Cardiology

Left atrial appendage occlusion (LAAO) is associated with fewer injuries and less bleeding from falls than anticoagulant medications in patients with atrial fibrillation (AF) and a previous stroke, a new cohort study suggests.

Investigators prospectively followed more than 1,250 patients with AF and a previous ischemic stroke. Approximately half underwent LAAO, while the other half were treated with direct oral anticoagulants (DOACs). Patients were followed for close to 2 years.

Slightly more than 20% of patients fell during that period in each group, and after their falls, patients on DOACs had significantly more severe injuries and longer hospital stays, compared with those treated by LAAO, who were not taking anticoagulants. The risk for a major bleed, including an intracranial bleed, was 70% lower in the LAAO group.

LAAO has previously been considered for people at risk of bleeding events – for example, those with gastrointestinal (GI) bleeds, bruising, or intracranial bleeding – but had not yet been studied in those at risk for falls, coauthor Moussa Mansour, MD, professor of medicine, Harvard Medical School, and director of the Atrial Fibrillation Program at Massachusetts General Hospital, Boston, said in an interview.

This is the first study to focus on LAAO specifically for those at risk for falling and demonstrated that the LAAO has utility in this population as well, which is important because the U.S. population is an aging population, and at advanced ages, “people’s balance becomes unsteady and they are at high risk of falling,” he said.

The findings were published online as a research letter in the Journal of the American College of Cardiology.
 

Multidisciplinary collaboration

“More than one in five of our neurology patients with AF fall – many with devastating consequences – making stroke prevention extremely challenging,” senior author MingMing Ning, MD, MMsc, associate professor of neurology, Harvard Medical School, and director of the Cardio-Neurology and the Clinical Proteomics Research Center at Massachusetts General Hospital, Boston, said in an interview.

“There is a dire need to tailor treatment to keep our patients safe while preventing future strokes,” she said.

Anticoagulants are effective in stroke prevention in these patients but are associated with a higher risk for major bleeding, especially after a fall.

The current prospective observational study recruited 1,266 stroke patients who were treated either with LAAO or DOACs (n = 570 and 696, respectively). Patients were followed for a median of 1.8 years (IQR: 0.9-3.0).

During the follow-up period, 22.6% of LAAO-treated patients and 22.7% of DOAC-treated patients sustained a fall (mean age 78.9 years, 57.4% male and 79.1 years, 52.5% male respectively).

Fall severity, evaluated via the Injury Severity Score, was less in the LAAO vs. the DOAC group, with ISS scores of 1 (IQR 1-4) vs. 4 (IQR 1.75-9).

LAAO was associated with significantly reduced severity of fall-related injuries (OR, –1.09, 95% confidence interval [CI], –1.52 to –0.66; P < .001) – a finding that remained statistically significant after adjustment for confounders such as age, sex, and comorbidities contributing to fall risk, such as hypertension, hyperlipidemia, and diabetes.

The incidence of major trauma (defined as ISS >15) was lower in the LAAO group, compared to the DOAC group (0.8% vs. 6.3%, respectively, P = .026), and LAAO-treated patients had a shorter length of hospital stay, with fewer LAAO patients compared with DOAC patients staying in the hospital for more than 3 days (17% vs. 29.1%, respectively, P = .018).

The risk for major post-fall bleeding was lower in the LAAO vs. the DOAC group (4.7% vs. 15.2%, AOR, 0.29; 95% CI, 0.11-0.73; P = .009) – a finding that included intracranial bleeding (3.1% vs. 9.5%; AOR, 0.29; 95% CI, 0.09-0.90; P = .033).

“Many people are living to advanced ages, where their balance becomes unsteady, and in addition, we have an increase in the prevalence of AF because people are living longer and it’s a disease of the elderly, because we have more hypertension, and we also have more tools to diagnose AF. It’s almost a ‘perfect storm’ situation, and we need effective interventions in this population,” said Dr. Mansour.

Before the study, people at risk for falling were not being considered for LAAO; but now, “we believe they should be considered,” he added. “And although people in the current study had all experienced an ischemic stroke, any patient at risk of a fall will potentially benefit.”

Beyond demonstrating the role of LAAO in reducing the risk of post-fall bleeding injuries, the study – which was conducted by specialists in neurology and cardiology among other fields – highlights the importance of multidisciplinary collaboration, which is “key” for effective stroke prevention, Dr. Ning said.

She emphasized that “we need to learn from our patients and tailor treatment to their needs. A patient’s risk of falling, lifestyle, and medication adherence are all important for individualizing care and improving quality of life.”
 

Better option

Commenting for this article, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the authors “should be commended for this prospective study on real-world patients that has yielded highly meaningful data from a clinical standpoint.”

Dr. Natale, who was not involved with the study, said it has “several strong points,” such as a fairly large sample size, exclusive population with a history of AF-related stroke, long follow-up duration, evaluation of fall incidents by blinded experts, and severity of fall assessed by a validated questionnaire.

“This is the first study that directly compared the outcomes of traumatic fall in patients receiving LAAO vs. DOAC,” he said. “Given that history of fall is an independent predictor of bleeding and death, the study findings by Deng et al. offer the hope for a safer life with the LAAO option in the aging, fall-prone AF population.”

The take-home message is that, in patients with history of stroke, LAAO “is a better option, in terms of significantly reduced injury severity and shortened hospital length of stay after traumatic falls,” Dr. Natale said.

This study was supported in part by research grants from Boston Scientific, the Leducq Foundation, and the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
 

A version of this article appeared on Medscape.com.

Left atrial appendage occlusion (LAAO) is associated with fewer injuries and less bleeding from falls than anticoagulant medications in patients with atrial fibrillation (AF) and a previous stroke, a new cohort study suggests.

Investigators prospectively followed more than 1,250 patients with AF and a previous ischemic stroke. Approximately half underwent LAAO, while the other half were treated with direct oral anticoagulants (DOACs). Patients were followed for close to 2 years.

Slightly more than 20% of patients fell during that period in each group, and after their falls, patients on DOACs had significantly more severe injuries and longer hospital stays, compared with those treated by LAAO, who were not taking anticoagulants. The risk for a major bleed, including an intracranial bleed, was 70% lower in the LAAO group.

LAAO has previously been considered for people at risk of bleeding events – for example, those with gastrointestinal (GI) bleeds, bruising, or intracranial bleeding – but had not yet been studied in those at risk for falls, coauthor Moussa Mansour, MD, professor of medicine, Harvard Medical School, and director of the Atrial Fibrillation Program at Massachusetts General Hospital, Boston, said in an interview.

This is the first study to focus on LAAO specifically for those at risk for falling and demonstrated that the LAAO has utility in this population as well, which is important because the U.S. population is an aging population, and at advanced ages, “people’s balance becomes unsteady and they are at high risk of falling,” he said.

The findings were published online as a research letter in the Journal of the American College of Cardiology.
 

Multidisciplinary collaboration

“More than one in five of our neurology patients with AF fall – many with devastating consequences – making stroke prevention extremely challenging,” senior author MingMing Ning, MD, MMsc, associate professor of neurology, Harvard Medical School, and director of the Cardio-Neurology and the Clinical Proteomics Research Center at Massachusetts General Hospital, Boston, said in an interview.

“There is a dire need to tailor treatment to keep our patients safe while preventing future strokes,” she said.

Anticoagulants are effective in stroke prevention in these patients but are associated with a higher risk for major bleeding, especially after a fall.

The current prospective observational study recruited 1,266 stroke patients who were treated either with LAAO or DOACs (n = 570 and 696, respectively). Patients were followed for a median of 1.8 years (IQR: 0.9-3.0).

During the follow-up period, 22.6% of LAAO-treated patients and 22.7% of DOAC-treated patients sustained a fall (mean age 78.9 years, 57.4% male and 79.1 years, 52.5% male respectively).

Fall severity, evaluated via the Injury Severity Score, was less in the LAAO vs. the DOAC group, with ISS scores of 1 (IQR 1-4) vs. 4 (IQR 1.75-9).

LAAO was associated with significantly reduced severity of fall-related injuries (OR, –1.09, 95% confidence interval [CI], –1.52 to –0.66; P < .001) – a finding that remained statistically significant after adjustment for confounders such as age, sex, and comorbidities contributing to fall risk, such as hypertension, hyperlipidemia, and diabetes.

The incidence of major trauma (defined as ISS >15) was lower in the LAAO group, compared to the DOAC group (0.8% vs. 6.3%, respectively, P = .026), and LAAO-treated patients had a shorter length of hospital stay, with fewer LAAO patients compared with DOAC patients staying in the hospital for more than 3 days (17% vs. 29.1%, respectively, P = .018).

The risk for major post-fall bleeding was lower in the LAAO vs. the DOAC group (4.7% vs. 15.2%, AOR, 0.29; 95% CI, 0.11-0.73; P = .009) – a finding that included intracranial bleeding (3.1% vs. 9.5%; AOR, 0.29; 95% CI, 0.09-0.90; P = .033).

“Many people are living to advanced ages, where their balance becomes unsteady, and in addition, we have an increase in the prevalence of AF because people are living longer and it’s a disease of the elderly, because we have more hypertension, and we also have more tools to diagnose AF. It’s almost a ‘perfect storm’ situation, and we need effective interventions in this population,” said Dr. Mansour.

Before the study, people at risk for falling were not being considered for LAAO; but now, “we believe they should be considered,” he added. “And although people in the current study had all experienced an ischemic stroke, any patient at risk of a fall will potentially benefit.”

Beyond demonstrating the role of LAAO in reducing the risk of post-fall bleeding injuries, the study – which was conducted by specialists in neurology and cardiology among other fields – highlights the importance of multidisciplinary collaboration, which is “key” for effective stroke prevention, Dr. Ning said.

She emphasized that “we need to learn from our patients and tailor treatment to their needs. A patient’s risk of falling, lifestyle, and medication adherence are all important for individualizing care and improving quality of life.”
 

Better option

Commenting for this article, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the authors “should be commended for this prospective study on real-world patients that has yielded highly meaningful data from a clinical standpoint.”

Dr. Natale, who was not involved with the study, said it has “several strong points,” such as a fairly large sample size, exclusive population with a history of AF-related stroke, long follow-up duration, evaluation of fall incidents by blinded experts, and severity of fall assessed by a validated questionnaire.

“This is the first study that directly compared the outcomes of traumatic fall in patients receiving LAAO vs. DOAC,” he said. “Given that history of fall is an independent predictor of bleeding and death, the study findings by Deng et al. offer the hope for a safer life with the LAAO option in the aging, fall-prone AF population.”

