortality, adding salt to foods was significantly associated with higher risk of stroke mortality but not coronary heart disease mortality.
Other analyses suggested that the association of adding salt to foods with an increased risk of premature mortality appeared to be attenuated with increasing intake of food high in potassium (fruits and vegetables).
The authors point out that the amounts of discretionary sodium intake (the salt used at the table or in home cooking) have been largely overlooked in previous studies, even though adding salt to foods accounts for a considerable proportion of total sodium intake (6%-20%) in Western diets.
“Our findings also support the notion that even a modest reduction in sodium intake is likely to result in substantial health benefits, especially when it is achieved in the general population,” they conclude.
Conflicting information from different studies
But the current findings seem to directly contradict those from another recent study by Messerli and colleagues showing higher sodium intake correlates with improved life expectancy.
Addressing these contradictory results, Dr. Qi commented: “The study of Messerli et al. is based on an ecological design, in which the analysis is performed on country average sodium intake, rather than at the individual level. This type of ecological study has several major limitations, such as the lack of individuals’ sodium intake, uncontrolled confounding, and the cross-sectional nature. Typically, ecological studies are not considered useful for testing hypothesis in epidemiological studies.”
Dr. Qi noted that, in contrast, his current study analyzes individuals’ exposure, and has a prospective design. “Our findings are supported by previous large-scale observational studies and clinical trials which show the high intake of sodium may adversely affect chronic diseases such as cardiovascular disease and hypertension.” =
Lead author of the ecological study, Franz Messerli, MD, Bern (Switzerland) University Hospital, however, was not convinced by the findings from Dr. Qi’s study.
“The difference in 24-hour sodium intake between those who never/rarely added salt and those who always did is a minuscule 0.17 g. It is highly unlikely that such negligible quantity has any impact on blood pressure, not to mention cardiovascular mortality or life expectancy,” he commented in an interview.
He also pointed out that, in Dr. Qi’s study, people who added salt more frequently also consumed more red meat and processed meat, as well as less fish and less fruit and vegetables. “I would suggest that the bad habit of adding salt at the table is simply a powerful marker for an unhealthy diet.”
“There is no question that an excessive salt intake is harmful in hypertensive patients and increases the risk of stroke. But 0.17 g is not going to make any difference,” Dr. Messerli added.
What is the optimum level?
In an editorial accompanying the study by Dr. Qi and colleagues in the European Heart Journal, Annika Rosengren, MD, PhD, Sahlgrenska University Hospital, Gothenburg, Sweden, noted that guidelines recommend a salt intake below 5 g, or about a teaspoon, per day. But few individuals meet this recommendation.
Because several recent studies show a U- or J-shaped association between salt and atherosclerotic cardiovascular disease, reducing salt intake across the whole population may not be universally beneficial, Dr. Rosengren said.
“So far, what the collective evidence about salt seems to indicate is that healthy people consuming what constitutes normal levels of ordinary salt need not worry too much about their salt intake,” she wrote.
Instead, she advised a diet rich in fruit and vegetables should be a priority to counterbalance potentially harmful effects of salt, and for many other reasons.
And she added that people at high risk, such as those with hypertension who have a high salt intake, are probably well advised to cut down, and not adding extra salt to already prepared foods is one way of achieving this. However, at the individual level, the optimal salt consumption range, or the “sweet spot” remains to be determined.
“Not adding extra salt to food is unlikely to be harmful and could contribute to strategies to lower population blood pressure levels,” Dr. Rosengren concluded.
A version of this article first appeared on Medscape.com.
in a new study.
In the study of more than 500,000 people, compared with those who never or rarely added salt, those who always added salt to their food had a 28% increased risk of dying prematurely (defined as death before the age of 75 years).
Results also showed that adding salt to food was linked to a lower life expectancy. At the age of 50 years, life expectancy was reduced by 1.5 years in women and by 2.28 years in men who always added salt to their food, compared with those who never or rarely did.
However, these increased risks appeared to be attenuated with increasing intakes of high-potassium foods (vegetables and fruits).
The study was published online in the European Heart Journal.
“As far as we are aware, this is the first study to analyze adding salt to meals as a unique measurement for dietary sodium intake. Such a measure is less likely affected by other dietary components, especially potassium intake,” senior author Lu Qi, MD, Tulane University, New Orleans, told this news organization.
“Our study provides supportive evidence from a novel perspective to show the adverse effects of high sodium intake on human health, which is still a controversial topic. Our findings support the advice that reduction of salt intake by reducing the salt added to meals may benefit health and improve life expectancy. Our results also suggest that high intakes of fruits and vegetables are beneficial regarding lowering the adverse effects of salt,” he added.
Link between dietary salt and health is subject of longstanding debate
The researchers explained that the relationship between dietary salt intake and health remains a subject of longstanding debate, with previous studies on the association between sodium intake and mortality having shown conflicting results.
They attributed the inconsistent results to the low accuracy of sodium measurement, noting that sodium intake varies widely from day to day, but the majority of previous studies have largely relied on a single day’s urine collection or dietary survey for estimating the sodium intake, which is inadequate to assess an individual’s usual consumption levels.
They also pointed out that it is difficult to separate the contributions of intakes of sodium and potassium to health based on current methods for measuring dietary sodium and potassium, and this may confound the association between sodium intake and health outcomes.
They noted that the hypothesis that a high-potassium intake may attenuate the adverse association of high-sodium intake with health outcomes has been proposed for many years, but studies assessing the interaction between sodium intake and potassium intake on the risk of mortality are scarce.
Adding salt to food at the table is a common eating behavior directly related to an individual’s long-term preference for salty tasting foods and habitual salt intake, the authors said, adding that commonly used table salt contains 97%-99% sodium chloride, minimizing the potential confounding effects of other dietary factors including potassium. “Therefore, adding salt to foods provides a unique assessment to evaluate the association between habitual sodium intake and mortality.”
UK Biobank study
For the current study Dr. Qi and colleagues analyzed data from 501,379 people taking part in the UK Biobank study. When joining the study between 2006 and 2010, the participants were asked whether they added salt to their foods never/rarely, sometimes, usually or always. Participants were then followed for a median of 9 years.
After adjustment for sex, age, race, smoking, moderate drinking, body mass index, physical activity, Townsend deprivation index, high cholesterol, chronic kidney disease, diabetes, cardiovascular disease, and cancer, results showed an increasing risk of all-cause premature mortality rose with increasing frequency of adding salt to foods.
The adjusted hazard ratios, compared with those who never or rarely added salt, were 1.02 (95% CI, 0.99-1.06) for those who added salt sometimes, 1.07 (95% CI, 1.02-1.11) for those who usually added salt, and 1.28 (95% CI, 1.20-1.35) for those who always added salt.
The researchers also estimated the lower survival time caused by the high frequency of adding salt to foods. At age 50, women who always added salt to foods had an average 1.50 fewer years of life expectancy, and men who always added salt had an average 2.28 fewer years of life expectancy, as compared with their counterparts who never/rarely added salt to foods.
For cause-specific premature mortality, results showed that higher frequency of adding salt to foods was significantly associated with a higher risk of cardiovascular mortality and cancer mortality, but not for dementia mortality or respiratory mortality. For the subtypes of cardiovascular mortality, adding salt to foods was significantly associated with higher risk of stroke mortality but not coronary heart disease mortality.
Other analyses suggested that the association of adding salt to foods with an increased risk of premature mortality appeared to be attenuated with increasing intake of food high in potassium (fruits and vegetables).
The authors point out that the amounts of discretionary sodium intake (the salt used at the table or in home cooking) have been largely overlooked in previous studies, even though adding salt to foods accounts for a considerable proportion of total sodium intake (6%-20%) in Western diets.
“Our findings also support the notion that even a modest reduction in sodium intake is likely to result in substantial health benefits, especially when it is achieved in the general population,” they conclude.
Conflicting information from different studies
But the current findings seem to directly contradict those from another recent study by Messerli and colleagues showing higher sodium intake correlates with improved life expectancy.
