Cardiology

President Donald Trump has advised state governors not to wait on the federal government when it comes to ensuring readiness for a surge in patients from the COVID-19 outbreak.

Courtesy CDC

“If they are able to get ventilators, respirators, if they are able to get certain things without having to go through the longer process of federal government,” they should order on their own and bypass the federal government ordering system, the president stated during a March 16 press briefing.

That being said, he noted that the federal government is “ordering tremendous numbers of ventilators, respirators, [and] masks,” although he could not give a specific number on how much has been ordered or how many has already been stockpiled.

“It is always going to be faster if they can get them directly, if they need them, and I have given them authorization to order directly,” President Trump said.

The comments came as the White House revised recommendations on gatherings. The new guidelines now limit gatherings to no more than 10 people. Officials are further advising Americans to self-quarantine for 2 weeks if they are sick, if someone in their house is sick, or if someone in their house has tested positive for COVID-19.

Additionally, the White House called on Americans to limit discretionary travel and to avoid eating and drinking in restaurants, bars, and food courts during the next 15 days, even if they are feeling healthy and are asymptomatic.

“With several weeks of focused action, we can turn the corner and turn it quickly,” the president said.

In terms of testing, the Food and Drug Administration has granted emergency use authorization to two commercial diagnostic tests: Thermo Fisher for its TaqPath COVID-19 Combo Kit and Roche for its cobas SARS-CoV-2 test. White House officials said up to 1 million tests will be available this week, with 2 million next week.

The president also announced that phase 1 testing of a vaccine has begun. The test involves more than 40 healthy volunteers in the Seattle area who will receive three shots over the trial period. Phase 1 testing is generally conducted to determine safety of a new therapeutic.

gtwachtman@mdedge.com

President Donald Trump has advised state governors not to wait on the federal government when it comes to ensuring readiness for a surge in patients from the COVID-19 outbreak.

Courtesy CDC

“If they are able to get ventilators, respirators, if they are able to get certain things without having to go through the longer process of federal government,” they should order on their own and bypass the federal government ordering system, the president stated during a March 16 press briefing.

That being said, he noted that the federal government is “ordering tremendous numbers of ventilators, respirators, [and] masks,” although he could not give a specific number on how much has been ordered or how many has already been stockpiled.

“It is always going to be faster if they can get them directly, if they need them, and I have given them authorization to order directly,” President Trump said.

The comments came as the White House revised recommendations on gatherings. The new guidelines now limit gatherings to no more than 10 people. Officials are further advising Americans to self-quarantine for 2 weeks if they are sick, if someone in their house is sick, or if someone in their house has tested positive for COVID-19.

Additionally, the White House called on Americans to limit discretionary travel and to avoid eating and drinking in restaurants, bars, and food courts during the next 15 days, even if they are feeling healthy and are asymptomatic.

“With several weeks of focused action, we can turn the corner and turn it quickly,” the president said.

In terms of testing, the Food and Drug Administration has granted emergency use authorization to two commercial diagnostic tests: Thermo Fisher for its TaqPath COVID-19 Combo Kit and Roche for its cobas SARS-CoV-2 test. White House officials said up to 1 million tests will be available this week, with 2 million next week.

The president also announced that phase 1 testing of a vaccine has begun. The test involves more than 40 healthy volunteers in the Seattle area who will receive three shots over the trial period. Phase 1 testing is generally conducted to determine safety of a new therapeutic.

gtwachtman@mdedge.com

President Donald Trump has advised state governors not to wait on the federal government when it comes to ensuring readiness for a surge in patients from the COVID-19 outbreak.

Courtesy CDC

“If they are able to get ventilators, respirators, if they are able to get certain things without having to go through the longer process of federal government,” they should order on their own and bypass the federal government ordering system, the president stated during a March 16 press briefing.

That being said, he noted that the federal government is “ordering tremendous numbers of ventilators, respirators, [and] masks,” although he could not give a specific number on how much has been ordered or how many has already been stockpiled.

“It is always going to be faster if they can get them directly, if they need them, and I have given them authorization to order directly,” President Trump said.

The comments came as the White House revised recommendations on gatherings. The new guidelines now limit gatherings to no more than 10 people. Officials are further advising Americans to self-quarantine for 2 weeks if they are sick, if someone in their house is sick, or if someone in their house has tested positive for COVID-19.

Additionally, the White House called on Americans to limit discretionary travel and to avoid eating and drinking in restaurants, bars, and food courts during the next 15 days, even if they are feeling healthy and are asymptomatic.

“With several weeks of focused action, we can turn the corner and turn it quickly,” the president said.

In terms of testing, the Food and Drug Administration has granted emergency use authorization to two commercial diagnostic tests: Thermo Fisher for its TaqPath COVID-19 Combo Kit and Roche for its cobas SARS-CoV-2 test. White House officials said up to 1 million tests will be available this week, with 2 million next week.

The president also announced that phase 1 testing of a vaccine has begun. The test involves more than 40 healthy volunteers in the Seattle area who will receive three shots over the trial period. Phase 1 testing is generally conducted to determine safety of a new therapeutic.

gtwachtman@mdedge.com

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The European Society of Cardiology (ESC) has issued a statement urging physicians and patients to continue treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), in light of a newly described theory that those agents could increase the risk of developing COVID-19 and/or worsen its severity.

The concern arises from the observation that the new coronavirus SARS-CoV-2 causing COVID-19 binds to angiotensin-converting enzyme 2 (ACE2) to infect cells, and both ACE inhibitors and ARBs increase ACE2 levels.

This mechanism has been theorized as a possible risk factor for facilitating the acquisition of COVID-19 infection and worsening its severity. However, paradoxically, it has also been hypothesized to protect against acute lung injury from the disease.

Meanwhile, a Lancet Respiratory Medicine article was published March 11 entitled, “Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection?”

“We ... hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” said the authors.

This prompted some media coverage in the United Kingdom and “social media-related amplification,” leading to concern and, in some cases, discontinuation of the drugs by patients.

But on March 13, the ESC Council on Hypertension dismissed the concerns as entirely speculative, in a statement posted to the ESC website.

It said that the council “strongly recommend that physicians and patients should continue treatment with their usual antihypertensive therapy because there is no clinical or scientific evidence to suggest that treatment with ACE inhibitors or ARBs should be discontinued because of the COVID-19 infection.”

The statement, signed by Council Chair Professor Giovanni de Simone, MD, on behalf of the nucleus members, also says that in regard to the theorized protective effect against serious lung complications in individuals with COVID-19, the data come only from animal, and not human, studies.

“Speculation about the safety of ACE-inhibitor or ARB treatment in relation to COVID-19 does not have a sound scientific basis or evidence to support it,” the ESC panel concludes.

This article first appeared on Medscape.com.

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The European Society of Cardiology (ESC) has issued a statement urging physicians and patients to continue treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), in light of a newly described theory that those agents could increase the risk of developing COVID-19 and/or worsen its severity.

The concern arises from the observation that the new coronavirus SARS-CoV-2 causing COVID-19 binds to angiotensin-converting enzyme 2 (ACE2) to infect cells, and both ACE inhibitors and ARBs increase ACE2 levels.

This mechanism has been theorized as a possible risk factor for facilitating the acquisition of COVID-19 infection and worsening its severity. However, paradoxically, it has also been hypothesized to protect against acute lung injury from the disease.

Meanwhile, a Lancet Respiratory Medicine article was published March 11 entitled, “Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection?”

“We ... hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” said the authors.

This prompted some media coverage in the United Kingdom and “social media-related amplification,” leading to concern and, in some cases, discontinuation of the drugs by patients.

But on March 13, the ESC Council on Hypertension dismissed the concerns as entirely speculative, in a statement posted to the ESC website.

It said that the council “strongly recommend that physicians and patients should continue treatment with their usual antihypertensive therapy because there is no clinical or scientific evidence to suggest that treatment with ACE inhibitors or ARBs should be discontinued because of the COVID-19 infection.”

The statement, signed by Council Chair Professor Giovanni de Simone, MD, on behalf of the nucleus members, also says that in regard to the theorized protective effect against serious lung complications in individuals with COVID-19, the data come only from animal, and not human, studies.

“Speculation about the safety of ACE-inhibitor or ARB treatment in relation to COVID-19 does not have a sound scientific basis or evidence to support it,” the ESC panel concludes.

This article first appeared on Medscape.com.

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The European Society of Cardiology (ESC) has issued a statement urging physicians and patients to continue treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), in light of a newly described theory that those agents could increase the risk of developing COVID-19 and/or worsen its severity.

The concern arises from the observation that the new coronavirus SARS-CoV-2 causing COVID-19 binds to angiotensin-converting enzyme 2 (ACE2) to infect cells, and both ACE inhibitors and ARBs increase ACE2 levels.

This mechanism has been theorized as a possible risk factor for facilitating the acquisition of COVID-19 infection and worsening its severity. However, paradoxically, it has also been hypothesized to protect against acute lung injury from the disease.

Meanwhile, a Lancet Respiratory Medicine article was published March 11 entitled, “Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection?”

“We ... hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” said the authors.

This prompted some media coverage in the United Kingdom and “social media-related amplification,” leading to concern and, in some cases, discontinuation of the drugs by patients.

But on March 13, the ESC Council on Hypertension dismissed the concerns as entirely speculative, in a statement posted to the ESC website.

It said that the council “strongly recommend that physicians and patients should continue treatment with their usual antihypertensive therapy because there is no clinical or scientific evidence to suggest that treatment with ACE inhibitors or ARBs should be discontinued because of the COVID-19 infection.”

The statement, signed by Council Chair Professor Giovanni de Simone, MD, on behalf of the nucleus members, also says that in regard to the theorized protective effect against serious lung complications in individuals with COVID-19, the data come only from animal, and not human, studies.

“Speculation about the safety of ACE-inhibitor or ARB treatment in relation to COVID-19 does not have a sound scientific basis or evidence to support it,” the ESC panel concludes.

This article first appeared on Medscape.com.

PHOENIX – More favorable cardiovascular health at 28 weeks’ gestation was associated with lower risks for several adverse maternal and newborn pregnancy outcomes, according to results from a multinational cohort study.

Doug Brunk/MDedge News

“Over the past 10 years, cardiovascular health [CVH] has been characterized across most of the life course and is associated with a variety of health outcomes, but CVH as a whole has not been well studied during pregnancy,” Amanda M. Perak, MD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.

In an effort to examine the associations of maternal gestational CVH with adverse maternal and newborn outcomes, Dr. Perak of the departments of pediatrics and preventive medicine at Northwestern University and Lurie Children’s Hospital, both in Chicago, and colleagues drew from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study, which examined pregnant women at a target of 28 weeks’ gestation and assessed the associations of glycemia with pregnancy outcomes. The researchers analyzed data from an ancillary study of 2,230 mother-child dyads to characterize clinical gestational CVH with use of five metrics: body mass index, blood pressure, cholesterol, glucose, and smoking. The study excluded women with prepregnancy diabetes, preterm births, and cases of fetal death/major malformations.

Each maternal CVH metric was classified as ideal, intermediate, or poor according to modified definitions based on pregnancy guidelines. “For lipids, it’s known that levels change substantially during pregnancy, but there are no pregnancy guidelines,” Dr. Perak said. “We and others have also shown that higher triglycerides in pregnancy are associated with adverse pregnancy outcomes. We selected thresholds of less than 250 mg/dL for ideal and at least 500 mg/dL for poor, based on triglyceride distribution and clinical relevance.”

Total CVH was scored by assigning 2 points for ideal, 1 for intermediate, and 0 for each poor metric, for a total possible 10 points, with 10 being most favorable. They also created four CVH categories, ranging from all ideal to two or more poor metrics. Maternal adverse pregnancy outcomes included preeclampsia and unplanned primary cesarean section. Newborn adverse pregnancy outcomes included birth weight above the 90th percentile and a cord blood insulin sensitivity index lower than the 10th percentile.

The researchers used logistic and multinomial logistic regression of pregnancy outcomes on maternal gestational CVH in two adjusted models. Secondarily, they examined associations of individual CVH metrics with outcomes, with adjustment for the other metrics.

The cohort comprised mother-child dyads from nine field centers in six countries: the United States (25%), Barbados (23%), United Kingdom (21%), China (18%), Thailand (7%), and Canada (7%). The mothers’ mean age was 30 years, and the mean gestational age was 28 weeks. The mean gestational CVH score was 8.8 out of 10. Nearly half of mothers (42%) had ideal metrics, while 4% had two or more poor metrics. Delivery occurred at a mean of 39.8 weeks, and adverse pregnancy outcomes occurred in 4.7%-17.9% of pregnancies.

In the fully adjusted model, which accounted for maternal age, height, alcohol use, gestational age at pregnancy exam, maternal parity, and newborn sex and race/ethnicity, odds ratios per 1-point higher (better) CVH score were 0.61 (95% confidence interval, 0.53-0.70) for preeclampsia, 0.85 (95% CI, 0.76-0.95) for unplanned primary cesarean section (among primiparous mothers), 0.83 (95% CI, 0.77-0.91) for large for gestational age infant, and 0.79 (95% CI, 0.72-0.87) for infant insulin sensitivity index below the 10th percentile. CVH categories were also associated with outcomes. For example, odds ratios for preeclampsia were 4.61 (95% CI, 2.13-11.14) for mothers with one or more intermediate metrics, 7.62 (95% CI, 3.60-18.13) for mothers with one poor metric, and 12.02 (95% CI, 4.70-32.50) for mothers with two or more poor metrics, compared with mothers with all metrics ideal.

“Except for smoking, each CVH metric was independently associated with adverse outcomes,” Dr. Perak said. “However, total CVH was associated with a wider range of outcomes than any single metric. This suggests that CVH provides health insights beyond single risk factors.”

Strengths of the study, she continued, included geographic and racial diversity of participants and high-quality research measurements of CVH. Limitations were that the cohort excluded prepregnancy diabetes and preterm births. “Diet and exercise data were not available, and CVH was measured once at 28 weeks,” she said. “Further study is needed across pregnancy and in other settings, but this study provides the first data on the relevance of gestational CVH for pregnancy outcomes.”

In an interview, Stephen S. Rich, PhD, who directs the Center for Public Health Genomics at the University of Virginia, said that the data “provide strong epidemiologic support to focus on the full range of cardiovascular health. In my view, the primary limitation of the study is that there may be significant differences in how one achieves ideal CHV across a single country, not to mention across the world, particularly in absence of a highly controlled, research environment. It is not clear that the approach used in this study at nine selected sites in six relatively highly developed countries could be translated into primary care – particularly in the U.S. with different regulatory and reimbursement plans and payers. Nonetheless, the evidence suggests a way to reduce adverse outcomes in pregnancy and the area deserves greater research.”

According to Dr. Perak, gestational diabetes is associated with a twofold higher maternal risk for cardiovascular disease (Diabetologia. 2019;62:905-14), while diabetes is also associated with higher offspring risk for CVD (BMJ. 2019;367:16398). However, a paucity of data exists on gestational CVH. In one report, better gestational CVH was associated with less subclinical CVD for the mother 10 years later (J Am Heart Assoc. 2019 Jul 23. doi:10.1161/JAHA.118.011394). In a separate analysis, Dr. Perak and her colleagues found that better gestational CVH was associated with better offspring CVH in childhood. “Unfortunately, we also reported that, among pregnant women in the United States, fewer than 1 in 10 had high CVH,” she said (J Am Heart Assoc. 2020 Feb 17. doi:10.1161/JAHA.119.015123). “However, the relevance of gestational CVH for pregnancy outcomes is unknown, but a it’s key question when considering CVH monitoring in prenatal care.”