The take-home message is that, in patients with history of stroke, LAAO “is a better option, in terms of significantly reduced injury severity and shortened hospital length of stay after traumatic falls,” Dr. Natale said.

This study was supported in part by research grants from Boston Scientific, the Leducq Foundation, and the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
 

A version of this article appeared on Medscape.com.

Left atrial appendage occlusion (LAAO) is associated with fewer injuries and less bleeding from falls than anticoagulant medications in patients with atrial fibrillation (AF) and a previous stroke, a new cohort study suggests.

Investigators prospectively followed more than 1,250 patients with AF and a previous ischemic stroke. Approximately half underwent LAAO, while the other half were treated with direct oral anticoagulants (DOACs). Patients were followed for close to 2 years.

Slightly more than 20% of patients fell during that period in each group, and after their falls, patients on DOACs had significantly more severe injuries and longer hospital stays, compared with those treated by LAAO, who were not taking anticoagulants. The risk for a major bleed, including an intracranial bleed, was 70% lower in the LAAO group.

LAAO has previously been considered for people at risk of bleeding events – for example, those with gastrointestinal (GI) bleeds, bruising, or intracranial bleeding – but had not yet been studied in those at risk for falls, coauthor Moussa Mansour, MD, professor of medicine, Harvard Medical School, and director of the Atrial Fibrillation Program at Massachusetts General Hospital, Boston, said in an interview.

This is the first study to focus on LAAO specifically for those at risk for falling and demonstrated that the LAAO has utility in this population as well, which is important because the U.S. population is an aging population, and at advanced ages, “people’s balance becomes unsteady and they are at high risk of falling,” he said.

The findings were published online as a research letter in the Journal of the American College of Cardiology.
 

Multidisciplinary collaboration

“More than one in five of our neurology patients with AF fall – many with devastating consequences – making stroke prevention extremely challenging,” senior author MingMing Ning, MD, MMsc, associate professor of neurology, Harvard Medical School, and director of the Cardio-Neurology and the Clinical Proteomics Research Center at Massachusetts General Hospital, Boston, said in an interview.

“There is a dire need to tailor treatment to keep our patients safe while preventing future strokes,” she said.

Anticoagulants are effective in stroke prevention in these patients but are associated with a higher risk for major bleeding, especially after a fall.

The current prospective observational study recruited 1,266 stroke patients who were treated either with LAAO or DOACs (n = 570 and 696, respectively). Patients were followed for a median of 1.8 years (IQR: 0.9-3.0).

During the follow-up period, 22.6% of LAAO-treated patients and 22.7% of DOAC-treated patients sustained a fall (mean age 78.9 years, 57.4% male and 79.1 years, 52.5% male respectively).

Fall severity, evaluated via the Injury Severity Score, was less in the LAAO vs. the DOAC group, with ISS scores of 1 (IQR 1-4) vs. 4 (IQR 1.75-9).

LAAO was associated with significantly reduced severity of fall-related injuries (OR, –1.09, 95% confidence interval [CI], –1.52 to –0.66; P < .001) – a finding that remained statistically significant after adjustment for confounders such as age, sex, and comorbidities contributing to fall risk, such as hypertension, hyperlipidemia, and diabetes.

The incidence of major trauma (defined as ISS >15) was lower in the LAAO group, compared to the DOAC group (0.8% vs. 6.3%, respectively, P = .026), and LAAO-treated patients had a shorter length of hospital stay, with fewer LAAO patients compared with DOAC patients staying in the hospital for more than 3 days (17% vs. 29.1%, respectively, P = .018).

The risk for major post-fall bleeding was lower in the LAAO vs. the DOAC group (4.7% vs. 15.2%, AOR, 0.29; 95% CI, 0.11-0.73; P = .009) – a finding that included intracranial bleeding (3.1% vs. 9.5%; AOR, 0.29; 95% CI, 0.09-0.90; P = .033).

“Many people are living to advanced ages, where their balance becomes unsteady, and in addition, we have an increase in the prevalence of AF because people are living longer and it’s a disease of the elderly, because we have more hypertension, and we also have more tools to diagnose AF. It’s almost a ‘perfect storm’ situation, and we need effective interventions in this population,” said Dr. Mansour.

Before the study, people at risk for falling were not being considered for LAAO; but now, “we believe they should be considered,” he added. “And although people in the current study had all experienced an ischemic stroke, any patient at risk of a fall will potentially benefit.”

Beyond demonstrating the role of LAAO in reducing the risk of post-fall bleeding injuries, the study – which was conducted by specialists in neurology and cardiology among other fields – highlights the importance of multidisciplinary collaboration, which is “key” for effective stroke prevention, Dr. Ning said.

She emphasized that “we need to learn from our patients and tailor treatment to their needs. A patient’s risk of falling, lifestyle, and medication adherence are all important for individualizing care and improving quality of life.”
 

Better option

Commenting for this article, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the authors “should be commended for this prospective study on real-world patients that has yielded highly meaningful data from a clinical standpoint.”

Dr. Natale, who was not involved with the study, said it has “several strong points,” such as a fairly large sample size, exclusive population with a history of AF-related stroke, long follow-up duration, evaluation of fall incidents by blinded experts, and severity of fall assessed by a validated questionnaire.

“This is the first study that directly compared the outcomes of traumatic fall in patients receiving LAAO vs. DOAC,” he said. “Given that history of fall is an independent predictor of bleeding and death, the study findings by Deng et al. offer the hope for a safer life with the LAAO option in the aging, fall-prone AF population.”

The take-home message is that, in patients with history of stroke, LAAO “is a better option, in terms of significantly reduced injury severity and shortened hospital length of stay after traumatic falls,” Dr. Natale said.

This study was supported in part by research grants from Boston Scientific, the Leducq Foundation, and the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
 

A version of this article appeared on Medscape.com.

Drinking just one alcoholic beverage a day is enough to raise blood pressure (BP) in healthy adults, results of a “dose-response” meta-analysis suggest.

“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

copyright Fuse/Thinkstock

For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.

Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.

“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.

The study was published online in Hypertension.

The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).

Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.

Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.

For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.

Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.

Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
 

No safe level

“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.

“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.

Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”

Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”

Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.

“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”

The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.

A version of this article first appeared on Medscape.com.

Drinking just one alcoholic beverage a day is enough to raise blood pressure (BP) in healthy adults, results of a “dose-response” meta-analysis suggest.

“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

copyright Fuse/Thinkstock

For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.

Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.

“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.

The study was published online in Hypertension.

The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).

Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.

Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.

For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.

Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.

Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
 

No safe level

“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.

“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.

Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”

Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”

Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.

“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”

The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.

A version of this article first appeared on Medscape.com.

Drinking just one alcoholic beverage a day is enough to raise blood pressure (BP) in healthy adults, results of a “dose-response” meta-analysis suggest.

“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

copyright Fuse/Thinkstock

For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.

Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.

“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.

The study was published online in Hypertension.

The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).

Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.

Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.

For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.

Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.

Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
 

No safe level

“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.

“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.

Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”

Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”

Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.

“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”

The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.

A version of this article first appeared on Medscape.com.

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

GE HealthCare is recalling 7,559 TruSignal arterial oxygen saturation (SpO₂) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*

The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.

The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.

According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.

“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO₂, which can impact treatment decisions,” the notice warns.

In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:

• Use an alternate method for SpO₂ monitoring, including TruSignal sensors not impacted or an alternate SpO₂ device.
• If alternate methods are not available, use affected TruSignal SpO₂ sensors as long as they have not been saturated with fluids.
• If defibrillation is necessary when affected TruSignal SpO₂ sensors are being used, remove the affected TruSignal SpO₂ sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO₂ sensor after defibrillation is no longer needed.
• For Adult/Pediatric SpO₂ sensors, confirm that material does not cover the emitter or detector before using.
• Discard the sensor and use another sensor if any additional material is present.
• Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.

Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].

For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

A version of this article first appeared on Medscape.com.

*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.

GE HealthCare is recalling 7,559 TruSignal arterial oxygen saturation (SpO₂) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*

The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.

The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.

According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.

“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO₂, which can impact treatment decisions,” the notice warns.

In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:

• Use an alternate method for SpO₂ monitoring, including TruSignal sensors not impacted or an alternate SpO₂ device.
• If alternate methods are not available, use affected TruSignal SpO₂ sensors as long as they have not been saturated with fluids.
• If defibrillation is necessary when affected TruSignal SpO₂ sensors are being used, remove the affected TruSignal SpO₂ sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO₂ sensor after defibrillation is no longer needed.
• For Adult/Pediatric SpO₂ sensors, confirm that material does not cover the emitter or detector before using.
• Discard the sensor and use another sensor if any additional material is present.
• Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.

Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].

For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

A version of this article first appeared on Medscape.com.

*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.

GE HealthCare is recalling 7,559 TruSignal arterial oxygen saturation (SpO₂) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*

The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.

The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.

According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.

“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO₂, which can impact treatment decisions,” the notice warns.

In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:

• Use an alternate method for SpO₂ monitoring, including TruSignal sensors not impacted or an alternate SpO₂ device.
• If alternate methods are not available, use affected TruSignal SpO₂ sensors as long as they have not been saturated with fluids.
• If defibrillation is necessary when affected TruSignal SpO₂ sensors are being used, remove the affected TruSignal SpO₂ sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO₂ sensor after defibrillation is no longer needed.
• For Adult/Pediatric SpO₂ sensors, confirm that material does not cover the emitter or detector before using.
• Discard the sensor and use another sensor if any additional material is present.
• Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.

Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].

For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

A version of this article first appeared on Medscape.com.

*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.

Higher daily step counts, as measured by actigraphy, were linked to heart failure symptoms and health status, although reductions in step counts were not, in a new study.

Daily step counts between 1,000 and 5,000 were significantly associated with symptoms and physical limitations, as reflected in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom (TS) and physical limitation (PL) scores.

Participants whose step counts increased by 2,000 steps per day demonstrated a 5.2-point increase in their KCCQ-TS scores and a 5.33-point increase in their KCCQ-PL scores, with higher scores reflecting improvement.

oneinchpunch/Thinkstock

However, declines in step counts were not associated with significant declines in KCCQ-PL scores.

The findings are not yet ready to be implemented into practice, first author Jessica R. Golbus, MD, of the University of Michigan, Ann Arbor, said in an interview. However, she said, they “suggest that clinicians should interpret improvements in step counts as indicative of improving health status, though they should not necessarily be as concerned with reductions in step count.

“I would certainly, however, still encourage clinicians to discuss decrementing physical activity levels with their patients, though an intervention may not necessarily be warranted,” she added.