Addressing these contradictory results, Dr. Qi commented: “The study of Messerli et al. is based on an ecological design, in which the analysis is performed on country average sodium intake, rather than at the individual level. This type of ecological study has several major limitations, such as the lack of individuals’ sodium intake, uncontrolled confounding, and the cross-sectional nature. Typically, ecological studies are not considered useful for testing hypothesis in epidemiological studies.”
Dr. Qi noted that, in contrast, his current study analyzes individuals’ exposure, and has a prospective design. “Our findings are supported by previous large-scale observational studies and clinical trials which show the high intake of sodium may adversely affect chronic diseases such as cardiovascular disease and hypertension.” =
Lead author of the ecological study, Franz Messerli, MD, Bern (Switzerland) University Hospital, however, was not convinced by the findings from Dr. Qi’s study.
“The difference in 24-hour sodium intake between those who never/rarely added salt and those who always did is a minuscule 0.17 g. It is highly unlikely that such negligible quantity has any impact on blood pressure, not to mention cardiovascular mortality or life expectancy,” he commented in an interview.
He also pointed out that, in Dr. Qi’s study, people who added salt more frequently also consumed more red meat and processed meat, as well as less fish and less fruit and vegetables. “I would suggest that the bad habit of adding salt at the table is simply a powerful marker for an unhealthy diet.”
“There is no question that an excessive salt intake is harmful in hypertensive patients and increases the risk of stroke. But 0.17 g is not going to make any difference,” Dr. Messerli added.
What is the optimum level?
In an editorial accompanying the study by Dr. Qi and colleagues in the European Heart Journal, Annika Rosengren, MD, PhD, Sahlgrenska University Hospital, Gothenburg, Sweden, noted that guidelines recommend a salt intake below 5 g, or about a teaspoon, per day. But few individuals meet this recommendation.
Because several recent studies show a U- or J-shaped association between salt and atherosclerotic cardiovascular disease, reducing salt intake across the whole population may not be universally beneficial, Dr. Rosengren said.
“So far, what the collective evidence about salt seems to indicate is that healthy people consuming what constitutes normal levels of ordinary salt need not worry too much about their salt intake,” she wrote.
Instead, she advised a diet rich in fruit and vegetables should be a priority to counterbalance potentially harmful effects of salt, and for many other reasons.
And she added that people at high risk, such as those with hypertension who have a high salt intake, are probably well advised to cut down, and not adding extra salt to already prepared foods is one way of achieving this. However, at the individual level, the optimal salt consumption range, or the “sweet spot” remains to be determined.
“Not adding extra salt to food is unlikely to be harmful and could contribute to strategies to lower population blood pressure levels,” Dr. Rosengren concluded.
A version of this article first appeared on Medscape.com.
in a new study.
In the study of more than 500,000 people, compared with those who never or rarely added salt, those who always added salt to their food had a 28% increased risk of dying prematurely (defined as death before the age of 75 years).
Results also showed that adding salt to food was linked to a lower life expectancy. At the age of 50 years, life expectancy was reduced by 1.5 years in women and by 2.28 years in men who always added salt to their food, compared with those who never or rarely did.
However, these increased risks appeared to be attenuated with increasing intakes of high-potassium foods (vegetables and fruits).
The study was published online in the European Heart Journal.
“As far as we are aware, this is the first study to analyze adding salt to meals as a unique measurement for dietary sodium intake. Such a measure is less likely affected by other dietary components, especially potassium intake,” senior author Lu Qi, MD, Tulane University, New Orleans, told this news organization.
“Our study provides supportive evidence from a novel perspective to show the adverse effects of high sodium intake on human health, which is still a controversial topic. Our findings support the advice that reduction of salt intake by reducing the salt added to meals may benefit health and improve life expectancy. Our results also suggest that high intakes of fruits and vegetables are beneficial regarding lowering the adverse effects of salt,” he added.
Link between dietary salt and health is subject of longstanding debate
The researchers explained that the relationship between dietary salt intake and health remains a subject of longstanding debate, with previous studies on the association between sodium intake and mortality having shown conflicting results.
They attributed the inconsistent results to the low accuracy of sodium measurement, noting that sodium intake varies widely from day to day, but the majority of previous studies have largely relied on a single day’s urine collection or dietary survey for estimating the sodium intake, which is inadequate to assess an individual’s usual consumption levels.
They also pointed out that it is difficult to separate the contributions of intakes of sodium and potassium to health based on current methods for measuring dietary sodium and potassium, and this may confound the association between sodium intake and health outcomes.
They noted that the hypothesis that a high-potassium intake may attenuate the adverse association of high-sodium intake with health outcomes has been proposed for many years, but studies assessing the interaction between sodium intake and potassium intake on the risk of mortality are scarce.
Adding salt to food at the table is a common eating behavior directly related to an individual’s long-term preference for salty tasting foods and habitual salt intake, the authors said, adding that commonly used table salt contains 97%-99% sodium chloride, minimizing the potential confounding effects of other dietary factors including potassium. “Therefore, adding salt to foods provides a unique assessment to evaluate the association between habitual sodium intake and mortality.”
UK Biobank study
For the current study Dr. Qi and colleagues analyzed data from 501,379 people taking part in the UK Biobank study. When joining the study between 2006 and 2010, the participants were asked whether they added salt to their foods never/rarely, sometimes, usually or always. Participants were then followed for a median of 9 years.
After adjustment for sex, age, race, smoking, moderate drinking, body mass index, physical activity, Townsend deprivation index, high cholesterol, chronic kidney disease, diabetes, cardiovascular disease, and cancer, results showed an increasing risk of all-cause premature mortality rose with increasing frequency of adding salt to foods.
The adjusted hazard ratios, compared with those who never or rarely added salt, were 1.02 (95% CI, 0.99-1.06) for those who added salt sometimes, 1.07 (95% CI, 1.02-1.11) for those who usually added salt, and 1.28 (95% CI, 1.20-1.35) for those who always added salt.
The researchers also estimated the lower survival time caused by the high frequency of adding salt to foods. At age 50, women who always added salt to foods had an average 1.50 fewer years of life expectancy, and men who always added salt had an average 2.28 fewer years of life expectancy, as compared with their counterparts who never/rarely added salt to foods.
For cause-specific premature mortality, results showed that higher frequency of adding salt to foods was significantly associated with a higher risk of cardiovascular mortality and cancer mortality, but not for dementia mortality or respiratory mortality. For the subtypes of cardiovascular mortality, adding salt to foods was significantly associated with higher risk of stroke mortality but not coronary heart disease mortality.
Other analyses suggested that the association of adding salt to foods with an increased risk of premature mortality appeared to be attenuated with increasing intake of food high in potassium (fruits and vegetables).
The authors point out that the amounts of discretionary sodium intake (the salt used at the table or in home cooking) have been largely overlooked in previous studies, even though adding salt to foods accounts for a considerable proportion of total sodium intake (6%-20%) in Western diets.
“Our findings also support the notion that even a modest reduction in sodium intake is likely to result in substantial health benefits, especially when it is achieved in the general population,” they conclude.
Conflicting information from different studies
But the current findings seem to directly contradict those from another recent study by Messerli and colleagues showing higher sodium intake correlates with improved life expectancy.
Addressing these contradictory results, Dr. Qi commented: “The study of Messerli et al. is based on an ecological design, in which the analysis is performed on country average sodium intake, rather than at the individual level. This type of ecological study has several major limitations, such as the lack of individuals’ sodium intake, uncontrolled confounding, and the cross-sectional nature. Typically, ecological studies are not considered useful for testing hypothesis in epidemiological studies.”
Dr. Qi noted that, in contrast, his current study analyzes individuals’ exposure, and has a prospective design. “Our findings are supported by previous large-scale observational studies and clinical trials which show the high intake of sodium may adversely affect chronic diseases such as cardiovascular disease and hypertension.” =
Lead author of the ecological study, Franz Messerli, MD, Bern (Switzerland) University Hospital, however, was not convinced by the findings from Dr. Qi’s study.
“The difference in 24-hour sodium intake between those who never/rarely added salt and those who always did is a minuscule 0.17 g. It is highly unlikely that such negligible quantity has any impact on blood pressure, not to mention cardiovascular mortality or life expectancy,” he commented in an interview.