Dr. Perak reported having received grant support from the National Heart, Lung, and Blood Institute, the American Heart Association, and Northwestern University. The HAPO Study was supported by NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases.

The meeting was sponsored by the American Heart Association.

dbrunk@mdedge.com

SOURCE: Perak A et al. Epi/Lifestyle 2020, Abstract 33.

PHOENIX – More favorable cardiovascular health at 28 weeks’ gestation was associated with lower risks for several adverse maternal and newborn pregnancy outcomes, according to results from a multinational cohort study.

Doug Brunk/MDedge News

“Over the past 10 years, cardiovascular health [CVH] has been characterized across most of the life course and is associated with a variety of health outcomes, but CVH as a whole has not been well studied during pregnancy,” Amanda M. Perak, MD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.

In an effort to examine the associations of maternal gestational CVH with adverse maternal and newborn outcomes, Dr. Perak of the departments of pediatrics and preventive medicine at Northwestern University and Lurie Children’s Hospital, both in Chicago, and colleagues drew from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study, which examined pregnant women at a target of 28 weeks’ gestation and assessed the associations of glycemia with pregnancy outcomes. The researchers analyzed data from an ancillary study of 2,230 mother-child dyads to characterize clinical gestational CVH with use of five metrics: body mass index, blood pressure, cholesterol, glucose, and smoking. The study excluded women with prepregnancy diabetes, preterm births, and cases of fetal death/major malformations.

Each maternal CVH metric was classified as ideal, intermediate, or poor according to modified definitions based on pregnancy guidelines. “For lipids, it’s known that levels change substantially during pregnancy, but there are no pregnancy guidelines,” Dr. Perak said. “We and others have also shown that higher triglycerides in pregnancy are associated with adverse pregnancy outcomes. We selected thresholds of less than 250 mg/dL for ideal and at least 500 mg/dL for poor, based on triglyceride distribution and clinical relevance.”

Total CVH was scored by assigning 2 points for ideal, 1 for intermediate, and 0 for each poor metric, for a total possible 10 points, with 10 being most favorable. They also created four CVH categories, ranging from all ideal to two or more poor metrics. Maternal adverse pregnancy outcomes included preeclampsia and unplanned primary cesarean section. Newborn adverse pregnancy outcomes included birth weight above the 90th percentile and a cord blood insulin sensitivity index lower than the 10th percentile.

The researchers used logistic and multinomial logistic regression of pregnancy outcomes on maternal gestational CVH in two adjusted models. Secondarily, they examined associations of individual CVH metrics with outcomes, with adjustment for the other metrics.

The cohort comprised mother-child dyads from nine field centers in six countries: the United States (25%), Barbados (23%), United Kingdom (21%), China (18%), Thailand (7%), and Canada (7%). The mothers’ mean age was 30 years, and the mean gestational age was 28 weeks. The mean gestational CVH score was 8.8 out of 10. Nearly half of mothers (42%) had ideal metrics, while 4% had two or more poor metrics. Delivery occurred at a mean of 39.8 weeks, and adverse pregnancy outcomes occurred in 4.7%-17.9% of pregnancies.

In the fully adjusted model, which accounted for maternal age, height, alcohol use, gestational age at pregnancy exam, maternal parity, and newborn sex and race/ethnicity, odds ratios per 1-point higher (better) CVH score were 0.61 (95% confidence interval, 0.53-0.70) for preeclampsia, 0.85 (95% CI, 0.76-0.95) for unplanned primary cesarean section (among primiparous mothers), 0.83 (95% CI, 0.77-0.91) for large for gestational age infant, and 0.79 (95% CI, 0.72-0.87) for infant insulin sensitivity index below the 10th percentile. CVH categories were also associated with outcomes. For example, odds ratios for preeclampsia were 4.61 (95% CI, 2.13-11.14) for mothers with one or more intermediate metrics, 7.62 (95% CI, 3.60-18.13) for mothers with one poor metric, and 12.02 (95% CI, 4.70-32.50) for mothers with two or more poor metrics, compared with mothers with all metrics ideal.

“Except for smoking, each CVH metric was independently associated with adverse outcomes,” Dr. Perak said. “However, total CVH was associated with a wider range of outcomes than any single metric. This suggests that CVH provides health insights beyond single risk factors.”

Strengths of the study, she continued, included geographic and racial diversity of participants and high-quality research measurements of CVH. Limitations were that the cohort excluded prepregnancy diabetes and preterm births. “Diet and exercise data were not available, and CVH was measured once at 28 weeks,” she said. “Further study is needed across pregnancy and in other settings, but this study provides the first data on the relevance of gestational CVH for pregnancy outcomes.”

In an interview, Stephen S. Rich, PhD, who directs the Center for Public Health Genomics at the University of Virginia, said that the data “provide strong epidemiologic support to focus on the full range of cardiovascular health. In my view, the primary limitation of the study is that there may be significant differences in how one achieves ideal CHV across a single country, not to mention across the world, particularly in absence of a highly controlled, research environment. It is not clear that the approach used in this study at nine selected sites in six relatively highly developed countries could be translated into primary care – particularly in the U.S. with different regulatory and reimbursement plans and payers. Nonetheless, the evidence suggests a way to reduce adverse outcomes in pregnancy and the area deserves greater research.”

According to Dr. Perak, gestational diabetes is associated with a twofold higher maternal risk for cardiovascular disease (Diabetologia. 2019;62:905-14), while diabetes is also associated with higher offspring risk for CVD (BMJ. 2019;367:16398). However, a paucity of data exists on gestational CVH. In one report, better gestational CVH was associated with less subclinical CVD for the mother 10 years later (J Am Heart Assoc. 2019 Jul 23. doi:10.1161/JAHA.118.011394). In a separate analysis, Dr. Perak and her colleagues found that better gestational CVH was associated with better offspring CVH in childhood. “Unfortunately, we also reported that, among pregnant women in the United States, fewer than 1 in 10 had high CVH,” she said (J Am Heart Assoc. 2020 Feb 17. doi:10.1161/JAHA.119.015123). “However, the relevance of gestational CVH for pregnancy outcomes is unknown, but a it’s key question when considering CVH monitoring in prenatal care.”

Dr. Perak reported having received grant support from the National Heart, Lung, and Blood Institute, the American Heart Association, and Northwestern University. The HAPO Study was supported by NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases.

The meeting was sponsored by the American Heart Association.

dbrunk@mdedge.com

SOURCE: Perak A et al. Epi/Lifestyle 2020, Abstract 33.

PHOENIX – More favorable cardiovascular health at 28 weeks’ gestation was associated with lower risks for several adverse maternal and newborn pregnancy outcomes, according to results from a multinational cohort study.

Doug Brunk/MDedge News

“Over the past 10 years, cardiovascular health [CVH] has been characterized across most of the life course and is associated with a variety of health outcomes, but CVH as a whole has not been well studied during pregnancy,” Amanda M. Perak, MD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.

In an effort to examine the associations of maternal gestational CVH with adverse maternal and newborn outcomes, Dr. Perak of the departments of pediatrics and preventive medicine at Northwestern University and Lurie Children’s Hospital, both in Chicago, and colleagues drew from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study, which examined pregnant women at a target of 28 weeks’ gestation and assessed the associations of glycemia with pregnancy outcomes. The researchers analyzed data from an ancillary study of 2,230 mother-child dyads to characterize clinical gestational CVH with use of five metrics: body mass index, blood pressure, cholesterol, glucose, and smoking. The study excluded women with prepregnancy diabetes, preterm births, and cases of fetal death/major malformations.

Each maternal CVH metric was classified as ideal, intermediate, or poor according to modified definitions based on pregnancy guidelines. “For lipids, it’s known that levels change substantially during pregnancy, but there are no pregnancy guidelines,” Dr. Perak said. “We and others have also shown that higher triglycerides in pregnancy are associated with adverse pregnancy outcomes. We selected thresholds of less than 250 mg/dL for ideal and at least 500 mg/dL for poor, based on triglyceride distribution and clinical relevance.”

Total CVH was scored by assigning 2 points for ideal, 1 for intermediate, and 0 for each poor metric, for a total possible 10 points, with 10 being most favorable. They also created four CVH categories, ranging from all ideal to two or more poor metrics. Maternal adverse pregnancy outcomes included preeclampsia and unplanned primary cesarean section. Newborn adverse pregnancy outcomes included birth weight above the 90th percentile and a cord blood insulin sensitivity index lower than the 10th percentile.

The researchers used logistic and multinomial logistic regression of pregnancy outcomes on maternal gestational CVH in two adjusted models. Secondarily, they examined associations of individual CVH metrics with outcomes, with adjustment for the other metrics.

The cohort comprised mother-child dyads from nine field centers in six countries: the United States (25%), Barbados (23%), United Kingdom (21%), China (18%), Thailand (7%), and Canada (7%). The mothers’ mean age was 30 years, and the mean gestational age was 28 weeks. The mean gestational CVH score was 8.8 out of 10. Nearly half of mothers (42%) had ideal metrics, while 4% had two or more poor metrics. Delivery occurred at a mean of 39.8 weeks, and adverse pregnancy outcomes occurred in 4.7%-17.9% of pregnancies.

In the fully adjusted model, which accounted for maternal age, height, alcohol use, gestational age at pregnancy exam, maternal parity, and newborn sex and race/ethnicity, odds ratios per 1-point higher (better) CVH score were 0.61 (95% confidence interval, 0.53-0.70) for preeclampsia, 0.85 (95% CI, 0.76-0.95) for unplanned primary cesarean section (among primiparous mothers), 0.83 (95% CI, 0.77-0.91) for large for gestational age infant, and 0.79 (95% CI, 0.72-0.87) for infant insulin sensitivity index below the 10th percentile. CVH categories were also associated with outcomes. For example, odds ratios for preeclampsia were 4.61 (95% CI, 2.13-11.14) for mothers with one or more intermediate metrics, 7.62 (95% CI, 3.60-18.13) for mothers with one poor metric, and 12.02 (95% CI, 4.70-32.50) for mothers with two or more poor metrics, compared with mothers with all metrics ideal.

“Except for smoking, each CVH metric was independently associated with adverse outcomes,” Dr. Perak said. “However, total CVH was associated with a wider range of outcomes than any single metric. This suggests that CVH provides health insights beyond single risk factors.”

Strengths of the study, she continued, included geographic and racial diversity of participants and high-quality research measurements of CVH. Limitations were that the cohort excluded prepregnancy diabetes and preterm births. “Diet and exercise data were not available, and CVH was measured once at 28 weeks,” she said. “Further study is needed across pregnancy and in other settings, but this study provides the first data on the relevance of gestational CVH for pregnancy outcomes.”

In an interview, Stephen S. Rich, PhD, who directs the Center for Public Health Genomics at the University of Virginia, said that the data “provide strong epidemiologic support to focus on the full range of cardiovascular health. In my view, the primary limitation of the study is that there may be significant differences in how one achieves ideal CHV across a single country, not to mention across the world, particularly in absence of a highly controlled, research environment. It is not clear that the approach used in this study at nine selected sites in six relatively highly developed countries could be translated into primary care – particularly in the U.S. with different regulatory and reimbursement plans and payers. Nonetheless, the evidence suggests a way to reduce adverse outcomes in pregnancy and the area deserves greater research.”

According to Dr. Perak, gestational diabetes is associated with a twofold higher maternal risk for cardiovascular disease (Diabetologia. 2019;62:905-14), while diabetes is also associated with higher offspring risk for CVD (BMJ. 2019;367:16398). However, a paucity of data exists on gestational CVH. In one report, better gestational CVH was associated with less subclinical CVD for the mother 10 years later (J Am Heart Assoc. 2019 Jul 23. doi:10.1161/JAHA.118.011394). In a separate analysis, Dr. Perak and her colleagues found that better gestational CVH was associated with better offspring CVH in childhood. “Unfortunately, we also reported that, among pregnant women in the United States, fewer than 1 in 10 had high CVH,” she said (J Am Heart Assoc. 2020 Feb 17. doi:10.1161/JAHA.119.015123). “However, the relevance of gestational CVH for pregnancy outcomes is unknown, but a it’s key question when considering CVH monitoring in prenatal care.”

Dr. Perak reported having received grant support from the National Heart, Lung, and Blood Institute, the American Heart Association, and Northwestern University. The HAPO Study was supported by NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases.

The meeting was sponsored by the American Heart Association.

dbrunk@mdedge.com

SOURCE: Perak A et al. Epi/Lifestyle 2020, Abstract 33.

KENT, WASHINGTON – The first thing I learned in this outbreak is that my sense of alarm has been deadened by years of medical practice. As a primary care doctor working south of Seattle, in the University of Washington’s Kent neighborhood clinic, I have dealt with long hours, the sometimes-insurmountable problems of the patients I care for, and the constant, gnawing fear of missing something and doing harm. To get through my day, I’ve done my best to rationalize that fear, to explain it away.

I can’t explain how, when I heard the news of the coronavirus epidemic in China, I didn’t think it would affect me. I can’t explain how news of the first patient presenting to an urgent care north of Seattle didn’t cause me, or all health care providers, to think about how we would respond. I can’t explain why so many doctors were dismissive of the very real threat that was about to explode. I can’t explain why it took 6 weeks for the COVID-19 outbreak to seem real to me.

If you work in a doctor’s office, emergency department, hospital, or urgent care center and have not seen a coronavirus case yet, you may have time to think through what is likely to happen in your community. After Washington state’s first case of COVID-19 became publicly known, few health care workers or leaders took the opportunity to work on our protocols, run drills, and check our supplies. We did not activate a chain of command or decide how information was going to be communicated to the front line and back to leadership. Few of us ran worst-case scenarios.

By March 12, we had 376 confirmed cases, and likely more than a thousand are undetected. The moment of realization of the severity of the outbreak didn’t come to me until Saturday, Feb. 29. In the week prior, several patients had come into the clinic with symptoms and potential exposures, but not meeting the narrow Centers for Disease Control and Prevention testing criteria. They were all advised by the Washington Department of Health to go home. At the time, it seemed like decent advice. Frontline providers didn’t know that there had been two cases of community transmission weeks before, or that one was about to become the first death in Washington state. I still advised patients to quarantine themselves. In the absence of testing, we had to assume everyone was positive and should stay home until 72 hours after their symptoms resolved. Studying the state’s FMLA [Family and Medical Leave Act] intently, I wrote insistent letters to inflexible bosses, explaining that their employees needed to stay home.

I worked that Saturday. Half of my patients had coughs. Our team insisted that they wear masks. One woman refused, and I refused to see her until she did. In a customer service–oriented health care system, I had been schooled to accommodate almost any patient request. But I was not about to put my staff and other patients at risk. Reluctantly, she complied.

On my lunch break, my partner called me to tell me he was at the grocery store. “Why?” I asked, since we usually went together. It became clear he was worried about an outbreak. He had been following the news closely and tried to tell me how deadly this could get and how quickly the disease could spread. I brushed his fears aside, as more evidence of his sweet and overly cautious nature. “It’ll be fine,” I said with misplaced confidence.

Later that day, I heard about the first death and the outbreak at Life Care, a nursing home north of Seattle. I learned that firefighters who had responded to distress calls were under quarantine. I learned through an epidemiologist that there were likely hundreds of undetected cases throughout Washington.

On Monday, our clinic decided to convert all cases with symptoms into telemedicine visits. Luckily, we had been building the capacity to see and treat patients virtually for a while. We have ramped up quickly, but there have been bumps along the way. It’s difficult to convince those who are anxious about their symptoms to allow us to use telemedicine for everyone’s safety. It is unclear how much liability we are taking on as individual providers with this approach or who will speak up for us if something goes wrong.

Patients don’t seem to know where to get their information, and they have been turning to increasingly bizarre sources. For the poorest, who have had so much trouble accessing care, I cannot blame them for not knowing whom to trust. I post what I know on Twitter and Facebook, but I know I’m no match for cynical social media algorithms.

Testing was still not available at my clinic the first week of March, and it remains largely unavailable throughout much of the country. We have lost weeks of opportunity to contain this. Luckily, on March 4, the University of Washington was finally allowed to use their homegrown test and bypass the limited supply from the CDC. But our capacity at UW is still limited, and the test remained unavailable to the majority of those potentially showing symptoms until March 9.

I am used to being less worried than my patients. I am used to reassuring them. But over the first week of March, I had an eerie sense that my alarm far outstripped theirs. I got relatively few questions about coronavirus, even as the number of cases continued to rise. It wasn’t until the end of the week that I noticed a few were truly fearful. Patients started stealing the gloves and the hand sanitizer, and we had to zealously guard them. My hands are raw from washing.

Throughout this time, I have been grateful for a centralized drive with clear protocols. I am grateful for clear messages at the beginning and end of the day from our CEO. I hope that other clinics model this and have daily in-person meetings, because too much cannot be conveyed in an email when the situation changes hourly.

But our health system nationally was already stretched thin before, and providers have sacrificed a lot, especially in the most critical settings, to provide decent patient care. Now we are asked to risk our health and safety, and our family’s, and I worry about the erosion of trust and work conditions for those on the front lines. I also worry our patients won’t believe us when we have allowed the costs of care to continue to rise and ruin their lives. I worry about the millions of people without doctors to call because they have no insurance, and because so many primary care physicians have left unsustainable jobs.

I am grateful that few of my colleagues have been sick and that those that were called out. I am grateful for the new nurse practitioners in our clinic who took the lion’s share of possibly affected patients and triaged hundreds of phone calls, creating note and message templates that we all use. I am grateful that my clinic manager insisted on doing a drill with all the staff members.

I am grateful that we were reminded that we are a team and that if the call center and cleaning crews and front desk are excluded, then our protocols are useless. I am grateful that our registered nurses quickly shifted to triage. I am grateful that I have testing available.

This week, for the first time since I started working, multiple patients asked how I am doing and expressed their thanks. I am most grateful for them.

I can’t tell you what to do or what is going to happen, but I can tell you that you need to prepare now. You need to run drills and catch the holes in your plans before the pandemic reaches you. You need to be creative and honest about the flaws in your organization that this pandemic will inevitably expose. You need to meet with your team every day and remember that we are all going to be stretched even thinner than before.

Most of us will get through this, but many of us won’t. And for those who do, we need to be honest about our successes and failures. We need to build a system that can do better next time. Because this is not the last pandemic we will face.
 

Dr. Elisabeth Poorman is a general internist at a University of Washington neighborhood clinic in Kent. She completed her residency at Cambridge (Mass.) Health Alliance and specializes in addiction medicine. She also serves on the editorial advisory board of Internal Medicine News.

KENT, WASHINGTON – The first thing I learned in this outbreak is that my sense of alarm has been deadened by years of medical practice. As a primary care doctor working south of Seattle, in the University of Washington’s Kent neighborhood clinic, I have dealt with long hours, the sometimes-insurmountable problems of the patients I care for, and the constant, gnawing fear of missing something and doing harm. To get through my day, I’ve done my best to rationalize that fear, to explain it away.

I can’t explain how, when I heard the news of the coronavirus epidemic in China, I didn’t think it would affect me. I can’t explain how news of the first patient presenting to an urgent care north of Seattle didn’t cause me, or all health care providers, to think about how we would respond. I can’t explain why so many doctors were dismissive of the very real threat that was about to explode. I can’t explain why it took 6 weeks for the COVID-19 outbreak to seem real to me.

If you work in a doctor’s office, emergency department, hospital, or urgent care center and have not seen a coronavirus case yet, you may have time to think through what is likely to happen in your community. After Washington state’s first case of COVID-19 became publicly known, few health care workers or leaders took the opportunity to work on our protocols, run drills, and check our supplies. We did not activate a chain of command or decide how information was going to be communicated to the front line and back to leadership. Few of us ran worst-case scenarios.

By March 12, we had 376 confirmed cases, and likely more than a thousand are undetected. The moment of realization of the severity of the outbreak didn’t come to me until Saturday, Feb. 29. In the week prior, several patients had come into the clinic with symptoms and potential exposures, but not meeting the narrow Centers for Disease Control and Prevention testing criteria. They were all advised by the Washington Department of Health to go home. At the time, it seemed like decent advice. Frontline providers didn’t know that there had been two cases of community transmission weeks before, or that one was about to become the first death in Washington state. I still advised patients to quarantine themselves. In the absence of testing, we had to assume everyone was positive and should stay home until 72 hours after their symptoms resolved. Studying the state’s FMLA [Family and Medical Leave Act] intently, I wrote insistent letters to inflexible bosses, explaining that their employees needed to stay home.

I worked that Saturday. Half of my patients had coughs. Our team insisted that they wear masks. One woman refused, and I refused to see her until she did. In a customer service–oriented health care system, I had been schooled to accommodate almost any patient request. But I was not about to put my staff and other patients at risk. Reluctantly, she complied.

On my lunch break, my partner called me to tell me he was at the grocery store. “Why?” I asked, since we usually went together. It became clear he was worried about an outbreak. He had been following the news closely and tried to tell me how deadly this could get and how quickly the disease could spread. I brushed his fears aside, as more evidence of his sweet and overly cautious nature. “It’ll be fine,” I said with misplaced confidence.

Later that day, I heard about the first death and the outbreak at Life Care, a nursing home north of Seattle. I learned that firefighters who had responded to distress calls were under quarantine. I learned through an epidemiologist that there were likely hundreds of undetected cases throughout Washington.

On Monday, our clinic decided to convert all cases with symptoms into telemedicine visits. Luckily, we had been building the capacity to see and treat patients virtually for a while. We have ramped up quickly, but there have been bumps along the way. It’s difficult to convince those who are anxious about their symptoms to allow us to use telemedicine for everyone’s safety. It is unclear how much liability we are taking on as individual providers with this approach or who will speak up for us if something goes wrong.

Patients don’t seem to know where to get their information, and they have been turning to increasingly bizarre sources. For the poorest, who have had so much trouble accessing care, I cannot blame them for not knowing whom to trust. I post what I know on Twitter and Facebook, but I know I’m no match for cynical social media algorithms.

Testing was still not available at my clinic the first week of March, and it remains largely unavailable throughout much of the country. We have lost weeks of opportunity to contain this. Luckily, on March 4, the University of Washington was finally allowed to use their homegrown test and bypass the limited supply from the CDC. But our capacity at UW is still limited, and the test remained unavailable to the majority of those potentially showing symptoms until March 9.

I am used to being less worried than my patients. I am used to reassuring them. But over the first week of March, I had an eerie sense that my alarm far outstripped theirs. I got relatively few questions about coronavirus, even as the number of cases continued to rise. It wasn’t until the end of the week that I noticed a few were truly fearful. Patients started stealing the gloves and the hand sanitizer, and we had to zealously guard them. My hands are raw from washing.

Throughout this time, I have been grateful for a centralized drive with clear protocols. I am grateful for clear messages at the beginning and end of the day from our CEO. I hope that other clinics model this and have daily in-person meetings, because too much cannot be conveyed in an email when the situation changes hourly.

But our health system nationally was already stretched thin before, and providers have sacrificed a lot, especially in the most critical settings, to provide decent patient care. Now we are asked to risk our health and safety, and our family’s, and I worry about the erosion of trust and work conditions for those on the front lines. I also worry our patients won’t believe us when we have allowed the costs of care to continue to rise and ruin their lives. I worry about the millions of people without doctors to call because they have no insurance, and because so many primary care physicians have left unsustainable jobs.

I am grateful that few of my colleagues have been sick and that those that were called out. I am grateful for the new nurse practitioners in our clinic who took the lion’s share of possibly affected patients and triaged hundreds of phone calls, creating note and message templates that we all use. I am grateful that my clinic manager insisted on doing a drill with all the staff members.

I am grateful that we were reminded that we are a team and that if the call center and cleaning crews and front desk are excluded, then our protocols are useless. I am grateful that our registered nurses quickly shifted to triage. I am grateful that I have testing available.

This week, for the first time since I started working, multiple patients asked how I am doing and expressed their thanks. I am most grateful for them.

I can’t tell you what to do or what is going to happen, but I can tell you that you need to prepare now. You need to run drills and catch the holes in your plans before the pandemic reaches you. You need to be creative and honest about the flaws in your organization that this pandemic will inevitably expose. You need to meet with your team every day and remember that we are all going to be stretched even thinner than before.

Most of us will get through this, but many of us won’t. And for those who do, we need to be honest about our successes and failures. We need to build a system that can do better next time. Because this is not the last pandemic we will face.
 

Dr. Elisabeth Poorman is a general internist at a University of Washington neighborhood clinic in Kent. She completed her residency at Cambridge (Mass.) Health Alliance and specializes in addiction medicine. She also serves on the editorial advisory board of Internal Medicine News.

KENT, WASHINGTON – The first thing I learned in this outbreak is that my sense of alarm has been deadened by years of medical practice. As a primary care doctor working south of Seattle, in the University of Washington’s Kent neighborhood clinic, I have dealt with long hours, the sometimes-insurmountable problems of the patients I care for, and the constant, gnawing fear of missing something and doing harm. To get through my day, I’ve done my best to rationalize that fear, to explain it away.

I can’t explain how, when I heard the news of the coronavirus epidemic in China, I didn’t think it would affect me. I can’t explain how news of the first patient presenting to an urgent care north of Seattle didn’t cause me, or all health care providers, to think about how we would respond. I can’t explain why so many doctors were dismissive of the very real threat that was about to explode. I can’t explain why it took 6 weeks for the COVID-19 outbreak to seem real to me.

If you work in a doctor’s office, emergency department, hospital, or urgent care center and have not seen a coronavirus case yet, you may have time to think through what is likely to happen in your community. After Washington state’s first case of COVID-19 became publicly known, few health care workers or leaders took the opportunity to work on our protocols, run drills, and check our supplies. We did not activate a chain of command or decide how information was going to be communicated to the front line and back to leadership. Few of us ran worst-case scenarios.

By March 12, we had 376 confirmed cases, and likely more than a thousand are undetected. The moment of realization of the severity of the outbreak didn’t come to me until Saturday, Feb. 29. In the week prior, several patients had come into the clinic with symptoms and potential exposures, but not meeting the narrow Centers for Disease Control and Prevention testing criteria. They were all advised by the Washington Department of Health to go home. At the time, it seemed like decent advice. Frontline providers didn’t know that there had been two cases of community transmission weeks before, or that one was about to become the first death in Washington state. I still advised patients to quarantine themselves. In the absence of testing, we had to assume everyone was positive and should stay home until 72 hours after their symptoms resolved. Studying the state’s FMLA [Family and Medical Leave Act] intently, I wrote insistent letters to inflexible bosses, explaining that their employees needed to stay home.

I worked that Saturday. Half of my patients had coughs. Our team insisted that they wear masks. One woman refused, and I refused to see her until she did. In a customer service–oriented health care system, I had been schooled to accommodate almost any patient request. But I was not about to put my staff and other patients at risk. Reluctantly, she complied.

On my lunch break, my partner called me to tell me he was at the grocery store. “Why?” I asked, since we usually went together. It became clear he was worried about an outbreak. He had been following the news closely and tried to tell me how deadly this could get and how quickly the disease could spread. I brushed his fears aside, as more evidence of his sweet and overly cautious nature. “It’ll be fine,” I said with misplaced confidence.

Later that day, I heard about the first death and the outbreak at Life Care, a nursing home north of Seattle. I learned that firefighters who had responded to distress calls were under quarantine. I learned through an epidemiologist that there were likely hundreds of undetected cases throughout Washington.

On Monday, our clinic decided to convert all cases with symptoms into telemedicine visits. Luckily, we had been building the capacity to see and treat patients virtually for a while. We have ramped up quickly, but there have been bumps along the way. It’s difficult to convince those who are anxious about their symptoms to allow us to use telemedicine for everyone’s safety. It is unclear how much liability we are taking on as individual providers with this approach or who will speak up for us if something goes wrong.

Patients don’t seem to know where to get their information, and they have been turning to increasingly bizarre sources. For the poorest, who have had so much trouble accessing care, I cannot blame them for not knowing whom to trust. I post what I know on Twitter and Facebook, but I know I’m no match for cynical social media algorithms.

Testing was still not available at my clinic the first week of March, and it remains largely unavailable throughout much of the country. We have lost weeks of opportunity to contain this. Luckily, on March 4, the University of Washington was finally allowed to use their homegrown test and bypass the limited supply from the CDC. But our capacity at UW is still limited, and the test remained unavailable to the majority of those potentially showing symptoms until March 9.

I am used to being less worried than my patients. I am used to reassuring them. But over the first week of March, I had an eerie sense that my alarm far outstripped theirs. I got relatively few questions about coronavirus, even as the number of cases continued to rise. It wasn’t until the end of the week that I noticed a few were truly fearful. Patients started stealing the gloves and the hand sanitizer, and we had to zealously guard them. My hands are raw from washing.

Throughout this time, I have been grateful for a centralized drive with clear protocols. I am grateful for clear messages at the beginning and end of the day from our CEO. I hope that other clinics model this and have daily in-person meetings, because too much cannot be conveyed in an email when the situation changes hourly.

But our health system nationally was already stretched thin before, and providers have sacrificed a lot, especially in the most critical settings, to provide decent patient care. Now we are asked to risk our health and safety, and our family’s, and I worry about the erosion of trust and work conditions for those on the front lines. I also worry our patients won’t believe us when we have allowed the costs of care to continue to rise and ruin their lives. I worry about the millions of people without doctors to call because they have no insurance, and because so many primary care physicians have left unsustainable jobs.

I am grateful that few of my colleagues have been sick and that those that were called out. I am grateful for the new nurse practitioners in our clinic who took the lion’s share of possibly affected patients and triaged hundreds of phone calls, creating note and message templates that we all use. I am grateful that my clinic manager insisted on doing a drill with all the staff members.

I am grateful that we were reminded that we are a team and that if the call center and cleaning crews and front desk are excluded, then our protocols are useless. I am grateful that our registered nurses quickly shifted to triage. I am grateful that I have testing available.

This week, for the first time since I started working, multiple patients asked how I am doing and expressed their thanks. I am most grateful for them.

I can’t tell you what to do or what is going to happen, but I can tell you that you need to prepare now. You need to run drills and catch the holes in your plans before the pandemic reaches you. You need to be creative and honest about the flaws in your organization that this pandemic will inevitably expose. You need to meet with your team every day and remember that we are all going to be stretched even thinner than before.

Most of us will get through this, but many of us won’t. And for those who do, we need to be honest about our successes and failures. We need to build a system that can do better next time. Because this is not the last pandemic we will face.
 

Dr. Elisabeth Poorman is a general internist at a University of Washington neighborhood clinic in Kent. She completed her residency at Cambridge (Mass.) Health Alliance and specializes in addiction medicine. She also serves on the editorial advisory board of Internal Medicine News.

PHOENIX – Consumption of red meat, particularly the processed form, is linked to a higher risk of developing coronary heart disease in men, results from a large prospective analysis demonstrated.

“The findings of this study are in line with randomized trials showing that the consumption of red meat, as compared with plant-based protein sources, increases LDL cholesterol levels, and with previous studies on red meat and risk of coronary heart disease,” lead study author Laila Al-Shaar, MPH, PhD, said in an interview in advance of the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.

According to Dr. Al-Shaar, a postdoctoral research fellow in the department of nutrition at the T.H. Chan School of Public Health at Harvard University, Boston, most of the existing studies on red meat and heart disease have examined the impact of increasing consumption of red meat while decreasing consumption of all other foods. For the current study, she and her colleagues used a substitution analysis approach to understand how replacing red meat (total, processed, or unprocessed) with another protein-rich food was associated with the risk of heart disease. “This would potentially provide more specific guidance for healthier alternatives for those planning to cut down their red meat intake,” she said.

She and her colleagues prospectively followed 43,259 men in the Health Professionals Follow-up Study (1986-2012) who had no known history of cancer or cardiovascular disease. Diet was assessed by a standardized and validated food frequency questionnaire that was updated every 4 years. Dr. Al-Shaar and her colleagues used multivariate Cox models to estimate hazard ratios and 95% confidence intervals of CHD risk across categories of red meat consumption. They performed substitution analyses by comparing coefficients in models including alternative foods as continuous variables.

Over roughly 933,000 person-years of follow-up, the researchers documented 4,148 incident CHD cases. Of these, 1,680 were fatal. After multivariate adjustment for dietary and nondietary risk factors, both total and processed red meat intake were associated with a modestly higher risk of CHD (hazard ratio for a one serving/day increment, 1.08; 95% confidence interval, 1.01-1.14 for total red meat; and HR, 1.13; 95% CI, 1.03-1.22 for processed red meat). Substitutions of one serving per day of other foods (including nuts, legumes, soy, whole grains, and low- and high-fat dairy) for one serving per day of total red meat were associated with a 10%-47% lower CHD risk.

Stronger inverse associations were observed between some of these substitutions for red meat and risk of fatal CHD. Substituting nuts lowered the risk of fatal heart disease by 17%, while replacing red meat with whole grains was linked to a 48% reduction in that outcome. Those associations were more pronounced when replacing processed red meat.

“Processed meats and meats in general have been thought to be potentially not favorable in terms of cardiovascular disease and cardiovascular disease risk,” Robert H. Eckel, MD, professor emeritus of medicine at the University of Colorado Anschutz Medical Campus, Aurora, said in an interview. “Now we have increasing data that not only is there a negative cardiovascular disease impact of animal protein, but we see this on all-cause mortality, including cancer.”

Dr. Al-Shaar said that the findings “support current recommendations to limit consumption of red meat and suggest that high-quality plant-based proteins such as nuts, legumes, and soy are good alternatives for individuals planning to have better food choices and healthier eating patterns.”

She acknowledged certain limitations of the study, including its observational design and the fact that it was limited to non-Hispanic white health professionals, “thus limiting the generalizability of its findings to the whole population.”

Dr. Eckel, who is a past president of the American Heart Association, underscored the importance of one’s overall diet in mitigating the risk of developing coronary heart disease. “It’s not simply substituting animal protein with plant protein,” he said. “Fruits and vegetables and whole grains, lean protein from fish – a Mediterranean-style diet – is what the AHA recommends.”

Dr. Al-Shaar reported having no financial disclosures. The study was supported by a T32 training grant from the National Institutes of Health and by other grants from the NIH. The meeting was sponsored by the AHA.

dbrunk@mdedge.com

SOURCE: Al-Shaar L et al. Epi/Lifestyle 2020, Abstract P512.

PHOENIX – Consumption of red meat, particularly the processed form, is linked to a higher risk of developing coronary heart disease in men, results from a large prospective analysis demonstrated.

“The findings of this study are in line with randomized trials showing that the consumption of red meat, as compared with plant-based protein sources, increases LDL cholesterol levels, and with previous studies on red meat and risk of coronary heart disease,” lead study author Laila Al-Shaar, MPH, PhD, said in an interview in advance of the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.

According to Dr. Al-Shaar, a postdoctoral research fellow in the department of nutrition at the T.H. Chan School of Public Health at Harvard University, Boston, most of the existing studies on red meat and heart disease have examined the impact of increasing consumption of red meat while decreasing consumption of all other foods. For the current study, she and her colleagues used a substitution analysis approach to understand how replacing red meat (total, processed, or unprocessed) with another protein-rich food was associated with the risk of heart disease. “This would potentially provide more specific guidance for healthier alternatives for those planning to cut down their red meat intake,” she said.

She and her colleagues prospectively followed 43,259 men in the Health Professionals Follow-up Study (1986-2012) who had no known history of cancer or cardiovascular disease. Diet was assessed by a standardized and validated food frequency questionnaire that was updated every 4 years. Dr. Al-Shaar and her colleagues used multivariate Cox models to estimate hazard ratios and 95% confidence intervals of CHD risk across categories of red meat consumption. They performed substitution analyses by comparing coefficients in models including alternative foods as continuous variables.

Over roughly 933,000 person-years of follow-up, the researchers documented 4,148 incident CHD cases. Of these, 1,680 were fatal. After multivariate adjustment for dietary and nondietary risk factors, both total and processed red meat intake were associated with a modestly higher risk of CHD (hazard ratio for a one serving/day increment, 1.08; 95% confidence interval, 1.01-1.14 for total red meat; and HR, 1.13; 95% CI, 1.03-1.22 for processed red meat). Substitutions of one serving per day of other foods (including nuts, legumes, soy, whole grains, and low- and high-fat dairy) for one serving per day of total red meat were associated with a 10%-47% lower CHD risk.

Stronger inverse associations were observed between some of these substitutions for red meat and risk of fatal CHD. Substituting nuts lowered the risk of fatal heart disease by 17%, while replacing red meat with whole grains was linked to a 48% reduction in that outcome. Those associations were more pronounced when replacing processed red meat.

“Processed meats and meats in general have been thought to be potentially not favorable in terms of cardiovascular disease and cardiovascular disease risk,” Robert H. Eckel, MD, professor emeritus of medicine at the University of Colorado Anschutz Medical Campus, Aurora, said in an interview. “Now we have increasing data that not only is there a negative cardiovascular disease impact of animal protein, but we see this on all-cause mortality, including cancer.”

Dr. Al-Shaar said that the findings “support current recommendations to limit consumption of red meat and suggest that high-quality plant-based proteins such as nuts, legumes, and soy are good alternatives for individuals planning to have better food choices and healthier eating patterns.”

She acknowledged certain limitations of the study, including its observational design and the fact that it was limited to non-Hispanic white health professionals, “thus limiting the generalizability of its findings to the whole population.”

Dr. Eckel, who is a past president of the American Heart Association, underscored the importance of one’s overall diet in mitigating the risk of developing coronary heart disease. “It’s not simply substituting animal protein with plant protein,” he said. “Fruits and vegetables and whole grains, lean protein from fish – a Mediterranean-style diet – is what the AHA recommends.”

Dr. Al-Shaar reported having no financial disclosures. The study was supported by a T32 training grant from the National Institutes of Health and by other grants from the NIH. The meeting was sponsored by the AHA.

dbrunk@mdedge.com

SOURCE: Al-Shaar L et al. Epi/Lifestyle 2020, Abstract P512.

PHOENIX – Consumption of red meat, particularly the processed form, is linked to a higher risk of developing coronary heart disease in men, results from a large prospective analysis demonstrated.

“The findings of this study are in line with randomized trials showing that the consumption of red meat, as compared with plant-based protein sources, increases LDL cholesterol levels, and with previous studies on red meat and risk of coronary heart disease,” lead study author Laila Al-Shaar, MPH, PhD, said in an interview in advance of the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.

According to Dr. Al-Shaar, a postdoctoral research fellow in the department of nutrition at the T.H. Chan School of Public Health at Harvard University, Boston, most of the existing studies on red meat and heart disease have examined the impact of increasing consumption of red meat while decreasing consumption of all other foods. For the current study, she and her colleagues used a substitution analysis approach to understand how replacing red meat (total, processed, or unprocessed) with another protein-rich food was associated with the risk of heart disease. “This would potentially provide more specific guidance for healthier alternatives for those planning to cut down their red meat intake,” she said.

She and her colleagues prospectively followed 43,259 men in the Health Professionals Follow-up Study (1986-2012) who had no known history of cancer or cardiovascular disease. Diet was assessed by a standardized and validated food frequency questionnaire that was updated every 4 years. Dr. Al-Shaar and her colleagues used multivariate Cox models to estimate hazard ratios and 95% confidence intervals of CHD risk across categories of red meat consumption. They performed substitution analyses by comparing coefficients in models including alternative foods as continuous variables.

Over roughly 933,000 person-years of follow-up, the researchers documented 4,148 incident CHD cases. Of these, 1,680 were fatal. After multivariate adjustment for dietary and nondietary risk factors, both total and processed red meat intake were associated with a modestly higher risk of CHD (hazard ratio for a one serving/day increment, 1.08; 95% confidence interval, 1.01-1.14 for total red meat; and HR, 1.13; 95% CI, 1.03-1.22 for processed red meat). Substitutions of one serving per day of other foods (including nuts, legumes, soy, whole grains, and low- and high-fat dairy) for one serving per day of total red meat were associated with a 10%-47% lower CHD risk.

Stronger inverse associations were observed between some of these substitutions for red meat and risk of fatal CHD. Substituting nuts lowered the risk of fatal heart disease by 17%, while replacing red meat with whole grains was linked to a 48% reduction in that outcome. Those associations were more pronounced when replacing processed red meat.

“Processed meats and meats in general have been thought to be potentially not favorable in terms of cardiovascular disease and cardiovascular disease risk,” Robert H. Eckel, MD, professor emeritus of medicine at the University of Colorado Anschutz Medical Campus, Aurora, said in an interview. “Now we have increasing data that not only is there a negative cardiovascular disease impact of animal protein, but we see this on all-cause mortality, including cancer.”

Dr. Al-Shaar said that the findings “support current recommendations to limit consumption of red meat and suggest that high-quality plant-based proteins such as nuts, legumes, and soy are good alternatives for individuals planning to have better food choices and healthier eating patterns.”

She acknowledged certain limitations of the study, including its observational design and the fact that it was limited to non-Hispanic white health professionals, “thus limiting the generalizability of its findings to the whole population.”

Dr. Eckel, who is a past president of the American Heart Association, underscored the importance of one’s overall diet in mitigating the risk of developing coronary heart disease. “It’s not simply substituting animal protein with plant protein,” he said. “Fruits and vegetables and whole grains, lean protein from fish – a Mediterranean-style diet – is what the AHA recommends.”

Dr. Al-Shaar reported having no financial disclosures. The study was supported by a T32 training grant from the National Institutes of Health and by other grants from the NIH. The meeting was sponsored by the AHA.

dbrunk@mdedge.com

SOURCE: Al-Shaar L et al. Epi/Lifestyle 2020, Abstract P512.

The US Food and Drug Administration (FDA) has issued new draft guidance for industry on evaluating the safety of new drugs for type 2 diabetes and removed the “outdated” 12-year-old requirement for standardized cardiovascular outcomes trials (CVOTs).

The new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” will replace the December 2008 requirement that manufacturers conduct CVOTs to rule out unacceptable cardiovascular safety risk. That move followed concerns raised at the time about the thiazolidinedione class of glucose-lowering drugs.

Since then, “FDA has reviewed the results of several [CVOTs] conducted to meet the December 2008 guidance recommendations. None of the CVOTs to date have identified an increased risk of ischemic cardiovascular events; some of the CVOTs have instead demonstrated a reduced risk for cardiovascular events,” according to the federal register announcement.

In October 2018, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee narrowly voted (10 to 9) to continue requiring CVOTs, but most panel members also recommended some changes to them, including requirements for safety data beyond cardiovascular events.

Based on the CVOT results over the years and the panel’s recommendations, “FDA is revisiting the recommendations of the December 2008 guidance and is now proposing an updated approach to evaluating the safety of new drugs and biologics to improve glycemic control.”

“The new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes,” the FDA said.

Instead, the draft calls for at least 4000 patient-years of exposure to the new drug in phase 3 trials and inclusion of study participants with comorbid conditions and/or diabetes complications, including at least 500 with stage 3-4 chronic kidney disease, 600 with established cardiovascular disease, and at least 600 over the age of 65 years.

The FDA is soliciting stakeholder input on these and other issues, including study duration, subject demographics, specific safety concerns, and event adjudication.

In a statement, Lisa Yanoff, MD, acting director of the Division for Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said: “By following previous FDA recommendations, sponsors have shown that new type 2 diabetes drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients. Now, with this proposed approach, we will have broader, valuable safety information for these medications.”

The draft is open for comments for 90 days after March 9, 2020. It is available online, along with a link for submitting comments.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has issued new draft guidance for industry on evaluating the safety of new drugs for type 2 diabetes and removed the “outdated” 12-year-old requirement for standardized cardiovascular outcomes trials (CVOTs).

The new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” will replace the December 2008 requirement that manufacturers conduct CVOTs to rule out unacceptable cardiovascular safety risk. That move followed concerns raised at the time about the thiazolidinedione class of glucose-lowering drugs.

Since then, “FDA has reviewed the results of several [CVOTs] conducted to meet the December 2008 guidance recommendations. None of the CVOTs to date have identified an increased risk of ischemic cardiovascular events; some of the CVOTs have instead demonstrated a reduced risk for cardiovascular events,” according to the federal register announcement.

In October 2018, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee narrowly voted (10 to 9) to continue requiring CVOTs, but most panel members also recommended some changes to them, including requirements for safety data beyond cardiovascular events.

Based on the CVOT results over the years and the panel’s recommendations, “FDA is revisiting the recommendations of the December 2008 guidance and is now proposing an updated approach to evaluating the safety of new drugs and biologics to improve glycemic control.”

“The new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes,” the FDA said.

Instead, the draft calls for at least 4000 patient-years of exposure to the new drug in phase 3 trials and inclusion of study participants with comorbid conditions and/or diabetes complications, including at least 500 with stage 3-4 chronic kidney disease, 600 with established cardiovascular disease, and at least 600 over the age of 65 years.

The FDA is soliciting stakeholder input on these and other issues, including study duration, subject demographics, specific safety concerns, and event adjudication.

In a statement, Lisa Yanoff, MD, acting director of the Division for Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said: “By following previous FDA recommendations, sponsors have shown that new type 2 diabetes drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients. Now, with this proposed approach, we will have broader, valuable safety information for these medications.”

The draft is open for comments for 90 days after March 9, 2020. It is available online, along with a link for submitting comments.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has issued new draft guidance for industry on evaluating the safety of new drugs for type 2 diabetes and removed the “outdated” 12-year-old requirement for standardized cardiovascular outcomes trials (CVOTs).

The new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” will replace the December 2008 requirement that manufacturers conduct CVOTs to rule out unacceptable cardiovascular safety risk. That move followed concerns raised at the time about the thiazolidinedione class of glucose-lowering drugs.

Since then, “FDA has reviewed the results of several [CVOTs] conducted to meet the December 2008 guidance recommendations. None of the CVOTs to date have identified an increased risk of ischemic cardiovascular events; some of the CVOTs have instead demonstrated a reduced risk for cardiovascular events,” according to the federal register announcement.

In October 2018, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee narrowly voted (10 to 9) to continue requiring CVOTs, but most panel members also recommended some changes to them, including requirements for safety data beyond cardiovascular events.

Based on the CVOT results over the years and the panel’s recommendations, “FDA is revisiting the recommendations of the December 2008 guidance and is now proposing an updated approach to evaluating the safety of new drugs and biologics to improve glycemic control.”

“The new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes,” the FDA said.

Instead, the draft calls for at least 4000 patient-years of exposure to the new drug in phase 3 trials and inclusion of study participants with comorbid conditions and/or diabetes complications, including at least 500 with stage 3-4 chronic kidney disease, 600 with established cardiovascular disease, and at least 600 over the age of 65 years.

The FDA is soliciting stakeholder input on these and other issues, including study duration, subject demographics, specific safety concerns, and event adjudication.

In a statement, Lisa Yanoff, MD, acting director of the Division for Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said: “By following previous FDA recommendations, sponsors have shown that new type 2 diabetes drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients. Now, with this proposed approach, we will have broader, valuable safety information for these medications.”

The draft is open for comments for 90 days after March 9, 2020. It is available online, along with a link for submitting comments.

This article first appeared on Medscape.com.

PHOENIX – Statin use for the secondary prevention of cardiovascular disease increased modestly between 2008 and 2017 in the United States, but more than 40% of patients with established atherosclerotic cardiovascular disease are still not on a statin.

Doug Brunk/MDedge News

In addition, even after release of the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation. 2014;129:S1-45) that markedly increased the pool of eligible patients, disparities exist in the proportion of women versus men, and blacks and Hispanics versus whites with atherosclerotic cardiovascular disease (ASCVD) who are currently receiving a statin.

“Despite repeated calls for the use of statins for secondary prevention of CVD in multiple guidelines, gender and racial inequalities in the use of statins persist,” Joseph A. Salami, MD, MPH, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the American Heart Association. “Cardiovascular disease remains the leading cause of death in the U.S. In 2017, it was responsible for 647,457 deaths. We have an opportunity to improve CVD-related outcomes and cost by intensifying efforts to use statins for the secondary prevention of CVD and closing gender and racial gaps. Action is needed.”

Dr. Salami, a biostatistician with the Baptist Health South Florida Center for Advanced Analytics in Coral Gables, based his remarks on an analysis of data contained in the 2008-2017 Medical Expenditure Panel Survey (MEPS), a national representative survey sponsored by the Agency for Healthcare Research and Quality. “Between 2013 and 2018 there were six different guidelines released encouraging statin use among ASCVD patients,” he said. “Besides the good number needed to treat, statin use on secondary prevention of CVD is cost effective.”

Given the proven efficacy of statin use in the prevention of CVD, he and his associates set out to examine trends in the proportion of adults with ASCVD using statins and to assess for gender and racial differences in their use. The researchers used ICD-9 and ICD-10 codes to define ASCVD among the MEPS study population, as well as self-reported history of coronary artery disease, peripheral artery disease, and stroke. After excluding adults aged younger than 40 years and those without ASCVD, this left a population of 15,911 patients. Of these, 44% were female, their mean age was 62 years, and 72% were Caucasian.

Overall, statin use increased from 50% in 2008 to 58.7% in 2017, with an average annual percentage change of 0.95% between 2010 and 2017 (P = .01). However, the annual percentage change in statin use was 0.25% among men versus 0.14% among women (P = .022). “Each year during the study period, more than 3 million women with ASCVD were not prescribed a statin, which translated into about 36 million adult-years,” Dr. Salami said. “In 2017, 16% of these women were African Americans and 15% were Hispanic.”

Logistic regression analysis revealed that in 2017, females with ASCVD were less likely to be prescribed a statin, compared with males (odds ratio, 0.52; P less than .001). In addition, compared with whites, blacks were less likely to be prescribed a statin (OR, 0.69; P = .012), as were Hispanics (OR, 0.62; P = .003). “In a multivariate logistic regression controlling for age, health insurance status, and comorbidities, the gender disparity remained statistically significant, but the racial disparity did not,” Dr. Salami said.

In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, characterized the study’s findings as sobering. “This should be an eye-opener for all of us in medicine, whether we are physicians, pharmacists, nurses, or researchers,” said Dr. Brown, who is a cardiologist and physician scientist at the Mayo Clinic in Rochester, Minn. “We’re all in this together, and we all have a role to play in addressing social determinants of health. I think we need to recognize the fact that we’re not treating blacks, Hispanics, and women to the degree that we should be, compared to whites and men. I think we need to do better, and we need to figure out how to reach that population, and how to improve.”

Dr. Salami acknowledged certain limitations of the study, including the fact that MEPS was carried out in a noninstitutionalized adult population and that the definition of ASCVD was based partly on self-report. “Therefore, an underestimation of number adults with ASCVD is likely,” he said. “We also couldn’t determine adherence to medication nor long-term use of statins among adults with ASCVD.”

He concluded his presentation by noting that, over the 10-year study period, there were about 71.2 million ASCVD adult-years without a statin prescription. “That is a staggering number,” Dr. Salami said.

He reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Salami A et al. Epi/Lifestyle 2020, Abstract 4.

PHOENIX – Statin use for the secondary prevention of cardiovascular disease increased modestly between 2008 and 2017 in the United States, but more than 40% of patients with established atherosclerotic cardiovascular disease are still not on a statin.

Doug Brunk/MDedge News

In addition, even after release of the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation. 2014;129:S1-45) that markedly increased the pool of eligible patients, disparities exist in the proportion of women versus men, and blacks and Hispanics versus whites with atherosclerotic cardiovascular disease (ASCVD) who are currently receiving a statin.

“Despite repeated calls for the use of statins for secondary prevention of CVD in multiple guidelines, gender and racial inequalities in the use of statins persist,” Joseph A. Salami, MD, MPH, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the American Heart Association. “Cardiovascular disease remains the leading cause of death in the U.S. In 2017, it was responsible for 647,457 deaths. We have an opportunity to improve CVD-related outcomes and cost by intensifying efforts to use statins for the secondary prevention of CVD and closing gender and racial gaps. Action is needed.”

Dr. Salami, a biostatistician with the Baptist Health South Florida Center for Advanced Analytics in Coral Gables, based his remarks on an analysis of data contained in the 2008-2017 Medical Expenditure Panel Survey (MEPS), a national representative survey sponsored by the Agency for Healthcare Research and Quality. “Between 2013 and 2018 there were six different guidelines released encouraging statin use among ASCVD patients,” he said. “Besides the good number needed to treat, statin use on secondary prevention of CVD is cost effective.”

Given the proven efficacy of statin use in the prevention of CVD, he and his associates set out to examine trends in the proportion of adults with ASCVD using statins and to assess for gender and racial differences in their use. The researchers used ICD-9 and ICD-10 codes to define ASCVD among the MEPS study population, as well as self-reported history of coronary artery disease, peripheral artery disease, and stroke. After excluding adults aged younger than 40 years and those without ASCVD, this left a population of 15,911 patients. Of these, 44% were female, their mean age was 62 years, and 72% were Caucasian.

Overall, statin use increased from 50% in 2008 to 58.7% in 2017, with an average annual percentage change of 0.95% between 2010 and 2017 (P = .01). However, the annual percentage change in statin use was 0.25% among men versus 0.14% among women (P = .022). “Each year during the study period, more than 3 million women with ASCVD were not prescribed a statin, which translated into about 36 million adult-years,” Dr. Salami said. “In 2017, 16% of these women were African Americans and 15% were Hispanic.”

Logistic regression analysis revealed that in 2017, females with ASCVD were less likely to be prescribed a statin, compared with males (odds ratio, 0.52; P less than .001). In addition, compared with whites, blacks were less likely to be prescribed a statin (OR, 0.69; P = .012), as were Hispanics (OR, 0.62; P = .003). “In a multivariate logistic regression controlling for age, health insurance status, and comorbidities, the gender disparity remained statistically significant, but the racial disparity did not,” Dr. Salami said.

In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, characterized the study’s findings as sobering. “This should be an eye-opener for all of us in medicine, whether we are physicians, pharmacists, nurses, or researchers,” said Dr. Brown, who is a cardiologist and physician scientist at the Mayo Clinic in Rochester, Minn. “We’re all in this together, and we all have a role to play in addressing social determinants of health. I think we need to recognize the fact that we’re not treating blacks, Hispanics, and women to the degree that we should be, compared to whites and men. I think we need to do better, and we need to figure out how to reach that population, and how to improve.”

Dr. Salami acknowledged certain limitations of the study, including the fact that MEPS was carried out in a noninstitutionalized adult population and that the definition of ASCVD was based partly on self-report. “Therefore, an underestimation of number adults with ASCVD is likely,” he said. “We also couldn’t determine adherence to medication nor long-term use of statins among adults with ASCVD.”

He concluded his presentation by noting that, over the 10-year study period, there were about 71.2 million ASCVD adult-years without a statin prescription. “That is a staggering number,” Dr. Salami said.

He reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Salami A et al. Epi/Lifestyle 2020, Abstract 4.

PHOENIX – Statin use for the secondary prevention of cardiovascular disease increased modestly between 2008 and 2017 in the United States, but more than 40% of patients with established atherosclerotic cardiovascular disease are still not on a statin.

Doug Brunk/MDedge News

In addition, even after release of the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation. 2014;129:S1-45) that markedly increased the pool of eligible patients, disparities exist in the proportion of women versus men, and blacks and Hispanics versus whites with atherosclerotic cardiovascular disease (ASCVD) who are currently receiving a statin.

“Despite repeated calls for the use of statins for secondary prevention of CVD in multiple guidelines, gender and racial inequalities in the use of statins persist,” Joseph A. Salami, MD, MPH, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the American Heart Association. “Cardiovascular disease remains the leading cause of death in the U.S. In 2017, it was responsible for 647,457 deaths. We have an opportunity to improve CVD-related outcomes and cost by intensifying efforts to use statins for the secondary prevention of CVD and closing gender and racial gaps. Action is needed.”

Dr. Salami, a biostatistician with the Baptist Health South Florida Center for Advanced Analytics in Coral Gables, based his remarks on an analysis of data contained in the 2008-2017 Medical Expenditure Panel Survey (MEPS), a national representative survey sponsored by the Agency for Healthcare Research and Quality. “Between 2013 and 2018 there were six different guidelines released encouraging statin use among ASCVD patients,” he said. “Besides the good number needed to treat, statin use on secondary prevention of CVD is cost effective.”

Given the proven efficacy of statin use in the prevention of CVD, he and his associates set out to examine trends in the proportion of adults with ASCVD using statins and to assess for gender and racial differences in their use. The researchers used ICD-9 and ICD-10 codes to define ASCVD among the MEPS study population, as well as self-reported history of coronary artery disease, peripheral artery disease, and stroke. After excluding adults aged younger than 40 years and those without ASCVD, this left a population of 15,911 patients. Of these, 44% were female, their mean age was 62 years, and 72% were Caucasian.

Overall, statin use increased from 50% in 2008 to 58.7% in 2017, with an average annual percentage change of 0.95% between 2010 and 2017 (P = .01). However, the annual percentage change in statin use was 0.25% among men versus 0.14% among women (P = .022). “Each year during the study period, more than 3 million women with ASCVD were not prescribed a statin, which translated into about 36 million adult-years,” Dr. Salami said. “In 2017, 16% of these women were African Americans and 15% were Hispanic.”

Logistic regression analysis revealed that in 2017, females with ASCVD were less likely to be prescribed a statin, compared with males (odds ratio, 0.52; P less than .001). In addition, compared with whites, blacks were less likely to be prescribed a statin (OR, 0.69; P = .012), as were Hispanics (OR, 0.62; P = .003). “In a multivariate logistic regression controlling for age, health insurance status, and comorbidities, the gender disparity remained statistically significant, but the racial disparity did not,” Dr. Salami said.

In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, characterized the study’s findings as sobering. “This should be an eye-opener for all of us in medicine, whether we are physicians, pharmacists, nurses, or researchers,” said Dr. Brown, who is a cardiologist and physician scientist at the Mayo Clinic in Rochester, Minn. “We’re all in this together, and we all have a role to play in addressing social determinants of health. I think we need to recognize the fact that we’re not treating blacks, Hispanics, and women to the degree that we should be, compared to whites and men. I think we need to do better, and we need to figure out how to reach that population, and how to improve.”

Dr. Salami acknowledged certain limitations of the study, including the fact that MEPS was carried out in a noninstitutionalized adult population and that the definition of ASCVD was based partly on self-report. “Therefore, an underestimation of number adults with ASCVD is likely,” he said. “We also couldn’t determine adherence to medication nor long-term use of statins among adults with ASCVD.”

He concluded his presentation by noting that, over the 10-year study period, there were about 71.2 million ASCVD adult-years without a statin prescription. “That is a staggering number,” Dr. Salami said.

He reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Salami A et al. Epi/Lifestyle 2020, Abstract 4.

Patients who did not survive hospitalization for COVID-19 in Wuhan were more likely to be older, have comorbidities, and elevated D-dimer, according to the first study to examine risk factors associated with death among adults hospitalized with COVID-19. “Older age, showing signs of sepsis on admission, underlying diseases like high blood pressure and diabetes, and the prolonged use of noninvasive ventilation were important factors in the deaths of these patients,” coauthor Zhibo Liu said in a news release. Abnormal blood clotting was part of the clinical picture too.

Fei Zhou, MD, from the Chinese Academy of Medical Sciences, and colleagues conducted a retrospective, observational, multicenter cohort study of 191 patients, 137 of whom were discharged and 54 of whom died in the hospital.

The study, published online today in The Lancet, included all adult inpatients with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital who had been discharged or died by January 31 of this year. Severely ill patients in the province were transferred to these hospitals until February 1.

The researchers compared demographic, clinical, treatment, and laboratory data from electronic medical records between survivors and those who succumbed to the disease. The analysis also tested serial samples for viral RNA. Overall, 91 (48%) of the 191 patients had comorbidity. Most common was hypertension (30%), followed by diabetes (19%) and coronary heart disease (8%).

The odds of dying in the hospital increased with age (odds ratio 1.10; 95% confidence interval, 1.03-1.17; per year increase in age), higher Sequential Organ Failure Assessment (SOFA) score (5.65, 2.61-12.23; P < .0001), and D-dimer level exceeding 1 mcg/L on admission. The SOFA was previously called the “sepsis-related organ failure assessment score” and assesses rate of organ failure in intensive care units. Elevated D-dimer indicates increased risk of abnormal blood clotting, such as deep vein thrombosis.

Nonsurvivors compared with survivors had higher frequencies of respiratory failure (98% vs 36%), sepsis (100%, vs 42%), and secondary infections (50% vs 1%).

The average age of survivors was 52 years compared to 69 for those who died. Liu cited weakening of the immune system and increased inflammation, which damages organs and also promotes viral replication, as explanations for the age effect.

From the time of initial symptoms, median time to discharge from the hospital was 22 days. Average time to death was 18.5 days.

Fever persisted for a median of 12 days among all patients, and cough persisted for a median 19 days; 45% of the survivors were still coughing on discharge. In survivors, shortness of breath improved after 13 days, but persisted until death in the others.

Viral shedding persisted for a median duration of 20 days in survivors, ranging from 8 to 37. The virus (SARS-CoV-2) was detectable in nonsurvivors until death. Antiviral treatment did not curtail viral shedding.

But the viral shedding data come with a caveat. “The extended viral shedding noted in our study has important implications for guiding decisions around isolation precautions and antiviral treatment in patients with confirmed COVID-19 infection. However, we need to be clear that viral shedding time should not be confused with other self-isolation guidance for people who may have been exposed to COVID-19 but do not have symptoms, as this guidance is based on the incubation time of the virus,” explained colead author Bin Cao.

“Older age, elevated D-dimer levels, and high SOFA score could help clinicians to identify at an early stage those patients with COVID-19 who have poor prognosis. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future,” the researchers conclude.

A limitation in interpreting the findings of the study is that hospitalized patients do not represent the entire infected population. The researchers caution that “the number of deaths does not reflect the true mortality of COVID-19.” They also note that they did not have enough genetic material to accurately assess duration of viral shedding.

This article first appeared on Medscape.com.

Patients who did not survive hospitalization for COVID-19 in Wuhan were more likely to be older, have comorbidities, and elevated D-dimer, according to the first study to examine risk factors associated with death among adults hospitalized with COVID-19. “Older age, showing signs of sepsis on admission, underlying diseases like high blood pressure and diabetes, and the prolonged use of noninvasive ventilation were important factors in the deaths of these patients,” coauthor Zhibo Liu said in a news release. Abnormal blood clotting was part of the clinical picture too.

Fei Zhou, MD, from the Chinese Academy of Medical Sciences, and colleagues conducted a retrospective, observational, multicenter cohort study of 191 patients, 137 of whom were discharged and 54 of whom died in the hospital.

The study, published online today in The Lancet, included all adult inpatients with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital who had been discharged or died by January 31 of this year. Severely ill patients in the province were transferred to these hospitals until February 1.

The researchers compared demographic, clinical, treatment, and laboratory data from electronic medical records between survivors and those who succumbed to the disease. The analysis also tested serial samples for viral RNA. Overall, 91 (48%) of the 191 patients had comorbidity. Most common was hypertension (30%), followed by diabetes (19%) and coronary heart disease (8%).

The odds of dying in the hospital increased with age (odds ratio 1.10; 95% confidence interval, 1.03-1.17; per year increase in age), higher Sequential Organ Failure Assessment (SOFA) score (5.65, 2.61-12.23; P < .0001), and D-dimer level exceeding 1 mcg/L on admission. The SOFA was previously called the “sepsis-related organ failure assessment score” and assesses rate of organ failure in intensive care units. Elevated D-dimer indicates increased risk of abnormal blood clotting, such as deep vein thrombosis.

Nonsurvivors compared with survivors had higher frequencies of respiratory failure (98% vs 36%), sepsis (100%, vs 42%), and secondary infections (50% vs 1%).

The average age of survivors was 52 years compared to 69 for those who died. Liu cited weakening of the immune system and increased inflammation, which damages organs and also promotes viral replication, as explanations for the age effect.

From the time of initial symptoms, median time to discharge from the hospital was 22 days. Average time to death was 18.5 days.

Fever persisted for a median of 12 days among all patients, and cough persisted for a median 19 days; 45% of the survivors were still coughing on discharge. In survivors, shortness of breath improved after 13 days, but persisted until death in the others.

Viral shedding persisted for a median duration of 20 days in survivors, ranging from 8 to 37. The virus (SARS-CoV-2) was detectable in nonsurvivors until death. Antiviral treatment did not curtail viral shedding.

But the viral shedding data come with a caveat. “The extended viral shedding noted in our study has important implications for guiding decisions around isolation precautions and antiviral treatment in patients with confirmed COVID-19 infection. However, we need to be clear that viral shedding time should not be confused with other self-isolation guidance for people who may have been exposed to COVID-19 but do not have symptoms, as this guidance is based on the incubation time of the virus,” explained colead author Bin Cao.

“Older age, elevated D-dimer levels, and high SOFA score could help clinicians to identify at an early stage those patients with COVID-19 who have poor prognosis. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future,” the researchers conclude.

A limitation in interpreting the findings of the study is that hospitalized patients do not represent the entire infected population. The researchers caution that “the number of deaths does not reflect the true mortality of COVID-19.” They also note that they did not have enough genetic material to accurately assess duration of viral shedding.

This article first appeared on Medscape.com.

Patients who did not survive hospitalization for COVID-19 in Wuhan were more likely to be older, have comorbidities, and elevated D-dimer, according to the first study to examine risk factors associated with death among adults hospitalized with COVID-19. “Older age, showing signs of sepsis on admission, underlying diseases like high blood pressure and diabetes, and the prolonged use of noninvasive ventilation were important factors in the deaths of these patients,” coauthor Zhibo Liu said in a news release. Abnormal blood clotting was part of the clinical picture too.

Fei Zhou, MD, from the Chinese Academy of Medical Sciences, and colleagues conducted a retrospective, observational, multicenter cohort study of 191 patients, 137 of whom were discharged and 54 of whom died in the hospital.

The study, published online today in The Lancet, included all adult inpatients with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital who had been discharged or died by January 31 of this year. Severely ill patients in the province were transferred to these hospitals until February 1.

The researchers compared demographic, clinical, treatment, and laboratory data from electronic medical records between survivors and those who succumbed to the disease. The analysis also tested serial samples for viral RNA. Overall, 91 (48%) of the 191 patients had comorbidity. Most common was hypertension (30%), followed by diabetes (19%) and coronary heart disease (8%).

The odds of dying in the hospital increased with age (odds ratio 1.10; 95% confidence interval, 1.03-1.17; per year increase in age), higher Sequential Organ Failure Assessment (SOFA) score (5.65, 2.61-12.23; P < .0001), and D-dimer level exceeding 1 mcg/L on admission. The SOFA was previously called the “sepsis-related organ failure assessment score” and assesses rate of organ failure in intensive care units. Elevated D-dimer indicates increased risk of abnormal blood clotting, such as deep vein thrombosis.

Nonsurvivors compared with survivors had higher frequencies of respiratory failure (98% vs 36%), sepsis (100%, vs 42%), and secondary infections (50% vs 1%).

The average age of survivors was 52 years compared to 69 for those who died. Liu cited weakening of the immune system and increased inflammation, which damages organs and also promotes viral replication, as explanations for the age effect.

From the time of initial symptoms, median time to discharge from the hospital was 22 days. Average time to death was 18.5 days.

Fever persisted for a median of 12 days among all patients, and cough persisted for a median 19 days; 45% of the survivors were still coughing on discharge. In survivors, shortness of breath improved after 13 days, but persisted until death in the others.

Viral shedding persisted for a median duration of 20 days in survivors, ranging from 8 to 37. The virus (SARS-CoV-2) was detectable in nonsurvivors until death. Antiviral treatment did not curtail viral shedding.

But the viral shedding data come with a caveat. “The extended viral shedding noted in our study has important implications for guiding decisions around isolation precautions and antiviral treatment in patients with confirmed COVID-19 infection. However, we need to be clear that viral shedding time should not be confused with other self-isolation guidance for people who may have been exposed to COVID-19 but do not have symptoms, as this guidance is based on the incubation time of the virus,” explained colead author Bin Cao.

“Older age, elevated D-dimer levels, and high SOFA score could help clinicians to identify at an early stage those patients with COVID-19 who have poor prognosis. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future,” the researchers conclude.

A limitation in interpreting the findings of the study is that hospitalized patients do not represent the entire infected population. The researchers caution that “the number of deaths does not reflect the true mortality of COVID-19.” They also note that they did not have enough genetic material to accurately assess duration of viral shedding.

This article first appeared on Medscape.com.

LOS ANGELES – The edge that the direct-acting oral anticoagulant apixaban (Eliquis) has over warfarin for safely preventing ischemic events in patients with atrial fibrillation and either a recent acute coronary syndrome event or a recent percutaneous coronary intervention held up even in patients with a history of stroke, transient ischemic attack, or thromboembolic event, according to a prespecified secondary analysis of data collected in the AUGUSTUS trial.

Mitchel L. Zoler/MDedge News

The treatment advantages of apixaban, compared with warfarin, seen in the overall AUGUSTUS results, first reported in March 2019, “were consistent” with the benefits seen in the subgroup of enrolled patients with a prior stroke, transient ischemic attack (TIA), or thromboembolic (TE) event, M. Cecilia Bahit, MD, said at the International Stroke Conference sponsored by the American Heart Association.

All patients in AUGUSTUS received a P2Y12 inhibitor antiplatelet drug, which was clopidogrel for more than 90% of patients. The two-by-two factorial design of AUGUSTUS also assessed the safety and efficacy of either adding or withholding aspirin from the two-drug regimen that all patients in the study received with a P2Y12 inhibitor plus an anticoagulant (apixaban or warfarin). The most notable finding of the aspirin versus placebo analysis was that patients without a prior stroke, TIA, or TE event had a “more profound” increase in their rate of major or clinically relevant minor bleeds when also treated with aspirin, compared with patients who received aspirin and had a history of stroke, TIA, or TE event, reported Dr. Bahit, a chief of cardiology and director of clinical research at the INECO Foundation in Rosario, Argentina.

In general, the findings of the secondary analysis that took into account stroke, TIA, or TE history “confirmed” the main AUGUSTUS findings, Dr. Bahit said; an antithrombotic regimen of apixaban plus clopidogrel (or other P2Y12 inhibitor) without aspirin was superior for both efficacy and safety, compared with the alternative regimens that either substituted warfarin for apixaban or that added aspirin.

AUGUSTUS enrolled 4,614 atrial fibrillation (AFib) patients who either had a recent acute coronary syndrome (ACS) event or had recently undergone percutaneous coronary intervention (PCI) at any of 492 sites in 33 countries during 2015-2018. The study’s primary endpoint was the incidence of major or clinically relevant minor bleeds after 6 months, which was significantly lower in the subgroups that received apixaban instead of warfarin and in patients who received placebo instead of aspirin. The secondary endpoint of death or hospitalization after 6 months was also significantly lower in the apixaban-treated patients, compared with those on warfarin, while the aspirin and placebo subgroups showed no difference in the incidence of these events (N Engl J Med. 2019 Apr 18;380[16]:1509-24).

The results reported by Dr. Bahit also highlighted both the high risk faced by patients with AFib who also have had an ACS event or PCI, as well as a prior stroke, TIA, or TE event, noted Larry B. Goldstein, MD, professor and chairman of neurology at the University of Kentucky, Lexington. “It’s difficult, because these patients had an ACS event or PCI, and you don’t want a coronary too close up, but do these patients really need a P2Y12 inhibitor plus an anticoagulant? Could these patients do as well on apixaban only? I would have liked to see that treatment arm in the study,” Dr. Goldstein commented in an interview.

“These are challenging patients because they often require anticoagulation for the AFib as well as antiplatelet agents” for the recent PCI or ACS event, commented Mitchell S.V. Elkind, MD, professor of neurology at Columbia University, New York. “The question has always been: How many blood thinners should these patients be on? Potentially they could be on three different agents [an anticoagulant and two antiplatelet drugs], and we know that all of those drugs together pretty dramatically increase the risk of bleeding. About 15% of the patients in the overall AUGUSTUS trial had either cerebrovascular disease or systemic thromboembolism, so this was a small subgroup of the overall trial, but the overall trial was large so it’s a significant number of patients who met this criteria. The results confirmed that even in a group of patients who may be considered at high risk because they have a prior history of cerebrovascular disease use of apixaban instead of warfarin seemed safer, and that those patients did not need to be on aspirin as well as their other antiplatelet agent. Patients with a history of stroke, in fact, had a lower risk of bleeding than the other patients in this trial, so one could argue that they should be on an agent like apixaban as well as an antiplatelet agent like clopidogrel without addition of aspirin,” he said in a recorded statement.

In addition to implications for using prescription drugs like apixaban and clopidogrel, the findings also send a message about the need for very aggressive implementation of lifestyle measures that can reduce cardiovascular disease risk in these patients, added Dr. Goldstein. The AUGUSTUS outcome analyses that subdivided the study population into those with a prior stroke, TIA, or TE event – 633 patients or about 14% of the 4,581 patients eligible for this analysis – and those who did not have this history showed the extremely high, incrementally elevated risk faced by patients with these prior events.

A history of stroke, TIA, or TE event linked with a jump in the 90-day rate of major or clinically relevant minor bleeds from 13% without this history to 17%, which is a 31% relative increase; it boosted the 90-day rate of death or hospitalization from 25% to 31%, a 24% relative increase; and it jacked up the rate of death or ischemic events from 6% to 9%, a 50% relative increase, Dr. Bahit reported.

These substantial increases “suggest we need to be very aggressive” in managing these high-risk patients who combine a background of AFib, a prior stroke, TIA, or TE events, and a recent ACS event or PCI, Dr. Goldstein observed. In these patients, he suggested that clinicians make sure to address smoking cessation, obesity, exercise, diet, and statin use, and get each of these to an optimal level to further cut risk. If all five of these basic interventions were successfully administered to a patient they could collectively cut the patient’s event risk by about 80%, he added.

AUGUSTUS was funded by Bristol-Myers Squibb and Pfizer, the companies that jointly market apixaban. Dr. Bahit has received honoraria from Pfizer, and from CSL Behring and Merck. Dr. Elkind and Dr. Goldstein had no relevant disclosures.

mzoler@mdedge.com

SOURCE: Bahit MC et al. ISC 2020, Abstract LB22.

LOS ANGELES – The edge that the direct-acting oral anticoagulant apixaban (Eliquis) has over warfarin for safely preventing ischemic events in patients with atrial fibrillation and either a recent acute coronary syndrome event or a recent percutaneous coronary intervention held up even in patients with a history of stroke, transient ischemic attack, or thromboembolic event, according to a prespecified secondary analysis of data collected in the AUGUSTUS trial.

Mitchel L. Zoler/MDedge News

The treatment advantages of apixaban, compared with warfarin, seen in the overall AUGUSTUS results, first reported in March 2019, “were consistent” with the benefits seen in the subgroup of enrolled patients with a prior stroke, transient ischemic attack (TIA), or thromboembolic (TE) event, M. Cecilia Bahit, MD, said at the International Stroke Conference sponsored by the American Heart Association.

All patients in AUGUSTUS received a P2Y12 inhibitor antiplatelet drug, which was clopidogrel for more than 90% of patients. The two-by-two factorial design of AUGUSTUS also assessed the safety and efficacy of either adding or withholding aspirin from the two-drug regimen that all patients in the study received with a P2Y12 inhibitor plus an anticoagulant (apixaban or warfarin). The most notable finding of the aspirin versus placebo analysis was that patients without a prior stroke, TIA, or TE event had a “more profound” increase in their rate of major or clinically relevant minor bleeds when also treated with aspirin, compared with patients who received aspirin and had a history of stroke, TIA, or TE event, reported Dr. Bahit, a chief of cardiology and director of clinical research at the INECO Foundation in Rosario, Argentina.

In general, the findings of the secondary analysis that took into account stroke, TIA, or TE history “confirmed” the main AUGUSTUS findings, Dr. Bahit said; an antithrombotic regimen of apixaban plus clopidogrel (or other P2Y12 inhibitor) without aspirin was superior for both efficacy and safety, compared with the alternative regimens that either substituted warfarin for apixaban or that added aspirin.

AUGUSTUS enrolled 4,614 atrial fibrillation (AFib) patients who either had a recent acute coronary syndrome (ACS) event or had recently undergone percutaneous coronary intervention (PCI) at any of 492 sites in 33 countries during 2015-2018. The study’s primary endpoint was the incidence of major or clinically relevant minor bleeds after 6 months, which was significantly lower in the subgroups that received apixaban instead of warfarin and in patients who received placebo instead of aspirin. The secondary endpoint of death or hospitalization after 6 months was also significantly lower in the apixaban-treated patients, compared with those on warfarin, while the aspirin and placebo subgroups showed no difference in the incidence of these events (N Engl J Med. 2019 Apr 18;380[16]:1509-24).

The results reported by Dr. Bahit also highlighted both the high risk faced by patients with AFib who also have had an ACS event or PCI, as well as a prior stroke, TIA, or TE event, noted Larry B. Goldstein, MD, professor and chairman of neurology at the University of Kentucky, Lexington. “It’s difficult, because these patients had an ACS event or PCI, and you don’t want a coronary too close up, but do these patients really need a P2Y12 inhibitor plus an anticoagulant? Could these patients do as well on apixaban only? I would have liked to see that treatment arm in the study,” Dr. Goldstein commented in an interview.

“These are challenging patients because they often require anticoagulation for the AFib as well as antiplatelet agents” for the recent PCI or ACS event, commented Mitchell S.V. Elkind, MD, professor of neurology at Columbia University, New York. “The question has always been: How many blood thinners should these patients be on? Potentially they could be on three different agents [an anticoagulant and two antiplatelet drugs], and we know that all of those drugs together pretty dramatically increase the risk of bleeding. About 15% of the patients in the overall AUGUSTUS trial had either cerebrovascular disease or systemic thromboembolism, so this was a small subgroup of the overall trial, but the overall trial was large so it’s a significant number of patients who met this criteria. The results confirmed that even in a group of patients who may be considered at high risk because they have a prior history of cerebrovascular disease use of apixaban instead of warfarin seemed safer, and that those patients did not need to be on aspirin as well as their other antiplatelet agent. Patients with a history of stroke, in fact, had a lower risk of bleeding than the other patients in this trial, so one could argue that they should be on an agent like apixaban as well as an antiplatelet agent like clopidogrel without addition of aspirin,” he said in a recorded statement.

In addition to implications for using prescription drugs like apixaban and clopidogrel, the findings also send a message about the need for very aggressive implementation of lifestyle measures that can reduce cardiovascular disease risk in these patients, added Dr. Goldstein. The AUGUSTUS outcome analyses that subdivided the study population into those with a prior stroke, TIA, or TE event – 633 patients or about 14% of the 4,581 patients eligible for this analysis – and those who did not have this history showed the extremely high, incrementally elevated risk faced by patients with these prior events.

A history of stroke, TIA, or TE event linked with a jump in the 90-day rate of major or clinically relevant minor bleeds from 13% without this history to 17%, which is a 31% relative increase; it boosted the 90-day rate of death or hospitalization from 25% to 31%, a 24% relative increase; and it jacked up the rate of death or ischemic events from 6% to 9%, a 50% relative increase, Dr. Bahit reported.

These substantial increases “suggest we need to be very aggressive” in managing these high-risk patients who combine a background of AFib, a prior stroke, TIA, or TE events, and a recent ACS event or PCI, Dr. Goldstein observed. In these patients, he suggested that clinicians make sure to address smoking cessation, obesity, exercise, diet, and statin use, and get each of these to an optimal level to further cut risk. If all five of these basic interventions were successfully administered to a patient they could collectively cut the patient’s event risk by about 80%, he added.

AUGUSTUS was funded by Bristol-Myers Squibb and Pfizer, the companies that jointly market apixaban. Dr. Bahit has received honoraria from Pfizer, and from CSL Behring and Merck. Dr. Elkind and Dr. Goldstein had no relevant disclosures.

mzoler@mdedge.com

SOURCE: Bahit MC et al. ISC 2020, Abstract LB22.

LOS ANGELES – The edge that the direct-acting oral anticoagulant apixaban (Eliquis) has over warfarin for safely preventing ischemic events in patients with atrial fibrillation and either a recent acute coronary syndrome event or a recent percutaneous coronary intervention held up even in patients with a history of stroke, transient ischemic attack, or thromboembolic event, according to a prespecified secondary analysis of data collected in the AUGUSTUS trial.

Mitchel L. Zoler/MDedge News

The treatment advantages of apixaban, compared with warfarin, seen in the overall AUGUSTUS results, first reported in March 2019, “were consistent” with the benefits seen in the subgroup of enrolled patients with a prior stroke, transient ischemic attack (TIA), or thromboembolic (TE) event, M. Cecilia Bahit, MD, said at the International Stroke Conference sponsored by the American Heart Association.

All patients in AUGUSTUS received a P2Y12 inhibitor antiplatelet drug, which was clopidogrel for more than 90% of patients. The two-by-two factorial design of AUGUSTUS also assessed the safety and efficacy of either adding or withholding aspirin from the two-drug regimen that all patients in the study received with a P2Y12 inhibitor plus an anticoagulant (apixaban or warfarin). The most notable finding of the aspirin versus placebo analysis was that patients without a prior stroke, TIA, or TE event had a “more profound” increase in their rate of major or clinically relevant minor bleeds when also treated with aspirin, compared with patients who received aspirin and had a history of stroke, TIA, or TE event, reported Dr. Bahit, a chief of cardiology and director of clinical research at the INECO Foundation in Rosario, Argentina.

In general, the findings of the secondary analysis that took into account stroke, TIA, or TE history “confirmed” the main AUGUSTUS findings, Dr. Bahit said; an antithrombotic regimen of apixaban plus clopidogrel (or other P2Y12 inhibitor) without aspirin was superior for both efficacy and safety, compared with the alternative regimens that either substituted warfarin for apixaban or that added aspirin.

AUGUSTUS enrolled 4,614 atrial fibrillation (AFib) patients who either had a recent acute coronary syndrome (ACS) event or had recently undergone percutaneous coronary intervention (PCI) at any of 492 sites in 33 countries during 2015-2018. The study’s primary endpoint was the incidence of major or clinically relevant minor bleeds after 6 months, which was significantly lower in the subgroups that received apixaban instead of warfarin and in patients who received placebo instead of aspirin. The secondary endpoint of death or hospitalization after 6 months was also significantly lower in the apixaban-treated patients, compared with those on warfarin, while the aspirin and placebo subgroups showed no difference in the incidence of these events (N Engl J Med. 2019 Apr 18;380[16]:1509-24).

The results reported by Dr. Bahit also highlighted both the high risk faced by patients with AFib who also have had an ACS event or PCI, as well as a prior stroke, TIA, or TE event, noted Larry B. Goldstein, MD, professor and chairman of neurology at the University of Kentucky, Lexington. “It’s difficult, because these patients had an ACS event or PCI, and you don’t want a coronary too close up, but do these patients really need a P2Y12 inhibitor plus an anticoagulant? Could these patients do as well on apixaban only? I would have liked to see that treatment arm in the study,” Dr. Goldstein commented in an interview.

“These are challenging patients because they often require anticoagulation for the AFib as well as antiplatelet agents” for the recent PCI or ACS event, commented Mitchell S.V. Elkind, MD, professor of neurology at Columbia University, New York. “The question has always been: How many blood thinners should these patients be on? Potentially they could be on three different agents [an anticoagulant and two antiplatelet drugs], and we know that all of those drugs together pretty dramatically increase the risk of bleeding. About 15% of the patients in the overall AUGUSTUS trial had either cerebrovascular disease or systemic thromboembolism, so this was a small subgroup of the overall trial, but the overall trial was large so it’s a significant number of patients who met this criteria. The results confirmed that even in a group of patients who may be considered at high risk because they have a prior history of cerebrovascular disease use of apixaban instead of warfarin seemed safer, and that those patients did not need to be on aspirin as well as their other antiplatelet agent. Patients with a history of stroke, in fact, had a lower risk of bleeding than the other patients in this trial, so one could argue that they should be on an agent like apixaban as well as an antiplatelet agent like clopidogrel without addition of aspirin,” he said in a recorded statement.

In addition to implications for using prescription drugs like apixaban and clopidogrel, the findings also send a message about the need for very aggressive implementation of lifestyle measures that can reduce cardiovascular disease risk in these patients, added Dr. Goldstein. The AUGUSTUS outcome analyses that subdivided the study population into those with a prior stroke, TIA, or TE event – 633 patients or about 14% of the 4,581 patients eligible for this analysis – and those who did not have this history showed the extremely high, incrementally elevated risk faced by patients with these prior events.

A history of stroke, TIA, or TE event linked with a jump in the 90-day rate of major or clinically relevant minor bleeds from 13% without this history to 17%, which is a 31% relative increase; it boosted the 90-day rate of death or hospitalization from 25% to 31%, a 24% relative increase; and it jacked up the rate of death or ischemic events from 6% to 9%, a 50% relative increase, Dr. Bahit reported.

These substantial increases “suggest we need to be very aggressive” in managing these high-risk patients who combine a background of AFib, a prior stroke, TIA, or TE events, and a recent ACS event or PCI, Dr. Goldstein observed. In these patients, he suggested that clinicians make sure to address smoking cessation, obesity, exercise, diet, and statin use, and get each of these to an optimal level to further cut risk. If all five of these basic interventions were successfully administered to a patient they could collectively cut the patient’s event risk by about 80%, he added.

AUGUSTUS was funded by Bristol-Myers Squibb and Pfizer, the companies that jointly market apixaban. Dr. Bahit has received honoraria from Pfizer, and from CSL Behring and Merck. Dr. Elkind and Dr. Goldstein had no relevant disclosures.

mzoler@mdedge.com

SOURCE: Bahit MC et al. ISC 2020, Abstract LB22.

PHOENIX – The level of physical activity people engage in during their golden years doesn’t have to be strenuous in order to be effective, results from two studies presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting showed.

Courtesy University of California, San Diego

In one study, women who walked 2,100-4,500 steps each day reduced their risk of dying from cardiovascular disease by up to 38%, compared with those who walked fewer than 2,100 steps each day. In addition, women who walked more than 4,500 steps each day reduced their risk of cardiovascular disease (CVD) mortality risk by 48%.

The findings come from an ancillary analysis of the Women’s Health Study known as the Objective Physical Activity and Cardiovascular Health (OPACH) Study.

“Our work shows that both light-intensity and moderate-/vigorous-intensity steps are associated with reduced risk of cardiovascular disease death,” lead author Andrea Z. LaCroix, PhD, said in an interview. “And our previous studies show that all movement while standing, stepping, or just moving about at whatever intensity you choose, appears to have cardiovascular benefits, whereas long hours spent sedentary, especially prolonged sitting bouts are associated with increased risk of cardiovascular disease. These new findings on steps are best interpreted as showing that moving instead of sitting is good for your heart and blood vessels as we get older. Find the things you love to do and get moving.”

For OPACH, 6,379 women with an average age of 79 years wore ActiGraph GT3X+ triaxial accelerometers on their wrist for 7 days during 2012-2014, as a way to ascertain the number of steps they took. The researchers followed the study participants to March 1, 2019, and used Cox proportional hazard models to estimate CVD mortality across four quartiles of steps per day, adjusted for age, race/ethnicity, education, smoking, alcohol consumption, self-reported health, comorbidities, and physical function. The lowest quartile reference category was less than 2,108 steps per day. The second, third and fourth quartiles were: 2,108 to fewer than 3,136 steps, 3,136 to fewer than 4,499, and 4,500 and above.

Dr. LaCroix, distinguished professor and chief of epidemiology at the University of California, San Diego, reported that women who walked 2,100-4,500 steps daily reduced their risk of dying from CVD by up to up to 38%, compared with women who walked fewer than 2,100 daily steps. The women who walked more than 4,500 steps per day reduced their risk by 48%.

She noted that, for many years, common wisdom was that 10,000 steps per day should be used as a general fitness target, [but] that goal “was never evidence based, and so far, emerging evidence using accelerometers to measure steps shows benefit way below the level of 10,000 steps.” Dr. LaCroix added that, in this study, “we were able separate steps taken at a light intensity of energy expenditure versus a moderate or vigorous level of energy expenditure. This is like comparing slower versus faster steps. Both influenced the risk of CVD death and we found no evidence that faster steps were more beneficial for reducing risk of CVD death than slower steps. So, the main message I want my demographic [women aged over 60] to understand is that all movement appears to be good for your heart.”

Barry A. Franklin, PhD, director of preventive cardiology and cardiac rehabilitation at Beaumont Health in Royal Oak, Mich., characterized the study findings as “good news” but not entirely surprising. “It goes along with other research showing that the biggest bang from the buck is going from the least fit, least active cohort, which we call the bottom 20%, to the next lowest level,” he said in an interview. “So, by simply doing some steps, certainly less than 10,000, there were significant benefits for this older age group.”

Dr. LaCroix acknowledged certain limitations of the OPACH study, including the fact that it did not include men or women aged younger than 60 years. In addition, the accelerometer used in this and other studies may measure fewer steps than women are actually taking. “Devices vary in their accuracy,” she said. “If you are tracking steps, try to aim for 4,500 or a little more, but know that every step counts.”

In a separate study, researchers found that an increase of 30 minutes per day of low-intensity physical activity (LIPA) may lower the risk of death among older adults, regardless of the amount of moderate to vigorous physical activity (MVPA) participants are involved in or whether they have impaired physical function. In addition, an increase of 30 minutes of sedentary time per day may increase the risk of death regardless of the amount of MVPA or whether participants have impaired physical function.

Those are key findings from an analysis of 1,262 participants in the Framingham Offspring Study.

“Given that MVPA tends to decline with age, particularly during the mid- to late-life transition, promoting LIPA and reducing sedentary time may be a more practical alternative among older adults for reducing the risk of mortality,” lead author Joowon Lee, PhD, said in an interview at the meeting sponsored by the American Heart Association.

According to Dr. Lee, a postdoctoral fellow at Boston University, prior studies found that the inverse association between MVPA and cardiovascular and all-cause mortality among older adults. “However, we focused on sedentary and light-intensity physical activity, which is prevalent in older adult population,” he said. “Additionally, we looked at the association between physical activity and mortality after excluding participants with frailty as a sensitivity analysis.”

The researchers drew from accelerometry-derived physical activity data from 1,262 Framingham Offspring Study participants at their ninth examination (2011-2014). The mean age of the subjects was 69 years, 54% were women, and they had worn the accelerometers at least 10 hours per day for at least 4 days prior to the exam visit. The researchers used multivariable Cox proportional hazards regression models to relate physician activity and sedentary time with all-cause mortality adjusting for potential confounders.

During a median follow-up of 4.8 years, 67 study participants died. Dr. Lee and colleagues observed that higher total physical activity, LIPA, adherence to physical activity guidelines (at least 150 minutes of activity each week), and lower sedentary time were associated with a lower risk of all-cause mortality. Specifically, they were 67% less likely to die of any cause if they spent at least 150 minutes per week in moderate to vigorous physical activity, compared with those who did not. In addition, the researchers found that each 30-minute interval of LIPA, such as doing household chores or casual walking, was associated with a 20% lower risk of dying from any cause. On the other hand, every additional 30 minutes of being sedentary was related to a 32% higher risk of dying from any cause. The results remained statistically significant even after excluding those with frailty.

“In the present analysis, an increase of 10 minutes in MVPA was not associated with the risk of all-cause mortality although meeting physical activity guidelines [MVPA of at least 150 minutes per week] was the strongest factor associated with the risk of all-cause mortality,” Dr. Lee said.

He acknowledged certain limitations of the analysis, including the fact that the study participants were white individuals with European ancestry. “Additionally, a small number of mortality events were observed in the current investigation,” he said. “So, an additional study of larger multiethnic samples of older adults is warranted to confirm our findings.”

“We tell people: ‘You need 30 minutes of moderate intensity exercise most days of the week,’ ” Dr. Franklin said. “That’s true, but a classic study in Lancet showed that if you do 12 or 15 minutes of moderate exercise, not 30 minutes, you also get a 14% reduction in mortality. Some exercise is better than none, and for older adults, they don’t even have to do moderate intensity exercise to get benefits.”

Dr. LaCroix’s study was funded by the National Heart, Lung, and Blood Institute; Dr. LaCroix reported having no financial disclosures. Dr. Lee’s study was supported by the National Heart, Lung, and Blood Institute; Dr. Lee reported having no disclosures.

dbrunk@mdedge.com

SOURCES: LaCroix A et al. Epi/Lifestyle 2020, Abstract 30; Lee J et al. Epi/Lifestyle 2020, Abstract 31.

PHOENIX – The level of physical activity people engage in during their golden years doesn’t have to be strenuous in order to be effective, results from two studies presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting showed.

Courtesy University of California, San Diego

In one study, women who walked 2,100-4,500 steps each day reduced their risk of dying from cardiovascular disease by up to 38%, compared with those who walked fewer than 2,100 steps each day. In addition, women who walked more than 4,500 steps each day reduced their risk of cardiovascular disease (CVD) mortality risk by 48%.

The findings come from an ancillary analysis of the Women’s Health Study known as the Objective Physical Activity and Cardiovascular Health (OPACH) Study.

“Our work shows that both light-intensity and moderate-/vigorous-intensity steps are associated with reduced risk of cardiovascular disease death,” lead author Andrea Z. LaCroix, PhD, said in an interview. “And our previous studies show that all movement while standing, stepping, or just moving about at whatever intensity you choose, appears to have cardiovascular benefits, whereas long hours spent sedentary, especially prolonged sitting bouts are associated with increased risk of cardiovascular disease. These new findings on steps are best interpreted as showing that moving instead of sitting is good for your heart and blood vessels as we get older. Find the things you love to do and get moving.”

For OPACH, 6,379 women with an average age of 79 years wore ActiGraph GT3X+ triaxial accelerometers on their wrist for 7 days during 2012-2014, as a way to ascertain the number of steps they took. The researchers followed the study participants to March 1, 2019, and used Cox proportional hazard models to estimate CVD mortality across four quartiles of steps per day, adjusted for age, race/ethnicity, education, smoking, alcohol consumption, self-reported health, comorbidities, and physical function. The lowest quartile reference category was less than 2,108 steps per day. The second, third and fourth quartiles were: 2,108 to fewer than 3,136 steps, 3,136 to fewer than 4,499, and 4,500 and above.

Dr. LaCroix, distinguished professor and chief of epidemiology at the University of California, San Diego, reported that women who walked 2,100-4,500 steps daily reduced their risk of dying from CVD by up to up to 38%, compared with women who walked fewer than 2,100 daily steps. The women who walked more than 4,500 steps per day reduced their risk by 48%.

She noted that, for many years, common wisdom was that 10,000 steps per day should be used as a general fitness target, [but] that goal “was never evidence based, and so far, emerging evidence using accelerometers to measure steps shows benefit way below the level of 10,000 steps.” Dr. LaCroix added that, in this study, “we were able separate steps taken at a light intensity of energy expenditure versus a moderate or vigorous level of energy expenditure. This is like comparing slower versus faster steps. Both influenced the risk of CVD death and we found no evidence that faster steps were more beneficial for reducing risk of CVD death than slower steps. So, the main message I want my demographic [women aged over 60] to understand is that all movement appears to be good for your heart.”

Barry A. Franklin, PhD, director of preventive cardiology and cardiac rehabilitation at Beaumont Health in Royal Oak, Mich., characterized the study findings as “good news” but not entirely surprising. “It goes along with other research showing that the biggest bang from the buck is going from the least fit, least active cohort, which we call the bottom 20%, to the next lowest level,” he said in an interview. “So, by simply doing some steps, certainly less than 10,000, there were significant benefits for this older age group.”

Dr. LaCroix acknowledged certain limitations of the OPACH study, including the fact that it did not include men or women aged younger than 60 years. In addition, the accelerometer used in this and other studies may measure fewer steps than women are actually taking. “Devices vary in their accuracy,” she said. “If you are tracking steps, try to aim for 4,500 or a little more, but know that every step counts.”

In a separate study, researchers found that an increase of 30 minutes per day of low-intensity physical activity (LIPA) may lower the risk of death among older adults, regardless of the amount of moderate to vigorous physical activity (MVPA) participants are involved in or whether they have impaired physical function. In addition, an increase of 30 minutes of sedentary time per day may increase the risk of death regardless of the amount of MVPA or whether participants have impaired physical function.

Those are key findings from an analysis of 1,262 participants in the Framingham Offspring Study.

“Given that MVPA tends to decline with age, particularly during the mid- to late-life transition, promoting LIPA and reducing sedentary time may be a more practical alternative among older adults for reducing the risk of mortality,” lead author Joowon Lee, PhD, said in an interview at the meeting sponsored by the American Heart Association.

According to Dr. Lee, a postdoctoral fellow at Boston University, prior studies found that the inverse association between MVPA and cardiovascular and all-cause mortality among older adults. “However, we focused on sedentary and light-intensity physical activity, which is prevalent in older adult population,” he said. “Additionally, we looked at the association between physical activity and mortality after excluding participants with frailty as a sensitivity analysis.”

The researchers drew from accelerometry-derived physical activity data from 1,262 Framingham Offspring Study participants at their ninth examination (2011-2014). The mean age of the subjects was 69 years, 54% were women, and they had worn the accelerometers at least 10 hours per day for at least 4 days prior to the exam visit. The researchers used multivariable Cox proportional hazards regression models to relate physician activity and sedentary time with all-cause mortality adjusting for potential confounders.

During a median follow-up of 4.8 years, 67 study participants died. Dr. Lee and colleagues observed that higher total physical activity, LIPA, adherence to physical activity guidelines (at least 150 minutes of activity each week), and lower sedentary time were associated with a lower risk of all-cause mortality. Specifically, they were 67% less likely to die of any cause if they spent at least 150 minutes per week in moderate to vigorous physical activity, compared with those who did not. In addition, the researchers found that each 30-minute interval of LIPA, such as doing household chores or casual walking, was associated with a 20% lower risk of dying from any cause. On the other hand, every additional 30 minutes of being sedentary was related to a 32% higher risk of dying from any cause. The results remained statistically significant even after excluding those with frailty.

“In the present analysis, an increase of 10 minutes in MVPA was not associated with the risk of all-cause mortality although meeting physical activity guidelines [MVPA of at least 150 minutes per week] was the strongest factor associated with the risk of all-cause mortality,” Dr. Lee said.

He acknowledged certain limitations of the analysis, including the fact that the study participants were white individuals with European ancestry. “Additionally, a small number of mortality events were observed in the current investigation,” he said. “So, an additional study of larger multiethnic samples of older adults is warranted to confirm our findings.”

“We tell people: ‘You need 30 minutes of moderate intensity exercise most days of the week,’ ” Dr. Franklin said. “That’s true, but a classic study in Lancet showed that if you do 12 or 15 minutes of moderate exercise, not 30 minutes, you also get a 14% reduction in mortality. Some exercise is better than none, and for older adults, they don’t even have to do moderate intensity exercise to get benefits.”

Dr. LaCroix’s study was funded by the National Heart, Lung, and Blood Institute; Dr. LaCroix reported having no financial disclosures. Dr. Lee’s study was supported by the National Heart, Lung, and Blood Institute; Dr. Lee reported having no disclosures.

dbrunk@mdedge.com

SOURCES: LaCroix A et al. Epi/Lifestyle 2020, Abstract 30; Lee J et al. Epi/Lifestyle 2020, Abstract 31.

PHOENIX – The level of physical activity people engage in during their golden years doesn’t have to be strenuous in order to be effective, results from two studies presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting showed.

Courtesy University of California, San Diego

In one study, women who walked 2,100-4,500 steps each day reduced their risk of dying from cardiovascular disease by up to 38%, compared with those who walked fewer than 2,100 steps each day. In addition, women who walked more than 4,500 steps each day reduced their risk of cardiovascular disease (CVD) mortality risk by 48%.

The findings come from an ancillary analysis of the Women’s Health Study known as the Objective Physical Activity and Cardiovascular Health (OPACH) Study.

“Our work shows that both light-intensity and moderate-/vigorous-intensity steps are associated with reduced risk of cardiovascular disease death,” lead author Andrea Z. LaCroix, PhD, said in an interview. “And our previous studies show that all movement while standing, stepping, or just moving about at whatever intensity you choose, appears to have cardiovascular benefits, whereas long hours spent sedentary, especially prolonged sitting bouts are associated with increased risk of cardiovascular disease. These new findings on steps are best interpreted as showing that moving instead of sitting is good for your heart and blood vessels as we get older. Find the things you love to do and get moving.”

For OPACH, 6,379 women with an average age of 79 years wore ActiGraph GT3X+ triaxial accelerometers on their wrist for 7 days during 2012-2014, as a way to ascertain the number of steps they took. The researchers followed the study participants to March 1, 2019, and used Cox proportional hazard models to estimate CVD mortality across four quartiles of steps per day, adjusted for age, race/ethnicity, education, smoking, alcohol consumption, self-reported health, comorbidities, and physical function. The lowest quartile reference category was less than 2,108 steps per day. The second, third and fourth quartiles were: 2,108 to fewer than 3,136 steps, 3,136 to fewer than 4,499, and 4,500 and above.

Dr. LaCroix, distinguished professor and chief of epidemiology at the University of California, San Diego, reported that women who walked 2,100-4,500 steps daily reduced their risk of dying from CVD by up to up to 38%, compared with women who walked fewer than 2,100 daily steps. The women who walked more than 4,500 steps per day reduced their risk by 48%.

She noted that, for many years, common wisdom was that 10,000 steps per day should be used as a general fitness target, [but] that goal “was never evidence based, and so far, emerging evidence using accelerometers to measure steps shows benefit way below the level of 10,000 steps.” Dr. LaCroix added that, in this study, “we were able separate steps taken at a light intensity of energy expenditure versus a moderate or vigorous level of energy expenditure. This is like comparing slower versus faster steps. Both influenced the risk of CVD death and we found no evidence that faster steps were more beneficial for reducing risk of CVD death than slower steps. So, the main message I want my demographic [women aged over 60] to understand is that all movement appears to be good for your heart.”

Barry A. Franklin, PhD, director of preventive cardiology and cardiac rehabilitation at Beaumont Health in Royal Oak, Mich., characterized the study findings as “good news” but not entirely surprising. “It goes along with other research showing that the biggest bang from the buck is going from the least fit, least active cohort, which we call the bottom 20%, to the next lowest level,” he said in an interview. “So, by simply doing some steps, certainly less than 10,000, there were significant benefits for this older age group.”

Dr. LaCroix acknowledged certain limitations of the OPACH study, including the fact that it did not include men or women aged younger than 60 years. In addition, the accelerometer used in this and other studies may measure fewer steps than women are actually taking. “Devices vary in their accuracy,” she said. “If you are tracking steps, try to aim for 4,500 or a little more, but know that every step counts.”

In a separate study, researchers found that an increase of 30 minutes per day of low-intensity physical activity (LIPA) may lower the risk of death among older adults, regardless of the amount of moderate to vigorous physical activity (MVPA) participants are involved in or whether they have impaired physical function. In addition, an increase of 30 minutes of sedentary time per day may increase the risk of death regardless of the amount of MVPA or whether participants have impaired physical function.

Those are key findings from an analysis of 1,262 participants in the Framingham Offspring Study.

“Given that MVPA tends to decline with age, particularly during the mid- to late-life transition, promoting LIPA and reducing sedentary time may be a more practical alternative among older adults for reducing the risk of mortality,” lead author Joowon Lee, PhD, said in an interview at the meeting sponsored by the American Heart Association.

According to Dr. Lee, a postdoctoral fellow at Boston University, prior studies found that the inverse association between MVPA and cardiovascular and all-cause mortality among older adults. “However, we focused on sedentary and light-intensity physical activity, which is prevalent in older adult population,” he said. “Additionally, we looked at the association between physical activity and mortality after excluding participants with frailty as a sensitivity analysis.”

The researchers drew from accelerometry-derived physical activity data from 1,262 Framingham Offspring Study participants at their ninth examination (2011-2014). The mean age of the subjects was 69 years, 54% were women, and they had worn the accelerometers at least 10 hours per day for at least 4 days prior to the exam visit. The researchers used multivariable Cox proportional hazards regression models to relate physician activity and sedentary time with all-cause mortality adjusting for potential confounders.

During a median follow-up of 4.8 years, 67 study participants died. Dr. Lee and colleagues observed that higher total physical activity, LIPA, adherence to physical activity guidelines (at least 150 minutes of activity each week), and lower sedentary time were associated with a lower risk of all-cause mortality. Specifically, they were 67% less likely to die of any cause if they spent at least 150 minutes per week in moderate to vigorous physical activity, compared with those who did not. In addition, the researchers found that each 30-minute interval of LIPA, such as doing household chores or casual walking, was associated with a 20% lower risk of dying from any cause. On the other hand, every additional 30 minutes of being sedentary was related to a 32% higher risk of dying from any cause. The results remained statistically significant even after excluding those with frailty.

“In the present analysis, an increase of 10 minutes in MVPA was not associated with the risk of all-cause mortality although meeting physical activity guidelines [MVPA of at least 150 minutes per week] was the strongest factor associated with the risk of all-cause mortality,” Dr. Lee said.

He acknowledged certain limitations of the analysis, including the fact that the study participants were white individuals with European ancestry. “Additionally, a small number of mortality events were observed in the current investigation,” he said. “So, an additional study of larger multiethnic samples of older adults is warranted to confirm our findings.”

“We tell people: ‘You need 30 minutes of moderate intensity exercise most days of the week,’ ” Dr. Franklin said. “That’s true, but a classic study in Lancet showed that if you do 12 or 15 minutes of moderate exercise, not 30 minutes, you also get a 14% reduction in mortality. Some exercise is better than none, and for older adults, they don’t even have to do moderate intensity exercise to get benefits.”

Dr. LaCroix’s study was funded by the National Heart, Lung, and Blood Institute; Dr. LaCroix reported having no financial disclosures. Dr. Lee’s study was supported by the National Heart, Lung, and Blood Institute; Dr. Lee reported having no disclosures.

dbrunk@mdedge.com

SOURCES: LaCroix A et al. Epi/Lifestyle 2020, Abstract 30; Lee J et al. Epi/Lifestyle 2020, Abstract 31.