The study was published online in JACC: Heart Failure.
 

Nonlinear relationship

The investigators analyzed data from the Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) trial, a randomized, controlled trial that enrolled participants with heart failure who had a smartphone.

Participants were given a Fitbit Versa 2 and completed serial KCCQs via the smartphone app.

The researchers assessed the relationship between daily step count and KCCQ-TS and KCCQ-PL scores at baseline, as well as changes in the scores between 2 and 12 weeks.

The study included 425 patients. The mean age was 63.5 years, 44.5% were women, and 83.3% were White; 40.9% had reduced ejection fraction, 59.1% had preserved ejection fraction, and 27.5% had type 2 diabetes.

At 2 weeks, the mean KCCQ-TS score was 62.7, and the mean KCCQ-PL score was 55.7.

KCCQ-TS scores increased by 2.5 points on average, and KCCQ-PL scores by 4 points through 12 weeks.

When categorized by 25-point ranges, the step count increased with increasing scores for both KCCQ-TS and KCCQ-PL. Those with KCCQ-TS scores of 0-24 averaged 2,437.6 steps daily, and those with scores of 75-100 averaged 4,870.9 steps daily.

Similarly, participants with KCCQ-PL scores of 0-24 averaged 2301.5 steps daily, and those with scores of 75-100 averaged 5,351.9. The relationship remained significant after adjustment.

There were nonlinear relationships between activity and KCCQ scores: Daily step counts below 5,000 steps were associated with KCCQ scores, but there was little association with counts above 5,000 steps.

Compared with participants who walked 2,000 steps per day, those who walked 1,000 had KCCQ-TS scores that were 3.11 points lower; participants who walked 3,000 had KCCQ-TS scores that were 2.89 points higher.

Similarly, participants who walked 1,000 steps per day had KCCQ-PL scores that were 5.36 points lower than those who walked 2,000 steps, and those who walked 3,000 steps had KCCQ-PL scores that were 4.97 points higher.

After adjustment, change in daily step counts was significantly associated with a change in KCCQ-PL scores from baseline through 12 weeks; for example, participants whose step counts increased by 2,000 steps per day experienced a 5.33 increase in their KCCQ-PL scores relative to participants whose step counts did not change.
 

‘New kid on the block’

Frederick Ho, PhD, a lecturer in public health at the University of Glasgow (Scotland), who is a volunteer spokesperson for the American Heart Association, called the study “promising.”

“The study follow-up is relatively short, so it is not known whether the association is valid longer term,” he said in an interview. “It is also possible that patients with more severe symptoms became physically less active, and at the same time had worse outcomes.

“A study with longer follow-up among patients from a broader background would provide confidence on the generalizability of the findings,” said Dr. Ho, who led a recent study that showed accelerometer-measured physical activity was associated with a lower risk of heart failure. “It’d also be interesting to validate the findings using different types of wearable devices.”

Previous studies have shown that wrist-worn wearables might overestimate light-intensity activities, compared with hip-worn devices, he noted. “I’d imagine that the findings would be slightly different due to different types of devices, but the overall premise should remain.”

In a related editorial, Mitchell Psotka, MD, PhD, writes that Dr. Golbus and colleagues “have thankfully moved our understanding of actigraphy forward, although it is still the new kid on the block and will require substantial further testing and validation before widespread reliable clinical and research use.”

Terminology and reporting features need to be standardized, and preferred methods of implementation need to be established, including how to wear the devices, he suggests.

Further research is needed to validate that “accelerometers and their digitally processed movement ‘counts’ actually measure activity and that this measured activity has clinical relevance.”

The study did not receive commercial funding. Dr. Golbus, Dr. Ho, and Dr. Psotka report no relevant relationships.

A version of this article first appeared on Medscape.com.

Higher daily step counts, as measured by actigraphy, were linked to heart failure symptoms and health status, although reductions in step counts were not, in a new study.

Daily step counts between 1,000 and 5,000 were significantly associated with symptoms and physical limitations, as reflected in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom (TS) and physical limitation (PL) scores.

Participants whose step counts increased by 2,000 steps per day demonstrated a 5.2-point increase in their KCCQ-TS scores and a 5.33-point increase in their KCCQ-PL scores, with higher scores reflecting improvement.

oneinchpunch/Thinkstock

However, declines in step counts were not associated with significant declines in KCCQ-PL scores.

The findings are not yet ready to be implemented into practice, first author Jessica R. Golbus, MD, of the University of Michigan, Ann Arbor, said in an interview. However, she said, they “suggest that clinicians should interpret improvements in step counts as indicative of improving health status, though they should not necessarily be as concerned with reductions in step count.

“I would certainly, however, still encourage clinicians to discuss decrementing physical activity levels with their patients, though an intervention may not necessarily be warranted,” she added.

The study was published online in JACC: Heart Failure.
 

Nonlinear relationship

The investigators analyzed data from the Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) trial, a randomized, controlled trial that enrolled participants with heart failure who had a smartphone.

Participants were given a Fitbit Versa 2 and completed serial KCCQs via the smartphone app.

The researchers assessed the relationship between daily step count and KCCQ-TS and KCCQ-PL scores at baseline, as well as changes in the scores between 2 and 12 weeks.

The study included 425 patients. The mean age was 63.5 years, 44.5% were women, and 83.3% were White; 40.9% had reduced ejection fraction, 59.1% had preserved ejection fraction, and 27.5% had type 2 diabetes.

At 2 weeks, the mean KCCQ-TS score was 62.7, and the mean KCCQ-PL score was 55.7.

KCCQ-TS scores increased by 2.5 points on average, and KCCQ-PL scores by 4 points through 12 weeks.

When categorized by 25-point ranges, the step count increased with increasing scores for both KCCQ-TS and KCCQ-PL. Those with KCCQ-TS scores of 0-24 averaged 2,437.6 steps daily, and those with scores of 75-100 averaged 4,870.9 steps daily.

Similarly, participants with KCCQ-PL scores of 0-24 averaged 2301.5 steps daily, and those with scores of 75-100 averaged 5,351.9. The relationship remained significant after adjustment.

There were nonlinear relationships between activity and KCCQ scores: Daily step counts below 5,000 steps were associated with KCCQ scores, but there was little association with counts above 5,000 steps.

Compared with participants who walked 2,000 steps per day, those who walked 1,000 had KCCQ-TS scores that were 3.11 points lower; participants who walked 3,000 had KCCQ-TS scores that were 2.89 points higher.

Similarly, participants who walked 1,000 steps per day had KCCQ-PL scores that were 5.36 points lower than those who walked 2,000 steps, and those who walked 3,000 steps had KCCQ-PL scores that were 4.97 points higher.

After adjustment, change in daily step counts was significantly associated with a change in KCCQ-PL scores from baseline through 12 weeks; for example, participants whose step counts increased by 2,000 steps per day experienced a 5.33 increase in their KCCQ-PL scores relative to participants whose step counts did not change.
 

‘New kid on the block’

Frederick Ho, PhD, a lecturer in public health at the University of Glasgow (Scotland), who is a volunteer spokesperson for the American Heart Association, called the study “promising.”

“The study follow-up is relatively short, so it is not known whether the association is valid longer term,” he said in an interview. “It is also possible that patients with more severe symptoms became physically less active, and at the same time had worse outcomes.

“A study with longer follow-up among patients from a broader background would provide confidence on the generalizability of the findings,” said Dr. Ho, who led a recent study that showed accelerometer-measured physical activity was associated with a lower risk of heart failure. “It’d also be interesting to validate the findings using different types of wearable devices.”

Previous studies have shown that wrist-worn wearables might overestimate light-intensity activities, compared with hip-worn devices, he noted. “I’d imagine that the findings would be slightly different due to different types of devices, but the overall premise should remain.”

In a related editorial, Mitchell Psotka, MD, PhD, writes that Dr. Golbus and colleagues “have thankfully moved our understanding of actigraphy forward, although it is still the new kid on the block and will require substantial further testing and validation before widespread reliable clinical and research use.”

Terminology and reporting features need to be standardized, and preferred methods of implementation need to be established, including how to wear the devices, he suggests.

Further research is needed to validate that “accelerometers and their digitally processed movement ‘counts’ actually measure activity and that this measured activity has clinical relevance.”

The study did not receive commercial funding. Dr. Golbus, Dr. Ho, and Dr. Psotka report no relevant relationships.

A version of this article first appeared on Medscape.com.

Higher daily step counts, as measured by actigraphy, were linked to heart failure symptoms and health status, although reductions in step counts were not, in a new study.

Daily step counts between 1,000 and 5,000 were significantly associated with symptoms and physical limitations, as reflected in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom (TS) and physical limitation (PL) scores.

Participants whose step counts increased by 2,000 steps per day demonstrated a 5.2-point increase in their KCCQ-TS scores and a 5.33-point increase in their KCCQ-PL scores, with higher scores reflecting improvement.

oneinchpunch/Thinkstock

However, declines in step counts were not associated with significant declines in KCCQ-PL scores.

The findings are not yet ready to be implemented into practice, first author Jessica R. Golbus, MD, of the University of Michigan, Ann Arbor, said in an interview. However, she said, they “suggest that clinicians should interpret improvements in step counts as indicative of improving health status, though they should not necessarily be as concerned with reductions in step count.

“I would certainly, however, still encourage clinicians to discuss decrementing physical activity levels with their patients, though an intervention may not necessarily be warranted,” she added.

The study was published online in JACC: Heart Failure.
 

Nonlinear relationship

The investigators analyzed data from the Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) trial, a randomized, controlled trial that enrolled participants with heart failure who had a smartphone.

Participants were given a Fitbit Versa 2 and completed serial KCCQs via the smartphone app.

The researchers assessed the relationship between daily step count and KCCQ-TS and KCCQ-PL scores at baseline, as well as changes in the scores between 2 and 12 weeks.

The study included 425 patients. The mean age was 63.5 years, 44.5% were women, and 83.3% were White; 40.9% had reduced ejection fraction, 59.1% had preserved ejection fraction, and 27.5% had type 2 diabetes.

At 2 weeks, the mean KCCQ-TS score was 62.7, and the mean KCCQ-PL score was 55.7.

KCCQ-TS scores increased by 2.5 points on average, and KCCQ-PL scores by 4 points through 12 weeks.

When categorized by 25-point ranges, the step count increased with increasing scores for both KCCQ-TS and KCCQ-PL. Those with KCCQ-TS scores of 0-24 averaged 2,437.6 steps daily, and those with scores of 75-100 averaged 4,870.9 steps daily.