He also pointed out that, in Dr. Qi’s study, people who added salt more frequently also consumed more red meat and processed meat, as well as less fish and less fruit and vegetables. “I would suggest that the bad habit of adding salt at the table is simply a powerful marker for an unhealthy diet.”
“There is no question that an excessive salt intake is harmful in hypertensive patients and increases the risk of stroke. But 0.17 g is not going to make any difference,” Dr. Messerli added.
What is the optimum level?
In an editorial accompanying the study by Dr. Qi and colleagues in the European Heart Journal, Annika Rosengren, MD, PhD, Sahlgrenska University Hospital, Gothenburg, Sweden, noted that guidelines recommend a salt intake below 5 g, or about a teaspoon, per day. But few individuals meet this recommendation.
Because several recent studies show a U- or J-shaped association between salt and atherosclerotic cardiovascular disease, reducing salt intake across the whole population may not be universally beneficial, Dr. Rosengren said.
“So far, what the collective evidence about salt seems to indicate is that healthy people consuming what constitutes normal levels of ordinary salt need not worry too much about their salt intake,” she wrote.
Instead, she advised a diet rich in fruit and vegetables should be a priority to counterbalance potentially harmful effects of salt, and for many other reasons.
And she added that people at high risk, such as those with hypertension who have a high salt intake, are probably well advised to cut down, and not adding extra salt to already prepared foods is one way of achieving this. However, at the individual level, the optimal salt consumption range, or the “sweet spot” remains to be determined.
“Not adding extra salt to food is unlikely to be harmful and could contribute to strategies to lower population blood pressure levels,” Dr. Rosengren concluded.
A version of this article first appeared on Medscape.com.
FROM THE EUROPEAN HEART JOURNAL
Doc releases song after racist massacre in Buffalo
Physician-musician Cleveland Francis, MD, responded to the recent mass shooting in Buffalo, New York, which left 10 dead, in the only way he knew how. He wrote and recorded a song to honor the victims as “a plea to the other side to recognize us as people,” the Black cardiologist told this news organization.
He couldn’t sleep after the shooting, and “this song was just in my head.” In the 1990s, Dr. Francis took a 3-year sabbatical from medicine to perform and tour as a country singer. He leveraged his Nashville connections to get “Buffalo” produced and recorded.
Acclaimed artist James Threalkill created the accompanying art, titled “The Heavenly Escort of the Buffalo 10,” after listening to a scratch demo.
Dr. Francis doesn’t want people to overlook the massacre as just another gun violence incident because this was “overt hate-crime racism,” he said.
According to the affidavit submitted by FBI agent Christopher J. Dlugokinski, the suspect’s “motive for the mass shooting was to prevent Black people from replacing White people and eliminating the White race, and to inspire others to commit similar attacks.”
Dr. Francis views the Buffalo shooting as distinct from cases like the murder of George Floyd that involved crime or police. It immediately made him think of the Mother Emanuel Church shooting in Charleston, South Carolina. “Having a black skin is now a death warrant,” he said.
The song is also an appeal for White people to fight racism. Dr. Francis is concerned about young men caught up in white supremacy and suggests that we be more alert to children or grandchildren who disconnect from their families, spend time on the dark web, and access guns. The lyrics deliberately don’t mention guns because Dr. Francis wanted to stay out of that debate. “I just sang: ‘What else do I have to do to prove to you that I’m human too?’ ”
Despite his country credentials, Dr. Francis wrote “Buffalo” as a Gospel song because that genre “connects with Black people more and because that civil rights movement was through the church with Dr. Martin Luther King,” he explained. Although he sings all styles of music, the song is performed by Nashville-based singer Michael Lusk so that it’s not a “Cleve Francis thing,” he said, referring to his stage name.
Songwriter Norman Kerner collaborated on the song. The music was produced and recorded by David Thein and mixed by Bob Bullock of Nashville, who Dr. Francis had worked with when he was an artist on Capitol Records.
They sent the video and artwork to the Mayor of Buffalo, Byron Brown, but have yet to hear back. Dr. Francis hopes it could be part of their healing, noting that some people used the song in their Juneteenth celebrations.
The Louisiana native grew up during segregation and was one of two Black students in the Medical College of Virginia class of 1973. After completing his cardiology fellowship, no one would hire him, so Dr. Francis set up his own practice in Northern Virginia. He now works at Inova Heart and Vascular Institute in Alexandria, Va. He remains optimistic about race relations in America and would love a Black pop or Gospel star to record “Buffalo” and bring it to a wider audience.
Dr. Francis is a regular blogger for Medscape. His contribution to country music is recognized in the National Museum of African American History and Culture in Washington, DC. You can find more of his music on YouTube.
A version of this article first appeared on Medscape.com.
Physician-musician Cleveland Francis, MD, responded to the recent mass shooting in Buffalo, New York, which left 10 dead, in the only way he knew how. He wrote and recorded a song to honor the victims as “a plea to the other side to recognize us as people,” the Black cardiologist told this news organization.
He couldn’t sleep after the shooting, and “this song was just in my head.” In the 1990s, Dr. Francis took a 3-year sabbatical from medicine to perform and tour as a country singer. He leveraged his Nashville connections to get “Buffalo” produced and recorded.
Acclaimed artist James Threalkill created the accompanying art, titled “The Heavenly Escort of the Buffalo 10,” after listening to a scratch demo.
Dr. Francis doesn’t want people to overlook the massacre as just another gun violence incident because this was “overt hate-crime racism,” he said.
According to the affidavit submitted by FBI agent Christopher J. Dlugokinski, the suspect’s “motive for the mass shooting was to prevent Black people from replacing White people and eliminating the White race, and to inspire others to commit similar attacks.”
Dr. Francis views the Buffalo shooting as distinct from cases like the murder of George Floyd that involved crime or police. It immediately made him think of the Mother Emanuel Church shooting in Charleston, South Carolina. “Having a black skin is now a death warrant,” he said.
The song is also an appeal for White people to fight racism. Dr. Francis is concerned about young men caught up in white supremacy and suggests that we be more alert to children or grandchildren who disconnect from their families, spend time on the dark web, and access guns. The lyrics deliberately don’t mention guns because Dr. Francis wanted to stay out of that debate. “I just sang: ‘What else do I have to do to prove to you that I’m human too?’ ”
Despite his country credentials, Dr. Francis wrote “Buffalo” as a Gospel song because that genre “connects with Black people more and because that civil rights movement was through the church with Dr. Martin Luther King,” he explained. Although he sings all styles of music, the song is performed by Nashville-based singer Michael Lusk so that it’s not a “Cleve Francis thing,” he said, referring to his stage name.
Songwriter Norman Kerner collaborated on the song. The music was produced and recorded by David Thein and mixed by Bob Bullock of Nashville, who Dr. Francis had worked with when he was an artist on Capitol Records.
They sent the video and artwork to the Mayor of Buffalo, Byron Brown, but have yet to hear back. Dr. Francis hopes it could be part of their healing, noting that some people used the song in their Juneteenth celebrations.
The Louisiana native grew up during segregation and was one of two Black students in the Medical College of Virginia class of 1973. After completing his cardiology fellowship, no one would hire him, so Dr. Francis set up his own practice in Northern Virginia. He now works at Inova Heart and Vascular Institute in Alexandria, Va. He remains optimistic about race relations in America and would love a Black pop or Gospel star to record “Buffalo” and bring it to a wider audience.
Dr. Francis is a regular blogger for Medscape. His contribution to country music is recognized in the National Museum of African American History and Culture in Washington, DC. You can find more of his music on YouTube.
A version of this article first appeared on Medscape.com.
Physician-musician Cleveland Francis, MD, responded to the recent mass shooting in Buffalo, New York, which left 10 dead, in the only way he knew how. He wrote and recorded a song to honor the victims as “a plea to the other side to recognize us as people,” the Black cardiologist told this news organization.