Similarly, participants with KCCQ-PL scores of 0-24 averaged 2301.5 steps daily, and those with scores of 75-100 averaged 5,351.9. The relationship remained significant after adjustment.

There were nonlinear relationships between activity and KCCQ scores: Daily step counts below 5,000 steps were associated with KCCQ scores, but there was little association with counts above 5,000 steps.

Compared with participants who walked 2,000 steps per day, those who walked 1,000 had KCCQ-TS scores that were 3.11 points lower; participants who walked 3,000 had KCCQ-TS scores that were 2.89 points higher.

Similarly, participants who walked 1,000 steps per day had KCCQ-PL scores that were 5.36 points lower than those who walked 2,000 steps, and those who walked 3,000 steps had KCCQ-PL scores that were 4.97 points higher.

After adjustment, change in daily step counts was significantly associated with a change in KCCQ-PL scores from baseline through 12 weeks; for example, participants whose step counts increased by 2,000 steps per day experienced a 5.33 increase in their KCCQ-PL scores relative to participants whose step counts did not change.
 

‘New kid on the block’

Frederick Ho, PhD, a lecturer in public health at the University of Glasgow (Scotland), who is a volunteer spokesperson for the American Heart Association, called the study “promising.”

“The study follow-up is relatively short, so it is not known whether the association is valid longer term,” he said in an interview. “It is also possible that patients with more severe symptoms became physically less active, and at the same time had worse outcomes.

“A study with longer follow-up among patients from a broader background would provide confidence on the generalizability of the findings,” said Dr. Ho, who led a recent study that showed accelerometer-measured physical activity was associated with a lower risk of heart failure. “It’d also be interesting to validate the findings using different types of wearable devices.”

Previous studies have shown that wrist-worn wearables might overestimate light-intensity activities, compared with hip-worn devices, he noted. “I’d imagine that the findings would be slightly different due to different types of devices, but the overall premise should remain.”

In a related editorial, Mitchell Psotka, MD, PhD, writes that Dr. Golbus and colleagues “have thankfully moved our understanding of actigraphy forward, although it is still the new kid on the block and will require substantial further testing and validation before widespread reliable clinical and research use.”

Terminology and reporting features need to be standardized, and preferred methods of implementation need to be established, including how to wear the devices, he suggests.

Further research is needed to validate that “accelerometers and their digitally processed movement ‘counts’ actually measure activity and that this measured activity has clinical relevance.”

The study did not receive commercial funding. Dr. Golbus, Dr. Ho, and Dr. Psotka report no relevant relationships.

A version of this article first appeared on Medscape.com.

A defined exercise program significantly improved cardiometabolic health and body composition in children with overweight and obesity, but no effect was seen on mental health, based on data from 92 children.

Childhood obesity is associated with negative health outcomes including type 2 diabetes, cardiovascular disease, and mental health disorders, and exercise is considered essential to treatment, wrote Jairo H. Migueles, PhD, of the University of Granada, Spain, and colleagues. However, the effect on children with obesity and overweight of an exercise program on physical and mental health, including within-individual changes, has not been well studied, they said.

In a study published in JAMA Network Open, the researchers reviewed data from 36 girls and 56 boys with overweight or obesity who were randomized to a 20-week exercise program with aerobic and resistance elements, or waitlisted to serve as controls. The participants ranged in age from 8 to 11 years with a mean age of 10 years. The data were collected between Nov. 1, 2014, and June 30, 2016, as part of a parallel-group randomized clinical trial. The exercise program consisted of three to five 90-minute exercise sessions per week for 20 weeks, and the control children continued their usual routines.

The main cardiometabolic outcomes measured in the study were divided into three categories: body composition, physical fitness, and traditional risk factors (waist circumference, blood lipid levels, glucose levels, insulin levels, and blood pressure).

A cardiometabolic risk score was defined by z score. The researchers also added cardiorespiratory fitness (CRF) to the cardiometabolic risk score. Mental health was assessed using composite standardized scores for psychological well-being and poor mental health.

After 20 weeks, cardiometabolic risk scores decreased by approximately 0.38 standard deviations in the exercise group compared with the control group. In addition, specific measures of cardiometabolic health improved significantly from baseline in the exercise group compared with control children for low-density lipoprotein (change of –7.00 mg/dL), body mass index (–5.9 kg/m²), fat mass index (−0.67), and visceral adipose tissue (31.44 g).

Cardiorespiratory fitness improved by 2.75 laps in the exercise group compared with control children. In addition, significantly more children in the exercise group showed meaningful changes (defined as individual changes of at least 0.2 SDs) compared with control children in measures of fat mass index (37 vs. 17, P < .001) and CRF performance (30 vs. 17, P = .03).

However, no significant effects appeared on mental health outcomes in exercisers, the researchers noted.

The reduction in cardiometabolic score was attributable mainly to improvements in cardiovascular fitness, blood lipid levels, and total and visceral adiposity, the researchers wrote in their discussion. The lack of changes in mental health measures may be a result of the healthy mental state of the children at the study outset, they said. “The null effect on mental health outcomes needs to be further investigated, including, among other things, whether the instruments are sensitive enough to detect changes and whether there is a ceiling effect in young children who might be mentally healthy overall,” they wrote.

The findings were limited by several factors, including the relatively small sample size and lack of blinding for some evaluators. However, the results show the potential of exercise programs to affect meaningful change and improve cardiometabolic health in overweight and obese children, although more research is needed to explore the effects of larger-scale and longer-lasting public health interventions combining exercise and other health behaviors such as diet, the researchers concluded.
 

Bottom line: Exercise works

The increasing rates of overweight and obesity in children in the United States have “significant downstream consequences that include increased risk of metabolic disease, including diabetes and hypertension, as well as increased rates of anxiety and depression,” Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, said in an interview.

Therefore, the effect of interventions such as exercise training on outcomes is important, he said. 

The current study findings are “what you would hope for and expect – improvement in cardiometabolic parameters and fitness,” said Dr. Skolnik. “It was encouraging to see the effect of this relatively short duration of intervention has a clear positive effect on weight, BMI, and cardiometabolic parameters,” he said. “The real benefit, of course, comes from sustaining these habits over a long period of time.”

The lack of improvement in mental health is not surprising given the small study population “who did not have a high rate of mental health problems to begin with,” Dr. Skolnik added.

Barriers to promoting exercise programs for obese and overweight children in primary care are many, Dr. Skolnik said, including “having the motivation and funding to create programs like this so they are readily available to youth.”

However, the key message from the current study is simple and straightforward, according to Dr. Skolnik. “Exercise works! It works to improve fitness, cardiometabolic parameters, and weight control,” he said.

“There is always room for more research,” Dr. Skolnik added. The questions now are not about whether exercise benefits health; they are about figuring out how to implement the known benefits of exercise into daily living for all children, athletes and nonathletes alike, he said. “We need to find nonjudgmental ways to encourage exercise as a part of routine daily healthy living, up there with brushing teeth every day,” he emphasized.

The study was supported by grants from the Spanish Ministry of Economy and Competitiveness and El Fondo Europeo de Desarrollo Regional (FEDER) and by the MCIN (Ministerio de Ciencia e Innovación) / AEI (Agencia Estatal de Investigación. The researchers and Dr. Skolnik had no financial conflicts to disclose. Dr. Skolnik serves on the editorial advisory board of Family Practice News.

A defined exercise program significantly improved cardiometabolic health and body composition in children with overweight and obesity, but no effect was seen on mental health, based on data from 92 children.

Childhood obesity is associated with negative health outcomes including type 2 diabetes, cardiovascular disease, and mental health disorders, and exercise is considered essential to treatment, wrote Jairo H. Migueles, PhD, of the University of Granada, Spain, and colleagues. However, the effect on children with obesity and overweight of an exercise program on physical and mental health, including within-individual changes, has not been well studied, they said.

In a study published in JAMA Network Open, the researchers reviewed data from 36 girls and 56 boys with overweight or obesity who were randomized to a 20-week exercise program with aerobic and resistance elements, or waitlisted to serve as controls. The participants ranged in age from 8 to 11 years with a mean age of 10 years. The data were collected between Nov. 1, 2014, and June 30, 2016, as part of a parallel-group randomized clinical trial. The exercise program consisted of three to five 90-minute exercise sessions per week for 20 weeks, and the control children continued their usual routines.

The main cardiometabolic outcomes measured in the study were divided into three categories: body composition, physical fitness, and traditional risk factors (waist circumference, blood lipid levels, glucose levels, insulin levels, and blood pressure).

A cardiometabolic risk score was defined by z score. The researchers also added cardiorespiratory fitness (CRF) to the cardiometabolic risk score. Mental health was assessed using composite standardized scores for psychological well-being and poor mental health.

After 20 weeks, cardiometabolic risk scores decreased by approximately 0.38 standard deviations in the exercise group compared with the control group. In addition, specific measures of cardiometabolic health improved significantly from baseline in the exercise group compared with control children for low-density lipoprotein (change of –7.00 mg/dL), body mass index (–5.9 kg/m²), fat mass index (−0.67), and visceral adipose tissue (31.44 g).

Cardiorespiratory fitness improved by 2.75 laps in the exercise group compared with control children. In addition, significantly more children in the exercise group showed meaningful changes (defined as individual changes of at least 0.2 SDs) compared with control children in measures of fat mass index (37 vs. 17, P < .001) and CRF performance (30 vs. 17, P = .03).

However, no significant effects appeared on mental health outcomes in exercisers, the researchers noted.

The reduction in cardiometabolic score was attributable mainly to improvements in cardiovascular fitness, blood lipid levels, and total and visceral adiposity, the researchers wrote in their discussion. The lack of changes in mental health measures may be a result of the healthy mental state of the children at the study outset, they said. “The null effect on mental health outcomes needs to be further investigated, including, among other things, whether the instruments are sensitive enough to detect changes and whether there is a ceiling effect in young children who might be mentally healthy overall,” they wrote.

The findings were limited by several factors, including the relatively small sample size and lack of blinding for some evaluators. However, the results show the potential of exercise programs to affect meaningful change and improve cardiometabolic health in overweight and obese children, although more research is needed to explore the effects of larger-scale and longer-lasting public health interventions combining exercise and other health behaviors such as diet, the researchers concluded.
 

Bottom line: Exercise works

The increasing rates of overweight and obesity in children in the United States have “significant downstream consequences that include increased risk of metabolic disease, including diabetes and hypertension, as well as increased rates of anxiety and depression,” Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, said in an interview.

Therefore, the effect of interventions such as exercise training on outcomes is important, he said. 

The current study findings are “what you would hope for and expect – improvement in cardiometabolic parameters and fitness,” said Dr. Skolnik. “It was encouraging to see the effect of this relatively short duration of intervention has a clear positive effect on weight, BMI, and cardiometabolic parameters,” he said. “The real benefit, of course, comes from sustaining these habits over a long period of time.”

The lack of improvement in mental health is not surprising given the small study population “who did not have a high rate of mental health problems to begin with,” Dr. Skolnik added.

Barriers to promoting exercise programs for obese and overweight children in primary care are many, Dr. Skolnik said, including “having the motivation and funding to create programs like this so they are readily available to youth.”

However, the key message from the current study is simple and straightforward, according to Dr. Skolnik. “Exercise works! It works to improve fitness, cardiometabolic parameters, and weight control,” he said.

“There is always room for more research,” Dr. Skolnik added. The questions now are not about whether exercise benefits health; they are about figuring out how to implement the known benefits of exercise into daily living for all children, athletes and nonathletes alike, he said. “We need to find nonjudgmental ways to encourage exercise as a part of routine daily healthy living, up there with brushing teeth every day,” he emphasized.

The study was supported by grants from the Spanish Ministry of Economy and Competitiveness and El Fondo Europeo de Desarrollo Regional (FEDER) and by the MCIN (Ministerio de Ciencia e Innovación) / AEI (Agencia Estatal de Investigación. The researchers and Dr. Skolnik had no financial conflicts to disclose. Dr. Skolnik serves on the editorial advisory board of Family Practice News.

A defined exercise program significantly improved cardiometabolic health and body composition in children with overweight and obesity, but no effect was seen on mental health, based on data from 92 children.

Childhood obesity is associated with negative health outcomes including type 2 diabetes, cardiovascular disease, and mental health disorders, and exercise is considered essential to treatment, wrote Jairo H. Migueles, PhD, of the University of Granada, Spain, and colleagues. However, the effect on children with obesity and overweight of an exercise program on physical and mental health, including within-individual changes, has not been well studied, they said.

In a study published in JAMA Network Open, the researchers reviewed data from 36 girls and 56 boys with overweight or obesity who were randomized to a 20-week exercise program with aerobic and resistance elements, or waitlisted to serve as controls. The participants ranged in age from 8 to 11 years with a mean age of 10 years. The data were collected between Nov. 1, 2014, and June 30, 2016, as part of a parallel-group randomized clinical trial. The exercise program consisted of three to five 90-minute exercise sessions per week for 20 weeks, and the control children continued their usual routines.

The main cardiometabolic outcomes measured in the study were divided into three categories: body composition, physical fitness, and traditional risk factors (waist circumference, blood lipid levels, glucose levels, insulin levels, and blood pressure).

A cardiometabolic risk score was defined by z score. The researchers also added cardiorespiratory fitness (CRF) to the cardiometabolic risk score. Mental health was assessed using composite standardized scores for psychological well-being and poor mental health.

After 20 weeks, cardiometabolic risk scores decreased by approximately 0.38 standard deviations in the exercise group compared with the control group. In addition, specific measures of cardiometabolic health improved significantly from baseline in the exercise group compared with control children for low-density lipoprotein (change of –7.00 mg/dL), body mass index (–5.9 kg/m²), fat mass index (−0.67), and visceral adipose tissue (31.44 g).

Cardiorespiratory fitness improved by 2.75 laps in the exercise group compared with control children. In addition, significantly more children in the exercise group showed meaningful changes (defined as individual changes of at least 0.2 SDs) compared with control children in measures of fat mass index (37 vs. 17, P < .001) and CRF performance (30 vs. 17, P = .03).

However, no significant effects appeared on mental health outcomes in exercisers, the researchers noted.

The reduction in cardiometabolic score was attributable mainly to improvements in cardiovascular fitness, blood lipid levels, and total and visceral adiposity, the researchers wrote in their discussion. The lack of changes in mental health measures may be a result of the healthy mental state of the children at the study outset, they said. “The null effect on mental health outcomes needs to be further investigated, including, among other things, whether the instruments are sensitive enough to detect changes and whether there is a ceiling effect in young children who might be mentally healthy overall,” they wrote.

The findings were limited by several factors, including the relatively small sample size and lack of blinding for some evaluators. However, the results show the potential of exercise programs to affect meaningful change and improve cardiometabolic health in overweight and obese children, although more research is needed to explore the effects of larger-scale and longer-lasting public health interventions combining exercise and other health behaviors such as diet, the researchers concluded.
 

Bottom line: Exercise works

The increasing rates of overweight and obesity in children in the United States have “significant downstream consequences that include increased risk of metabolic disease, including diabetes and hypertension, as well as increased rates of anxiety and depression,” Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, said in an interview.

Therefore, the effect of interventions such as exercise training on outcomes is important, he said. 

The current study findings are “what you would hope for and expect – improvement in cardiometabolic parameters and fitness,” said Dr. Skolnik. “It was encouraging to see the effect of this relatively short duration of intervention has a clear positive effect on weight, BMI, and cardiometabolic parameters,” he said. “The real benefit, of course, comes from sustaining these habits over a long period of time.”

The lack of improvement in mental health is not surprising given the small study population “who did not have a high rate of mental health problems to begin with,” Dr. Skolnik added.

Barriers to promoting exercise programs for obese and overweight children in primary care are many, Dr. Skolnik said, including “having the motivation and funding to create programs like this so they are readily available to youth.”

However, the key message from the current study is simple and straightforward, according to Dr. Skolnik. “Exercise works! It works to improve fitness, cardiometabolic parameters, and weight control,” he said.

“There is always room for more research,” Dr. Skolnik added. The questions now are not about whether exercise benefits health; they are about figuring out how to implement the known benefits of exercise into daily living for all children, athletes and nonathletes alike, he said. “We need to find nonjudgmental ways to encourage exercise as a part of routine daily healthy living, up there with brushing teeth every day,” he emphasized.

The study was supported by grants from the Spanish Ministry of Economy and Competitiveness and El Fondo Europeo de Desarrollo Regional (FEDER) and by the MCIN (Ministerio de Ciencia e Innovación) / AEI (Agencia Estatal de Investigación. The researchers and Dr. Skolnik had no financial conflicts to disclose. Dr. Skolnik serves on the editorial advisory board of Family Practice News.

Daily use of low-dose aspirin offers no significant protection against stroke and was linked to a higher rate of bleeding in the brain, according to new research published in JAMA.

The research matches other evidence advising that healthy older adults without a history of heart conditions or warning signs of stroke should not take low-dose aspirin. 

The findings also support the recommendation from the U.S. Preventive Services Task Force that low-dose aspirin should not be prescribed for preventing a first heart attack or stroke in healthy older adults, The New York Times reported.

“We can be very emphatic that healthy people who are not on aspirin and do not have multiple risk factors should not be starting it now,” said Randall Stafford, MD, of Stanford (Calif.) University, who was not involved in the study, in the Times.

It’s not as clear for others, he said.

“The longer you’ve been on aspirin and the more risk factors you have for heart attacks and strokes, the murkier it gets,” he said.

Some cardiac and stroke experts say daily aspirin should remain part of the regimen for people who have had a heart attack or stroke.

The JAMA report was based on data from a randomized control trial of 19,000 people from Australia and America. Participants were over the age of 70 and did not have heart disease. 

The data covered an average of almost 4.7 years and revealed that aspirin lowered the rate of ischemic stroke but not significantly. An ischemic stroke happens when a clot forms in a blood vessel that sends blood to the brain. 

There was also a 38% higher rate of brain bleeds for people who took aspirin daily, compared with those who took a placebo.

The Times wrote, “In the past, some doctors regarded aspirin as something of a wonder drug, capable of protecting healthy patients against a future heart attack or stroke. But recent studies have shown that the powerful drug has limited protective power among people who have not yet had such an event, and it comes with dangerous side effects.”

A version of this article first appeared on WebMD.com.

Daily use of low-dose aspirin offers no significant protection against stroke and was linked to a higher rate of bleeding in the brain, according to new research published in JAMA.

The research matches other evidence advising that healthy older adults without a history of heart conditions or warning signs of stroke should not take low-dose aspirin. 

The findings also support the recommendation from the U.S. Preventive Services Task Force that low-dose aspirin should not be prescribed for preventing a first heart attack or stroke in healthy older adults, The New York Times reported.

“We can be very emphatic that healthy people who are not on aspirin and do not have multiple risk factors should not be starting it now,” said Randall Stafford, MD, of Stanford (Calif.) University, who was not involved in the study, in the Times.

It’s not as clear for others, he said.

“The longer you’ve been on aspirin and the more risk factors you have for heart attacks and strokes, the murkier it gets,” he said.

Some cardiac and stroke experts say daily aspirin should remain part of the regimen for people who have had a heart attack or stroke.

The JAMA report was based on data from a randomized control trial of 19,000 people from Australia and America. Participants were over the age of 70 and did not have heart disease. 

The data covered an average of almost 4.7 years and revealed that aspirin lowered the rate of ischemic stroke but not significantly. An ischemic stroke happens when a clot forms in a blood vessel that sends blood to the brain. 

There was also a 38% higher rate of brain bleeds for people who took aspirin daily, compared with those who took a placebo.

The Times wrote, “In the past, some doctors regarded aspirin as something of a wonder drug, capable of protecting healthy patients against a future heart attack or stroke. But recent studies have shown that the powerful drug has limited protective power among people who have not yet had such an event, and it comes with dangerous side effects.”

A version of this article first appeared on WebMD.com.

Daily use of low-dose aspirin offers no significant protection against stroke and was linked to a higher rate of bleeding in the brain, according to new research published in JAMA.

The research matches other evidence advising that healthy older adults without a history of heart conditions or warning signs of stroke should not take low-dose aspirin. 

The findings also support the recommendation from the U.S. Preventive Services Task Force that low-dose aspirin should not be prescribed for preventing a first heart attack or stroke in healthy older adults, The New York Times reported.

“We can be very emphatic that healthy people who are not on aspirin and do not have multiple risk factors should not be starting it now,” said Randall Stafford, MD, of Stanford (Calif.) University, who was not involved in the study, in the Times.

It’s not as clear for others, he said.

“The longer you’ve been on aspirin and the more risk factors you have for heart attacks and strokes, the murkier it gets,” he said.

Some cardiac and stroke experts say daily aspirin should remain part of the regimen for people who have had a heart attack or stroke.

The JAMA report was based on data from a randomized control trial of 19,000 people from Australia and America. Participants were over the age of 70 and did not have heart disease. 

The data covered an average of almost 4.7 years and revealed that aspirin lowered the rate of ischemic stroke but not significantly. An ischemic stroke happens when a clot forms in a blood vessel that sends blood to the brain. 

There was also a 38% higher rate of brain bleeds for people who took aspirin daily, compared with those who took a placebo.

The Times wrote, “In the past, some doctors regarded aspirin as something of a wonder drug, capable of protecting healthy patients against a future heart attack or stroke. But recent studies have shown that the powerful drug has limited protective power among people who have not yet had such an event, and it comes with dangerous side effects.”

A version of this article first appeared on WebMD.com.

Stiff arteries may cause, rather than be a consequence of, metabolic syndrome, results of a longitudinal birth cohort study show.

New research published in the American Journal of Physiology found that arterial stiffness occurred before the presence of metabolic syndrome. A progressive rise in stiffness was associated with a cumulative increase in risk for the condition among the 3,862 people studied over a 7-year period starting in late adolescence. 

Results revealed a notable sex difference: Arterial stiffness increased the risk for metabolic syndrome by 9% for males but only by 1% for females. Males were also five times more likely than females to have metabolic syndrome.

“It seems metabolic syndrome has a new risk factor we haven’t thought about,” said author Andrew O. Agbaje, MD, clinical epidemiologist and researcher, University of Eastern Finland, Kuopio.

Arterial stiffness previously was associated with metabolic syndrome in numerous studies. But the new work is the first to find evidence for causality, Dr. Agbaje said in an interview.

“Interventions have focused on addressing the components of metabolic syndrome such as obesity, dyslipidemia, hyperglycemia, and hypertension,” Dr. Agbaje said. “But arterial stiffness may independently cause metabolic syndrome in 1 out of 10 male teens. I encourage clinicians to think about its role in preventing and managing metabolic syndrome, not just as a consequence but as a cause.”

The results have important implications for physicians, according to Sissi Cossio, MD, pediatric endocrinologist, Pediatrix Medical Group, Fort Lauderdale, Fla.

“The fact that arterial stiffness progression preceded metabolic syndrome is important because it could be used as an earlier detection marker of disease,” Dr. Cossio said.

To conduct the study, Dr. Agbaje and his research team used data collected by the Avon Longitudinal Study of Parents and Children at the University of Bristol in England. Arterial stiffness was measured using carotid-femoral pulse wave velocity, the speed of blood flow from the upper to the lower aorta. They assessed for metabolic syndrome by the presence of three or more risk factors, including high cholesterol, high triglycerides, and high trunk fat mass.

Participants were studied starting in gestation in the early 1990s, and were measured for arterial stiffness and metabolic syndrome starting at age 17 through age 24.

The overall risk for metabolic syndrome doubled within the 7-year study period of follow-up between 2009 and 2017, indicating that early intervention during adolescence is essential. 

Dr. Agbaje recommended that physicians start treating arterial stiffness and other markers of metabolic syndrome as early as possible, noting that, “potentially irreversible cardiovascular health damage might occur after age 17.” 

Arterial stiffness can be negated through physical activity and dietary changes that lower inflammation. Physicians should refer at-risk teens to a preventative clinic where they can be monitored and receive repeated measurements of arterial stiffness, lipid levels, blood pressure, glucose levels, and obesity every 3 months, Dr. Agbaje said.

“The health progress made after a year would be an indicator for physicians whether a more aggressive therapeutic approach is needed since it takes about 7 years for the risk of metabolic syndrome attributed to arterial stiffness to worsen remarkably in the young population,” he said.

Dr. Agbaje pointed to a few potential pathways through which arterial stiffness might create a disease cascade. Stiffer arteries disrupt blood flow to the liver and pancreas, which could adversely affect their functioning, he said. Damage to these organs may increase insulin and LDL cholesterol blood levels, increasing the risk for metabolic syndrome.

Arterial stiffness also can lead to higher blood pressure and insulin resistance, potentially inducing musculogenesis and vasculogenesis. The resulting excessive muscle mass may also increase the risk for the condition, he said.

Dr. Cossio acknowledged that treatments for metabolic syndrome become less effective with age, but emphasized that reversal is possible in adults with lifestyle changes and medications.

“Early detection will give patients the best chance at reversing the disease, and [primary care physicians] are a key factor in this process,” she said.

Dr. Cossio said that at-risk teens should receive treatment in a weight loss or endocrinology clinic. Treatment may include behavioral, surgical, and pharmacotherapeutic interventions.

“Teens with signs of insulin resistance and impaired fasting glucose, acanthosis, or prediabetes, should start metformin as the first line of therapy,” Dr. Cossio said. 

For weight management, she recommends antiobesity medications such as liraglutide, semaglutide, and the combination of phentermine/topiramate in children aged 12 years or older. In teenagers 16 years or older, phentermine alone is another option.

The research group that conducted the study reported received funding from the Jenny and Antti Wihuri Foundation, the North Savo Regional Fund and Central Finnish Cultural Foundation, the Aarne Koskelo Foundation, the Foundation for Pediatric Research, and the Finnish Foundation for Cardiovascular Research, among others. The authors declared no conflicts of interest, financial or otherwise.
 

A version of this article appeared on Medscape.com.

Stiff arteries may cause, rather than be a consequence of, metabolic syndrome, results of a longitudinal birth cohort study show.

New research published in the American Journal of Physiology found that arterial stiffness occurred before the presence of metabolic syndrome. A progressive rise in stiffness was associated with a cumulative increase in risk for the condition among the 3,862 people studied over a 7-year period starting in late adolescence. 

Results revealed a notable sex difference: Arterial stiffness increased the risk for metabolic syndrome by 9% for males but only by 1% for females. Males were also five times more likely than females to have metabolic syndrome.

“It seems metabolic syndrome has a new risk factor we haven’t thought about,” said author Andrew O. Agbaje, MD, clinical epidemiologist and researcher, University of Eastern Finland, Kuopio.

Arterial stiffness previously was associated with metabolic syndrome in numerous studies. But the new work is the first to find evidence for causality, Dr. Agbaje said in an interview.

“Interventions have focused on addressing the components of metabolic syndrome such as obesity, dyslipidemia, hyperglycemia, and hypertension,” Dr. Agbaje said. “But arterial stiffness may independently cause metabolic syndrome in 1 out of 10 male teens. I encourage clinicians to think about its role in preventing and managing metabolic syndrome, not just as a consequence but as a cause.”

The results have important implications for physicians, according to Sissi Cossio, MD, pediatric endocrinologist, Pediatrix Medical Group, Fort Lauderdale, Fla.

“The fact that arterial stiffness progression preceded metabolic syndrome is important because it could be used as an earlier detection marker of disease,” Dr. Cossio said.

To conduct the study, Dr. Agbaje and his research team used data collected by the Avon Longitudinal Study of Parents and Children at the University of Bristol in England. Arterial stiffness was measured using carotid-femoral pulse wave velocity, the speed of blood flow from the upper to the lower aorta. They assessed for metabolic syndrome by the presence of three or more risk factors, including high cholesterol, high triglycerides, and high trunk fat mass.

Participants were studied starting in gestation in the early 1990s, and were measured for arterial stiffness and metabolic syndrome starting at age 17 through age 24.

The overall risk for metabolic syndrome doubled within the 7-year study period of follow-up between 2009 and 2017, indicating that early intervention during adolescence is essential. 

Dr. Agbaje recommended that physicians start treating arterial stiffness and other markers of metabolic syndrome as early as possible, noting that, “potentially irreversible cardiovascular health damage might occur after age 17.” 

Arterial stiffness can be negated through physical activity and dietary changes that lower inflammation. Physicians should refer at-risk teens to a preventative clinic where they can be monitored and receive repeated measurements of arterial stiffness, lipid levels, blood pressure, glucose levels, and obesity every 3 months, Dr. Agbaje said.

“The health progress made after a year would be an indicator for physicians whether a more aggressive therapeutic approach is needed since it takes about 7 years for the risk of metabolic syndrome attributed to arterial stiffness to worsen remarkably in the young population,” he said.

Dr. Agbaje pointed to a few potential pathways through which arterial stiffness might create a disease cascade. Stiffer arteries disrupt blood flow to the liver and pancreas, which could adversely affect their functioning, he said. Damage to these organs may increase insulin and LDL cholesterol blood levels, increasing the risk for metabolic syndrome.

Arterial stiffness also can lead to higher blood pressure and insulin resistance, potentially inducing musculogenesis and vasculogenesis. The resulting excessive muscle mass may also increase the risk for the condition, he said.

Dr. Cossio acknowledged that treatments for metabolic syndrome become less effective with age, but emphasized that reversal is possible in adults with lifestyle changes and medications.

“Early detection will give patients the best chance at reversing the disease, and [primary care physicians] are a key factor in this process,” she said.

Dr. Cossio said that at-risk teens should receive treatment in a weight loss or endocrinology clinic. Treatment may include behavioral, surgical, and pharmacotherapeutic interventions.

“Teens with signs of insulin resistance and impaired fasting glucose, acanthosis, or prediabetes, should start metformin as the first line of therapy,” Dr. Cossio said. 

For weight management, she recommends antiobesity medications such as liraglutide, semaglutide, and the combination of phentermine/topiramate in children aged 12 years or older. In teenagers 16 years or older, phentermine alone is another option.

The research group that conducted the study reported received funding from the Jenny and Antti Wihuri Foundation, the North Savo Regional Fund and Central Finnish Cultural Foundation, the Aarne Koskelo Foundation, the Foundation for Pediatric Research, and the Finnish Foundation for Cardiovascular Research, among others. The authors declared no conflicts of interest, financial or otherwise.
 

A version of this article appeared on Medscape.com.

Stiff arteries may cause, rather than be a consequence of, metabolic syndrome, results of a longitudinal birth cohort study show.

New research published in the American Journal of Physiology found that arterial stiffness occurred before the presence of metabolic syndrome. A progressive rise in stiffness was associated with a cumulative increase in risk for the condition among the 3,862 people studied over a 7-year period starting in late adolescence. 

Results revealed a notable sex difference: Arterial stiffness increased the risk for metabolic syndrome by 9% for males but only by 1% for females. Males were also five times more likely than females to have metabolic syndrome.

“It seems metabolic syndrome has a new risk factor we haven’t thought about,” said author Andrew O. Agbaje, MD, clinical epidemiologist and researcher, University of Eastern Finland, Kuopio.

Arterial stiffness previously was associated with metabolic syndrome in numerous studies. But the new work is the first to find evidence for causality, Dr. Agbaje said in an interview.

“Interventions have focused on addressing the components of metabolic syndrome such as obesity, dyslipidemia, hyperglycemia, and hypertension,” Dr. Agbaje said. “But arterial stiffness may independently cause metabolic syndrome in 1 out of 10 male teens. I encourage clinicians to think about its role in preventing and managing metabolic syndrome, not just as a consequence but as a cause.”

The results have important implications for physicians, according to Sissi Cossio, MD, pediatric endocrinologist, Pediatrix Medical Group, Fort Lauderdale, Fla.

“The fact that arterial stiffness progression preceded metabolic syndrome is important because it could be used as an earlier detection marker of disease,” Dr. Cossio said.

To conduct the study, Dr. Agbaje and his research team used data collected by the Avon Longitudinal Study of Parents and Children at the University of Bristol in England. Arterial stiffness was measured using carotid-femoral pulse wave velocity, the speed of blood flow from the upper to the lower aorta. They assessed for metabolic syndrome by the presence of three or more risk factors, including high cholesterol, high triglycerides, and high trunk fat mass.

Participants were studied starting in gestation in the early 1990s, and were measured for arterial stiffness and metabolic syndrome starting at age 17 through age 24.

The overall risk for metabolic syndrome doubled within the 7-year study period of follow-up between 2009 and 2017, indicating that early intervention during adolescence is essential. 

Dr. Agbaje recommended that physicians start treating arterial stiffness and other markers of metabolic syndrome as early as possible, noting that, “potentially irreversible cardiovascular health damage might occur after age 17.” 

Arterial stiffness can be negated through physical activity and dietary changes that lower inflammation. Physicians should refer at-risk teens to a preventative clinic where they can be monitored and receive repeated measurements of arterial stiffness, lipid levels, blood pressure, glucose levels, and obesity every 3 months, Dr. Agbaje said.

“The health progress made after a year would be an indicator for physicians whether a more aggressive therapeutic approach is needed since it takes about 7 years for the risk of metabolic syndrome attributed to arterial stiffness to worsen remarkably in the young population,” he said.

Dr. Agbaje pointed to a few potential pathways through which arterial stiffness might create a disease cascade. Stiffer arteries disrupt blood flow to the liver and pancreas, which could adversely affect their functioning, he said. Damage to these organs may increase insulin and LDL cholesterol blood levels, increasing the risk for metabolic syndrome.

Arterial stiffness also can lead to higher blood pressure and insulin resistance, potentially inducing musculogenesis and vasculogenesis. The resulting excessive muscle mass may also increase the risk for the condition, he said.

Dr. Cossio acknowledged that treatments for metabolic syndrome become less effective with age, but emphasized that reversal is possible in adults with lifestyle changes and medications.

“Early detection will give patients the best chance at reversing the disease, and [primary care physicians] are a key factor in this process,” she said.

Dr. Cossio said that at-risk teens should receive treatment in a weight loss or endocrinology clinic. Treatment may include behavioral, surgical, and pharmacotherapeutic interventions.

“Teens with signs of insulin resistance and impaired fasting glucose, acanthosis, or prediabetes, should start metformin as the first line of therapy,” Dr. Cossio said. 

For weight management, she recommends antiobesity medications such as liraglutide, semaglutide, and the combination of phentermine/topiramate in children aged 12 years or older. In teenagers 16 years or older, phentermine alone is another option.

The research group that conducted the study reported received funding from the Jenny and Antti Wihuri Foundation, the North Savo Regional Fund and Central Finnish Cultural Foundation, the Aarne Koskelo Foundation, the Foundation for Pediatric Research, and the Finnish Foundation for Cardiovascular Research, among others. The authors declared no conflicts of interest, financial or otherwise.
 

A version of this article appeared on Medscape.com.

People with or at a high risk of cardiovascular disease who maintain a vegetarian diet for 6 months or longer show significant improvements in key risk factors, including cholesterol, glycemic control, and body weight, a meta-analysis of randomized controlled trials shows.

©KaterynaSednieva/Thinkstock

“To the best of our knowledge, this meta-analysis is the first that generates evidence from randomized controlled trials to assess the association of vegetarian diets with outcomes in people affected by cardiovascular diseases,” report the authors. The study was published online in JAMA Network Open.

“The greatest improvements in hemoglobin A1c and low-density lipoprotein cholesterol (LDL-C) were observed in individuals with type 2 diabetes and people at high risk of cardiovascular disease, highlighting the potential protective and synergistic effects of vegetarian diets for the primary prevention of cardiovascular disease,” they say.

Poor diet is well-established as increasing the morbidity and mortality associated with cardiovascular disease; however, although data has linked vegetarian diets to cardiovascular disease prevention in the general population, research on the effectiveness of such diets in people at high risk of cardiovascular disease is lacking.

“To the best of our knowledge, no meta-analysis of randomized controlled trials has been conducted to investigate the association of vegetarian diets with outcomes among people with CVD – indeed, research here has primarily focused on observational studies,” writes Tian Wang, RD, and colleagues at the University of Sydney.
 

Greater decreases in LDL-C, A1c, and body weight with vegetarian diets

For the meta-analysis, researchers identified 20 randomized controlled trials involving vegetarian diets that included 1,878 adults with or at a high risk of cardiovascular disease and included measurements of LDL-C, A1c, or systolic blood pressure.

The studies were conducted in the United States, Asia, Europe, and New Zealand between 1990 and 2021. Sample sizes ranged from 12 to 291 participants.

The mean range age of participants was 28-64 years. Studies included patients with cardiovascular disease (four studies), diabetes (seven studies), and those with at least two cardiovascular risk factors (nine studies).

The mean duration of the dietary intervention was 25.4 weeks (range 2-24 months). The most commonly prescribed diets were vegan (plant-based foods only), lacto-ovo-vegetarian (excluded meat, poultry, seafood, and dairy products, but allowed eggs), and lacto-vegetarian (same as previous but allowed dairy products).

Overall, those who consumed a vegetarian diet for an average of 6 months, versus comparison diets, had significantly greater decreases in LDL-C (6.6 mg/dL beyond the reduction achieved with standard therapy); A1c (0.24%); and body weight (3.4 kg), but the reduction in systolic blood pressure (0.1 mmHg) was not significantly greater.

Assessment of the overall certainty of evidence evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool showed a moderate level of evidence for reductions in LDL-C and A1c with the vegetarian diet.

Lacto-ovo vegetarian diets were associated with the greatest reduction in LDL-C (14.1 mg/dL); however, four out of the five trials restricted energy intake.

Of note, vegetarian diets were most effective for achieving glycemic control among people with type 2 diabetes and leading to improvements in weight among those at high risk of cardiovascular disease as well as those with type 2 diabetes.

The effects “suggest that vegetarian diets might have a synergistic [or at least nonantagonistic] use in potentiating the effects of optimal drug therapy in the prevention and treatment of a range of cardiometabolic diseases,” the authors write.

Although previous studies have shown similar improvements associated with a vegetarian diet, most studies did not stratify populations based on disease status, type of vegetarian diet, or comparison diet, the authors note.

The lack of improvement in systolic blood pressure is consistent with previous meta-analyses of vegetarian diets in general and suggests that salt intake may be the more important factor for those measures.

“[The meta-analysis] suggests that diet quality plays a major role in lowering blood pressure independent of animal food consumption, as the DASH [Dietary Approaches to Stop Hypertension] ... trial demonstrated,” the authors note.
 

Decreases in medication dose with vegetarian diet

Although most patients were taking medications to manage hypertension, hyperglycemia, and/or dyslipidemia at trial enrollment in as many as eight of the studies, the vegetarian diet intervention resulted in a decrease in medication dose.

In fact, medication use could obscure the favorable effects of vegetarian diets, which could have a larger effect size, the authors speculate.

“This hypothesis is supported by two randomized controlled trials in our meta-analysis that required patients not to take medication that could influence cardiometabolic outcomes, [and] these studies significantly improved systolic blood pressure and LDL-C,” they write.
 

Not all vegetarian diets are healthy

Although there are numerous variations in vegetarian diets, ranging from vegan diets that eliminate all animal food to pesco-vegetarian diets that allow fish or seafood, most that are well-balanced can provide health benefits including lower saturated fat, L-carnitine, and choline (precursors of the atherogenic TMAO), and other benefits that might explain the improvements seen in the meta-analysis.  

The diets may also be high in dietary fiber, mono- and polyunsaturated fatty acids, potassium, magnesium, and phytochemical, and have lower glycemic index scores.

Of note, 12 studies in the meta-analysis emphasized low-fat content, which the authors speculate may have contributed to the improvements observed in LDC-C.

Specifically, lacto-ovo vegetarian diets were associated with the greatest reduction in LDL-C (–14.1 mg/dL); however, four out of five of the trials restricted energy intake, which could have also played a role in improvements.

Importantly, not all vegetarian diets are healthy, and the authors caution about some that allow, for instance, deep-fried foods rich in trans-fatty acids and salt, such as tempura vegetables, potentially increasing the risk of type 2 diabetes and coronary heart disease.

They note that “more than one-third of the studies included in our meta-analysis did not emphasize the importance of consuming minimally processed plant-based whole foods.”

Overall, however, the fact that the greatest improvements in A1c and LDL-C were seen in patients with type 2 diabetes and those at high risk of CVD “highlight[s] the potential protective and synergistic effects of vegetarian diets for the primary prevention of CVD.”

A version of this article first appeared on Medscape.com.

People with or at a high risk of cardiovascular disease who maintain a vegetarian diet for 6 months or longer show significant improvements in key risk factors, including cholesterol, glycemic control, and body weight, a meta-analysis of randomized controlled trials shows.

©KaterynaSednieva/Thinkstock

“To the best of our knowledge, this meta-analysis is the first that generates evidence from randomized controlled trials to assess the association of vegetarian diets with outcomes in people affected by cardiovascular diseases,” report the authors. The study was published online in JAMA Network Open.

“The greatest improvements in hemoglobin A1c and low-density lipoprotein cholesterol (LDL-C) were observed in individuals with type 2 diabetes and people at high risk of cardiovascular disease, highlighting the potential protective and synergistic effects of vegetarian diets for the primary prevention of cardiovascular disease,” they say.

Poor diet is well-established as increasing the morbidity and mortality associated with cardiovascular disease; however, although data has linked vegetarian diets to cardiovascular disease prevention in the general population, research on the effectiveness of such diets in people at high risk of cardiovascular disease is lacking.

“To the best of our knowledge, no meta-analysis of randomized controlled trials has been conducted to investigate the association of vegetarian diets with outcomes among people with CVD – indeed, research here has primarily focused on observational studies,” writes Tian Wang, RD, and colleagues at the University of Sydney.
 

Greater decreases in LDL-C, A1c, and body weight with vegetarian diets

For the meta-analysis, researchers identified 20 randomized controlled trials involving vegetarian diets that included 1,878 adults with or at a high risk of cardiovascular disease and included measurements of LDL-C, A1c, or systolic blood pressure.

The studies were conducted in the United States, Asia, Europe, and New Zealand between 1990 and 2021. Sample sizes ranged from 12 to 291 participants.

The mean range age of participants was 28-64 years. Studies included patients with cardiovascular disease (four studies), diabetes (seven studies), and those with at least two cardiovascular risk factors (nine studies).

The mean duration of the dietary intervention was 25.4 weeks (range 2-24 months). The most commonly prescribed diets were vegan (plant-based foods only), lacto-ovo-vegetarian (excluded meat, poultry, seafood, and dairy products, but allowed eggs), and lacto-vegetarian (same as previous but allowed dairy products).

Overall, those who consumed a vegetarian diet for an average of 6 months, versus comparison diets, had significantly greater decreases in LDL-C (6.6 mg/dL beyond the reduction achieved with standard therapy); A1c (0.24%); and body weight (3.4 kg), but the reduction in systolic blood pressure (0.1 mmHg) was not significantly greater.

Assessment of the overall certainty of evidence evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool showed a moderate level of evidence for reductions in LDL-C and A1c with the vegetarian diet.

Lacto-ovo vegetarian diets were associated with the greatest reduction in LDL-C (14.1 mg/dL); however, four out of the five trials restricted energy intake.

Of note, vegetarian diets were most effective for achieving glycemic control among people with type 2 diabetes and leading to improvements in weight among those at high risk of cardiovascular disease as well as those with type 2 diabetes.

The effects “suggest that vegetarian diets might have a synergistic [or at least nonantagonistic] use in potentiating the effects of optimal drug therapy in the prevention and treatment of a range of cardiometabolic diseases,” the authors write.

Although previous studies have shown similar improvements associated with a vegetarian diet, most studies did not stratify populations based on disease status, type of vegetarian diet, or comparison diet, the authors note.

The lack of improvement in systolic blood pressure is consistent with previous meta-analyses of vegetarian diets in general and suggests that salt intake may be the more important factor for those measures.

“[The meta-analysis] suggests that diet quality plays a major role in lowering blood pressure independent of animal food consumption, as the DASH [Dietary Approaches to Stop Hypertension] ... trial demonstrated,” the authors note.
 

Decreases in medication dose with vegetarian diet

Although most patients were taking medications to manage hypertension, hyperglycemia, and/or dyslipidemia at trial enrollment in as many as eight of the studies, the vegetarian diet intervention resulted in a decrease in medication dose.

In fact, medication use could obscure the favorable effects of vegetarian diets, which could have a larger effect size, the authors speculate.

“This hypothesis is supported by two randomized controlled trials in our meta-analysis that required patients not to take medication that could influence cardiometabolic outcomes, [and] these studies significantly improved systolic blood pressure and LDL-C,” they write.
 

Not all vegetarian diets are healthy

Although there are numerous variations in vegetarian diets, ranging from vegan diets that eliminate all animal food to pesco-vegetarian diets that allow fish or seafood, most that are well-balanced can provide health benefits including lower saturated fat, L-carnitine, and choline (precursors of the atherogenic TMAO), and other benefits that might explain the improvements seen in the meta-analysis.  

The diets may also be high in dietary fiber, mono- and polyunsaturated fatty acids, potassium, magnesium, and phytochemical, and have lower glycemic index scores.

Of note, 12 studies in the meta-analysis emphasized low-fat content, which the authors speculate may have contributed to the improvements observed in LDC-C.

Specifically, lacto-ovo vegetarian diets were associated with the greatest reduction in LDL-C (–14.1 mg/dL); however, four out of five of the trials restricted energy intake, which could have also played a role in improvements.

Importantly, not all vegetarian diets are healthy, and the authors caution about some that allow, for instance, deep-fried foods rich in trans-fatty acids and salt, such as tempura vegetables, potentially increasing the risk of type 2 diabetes and coronary heart disease.

They note that “more than one-third of the studies included in our meta-analysis did not emphasize the importance of consuming minimally processed plant-based whole foods.”

Overall, however, the fact that the greatest improvements in A1c and LDL-C were seen in patients with type 2 diabetes and those at high risk of CVD “highlight[s] the potential protective and synergistic effects of vegetarian diets for the primary prevention of CVD.”

A version of this article first appeared on Medscape.com.

People with or at a high risk of cardiovascular disease who maintain a vegetarian diet for 6 months or longer show significant improvements in key risk factors, including cholesterol, glycemic control, and body weight, a meta-analysis of randomized controlled trials shows.

©KaterynaSednieva/Thinkstock

“To the best of our knowledge, this meta-analysis is the first that generates evidence from randomized controlled trials to assess the association of vegetarian diets with outcomes in people affected by cardiovascular diseases,” report the authors. The study was published online in JAMA Network Open.

“The greatest improvements in hemoglobin A1c and low-density lipoprotein cholesterol (LDL-C) were observed in individuals with type 2 diabetes and people at high risk of cardiovascular disease, highlighting the potential protective and synergistic effects of vegetarian diets for the primary prevention of cardiovascular disease,” they say.

Poor diet is well-established as increasing the morbidity and mortality associated with cardiovascular disease; however, although data has linked vegetarian diets to cardiovascular disease prevention in the general population, research on the effectiveness of such diets in people at high risk of cardiovascular disease is lacking.

“To the best of our knowledge, no meta-analysis of randomized controlled trials has been conducted to investigate the association of vegetarian diets with outcomes among people with CVD – indeed, research here has primarily focused on observational studies,” writes Tian Wang, RD, and colleagues at the University of Sydney.
 

Greater decreases in LDL-C, A1c, and body weight with vegetarian diets

For the meta-analysis, researchers identified 20 randomized controlled trials involving vegetarian diets that included 1,878 adults with or at a high risk of cardiovascular disease and included measurements of LDL-C, A1c, or systolic blood pressure.

The studies were conducted in the United States, Asia, Europe, and New Zealand between 1990 and 2021. Sample sizes ranged from 12 to 291 participants.

The mean range age of participants was 28-64 years. Studies included patients with cardiovascular disease (four studies), diabetes (seven studies), and those with at least two cardiovascular risk factors (nine studies).

The mean duration of the dietary intervention was 25.4 weeks (range 2-24 months). The most commonly prescribed diets were vegan (plant-based foods only), lacto-ovo-vegetarian (excluded meat, poultry, seafood, and dairy products, but allowed eggs), and lacto-vegetarian (same as previous but allowed dairy products).

Overall, those who consumed a vegetarian diet for an average of 6 months, versus comparison diets, had significantly greater decreases in LDL-C (6.6 mg/dL beyond the reduction achieved with standard therapy); A1c (0.24%); and body weight (3.4 kg), but the reduction in systolic blood pressure (0.1 mmHg) was not significantly greater.

Assessment of the overall certainty of evidence evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool showed a moderate level of evidence for reductions in LDL-C and A1c with the vegetarian diet.

Lacto-ovo vegetarian diets were associated with the greatest reduction in LDL-C (14.1 mg/dL); however, four out of the five trials restricted energy intake.

Of note, vegetarian diets were most effective for achieving glycemic control among people with type 2 diabetes and leading to improvements in weight among those at high risk of cardiovascular disease as well as those with type 2 diabetes.

The effects “suggest that vegetarian diets might have a synergistic [or at least nonantagonistic] use in potentiating the effects of optimal drug therapy in the prevention and treatment of a range of cardiometabolic diseases,” the authors write.

Although previous studies have shown similar improvements associated with a vegetarian diet, most studies did not stratify populations based on disease status, type of vegetarian diet, or comparison diet, the authors note.

The lack of improvement in systolic blood pressure is consistent with previous meta-analyses of vegetarian diets in general and suggests that salt intake may be the more important factor for those measures.

“[The meta-analysis] suggests that diet quality plays a major role in lowering blood pressure independent of animal food consumption, as the DASH [Dietary Approaches to Stop Hypertension] ... trial demonstrated,” the authors note.
 

Decreases in medication dose with vegetarian diet

Although most patients were taking medications to manage hypertension, hyperglycemia, and/or dyslipidemia at trial enrollment in as many as eight of the studies, the vegetarian diet intervention resulted in a decrease in medication dose.

In fact, medication use could obscure the favorable effects of vegetarian diets, which could have a larger effect size, the authors speculate.

“This hypothesis is supported by two randomized controlled trials in our meta-analysis that required patients not to take medication that could influence cardiometabolic outcomes, [and] these studies significantly improved systolic blood pressure and LDL-C,” they write.
 

Not all vegetarian diets are healthy

Although there are numerous variations in vegetarian diets, ranging from vegan diets that eliminate all animal food to pesco-vegetarian diets that allow fish or seafood, most that are well-balanced can provide health benefits including lower saturated fat, L-carnitine, and choline (precursors of the atherogenic TMAO), and other benefits that might explain the improvements seen in the meta-analysis.  

The diets may also be high in dietary fiber, mono- and polyunsaturated fatty acids, potassium, magnesium, and phytochemical, and have lower glycemic index scores.

Of note, 12 studies in the meta-analysis emphasized low-fat content, which the authors speculate may have contributed to the improvements observed in LDC-C.

Specifically, lacto-ovo vegetarian diets were associated with the greatest reduction in LDL-C (–14.1 mg/dL); however, four out of five of the trials restricted energy intake, which could have also played a role in improvements.

Importantly, not all vegetarian diets are healthy, and the authors caution about some that allow, for instance, deep-fried foods rich in trans-fatty acids and salt, such as tempura vegetables, potentially increasing the risk of type 2 diabetes and coronary heart disease.

They note that “more than one-third of the studies included in our meta-analysis did not emphasize the importance of consuming minimally processed plant-based whole foods.”

Overall, however, the fact that the greatest improvements in A1c and LDL-C were seen in patients with type 2 diabetes and those at high risk of CVD “highlight[s] the potential protective and synergistic effects of vegetarian diets for the primary prevention of CVD.”

A version of this article first appeared on Medscape.com.