He couldn’t sleep after the shooting, and “this song was just in my head.” In the 1990s, Dr. Francis took a 3-year sabbatical from medicine to perform and tour as a country singer. He leveraged his Nashville connections to get “Buffalo” produced and recorded.
Acclaimed artist James Threalkill created the accompanying art, titled “The Heavenly Escort of the Buffalo 10,” after listening to a scratch demo.
Dr. Francis doesn’t want people to overlook the massacre as just another gun violence incident because this was “overt hate-crime racism,” he said.
According to the affidavit submitted by FBI agent Christopher J. Dlugokinski, the suspect’s “motive for the mass shooting was to prevent Black people from replacing White people and eliminating the White race, and to inspire others to commit similar attacks.”
Dr. Francis views the Buffalo shooting as distinct from cases like the murder of George Floyd that involved crime or police. It immediately made him think of the Mother Emanuel Church shooting in Charleston, South Carolina. “Having a black skin is now a death warrant,” he said.
The song is also an appeal for White people to fight racism. Dr. Francis is concerned about young men caught up in white supremacy and suggests that we be more alert to children or grandchildren who disconnect from their families, spend time on the dark web, and access guns. The lyrics deliberately don’t mention guns because Dr. Francis wanted to stay out of that debate. “I just sang: ‘What else do I have to do to prove to you that I’m human too?’ ”
Despite his country credentials, Dr. Francis wrote “Buffalo” as a Gospel song because that genre “connects with Black people more and because that civil rights movement was through the church with Dr. Martin Luther King,” he explained. Although he sings all styles of music, the song is performed by Nashville-based singer Michael Lusk so that it’s not a “Cleve Francis thing,” he said, referring to his stage name.
Songwriter Norman Kerner collaborated on the song. The music was produced and recorded by David Thein and mixed by Bob Bullock of Nashville, who Dr. Francis had worked with when he was an artist on Capitol Records.
They sent the video and artwork to the Mayor of Buffalo, Byron Brown, but have yet to hear back. Dr. Francis hopes it could be part of their healing, noting that some people used the song in their Juneteenth celebrations.
The Louisiana native grew up during segregation and was one of two Black students in the Medical College of Virginia class of 1973. After completing his cardiology fellowship, no one would hire him, so Dr. Francis set up his own practice in Northern Virginia. He now works at Inova Heart and Vascular Institute in Alexandria, Va. He remains optimistic about race relations in America and would love a Black pop or Gospel star to record “Buffalo” and bring it to a wider audience.
Dr. Francis is a regular blogger for Medscape. His contribution to country music is recognized in the National Museum of African American History and Culture in Washington, DC. You can find more of his music on YouTube.
A version of this article first appeared on Medscape.com.
New AHA checklist: Only one in five adults has optimal heart health
About 80% of American adults have low to moderate cardiovascular (CV) health based on the American Heart Association checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health.
With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist.
“The new metric of sleep duration reflects the latest research findings: Sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure, or risk for type 2 diabetes more effectively,” AHA President Donald M. Lloyd-Jones, MD, said in a news release.
“In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home,” said Dr. Lloyd-Jones, chair of the department of preventive medicine at Northwestern University in Chicago.
The AHA Presidential Advisory – Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health – was published online in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the U.S. population is “suboptimal, and we see important differences across age and sociodemographic groups,” Dr. Lloyd-Jones said.
Refining Life’s Simple 7
The AHA first defined the seven metrics for optimal CV health in 2010. After 12 years and more than 2,400 scientific papers on the topic, new discoveries in CV health and ways to measure it provided an opportunity to revisit each health component in more detail and provide updates as needed, the AHA explains.
“We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people,” Dr. Lloyd-Jones said.
Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools, and the scoring system can now also be applied to anyone ages 2 and older. Here is a snapshot of Life’s Essential 8 metrics, including updates.
1. Diet (updated)
The tool includes a new guide to assess diet quality for adults and children at the individual and population level. At the population level, dietary assessment is based on daily intake of elements in the Dietary Approaches to Stop Hypertension (DASH) eating pattern. For individuals, the Mediterranean Eating Pattern for Americans (MEPA) is used to assess and monitor cardiovascular health.
2. Physical activity (no changes)
Physical activity continues to be measured by the total number of minutes of moderate or vigorous physical activity per week, as defined by the U.S. Physical Activity Guidelines for Americans (2nd edition). The optimal level is 150 minutes (2.5 hours) of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes (7 hours) or more per week for children ages 6 and older; and age-specific modifications for younger children.
3. Nicotine exposure (updated)
Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, has been added since the previous metric monitored only traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Second-hand smoke exposure for children and adults has also been added.
4. Sleep duration (new)
Sleep duration is associated with CV health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
5. Body mass index (no changes)
The AHA acknowledges that body mass index (BMI) is an imperfect metric. Yet, because it’s easily calculated and widely available, BMI continues as a “reasonable” gauge to assess weight categories that may lead to health problems. BMI of 18.5-24.9 is associated with the highest levels of CV health. The AHA notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as CVD or type 2 diabetes is higher at a lower BMI.
6. Blood lipids (updated)
The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
7. Blood glucose (updated)
This metric is expanded to include the option of hemoglobin A1c readings or blood glucose levels for people with or without type 1 or 2 diabetes or prediabetes.
8. Blood pressure (no changes)
Blood pressure criteria remain unchanged from 2017 guidance that established levels less than 120/80 mm Hg as optimal, and defined hypertension as 130-139 mm Hg systolic pressure or 80-89 mm Hg diastolic pressure.
‘Concerning’ new data
Results of the first study using Life’s Essential 8 show that the overall CV health of the U.S. population is “well below ideal,” with 80% of adults scoring at a low or moderate level, the researchers report.
Data for the analysis came from 2013-2018 U.S. National Health and Nutrition Examination surveys (NHANES) of more than 13,500 adults aged 20-79 years and nearly 9,900 children aged 2-19 years. Among the key findings:
- The average CV health score based on Life’s Essential 8 was 64.7 for adults and 65.5 for children – in the moderate range on the 0-100 scale.
- Only 0.45% of adults had a perfect score of 100; 20% had high CV health (score of 80 or higher), 63% moderate (score of 50-79), and 18% had low CV health (score of less than 50).
- Adult women had higher average CV health scores (67) compared with men (62.5).
- In general, adults scored lowest in the areas of diet, physical activity, and BMI.
- CV health scores were generally lower at older ages.
- Non-Hispanic Asian Americans had a higher average CV health score than other racial/ethnic groups. Non-Hispanic Whites had the second highest average CV health score, followed, in order, by Hispanic (other than Mexican), Mexican, and non-Hispanic Blacks.
- Children’s diet scores were low, at an average of 40.6.
- Adult sociodemographic groups varied notably in CV health scores for diet, nicotine exposure, blood glucose, and blood pressure.
“These data represent the first look at the cardiovascular health of the U.S. population using the AHA’s new Life’s Essential 8 scoring algorithm,” Dr. Lloyd-Jones said.
“Life’s Essential 8 is a major step forward in our ability to identify when cardiovascular health can be preserved and when it is suboptimal. It should energize efforts to improve cardiovascular health for all people and at every life stage,” Dr. Lloyd-Jones added.
“Analyses like this can help policymakers, communities, clinicians, and the public to understand the opportunities to intervene to improve and maintain optimal cardiovascular health across the life course,” he said.
This research had no commercial funding. The authors have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
About 80% of American adults have low to moderate cardiovascular (CV) health based on the American Heart Association checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health.
With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist.
“The new metric of sleep duration reflects the latest research findings: Sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure, or risk for type 2 diabetes more effectively,” AHA President Donald M. Lloyd-Jones, MD, said in a news release.
“In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home,” said Dr. Lloyd-Jones, chair of the department of preventive medicine at Northwestern University in Chicago.
The AHA Presidential Advisory – Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health – was published online in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the U.S. population is “suboptimal, and we see important differences across age and sociodemographic groups,” Dr. Lloyd-Jones said.
Refining Life’s Simple 7
The AHA first defined the seven metrics for optimal CV health in 2010. After 12 years and more than 2,400 scientific papers on the topic, new discoveries in CV health and ways to measure it provided an opportunity to revisit each health component in more detail and provide updates as needed, the AHA explains.
“We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people,” Dr. Lloyd-Jones said.
Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools, and the scoring system can now also be applied to anyone ages 2 and older. Here is a snapshot of Life’s Essential 8 metrics, including updates.
1. Diet (updated)
The tool includes a new guide to assess diet quality for adults and children at the individual and population level. At the population level, dietary assessment is based on daily intake of elements in the Dietary Approaches to Stop Hypertension (DASH) eating pattern. For individuals, the Mediterranean Eating Pattern for Americans (MEPA) is used to assess and monitor cardiovascular health.
2. Physical activity (no changes)
Physical activity continues to be measured by the total number of minutes of moderate or vigorous physical activity per week, as defined by the U.S. Physical Activity Guidelines for Americans (2nd edition). The optimal level is 150 minutes (2.5 hours) of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes (7 hours) or more per week for children ages 6 and older; and age-specific modifications for younger children.
3. Nicotine exposure (updated)
Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, has been added since the previous metric monitored only traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Second-hand smoke exposure for children and adults has also been added.
4. Sleep duration (new)
Sleep duration is associated with CV health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
5. Body mass index (no changes)
The AHA acknowledges that body mass index (BMI) is an imperfect metric. Yet, because it’s easily calculated and widely available, BMI continues as a “reasonable” gauge to assess weight categories that may lead to health problems. BMI of 18.5-24.9 is associated with the highest levels of CV health. The AHA notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as CVD or type 2 diabetes is higher at a lower BMI.
6. Blood lipids (updated)
The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
7. Blood glucose (updated)
This metric is expanded to include the option of hemoglobin A1c readings or blood glucose levels for people with or without type 1 or 2 diabetes or prediabetes.
8. Blood pressure (no changes)
Blood pressure criteria remain unchanged from 2017 guidance that established levels less than 120/80 mm Hg as optimal, and defined hypertension as 130-139 mm Hg systolic pressure or 80-89 mm Hg diastolic pressure.
‘Concerning’ new data
Results of the first study using Life’s Essential 8 show that the overall CV health of the U.S. population is “well below ideal,” with 80% of adults scoring at a low or moderate level, the researchers report.
Data for the analysis came from 2013-2018 U.S. National Health and Nutrition Examination surveys (NHANES) of more than 13,500 adults aged 20-79 years and nearly 9,900 children aged 2-19 years. Among the key findings:
- The average CV health score based on Life’s Essential 8 was 64.7 for adults and 65.5 for children – in the moderate range on the 0-100 scale.
- Only 0.45% of adults had a perfect score of 100; 20% had high CV health (score of 80 or higher), 63% moderate (score of 50-79), and 18% had low CV health (score of less than 50).
- Adult women had higher average CV health scores (67) compared with men (62.5).
- In general, adults scored lowest in the areas of diet, physical activity, and BMI.
- CV health scores were generally lower at older ages.
- Non-Hispanic Asian Americans had a higher average CV health score than other racial/ethnic groups. Non-Hispanic Whites had the second highest average CV health score, followed, in order, by Hispanic (other than Mexican), Mexican, and non-Hispanic Blacks.
- Children’s diet scores were low, at an average of 40.6.
- Adult sociodemographic groups varied notably in CV health scores for diet, nicotine exposure, blood glucose, and blood pressure.
“These data represent the first look at the cardiovascular health of the U.S. population using the AHA’s new Life’s Essential 8 scoring algorithm,” Dr. Lloyd-Jones said.
“Life’s Essential 8 is a major step forward in our ability to identify when cardiovascular health can be preserved and when it is suboptimal. It should energize efforts to improve cardiovascular health for all people and at every life stage,” Dr. Lloyd-Jones added.
“Analyses like this can help policymakers, communities, clinicians, and the public to understand the opportunities to intervene to improve and maintain optimal cardiovascular health across the life course,” he said.
This research had no commercial funding. The authors have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
About 80% of American adults have low to moderate cardiovascular (CV) health based on the American Heart Association checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health.
With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist.
“The new metric of sleep duration reflects the latest research findings: Sleep impacts overall health, and people who have healthier sleep patterns manage health factors such as weight, blood pressure, or risk for type 2 diabetes more effectively,” AHA President Donald M. Lloyd-Jones, MD, said in a news release.
“In addition, advances in ways to measure sleep, such as with wearable devices, now offer people the ability to reliably and routinely monitor their sleep habits at home,” said Dr. Lloyd-Jones, chair of the department of preventive medicine at Northwestern University in Chicago.
The AHA Presidential Advisory – Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health – was published online in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the U.S. population is “suboptimal, and we see important differences across age and sociodemographic groups,” Dr. Lloyd-Jones said.
Refining Life’s Simple 7
The AHA first defined the seven metrics for optimal CV health in 2010. After 12 years and more than 2,400 scientific papers on the topic, new discoveries in CV health and ways to measure it provided an opportunity to revisit each health component in more detail and provide updates as needed, the AHA explains.
“We felt it was the right time to conduct a comprehensive review of the latest research to refine the existing metrics and consider any new metrics that add value to assessing cardiovascular health for all people,” Dr. Lloyd-Jones said.
Four of the original metrics have been redefined for consistency with newer clinical guidelines or compatibility with new measurement tools, and the scoring system can now also be applied to anyone ages 2 and older. Here is a snapshot of Life’s Essential 8 metrics, including updates.
1. Diet (updated)
The tool includes a new guide to assess diet quality for adults and children at the individual and population level. At the population level, dietary assessment is based on daily intake of elements in the Dietary Approaches to Stop Hypertension (DASH) eating pattern. For individuals, the Mediterranean Eating Pattern for Americans (MEPA) is used to assess and monitor cardiovascular health.
2. Physical activity (no changes)
Physical activity continues to be measured by the total number of minutes of moderate or vigorous physical activity per week, as defined by the U.S. Physical Activity Guidelines for Americans (2nd edition). The optimal level is 150 minutes (2.5 hours) of moderate physical activity or more per week or 75 minutes per week of vigorous-intensity physical activity for adults; 420 minutes (7 hours) or more per week for children ages 6 and older; and age-specific modifications for younger children.
3. Nicotine exposure (updated)
Use of inhaled nicotine-delivery systems, which includes e-cigarettes or vaping devices, has been added since the previous metric monitored only traditional, combustible cigarettes. This reflects use by adults and youth and their implications on long-term health. Second-hand smoke exposure for children and adults has also been added.
4. Sleep duration (new)
Sleep duration is associated with CV health. Measured by average hours of sleep per night, the ideal level is 7-9 hours daily for adults. Ideal daily sleep ranges for children are 10-16 hours per 24 hours for ages 5 and younger; 9-12 hours for ages 6-12 years; and 8-10 hours for ages 13-18 years.
5. Body mass index (no changes)
The AHA acknowledges that body mass index (BMI) is an imperfect metric. Yet, because it’s easily calculated and widely available, BMI continues as a “reasonable” gauge to assess weight categories that may lead to health problems. BMI of 18.5-24.9 is associated with the highest levels of CV health. The AHA notes that BMI ranges and the subsequent health risks associated with them may differ among people from diverse racial or ethnic backgrounds or ancestry. This aligns with the World Health Organization recommendations to adjust BMI ranges for people of Asian or Pacific Islander ancestry because recent evidence indicates their risk of conditions such as CVD or type 2 diabetes is higher at a lower BMI.
6. Blood lipids (updated)
The metric for blood lipids (cholesterol and triglycerides) is updated to use non-HDL cholesterol as the preferred number to monitor, rather than total cholesterol. This shift is made because non-HDL cholesterol can be measured without fasting beforehand (thereby increasing its availability at any time of day and implementation at more appointments) and reliably calculated among all people.
7. Blood glucose (updated)
This metric is expanded to include the option of hemoglobin A1c readings or blood glucose levels for people with or without type 1 or 2 diabetes or prediabetes.
8. Blood pressure (no changes)
Blood pressure criteria remain unchanged from 2017 guidance that established levels less than 120/80 mm Hg as optimal, and defined hypertension as 130-139 mm Hg systolic pressure or 80-89 mm Hg diastolic pressure.
‘Concerning’ new data
Results of the first study using Life’s Essential 8 show that the overall CV health of the U.S. population is “well below ideal,” with 80% of adults scoring at a low or moderate level, the researchers report.
Data for the analysis came from 2013-2018 U.S. National Health and Nutrition Examination surveys (NHANES) of more than 13,500 adults aged 20-79 years and nearly 9,900 children aged 2-19 years. Among the key findings:
- The average CV health score based on Life’s Essential 8 was 64.7 for adults and 65.5 for children – in the moderate range on the 0-100 scale.
- Only 0.45% of adults had a perfect score of 100; 20% had high CV health (score of 80 or higher), 63% moderate (score of 50-79), and 18% had low CV health (score of less than 50).
- Adult women had higher average CV health scores (67) compared with men (62.5).
- In general, adults scored lowest in the areas of diet, physical activity, and BMI.
- CV health scores were generally lower at older ages.
- Non-Hispanic Asian Americans had a higher average CV health score than other racial/ethnic groups. Non-Hispanic Whites had the second highest average CV health score, followed, in order, by Hispanic (other than Mexican), Mexican, and non-Hispanic Blacks.
- Children’s diet scores were low, at an average of 40.6.
- Adult sociodemographic groups varied notably in CV health scores for diet, nicotine exposure, blood glucose, and blood pressure.
“These data represent the first look at the cardiovascular health of the U.S. population using the AHA’s new Life’s Essential 8 scoring algorithm,” Dr. Lloyd-Jones said.
“Life’s Essential 8 is a major step forward in our ability to identify when cardiovascular health can be preserved and when it is suboptimal. It should energize efforts to improve cardiovascular health for all people and at every life stage,” Dr. Lloyd-Jones added.
“Analyses like this can help policymakers, communities, clinicians, and the public to understand the opportunities to intervene to improve and maintain optimal cardiovascular health across the life course,” he said.
This research had no commercial funding. The authors have no reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Heart attack care not equal for women and people of color
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF EMERGENCY MEDICINE
New biomarker data add to concerns over REDUCE-IT trial
A new analysis of the REDUCE-IT study has reignited concerns that the benefit shown by the high-dose fish oil product in the study, icosapent ethyl (Vascepa, Amarin), may have been related to harms caused by the placebo mineral oil.
Results show that allocation to icosapent ethyl had minimal effects on a series of biomarkers associated with atherosclerotic disease, whereas levels of these biomarkers increased among those allocated to mineral oil.
At 12 months, the median percent increases from baseline in the mineral oil group were 1.5% for homocysteine, 2.2% for lipoprotein(a), 10.9% for oxidized low-density-lipoprotein (LDL) cholesterol, 16.2% for interleukin (IL)-6, 18.5% for lipoprotein-associated phospholipase A2, 21.9% for high-sensitivity C-reactive protein (hsCRP), and 28.9% for IL-1β. The changes were similar at 24 months. However, in the icosapent ethyl group, there were minimal changes in these biomarkers at 12 and 24 months.
The study was published online in Circulation.
The authors, led by Paul Ridker, MD, Brigham & Women’s Hospital, Boston, do not voice much opinion on what the results mean, concluding that “the effect of these findings on the interpretation of the REDUCE-IT trial results remains unclear and will require further investigation.”
They also say that a second icosapent ethyl trial using a nonmineral oil comparator “would help resolve ongoing controversy.”
However, the authors are a mixed group; Dr. Ridker and some of his coauthors were not part of the original REDUCE-IT trial, whereas other coauthors were members of the REDUCE-IT steering committee, and one was an employee of Amarin.
Lead investigator of the REDUCE-IT trial, Deepak Bhatt, MD, also from Brigham & Women’s Hospital, who is the senior author of the current study, played down the new findings, saying they did not offer much new incremental information on mechanistic insight.
“These are small degrees of biomarker increases on an absolute level we are seeing with the placebo that would not be expected to produce harm,” Dr. Bhatt told this news organization. He also said the Circulation peer-review process had removed some of the discussion, which could lead to some “misinterpretation” of the authors’ views.
Dr. Ridker was unavailable for further comment.
The publication of this study has inevitably poured fuel on the fire regarding the controversy that has long dogged the REDUCE-IT trial, with questions about the large reduction in event rates seen with icosapent ethyl without an obvious mechanistic explanation.
‘Smoking gun’
One of the loudest critics of the study, Steve Nissen, MD, Cleveland Clinic, described the new findings as “the closest thing I’ve seen to a smoking gun in medicine for a long, long time.”
“The result of this new analysis shows that mineral oil increases virtually every inflammatory and lipid marker that they measured,” he commented.
“There are a lot of theories, but the bottom line is that something really bad happened in the mineral-oil group, which makes icosapent ethyl look efficacious. In my view, this needs to be reviewed by the FDA for consideration of removing the label claim for cardiovascular benefit.”
Other experts in the field not directly involved in the study voiced concern about these new findings, adding to calls for another trial.
In a Twitter thread on the issue, Harlan Krumholz, MD, describes the Circulation publication as “an exceptionally important article,” adding that it is “time to rethink this drug.”
“My point is ... once you know you have non-neutral comparator and the effect on risk biomarkers is far from trivial ... then you have introduced substantial uncertainty about the trial result, as conveyed by the authors ... and no one can say what would happen with a neutral comparator,” Dr. Krumholz writes.
In an accompanying editorial in Circulation, Robert Harrington, MD, professor of medicine at Stanford (Calif.) University, concludes that “the hard reality is that we are left with uncertainties and the questions raised by use of the mineral oil as placebo can only be answered by another randomized controlled trial.”
“My main points are that the chosen placebo was not inert (an essential characteristic for an active control–placebo comparison), that the biomarker data show elevations in multiple markers involved with inflammatory pathways associated with atherosclerosis, and that these data create enough uncertainty in the trial interpretation that the best recourse to answer the criticisms is to do another trial with a truly inert placebo,” Dr. Harrington said in an interview.
He added that Dr. Bhatt’s point that the changes in biomarkers are too small to really matter clinically may be right. “But for me, the uncertainties mean that I have less confidence in the true magnitude of the treatment effect than I would have if there were no changes in the inflammatory markers.”
In Circulation, the authors say it is unclear why multiple biomarkers increased over time among REDUCE-IT participants allocated to mineral oil. They note that no substantive changes in these biomarkers were observed in the placebo groups over periods of 3-5 years in other trials, including JUPITER, CIRT, CANTOS, SPIRE, and the STRENGTH trials, which evaluated a different high-dose omega-3 oil product but used corn oil as the placebo.
“The core design of REDUCE-IT does not make it possible to resolve convincingly whether any adverse effects associated with mineral oil use as a comparator may have affected clinical outcomes,” they write.
They point out that regulatory agencies evaluating REDUCE-IT estimated that approximately 3% of the net clinical benefit observed with icosapent ethyl might have been a consequence of adverse biomarker effects on LDL cholesterol and hsCRP attributable to mineral oil. But in the context of an overall 25% relative risk reduction in first events and a 30% reduction in total ischemic events observed, a potential bias of this magnitude, even if doubled in size, would be unlikely to fully attenuate the overall benefit of icosapent ethyl observed.
They add that they are not aware of a method to assess what the potential magnitude might be of a combination of the multiple effects.
New data do not change the debate
“We did a large, well-powered randomized trial, and this paper shouldn’t change anything in how that trial should be interpreted,” Dr. Bhatt said in an interview.
He claims the new biomarkers evaluated in the study are correlated with LDL and CRP, data which have already been reported and analyzed so have limited relevance.
“It’s not really independent biomarker information; this is what we would expect to see when we see small increases in LDL and CRP. So, I don’t think this new information fundamentally changes the debate,” he said.
Dr. Bhatt also pointed out that the study highlights relative increases rather than absolute increases in the biomarkers, making it seem more alarming than is actually the case.
“The paper makes it seem like that there are large increases in these other biomarkers, but the values reported are relative increases and the absolute increases were actually rather small. In many cases, the changes reported are less than the lower limit of quantification of the assay used,” he noted.
He added: “Even if one is unable to get around the placebo issue in the REDUCE-IT trial, there will always be the JELIS trial – a randomized trial with no placebo showing a 19% relative risk reduction. While the biomarker data may be interesting, what really matters in the end is clinical events. And significant reductions in two independent trials should be enough.”
Dr. Bhatt says the REDUCE-IT steering committee does not believe another trial is needed. “Maybe a different population would be good – such as primary prevention, patients without elevated triglycerides – but just repeating REDUCE- IT with a different placebo would be a waste of resources,” he commented.
But Dr. Nissen refuted Dr. Bhatt’s claims.
“These biomarkers are not in the same pathways as LDL and CRP, and these are not small increases. In the CANTOS trial, a monoclonal antibody against interleukin-1β beta showed a significant benefit. The increase in interleukin-1β now reported in REDUCE-IT is exactly the opposite of CANTOS,” he pointed out.
“The FDA did not know about these additional biomarkers when it reviewed the data on LDL and CRP. Now we have new information. It needs to be looked at again,” Dr. Nissen added.
Funding for the study was provided by Amarin Pharma. Dr. Bhatt was the lead investigator of the REDUCE-IT trial. Dr. Nissen was the lead investigator the STRENGTH trial. Further disclosures of the authors can be found in Circulation.
A version of this article first appeared on Medscape.com.
A new analysis of the REDUCE-IT study has reignited concerns that the benefit shown by the high-dose fish oil product in the study, icosapent ethyl (Vascepa, Amarin), may have been related to harms caused by the placebo mineral oil.
Results show that allocation to icosapent ethyl had minimal effects on a series of biomarkers associated with atherosclerotic disease, whereas levels of these biomarkers increased among those allocated to mineral oil.
At 12 months, the median percent increases from baseline in the mineral oil group were 1.5% for homocysteine, 2.2% for lipoprotein(a), 10.9% for oxidized low-density-lipoprotein (LDL) cholesterol, 16.2% for interleukin (IL)-6, 18.5% for lipoprotein-associated phospholipase A2, 21.9% for high-sensitivity C-reactive protein (hsCRP), and 28.9% for IL-1β. The changes were similar at 24 months. However, in the icosapent ethyl group, there were minimal changes in these biomarkers at 12 and 24 months.
The study was published online in Circulation.
The authors, led by Paul Ridker, MD, Brigham & Women’s Hospital, Boston, do not voice much opinion on what the results mean, concluding that “the effect of these findings on the interpretation of the REDUCE-IT trial results remains unclear and will require further investigation.”
They also say that a second icosapent ethyl trial using a nonmineral oil comparator “would help resolve ongoing controversy.”
However, the authors are a mixed group; Dr. Ridker and some of his coauthors were not part of the original REDUCE-IT trial, whereas other coauthors were members of the REDUCE-IT steering committee, and one was an employee of Amarin.
Lead investigator of the REDUCE-IT trial, Deepak Bhatt, MD, also from Brigham & Women’s Hospital, who is the senior author of the current study, played down the new findings, saying they did not offer much new incremental information on mechanistic insight.
“These are small degrees of biomarker increases on an absolute level we are seeing with the placebo that would not be expected to produce harm,” Dr. Bhatt told this news organization. He also said the Circulation peer-review process had removed some of the discussion, which could lead to some “misinterpretation” of the authors’ views.
Dr. Ridker was unavailable for further comment.
The publication of this study has inevitably poured fuel on the fire regarding the controversy that has long dogged the REDUCE-IT trial, with questions about the large reduction in event rates seen with icosapent ethyl without an obvious mechanistic explanation.
‘Smoking gun’
One of the loudest critics of the study, Steve Nissen, MD, Cleveland Clinic, described the new findings as “the closest thing I’ve seen to a smoking gun in medicine for a long, long time.”
“The result of this new analysis shows that mineral oil increases virtually every inflammatory and lipid marker that they measured,” he commented.
“There are a lot of theories, but the bottom line is that something really bad happened in the mineral-oil group, which makes icosapent ethyl look efficacious. In my view, this needs to be reviewed by the FDA for consideration of removing the label claim for cardiovascular benefit.”
Other experts in the field not directly involved in the study voiced concern about these new findings, adding to calls for another trial.
In a Twitter thread on the issue, Harlan Krumholz, MD, describes the Circulation publication as “an exceptionally important article,” adding that it is “time to rethink this drug.”
“My point is ... once you know you have non-neutral comparator and the effect on risk biomarkers is far from trivial ... then you have introduced substantial uncertainty about the trial result, as conveyed by the authors ... and no one can say what would happen with a neutral comparator,” Dr. Krumholz writes.
In an accompanying editorial in Circulation, Robert Harrington, MD, professor of medicine at Stanford (Calif.) University, concludes that “the hard reality is that we are left with uncertainties and the questions raised by use of the mineral oil as placebo can only be answered by another randomized controlled trial.”
“My main points are that the chosen placebo was not inert (an essential characteristic for an active control–placebo comparison), that the biomarker data show elevations in multiple markers involved with inflammatory pathways associated with atherosclerosis, and that these data create enough uncertainty in the trial interpretation that the best recourse to answer the criticisms is to do another trial with a truly inert placebo,” Dr. Harrington said in an interview.
He added that Dr. Bhatt’s point that the changes in biomarkers are too small to really matter clinically may be right. “But for me, the uncertainties mean that I have less confidence in the true magnitude of the treatment effect than I would have if there were no changes in the inflammatory markers.”
In Circulation, the authors say it is unclear why multiple biomarkers increased over time among REDUCE-IT participants allocated to mineral oil. They note that no substantive changes in these biomarkers were observed in the placebo groups over periods of 3-5 years in other trials, including JUPITER, CIRT, CANTOS, SPIRE, and the STRENGTH trials, which evaluated a different high-dose omega-3 oil product but used corn oil as the placebo.
“The core design of REDUCE-IT does not make it possible to resolve convincingly whether any adverse effects associated with mineral oil use as a comparator may have affected clinical outcomes,” they write.
They point out that regulatory agencies evaluating REDUCE-IT estimated that approximately 3% of the net clinical benefit observed with icosapent ethyl might have been a consequence of adverse biomarker effects on LDL cholesterol and hsCRP attributable to mineral oil. But in the context of an overall 25% relative risk reduction in first events and a 30% reduction in total ischemic events observed, a potential bias of this magnitude, even if doubled in size, would be unlikely to fully attenuate the overall benefit of icosapent ethyl observed.
They add that they are not aware of a method to assess what the potential magnitude might be of a combination of the multiple effects.
New data do not change the debate
“We did a large, well-powered randomized trial, and this paper shouldn’t change anything in how that trial should be interpreted,” Dr. Bhatt said in an interview.
He claims the new biomarkers evaluated in the study are correlated with LDL and CRP, data which have already been reported and analyzed so have limited relevance.
“It’s not really independent biomarker information; this is what we would expect to see when we see small increases in LDL and CRP. So, I don’t think this new information fundamentally changes the debate,” he said.
Dr. Bhatt also pointed out that the study highlights relative increases rather than absolute increases in the biomarkers, making it seem more alarming than is actually the case.
“The paper makes it seem like that there are large increases in these other biomarkers, but the values reported are relative increases and the absolute increases were actually rather small. In many cases, the changes reported are less than the lower limit of quantification of the assay used,” he noted.
He added: “Even if one is unable to get around the placebo issue in the REDUCE-IT trial, there will always be the JELIS trial – a randomized trial with no placebo showing a 19% relative risk reduction. While the biomarker data may be interesting, what really matters in the end is clinical events. And significant reductions in two independent trials should be enough.”
Dr. Bhatt says the REDUCE-IT steering committee does not believe another trial is needed. “Maybe a different population would be good – such as primary prevention, patients without elevated triglycerides – but just repeating REDUCE- IT with a different placebo would be a waste of resources,” he commented.
But Dr. Nissen refuted Dr. Bhatt’s claims.
“These biomarkers are not in the same pathways as LDL and CRP, and these are not small increases. In the CANTOS trial, a monoclonal antibody against interleukin-1β beta showed a significant benefit. The increase in interleukin-1β now reported in REDUCE-IT is exactly the opposite of CANTOS,” he pointed out.
“The FDA did not know about these additional biomarkers when it reviewed the data on LDL and CRP. Now we have new information. It needs to be looked at again,” Dr. Nissen added.
Funding for the study was provided by Amarin Pharma. Dr. Bhatt was the lead investigator of the REDUCE-IT trial. Dr. Nissen was the lead investigator the STRENGTH trial. Further disclosures of the authors can be found in Circulation.
A version of this article first appeared on Medscape.com.
A new analysis of the REDUCE-IT study has reignited concerns that the benefit shown by the high-dose fish oil product in the study, icosapent ethyl (Vascepa, Amarin), may have been related to harms caused by the placebo mineral oil.
Results show that allocation to icosapent ethyl had minimal effects on a series of biomarkers associated with atherosclerotic disease, whereas levels of these biomarkers increased among those allocated to mineral oil.
At 12 months, the median percent increases from baseline in the mineral oil group were 1.5% for homocysteine, 2.2% for lipoprotein(a), 10.9% for oxidized low-density-lipoprotein (LDL) cholesterol, 16.2% for interleukin (IL)-6, 18.5% for lipoprotein-associated phospholipase A2, 21.9% for high-sensitivity C-reactive protein (hsCRP), and 28.9% for IL-1β. The changes were similar at 24 months. However, in the icosapent ethyl group, there were minimal changes in these biomarkers at 12 and 24 months.
The study was published online in Circulation.
The authors, led by Paul Ridker, MD, Brigham & Women’s Hospital, Boston, do not voice much opinion on what the results mean, concluding that “the effect of these findings on the interpretation of the REDUCE-IT trial results remains unclear and will require further investigation.”
They also say that a second icosapent ethyl trial using a nonmineral oil comparator “would help resolve ongoing controversy.”
However, the authors are a mixed group; Dr. Ridker and some of his coauthors were not part of the original REDUCE-IT trial, whereas other coauthors were members of the REDUCE-IT steering committee, and one was an employee of Amarin.
Lead investigator of the REDUCE-IT trial, Deepak Bhatt, MD, also from Brigham & Women’s Hospital, who is the senior author of the current study, played down the new findings, saying they did not offer much new incremental information on mechanistic insight.
“These are small degrees of biomarker increases on an absolute level we are seeing with the placebo that would not be expected to produce harm,” Dr. Bhatt told this news organization. He also said the Circulation peer-review process had removed some of the discussion, which could lead to some “misinterpretation” of the authors’ views.
Dr. Ridker was unavailable for further comment.
The publication of this study has inevitably poured fuel on the fire regarding the controversy that has long dogged the REDUCE-IT trial, with questions about the large reduction in event rates seen with icosapent ethyl without an obvious mechanistic explanation.
‘Smoking gun’
One of the loudest critics of the study, Steve Nissen, MD, Cleveland Clinic, described the new findings as “the closest thing I’ve seen to a smoking gun in medicine for a long, long time.”
“The result of this new analysis shows that mineral oil increases virtually every inflammatory and lipid marker that they measured,” he commented.
“There are a lot of theories, but the bottom line is that something really bad happened in the mineral-oil group, which makes icosapent ethyl look efficacious. In my view, this needs to be reviewed by the FDA for consideration of removing the label claim for cardiovascular benefit.”
Other experts in the field not directly involved in the study voiced concern about these new findings, adding to calls for another trial.
In a Twitter thread on the issue, Harlan Krumholz, MD, describes the Circulation publication as “an exceptionally important article,” adding that it is “time to rethink this drug.”
“My point is ... once you know you have non-neutral comparator and the effect on risk biomarkers is far from trivial ... then you have introduced substantial uncertainty about the trial result, as conveyed by the authors ... and no one can say what would happen with a neutral comparator,” Dr. Krumholz writes.
In an accompanying editorial in Circulation, Robert Harrington, MD, professor of medicine at Stanford (Calif.) University, concludes that “the hard reality is that we are left with uncertainties and the questions raised by use of the mineral oil as placebo can only be answered by another randomized controlled trial.”
“My main points are that the chosen placebo was not inert (an essential characteristic for an active control–placebo comparison), that the biomarker data show elevations in multiple markers involved with inflammatory pathways associated with atherosclerosis, and that these data create enough uncertainty in the trial interpretation that the best recourse to answer the criticisms is to do another trial with a truly inert placebo,” Dr. Harrington said in an interview.
He added that Dr. Bhatt’s point that the changes in biomarkers are too small to really matter clinically may be right. “But for me, the uncertainties mean that I have less confidence in the true magnitude of the treatment effect than I would have if there were no changes in the inflammatory markers.”
In Circulation, the authors say it is unclear why multiple biomarkers increased over time among REDUCE-IT participants allocated to mineral oil. They note that no substantive changes in these biomarkers were observed in the placebo groups over periods of 3-5 years in other trials, including JUPITER, CIRT, CANTOS, SPIRE, and the STRENGTH trials, which evaluated a different high-dose omega-3 oil product but used corn oil as the placebo.
“The core design of REDUCE-IT does not make it possible to resolve convincingly whether any adverse effects associated with mineral oil use as a comparator may have affected clinical outcomes,” they write.
They point out that regulatory agencies evaluating REDUCE-IT estimated that approximately 3% of the net clinical benefit observed with icosapent ethyl might have been a consequence of adverse biomarker effects on LDL cholesterol and hsCRP attributable to mineral oil. But in the context of an overall 25% relative risk reduction in first events and a 30% reduction in total ischemic events observed, a potential bias of this magnitude, even if doubled in size, would be unlikely to fully attenuate the overall benefit of icosapent ethyl observed.
They add that they are not aware of a method to assess what the potential magnitude might be of a combination of the multiple effects.
New data do not change the debate
“We did a large, well-powered randomized trial, and this paper shouldn’t change anything in how that trial should be interpreted,” Dr. Bhatt said in an interview.
He claims the new biomarkers evaluated in the study are correlated with LDL and CRP, data which have already been reported and analyzed so have limited relevance.
“It’s not really independent biomarker information; this is what we would expect to see when we see small increases in LDL and CRP. So, I don’t think this new information fundamentally changes the debate,” he said.
Dr. Bhatt also pointed out that the study highlights relative increases rather than absolute increases in the biomarkers, making it seem more alarming than is actually the case.
“The paper makes it seem like that there are large increases in these other biomarkers, but the values reported are relative increases and the absolute increases were actually rather small. In many cases, the changes reported are less than the lower limit of quantification of the assay used,” he noted.
He added: “Even if one is unable to get around the placebo issue in the REDUCE-IT trial, there will always be the JELIS trial – a randomized trial with no placebo showing a 19% relative risk reduction. While the biomarker data may be interesting, what really matters in the end is clinical events. And significant reductions in two independent trials should be enough.”
Dr. Bhatt says the REDUCE-IT steering committee does not believe another trial is needed. “Maybe a different population would be good – such as primary prevention, patients without elevated triglycerides – but just repeating REDUCE- IT with a different placebo would be a waste of resources,” he commented.
But Dr. Nissen refuted Dr. Bhatt’s claims.
“These biomarkers are not in the same pathways as LDL and CRP, and these are not small increases. In the CANTOS trial, a monoclonal antibody against interleukin-1β beta showed a significant benefit. The increase in interleukin-1β now reported in REDUCE-IT is exactly the opposite of CANTOS,” he pointed out.
“The FDA did not know about these additional biomarkers when it reviewed the data on LDL and CRP. Now we have new information. It needs to be looked at again,” Dr. Nissen added.
Funding for the study was provided by Amarin Pharma. Dr. Bhatt was the lead investigator of the REDUCE-IT trial. Dr. Nissen was the lead investigator the STRENGTH trial. Further disclosures of the authors can be found in Circulation.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION