Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.
Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.
Visual_Intermezzo/iStock/Getty Images Plus
“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.
“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.
“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.
“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.
The study was published online in the European Journal of Preventive Cardiology.
Clear cardiovascular benefits
A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.
During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.
Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).
Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.
Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).
Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.
Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).
“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.
Dr. Peter M. Kistler
Plausible mechanisms
There are a number of proposed mechanisms to explain the benefits of coffee on CVD.
“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.
Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.
“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.
“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.
“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
Direction of relationship unclear
Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”
However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.
Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.
“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.
The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.
Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.
Visual_Intermezzo/iStock/Getty Images Plus
“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.
“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.
“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.
“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.
The study was published online in the European Journal of Preventive Cardiology.
Clear cardiovascular benefits
A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.
During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.
Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).
Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.
Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).
Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.
Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).
“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.
Dr. Peter M. Kistler
Plausible mechanisms
There are a number of proposed mechanisms to explain the benefits of coffee on CVD.
“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.
Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.
“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.
“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.
“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
Direction of relationship unclear
Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”
However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.
Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.
“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.
The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.
Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.
Visual_Intermezzo/iStock/Getty Images Plus
“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.
“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.
“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.
“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.
The study was published online in the European Journal of Preventive Cardiology.
Clear cardiovascular benefits
A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.
During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.
Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).
Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.
Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).
Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.
Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).
“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.
Dr. Peter M. Kistler
Plausible mechanisms
There are a number of proposed mechanisms to explain the benefits of coffee on CVD.
“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.
Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.
“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.
“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.
“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
Direction of relationship unclear
Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”
However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.
Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.
“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.
The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Apremilast may have an overall benefit for patients with cardiometabolic disease and psoriasis, new results from a nonrandomized clinical trial suggest.
The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.
It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.
Fat reductions maintained at 1-year mark
The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.
Courtesy Dr. Joel M. Gelfand
Dr. Joel M. Gelfand
As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.
“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”
Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.
Courtesy NYU Langone
Dr. Michael S. Garshick
The trial does help answer the question of whether apremilast can induce weight loss, he said, something that earlier trials suggested. “This trial confirms that, which is exciting,” he said. The reduction in both visceral and subcutaneous fat “deserves a lot further study.”
Several questions remain, Dr. Garshick said. Both he and Dr. Gelfand pointed to the need for large, placebo-controlled trials. “We still don’t know which medications may be preferrable in psoriasis to reduce [cardiovascular] risk if any at all,” Dr. Garshick said.
Seventy patients enrolled
In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.
Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m2. Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).
There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.
“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”
This study highlights the importance of screening, Dr. Garshick said.
He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.
Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.
Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Apremilast may have an overall benefit for patients with cardiometabolic disease and psoriasis, new results from a nonrandomized clinical trial suggest.
The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.
It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.
Fat reductions maintained at 1-year mark
The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.
Courtesy Dr. Joel M. Gelfand
Dr. Joel M. Gelfand
As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.
“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”
Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.
Courtesy NYU Langone
Dr. Michael S. Garshick
The trial does help answer the question of whether apremilast can induce weight loss, he said, something that earlier trials suggested. “This trial confirms that, which is exciting,” he said. The reduction in both visceral and subcutaneous fat “deserves a lot further study.”
Several questions remain, Dr. Garshick said. Both he and Dr. Gelfand pointed to the need for large, placebo-controlled trials. “We still don’t know which medications may be preferrable in psoriasis to reduce [cardiovascular] risk if any at all,” Dr. Garshick said.
Seventy patients enrolled
In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.
Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m2. Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).
There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.
“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”
This study highlights the importance of screening, Dr. Garshick said.
He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.
Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.
Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Apremilast may have an overall benefit for patients with cardiometabolic disease and psoriasis, new results from a nonrandomized clinical trial suggest.
The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.
It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.
Fat reductions maintained at 1-year mark
The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.
Courtesy Dr. Joel M. Gelfand
Dr. Joel M. Gelfand
As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.
“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”
Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.
Courtesy NYU Langone
Dr. Michael S. Garshick
The trial does help answer the question of whether apremilast can induce weight loss, he said, something that earlier trials suggested. “This trial confirms that, which is exciting,” he said. The reduction in both visceral and subcutaneous fat “deserves a lot further study.”
Several questions remain, Dr. Garshick said. Both he and Dr. Gelfand pointed to the need for large, placebo-controlled trials. “We still don’t know which medications may be preferrable in psoriasis to reduce [cardiovascular] risk if any at all,” Dr. Garshick said.
Seventy patients enrolled
In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.
Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m2. Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).
There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.
“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”
This study highlights the importance of screening, Dr. Garshick said.
He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.
Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.
Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.
And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.
Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.
The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologiaand Diabetes Care.
During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”
“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.
Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
Weight management plays a prominent role in treatment
In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”
“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.
He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.
“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”
According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”
“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
Individualization featured throughout
The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.
Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.
The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
Designed to be used and user-friendly
Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.
A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.
Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.
Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.
And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.
Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.
The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologiaand Diabetes Care.
During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”
“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.
Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
Weight management plays a prominent role in treatment
In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”
“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.
He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.
“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”
According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”
“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
Individualization featured throughout
The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.
Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.
The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
Designed to be used and user-friendly
Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.
A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.
Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.
Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.
And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.
Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.
The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologiaand Diabetes Care.
During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”
“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.
Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
Weight management plays a prominent role in treatment
In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”
“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.
He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.
“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”
According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”
“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
Individualization featured throughout
The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.
Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.
The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
Designed to be used and user-friendly
Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.
A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.
Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.
Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.
A version of this article first appeared on Medscape.com.
A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.
In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.
Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.
Dr. Mamas A. Mamas
The fact that these visits rarely led to an inpatient admission (< 3%) or death (< 0.1%) suggests they were “mostly related to the management of hypertension,” lead author Mamas A. Mamas, MD, Keele University, Staffordshire, England, said in a news release.
The study was published online in the Journal of the American Heart Association.
Nationwide sample
The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.
In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.
In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).
In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).
On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.
“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”
He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
Sex differences in outcomes
The study found that outcomes from the emergency CVD visits were slightly different for men and women.
Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.
In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.
Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found.
“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.
The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.
Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.
“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization.
The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.
In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.
Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.
Dr. Mamas A. Mamas
The fact that these visits rarely led to an inpatient admission (< 3%) or death (< 0.1%) suggests they were “mostly related to the management of hypertension,” lead author Mamas A. Mamas, MD, Keele University, Staffordshire, England, said in a news release.
The study was published online in the Journal of the American Heart Association.
Nationwide sample
The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.
In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.
In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).
In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).
On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.
“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”
He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
Sex differences in outcomes
The study found that outcomes from the emergency CVD visits were slightly different for men and women.
Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.
In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.
Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found.
“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.
The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.
Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.
“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization.
The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.
In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.
Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.
Dr. Mamas A. Mamas
The fact that these visits rarely led to an inpatient admission (< 3%) or death (< 0.1%) suggests they were “mostly related to the management of hypertension,” lead author Mamas A. Mamas, MD, Keele University, Staffordshire, England, said in a news release.
The study was published online in the Journal of the American Heart Association.
Nationwide sample
The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.
In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.
In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).
In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).
On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.
“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”
He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
Sex differences in outcomes
The study found that outcomes from the emergency CVD visits were slightly different for men and women.
Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.
In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.
Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found.
“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.
The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.
Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.
“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization.
The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – There’s an intriguing plot twist in the story of SYMPLICITY HTN-3, the sham-controlled clinical trial that nearly put the kibosh on renal denervation (RDN) therapy as a promising approach to treatment-resistant hypertension (HTN).
The trial famously showed no benefit for systolic blood pressure (BP) from the invasive procedure at 6 months and 12 months, dampening enthusiasm for RDN in HTN for both physicians and industry. But it turns out that disappointment in the study may have been premature.
Dr. Deepak L. Bhatt
The procedure led to significant improvements in systolic BP, whether in-office or ambulatory, compared with a sham control procedure, in a new analysis that followed the trial’s patients out to 3 years. Those who underwent RDN also required less intense antihypertensive drug therapy.
“These findings support that durable blood pressure reductions with radiofrequency renal artery denervation, in the presence of lifestyle modification and maximal medical therapy, are safely achievable,” Deepak L. Bhatt, MD, said in a Sept. 18 presentation at the Transcatheter Cardiovascular Therapeutics annual meeting, which was sponsored by the Cardiovascular Research Foundation.
Dr. Bhatt, of Boston’s Brigham and Women’s Hospital and Harvard Medical School, is lead author on the report published in The Lancet simultaneously with his presentation.
Strides in RDN technology and trial design since the neutral primary SYMPLICITY HTN-3 results were reported in 2014 have long since restored faith in the procedure, which is currently in advanced stages of clinical trials and expected to eventually make a mark on practice.
But Roxana Mehran, MD, not connected to SYMPLICITY HTN-3, expressed caution in interpreting the current analysis based on secondary endpoints and extended follow-up time.
And elsewhere at the TCT sessions, observers of the trial as well as Dr. Bhatt urged similar cautions interpreting “positive” secondary results from trials that were “negative” in their primary analyses.
Still, “I believe there is no question that we have now enough evidence to say that renal denervation on top of medications is probably something that we’re going to be seeing in the future,” Dr. Mehran, of the Icahn School of Medicine at Mount Sinai, New York, told this news organization.
Importantly, and a bit controversially, the RDN group in the 36-month SYMPLICITY HTN-3 analysis includes patients originally assigned to the sham control group who crossed over to receive RDN after the trial was unblinded. Their “control” BP responses were thereafter imputed by accepted statistical methodology that Dr. Bhatt characterized as “last observation carried forward.”
That’s another reason to be circumspect about the current results, observed Naomi Fisher, MD, also of Brigham and Women’s and Harvard Medical School, as a panelist following Dr. Bhatt’s formal presentation.
“With all the missing data and imputational calculations,” she said, “I think we have to apply caution in the interpretation.”
She also pointed out that blinding in the trial was lifted at 6 months, allowing patients to learn their treatment assignment, and potentially influencing subsequent changes to medications.
They were prescribed, on average, about five antihypertensive meds, Dr. Fisher noted, and “that’s already a red flag. Patients taking that many medications generally aren’t universally taking them. There’s very high likelihood that there could have been variable adherence.”
Patients who learned they were in the sham control group, for example, could have “fallen off” taking their medications, potentially worsening outcomes and amplifying the apparent benefit of RDN. Such an effect, Dr. Fisher said, “could have contributed” to the study’s long-term results.
As previously reported, the single-blind SYMPLICITY HTN-3 had randomly assigned 535 patients to either RDN or a sham control procedure, 364 and 171 patients respectively, at 88 U.S. centers. The trial used the Symplicity Flex RDN radiofrequency ablation catheter (Medtronic).
For study entry, patients were required to have office systolic BP of at least 160 mm Hg and 24-hour ambulatory systolic BP of at least 135 mm Hg despite stable, maximally tolerated dosages of a diuretic plus at least two other antihypertensive agents.
Blinding was lifted at 6 months, per protocol, after which patients in the sham control group who still met the trial’s BP entry criteria were allowed to cross over and undergo RDN. The 101 controls who crossed over were combined with the original active-therapy cohort for the current analysis.
From baseline to 36 months, mean number of medication classes per patient maintained between 4.5 and 5, with no significant difference between groups at any point.
However, medication burden expressed as number of doses daily held steady between 9.7 to 10.2 for controls while the RDN group showed a steady decline from 10.2 to 8.4. Differences between RDN patients and controls were significant at both 24 months (P = .01) and 36 months (P = .005), Dr. Bhatt reported.
All relative decreases favor the RDN group, P < .0001
The RDN group spent a longer percentage of time with systolic BP at goal compared to those in the sham control group in an analysis that did not involve imputation of data, Dr. Bhatt reported. The proportions of time in therapeutic range were 18% for RDN patients and 9% for controls (P < .0001).
As in the 6- and 12-month analyses, there was no adverse safety signal associated with RDN in follow-up out to both 36 and 48 months. As Dr. Bhatt reported, the rates of the composite safety endpoint in RDN patients, crossovers, and noncrossover controls were 15%, 14%, and 14%, respectively.
The safety endpoint included death, new end-stage renal disease, significant embolic events causing end-organ damage, vascular complications, renal-artery reintervention, and “hypertensive emergency unrelated to nonadherence to medications,” Dr. Bhatt reported.
There are many patients with “out of control” HTN “who cannot remain compliant on their medications,” Dr. Mehran observed for this news organization. “I believe having an adjunct to medical management of these patients,” that is RDN, “is going to be tremendously important.”
SYMPLICITY HTN-3 was funded by Medtronic. Dr. Bhatt has disclosed ties with many companies, as well as WebMD, Medscape Cardiology, and other publications or organizations. Dr. Mehran disclosed ties to Abbott Vascular, AstraZeneca, Bayer, Bristol-Myers Squibb, CSL Behring, Daiichi-Sankyo/Eli Lilly, Medtronic, Novartis, OrbusNeich, Abiomed; Boston Scientific, Alleviant, Amgen, AM-Pharma, Applied Therapeutics, Arena, BAIM, Biosensors, Biotronik, CardiaWave, CellAegis, Concept Medical, CeloNova, CERC, Chiesi, Cytosorbents, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe, Philips, RenalPro, Vivasure, and Zoll; as well as Medscape/WebMD, and Cine-Med Research; and holding equity, stock, or stock options with Control Rad, Applied Therapeutics, and Elixir Medical. Dr. Fisher disclosed ties to Medtronic, Recor Medical, and Aktiia; and receiving grants or hold research contracts with Recor Medical and Aktiia.
A version of this article first appeared on Medscape.com.
BOSTON – There’s an intriguing plot twist in the story of SYMPLICITY HTN-3, the sham-controlled clinical trial that nearly put the kibosh on renal denervation (RDN) therapy as a promising approach to treatment-resistant hypertension (HTN).
The trial famously showed no benefit for systolic blood pressure (BP) from the invasive procedure at 6 months and 12 months, dampening enthusiasm for RDN in HTN for both physicians and industry. But it turns out that disappointment in the study may have been premature.
Dr. Deepak L. Bhatt
The procedure led to significant improvements in systolic BP, whether in-office or ambulatory, compared with a sham control procedure, in a new analysis that followed the trial’s patients out to 3 years. Those who underwent RDN also required less intense antihypertensive drug therapy.
“These findings support that durable blood pressure reductions with radiofrequency renal artery denervation, in the presence of lifestyle modification and maximal medical therapy, are safely achievable,” Deepak L. Bhatt, MD, said in a Sept. 18 presentation at the Transcatheter Cardiovascular Therapeutics annual meeting, which was sponsored by the Cardiovascular Research Foundation.
Dr. Bhatt, of Boston’s Brigham and Women’s Hospital and Harvard Medical School, is lead author on the report published in The Lancet simultaneously with his presentation.
Strides in RDN technology and trial design since the neutral primary SYMPLICITY HTN-3 results were reported in 2014 have long since restored faith in the procedure, which is currently in advanced stages of clinical trials and expected to eventually make a mark on practice.
But Roxana Mehran, MD, not connected to SYMPLICITY HTN-3, expressed caution in interpreting the current analysis based on secondary endpoints and extended follow-up time.
And elsewhere at the TCT sessions, observers of the trial as well as Dr. Bhatt urged similar cautions interpreting “positive” secondary results from trials that were “negative” in their primary analyses.
Still, “I believe there is no question that we have now enough evidence to say that renal denervation on top of medications is probably something that we’re going to be seeing in the future,” Dr. Mehran, of the Icahn School of Medicine at Mount Sinai, New York, told this news organization.
Importantly, and a bit controversially, the RDN group in the 36-month SYMPLICITY HTN-3 analysis includes patients originally assigned to the sham control group who crossed over to receive RDN after the trial was unblinded. Their “control” BP responses were thereafter imputed by accepted statistical methodology that Dr. Bhatt characterized as “last observation carried forward.”
That’s another reason to be circumspect about the current results, observed Naomi Fisher, MD, also of Brigham and Women’s and Harvard Medical School, as a panelist following Dr. Bhatt’s formal presentation.
“With all the missing data and imputational calculations,” she said, “I think we have to apply caution in the interpretation.”
She also pointed out that blinding in the trial was lifted at 6 months, allowing patients to learn their treatment assignment, and potentially influencing subsequent changes to medications.
They were prescribed, on average, about five antihypertensive meds, Dr. Fisher noted, and “that’s already a red flag. Patients taking that many medications generally aren’t universally taking them. There’s very high likelihood that there could have been variable adherence.”
Patients who learned they were in the sham control group, for example, could have “fallen off” taking their medications, potentially worsening outcomes and amplifying the apparent benefit of RDN. Such an effect, Dr. Fisher said, “could have contributed” to the study’s long-term results.
As previously reported, the single-blind SYMPLICITY HTN-3 had randomly assigned 535 patients to either RDN or a sham control procedure, 364 and 171 patients respectively, at 88 U.S. centers. The trial used the Symplicity Flex RDN radiofrequency ablation catheter (Medtronic).
For study entry, patients were required to have office systolic BP of at least 160 mm Hg and 24-hour ambulatory systolic BP of at least 135 mm Hg despite stable, maximally tolerated dosages of a diuretic plus at least two other antihypertensive agents.
Blinding was lifted at 6 months, per protocol, after which patients in the sham control group who still met the trial’s BP entry criteria were allowed to cross over and undergo RDN. The 101 controls who crossed over were combined with the original active-therapy cohort for the current analysis.
From baseline to 36 months, mean number of medication classes per patient maintained between 4.5 and 5, with no significant difference between groups at any point.
However, medication burden expressed as number of doses daily held steady between 9.7 to 10.2 for controls while the RDN group showed a steady decline from 10.2 to 8.4. Differences between RDN patients and controls were significant at both 24 months (P = .01) and 36 months (P = .005), Dr. Bhatt reported.
All relative decreases favor the RDN group, P < .0001
The RDN group spent a longer percentage of time with systolic BP at goal compared to those in the sham control group in an analysis that did not involve imputation of data, Dr. Bhatt reported. The proportions of time in therapeutic range were 18% for RDN patients and 9% for controls (P < .0001).
As in the 6- and 12-month analyses, there was no adverse safety signal associated with RDN in follow-up out to both 36 and 48 months. As Dr. Bhatt reported, the rates of the composite safety endpoint in RDN patients, crossovers, and noncrossover controls were 15%, 14%, and 14%, respectively.
The safety endpoint included death, new end-stage renal disease, significant embolic events causing end-organ damage, vascular complications, renal-artery reintervention, and “hypertensive emergency unrelated to nonadherence to medications,” Dr. Bhatt reported.
There are many patients with “out of control” HTN “who cannot remain compliant on their medications,” Dr. Mehran observed for this news organization. “I believe having an adjunct to medical management of these patients,” that is RDN, “is going to be tremendously important.”
SYMPLICITY HTN-3 was funded by Medtronic. Dr. Bhatt has disclosed ties with many companies, as well as WebMD, Medscape Cardiology, and other publications or organizations. Dr. Mehran disclosed ties to Abbott Vascular, AstraZeneca, Bayer, Bristol-Myers Squibb, CSL Behring, Daiichi-Sankyo/Eli Lilly, Medtronic, Novartis, OrbusNeich, Abiomed; Boston Scientific, Alleviant, Amgen, AM-Pharma, Applied Therapeutics, Arena, BAIM, Biosensors, Biotronik, CardiaWave, CellAegis, Concept Medical, CeloNova, CERC, Chiesi, Cytosorbents, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe, Philips, RenalPro, Vivasure, and Zoll; as well as Medscape/WebMD, and Cine-Med Research; and holding equity, stock, or stock options with Control Rad, Applied Therapeutics, and Elixir Medical. Dr. Fisher disclosed ties to Medtronic, Recor Medical, and Aktiia; and receiving grants or hold research contracts with Recor Medical and Aktiia.
A version of this article first appeared on Medscape.com.
BOSTON – There’s an intriguing plot twist in the story of SYMPLICITY HTN-3, the sham-controlled clinical trial that nearly put the kibosh on renal denervation (RDN) therapy as a promising approach to treatment-resistant hypertension (HTN).
The trial famously showed no benefit for systolic blood pressure (BP) from the invasive procedure at 6 months and 12 months, dampening enthusiasm for RDN in HTN for both physicians and industry. But it turns out that disappointment in the study may have been premature.
Dr. Deepak L. Bhatt
The procedure led to significant improvements in systolic BP, whether in-office or ambulatory, compared with a sham control procedure, in a new analysis that followed the trial’s patients out to 3 years. Those who underwent RDN also required less intense antihypertensive drug therapy.
“These findings support that durable blood pressure reductions with radiofrequency renal artery denervation, in the presence of lifestyle modification and maximal medical therapy, are safely achievable,” Deepak L. Bhatt, MD, said in a Sept. 18 presentation at the Transcatheter Cardiovascular Therapeutics annual meeting, which was sponsored by the Cardiovascular Research Foundation.
Dr. Bhatt, of Boston’s Brigham and Women’s Hospital and Harvard Medical School, is lead author on the report published in The Lancet simultaneously with his presentation.
Strides in RDN technology and trial design since the neutral primary SYMPLICITY HTN-3 results were reported in 2014 have long since restored faith in the procedure, which is currently in advanced stages of clinical trials and expected to eventually make a mark on practice.
But Roxana Mehran, MD, not connected to SYMPLICITY HTN-3, expressed caution in interpreting the current analysis based on secondary endpoints and extended follow-up time.
And elsewhere at the TCT sessions, observers of the trial as well as Dr. Bhatt urged similar cautions interpreting “positive” secondary results from trials that were “negative” in their primary analyses.
Still, “I believe there is no question that we have now enough evidence to say that renal denervation on top of medications is probably something that we’re going to be seeing in the future,” Dr. Mehran, of the Icahn School of Medicine at Mount Sinai, New York, told this news organization.
Importantly, and a bit controversially, the RDN group in the 36-month SYMPLICITY HTN-3 analysis includes patients originally assigned to the sham control group who crossed over to receive RDN after the trial was unblinded. Their “control” BP responses were thereafter imputed by accepted statistical methodology that Dr. Bhatt characterized as “last observation carried forward.”
That’s another reason to be circumspect about the current results, observed Naomi Fisher, MD, also of Brigham and Women’s and Harvard Medical School, as a panelist following Dr. Bhatt’s formal presentation.
“With all the missing data and imputational calculations,” she said, “I think we have to apply caution in the interpretation.”
She also pointed out that blinding in the trial was lifted at 6 months, allowing patients to learn their treatment assignment, and potentially influencing subsequent changes to medications.
They were prescribed, on average, about five antihypertensive meds, Dr. Fisher noted, and “that’s already a red flag. Patients taking that many medications generally aren’t universally taking them. There’s very high likelihood that there could have been variable adherence.”
Patients who learned they were in the sham control group, for example, could have “fallen off” taking their medications, potentially worsening outcomes and amplifying the apparent benefit of RDN. Such an effect, Dr. Fisher said, “could have contributed” to the study’s long-term results.
As previously reported, the single-blind SYMPLICITY HTN-3 had randomly assigned 535 patients to either RDN or a sham control procedure, 364 and 171 patients respectively, at 88 U.S. centers. The trial used the Symplicity Flex RDN radiofrequency ablation catheter (Medtronic).
For study entry, patients were required to have office systolic BP of at least 160 mm Hg and 24-hour ambulatory systolic BP of at least 135 mm Hg despite stable, maximally tolerated dosages of a diuretic plus at least two other antihypertensive agents.
Blinding was lifted at 6 months, per protocol, after which patients in the sham control group who still met the trial’s BP entry criteria were allowed to cross over and undergo RDN. The 101 controls who crossed over were combined with the original active-therapy cohort for the current analysis.
From baseline to 36 months, mean number of medication classes per patient maintained between 4.5 and 5, with no significant difference between groups at any point.
However, medication burden expressed as number of doses daily held steady between 9.7 to 10.2 for controls while the RDN group showed a steady decline from 10.2 to 8.4. Differences between RDN patients and controls were significant at both 24 months (P = .01) and 36 months (P = .005), Dr. Bhatt reported.
All relative decreases favor the RDN group, P < .0001
The RDN group spent a longer percentage of time with systolic BP at goal compared to those in the sham control group in an analysis that did not involve imputation of data, Dr. Bhatt reported. The proportions of time in therapeutic range were 18% for RDN patients and 9% for controls (P < .0001).
As in the 6- and 12-month analyses, there was no adverse safety signal associated with RDN in follow-up out to both 36 and 48 months. As Dr. Bhatt reported, the rates of the composite safety endpoint in RDN patients, crossovers, and noncrossover controls were 15%, 14%, and 14%, respectively.
The safety endpoint included death, new end-stage renal disease, significant embolic events causing end-organ damage, vascular complications, renal-artery reintervention, and “hypertensive emergency unrelated to nonadherence to medications,” Dr. Bhatt reported.
There are many patients with “out of control” HTN “who cannot remain compliant on their medications,” Dr. Mehran observed for this news organization. “I believe having an adjunct to medical management of these patients,” that is RDN, “is going to be tremendously important.”
SYMPLICITY HTN-3 was funded by Medtronic. Dr. Bhatt has disclosed ties with many companies, as well as WebMD, Medscape Cardiology, and other publications or organizations. Dr. Mehran disclosed ties to Abbott Vascular, AstraZeneca, Bayer, Bristol-Myers Squibb, CSL Behring, Daiichi-Sankyo/Eli Lilly, Medtronic, Novartis, OrbusNeich, Abiomed; Boston Scientific, Alleviant, Amgen, AM-Pharma, Applied Therapeutics, Arena, BAIM, Biosensors, Biotronik, CardiaWave, CellAegis, Concept Medical, CeloNova, CERC, Chiesi, Cytosorbents, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe, Philips, RenalPro, Vivasure, and Zoll; as well as Medscape/WebMD, and Cine-Med Research; and holding equity, stock, or stock options with Control Rad, Applied Therapeutics, and Elixir Medical. Dr. Fisher disclosed ties to Medtronic, Recor Medical, and Aktiia; and receiving grants or hold research contracts with Recor Medical and Aktiia.
A version of this article first appeared on Medscape.com.
Among people with HIV (PWH), coinfection with hepatitis C (HCV) is associated with an 85% increase in risk of myocardial infarction (MI) every decade, a new analysis suggests.
By contrast, the risk increases by 30% every 10 years among PWH without HCV infection.
“There is other evidence that suggests people with HIV and HCV have a greater burden of negative health outcomes,” senior author Keri N. Althoff, PhD, MPH, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, said in an interview. “But the magnitude of ‘greater’ was bigger than I expected.”
“Understanding the difference HCV can make in the risk of MI with increasing age among those with – compared to without – HCV is an important step for understanding additional potential benefits of HCV treatment (among PWH),” she said.
The amplified risk with age occurred even though, overall, the association between HCV coinfection and increased risk of type 1 myocardial infarction (T1MI) was not significant, the analysis showed.
The study was published online in the Journal of the American Heart Association.
How age counts
Dr. Althoff and colleagues analyzed data from 23,361 PWH aged 40-79 who had initiated antiretroviral therapy between 2000 and 2017. The primary outcome was T1MI.
A total of 4,677 participants (20%) had HCV. Eighty-nine T1MIs occurred among PWH with HCV (1.9%) vs. 314 among PWH without HCV (1.7%). In adjusted analyses, HCV was not associated with increased T1MI risk (adjusted hazard ratio, 0.98).
However, the risk of T1MI increased with age and was augmented in those with HCV (aHR per 10-year increase in age, 1.85) vs. those without HCV (aHR, 1.30).
Specifically, compared with those without HCV, the estimated T1MI risk was 17% higher among 50- to 59-year-olds with HCV and 77% higher among those 60 and older; neither association was statistically significant, although the authors suggest this probably was because of the smaller number of participants in the older age categories.
Even without HCV, the risk of T1MI increased in participants who had traditional risk factors. The risk was significantly higher among PWH aged 40-49 with diabetes, hypertension, chronic kidney disease, protease inhibitor (PI) use, and smoking, whereas among PWH aged 50-59, the T1MI risk was significantly greater among those with hypertension, PI use, and smoking.
Among those aged 60 or older, hypertension and low CD4 counts were associated with a significantly increased T1MI risk.
“Clinicians providing health care to people with HIV should know their patients’ HCV status,” Dr. Althoff said, “and provide support regarding HCV treatment and ways to reduce their cardiovascular risk, including smoking cessation, reaching and maintaining a healthy BMI, and substance use treatment.”
Truly additive?
American Heart Association expert volunteer Nieca Goldberg, MD, a clinical associate professor of medicine at New York University and medical director of Atria NY, said the increased T1MI risk with coinfection “makes sense” because both HIV and HCV are linked to inflammation.
However, she said in an interview, “the fact that the authors didn’t control for other, more traditional heart attack risk factors is a limitation. I would like to see a study that takes other risk factors into consideration to see if HCV is truly additive.”
Meanwhile, like Dr. Althoff, she said, “Clinicians should be taking a careful history that includes chronic infections as well as traditional heart risk factors.”
Additional studies are needed, Dr. Althoff agreed. “There are two paths we are keenly interested in pursuing. The first is understanding how metabolic risk factors for MI change after HCV treatment. We are working on this.”
“Ultimately,” she said, “we want to compare MI risk in people with HIV who had successful HCV treatment to those who have not had successful HCV treatment.”
In their current study, they had nearly 2 decades of follow-up, she noted. “Although we don’t need to wait that long, we would like to have close to a decade of potential follow-up time (since 2016, when sofosbuvir/velpatasvir became available) so that we have a large enough sample size to observe a sufficient number of MIs within the first 5 years after successful HCV treatment.”
No commercial funding or relevant disclosures were reported.
A version of this article first appeared on Medscape.com.
Among people with HIV (PWH), coinfection with hepatitis C (HCV) is associated with an 85% increase in risk of myocardial infarction (MI) every decade, a new analysis suggests.
By contrast, the risk increases by 30% every 10 years among PWH without HCV infection.
“There is other evidence that suggests people with HIV and HCV have a greater burden of negative health outcomes,” senior author Keri N. Althoff, PhD, MPH, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, said in an interview. “But the magnitude of ‘greater’ was bigger than I expected.”
“Understanding the difference HCV can make in the risk of MI with increasing age among those with – compared to without – HCV is an important step for understanding additional potential benefits of HCV treatment (among PWH),” she said.
The amplified risk with age occurred even though, overall, the association between HCV coinfection and increased risk of type 1 myocardial infarction (T1MI) was not significant, the analysis showed.
The study was published online in the Journal of the American Heart Association.
How age counts
Dr. Althoff and colleagues analyzed data from 23,361 PWH aged 40-79 who had initiated antiretroviral therapy between 2000 and 2017. The primary outcome was T1MI.
A total of 4,677 participants (20%) had HCV. Eighty-nine T1MIs occurred among PWH with HCV (1.9%) vs. 314 among PWH without HCV (1.7%). In adjusted analyses, HCV was not associated with increased T1MI risk (adjusted hazard ratio, 0.98).
However, the risk of T1MI increased with age and was augmented in those with HCV (aHR per 10-year increase in age, 1.85) vs. those without HCV (aHR, 1.30).
Specifically, compared with those without HCV, the estimated T1MI risk was 17% higher among 50- to 59-year-olds with HCV and 77% higher among those 60 and older; neither association was statistically significant, although the authors suggest this probably was because of the smaller number of participants in the older age categories.
Even without HCV, the risk of T1MI increased in participants who had traditional risk factors. The risk was significantly higher among PWH aged 40-49 with diabetes, hypertension, chronic kidney disease, protease inhibitor (PI) use, and smoking, whereas among PWH aged 50-59, the T1MI risk was significantly greater among those with hypertension, PI use, and smoking.
Among those aged 60 or older, hypertension and low CD4 counts were associated with a significantly increased T1MI risk.
“Clinicians providing health care to people with HIV should know their patients’ HCV status,” Dr. Althoff said, “and provide support regarding HCV treatment and ways to reduce their cardiovascular risk, including smoking cessation, reaching and maintaining a healthy BMI, and substance use treatment.”
Truly additive?
American Heart Association expert volunteer Nieca Goldberg, MD, a clinical associate professor of medicine at New York University and medical director of Atria NY, said the increased T1MI risk with coinfection “makes sense” because both HIV and HCV are linked to inflammation.
However, she said in an interview, “the fact that the authors didn’t control for other, more traditional heart attack risk factors is a limitation. I would like to see a study that takes other risk factors into consideration to see if HCV is truly additive.”
Meanwhile, like Dr. Althoff, she said, “Clinicians should be taking a careful history that includes chronic infections as well as traditional heart risk factors.”
Additional studies are needed, Dr. Althoff agreed. “There are two paths we are keenly interested in pursuing. The first is understanding how metabolic risk factors for MI change after HCV treatment. We are working on this.”
“Ultimately,” she said, “we want to compare MI risk in people with HIV who had successful HCV treatment to those who have not had successful HCV treatment.”
In their current study, they had nearly 2 decades of follow-up, she noted. “Although we don’t need to wait that long, we would like to have close to a decade of potential follow-up time (since 2016, when sofosbuvir/velpatasvir became available) so that we have a large enough sample size to observe a sufficient number of MIs within the first 5 years after successful HCV treatment.”
No commercial funding or relevant disclosures were reported.
A version of this article first appeared on Medscape.com.
Among people with HIV (PWH), coinfection with hepatitis C (HCV) is associated with an 85% increase in risk of myocardial infarction (MI) every decade, a new analysis suggests.
By contrast, the risk increases by 30% every 10 years among PWH without HCV infection.
“There is other evidence that suggests people with HIV and HCV have a greater burden of negative health outcomes,” senior author Keri N. Althoff, PhD, MPH, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, said in an interview. “But the magnitude of ‘greater’ was bigger than I expected.”
“Understanding the difference HCV can make in the risk of MI with increasing age among those with – compared to without – HCV is an important step for understanding additional potential benefits of HCV treatment (among PWH),” she said.
The amplified risk with age occurred even though, overall, the association between HCV coinfection and increased risk of type 1 myocardial infarction (T1MI) was not significant, the analysis showed.
The study was published online in the Journal of the American Heart Association.
How age counts
Dr. Althoff and colleagues analyzed data from 23,361 PWH aged 40-79 who had initiated antiretroviral therapy between 2000 and 2017. The primary outcome was T1MI.
A total of 4,677 participants (20%) had HCV. Eighty-nine T1MIs occurred among PWH with HCV (1.9%) vs. 314 among PWH without HCV (1.7%). In adjusted analyses, HCV was not associated with increased T1MI risk (adjusted hazard ratio, 0.98).
However, the risk of T1MI increased with age and was augmented in those with HCV (aHR per 10-year increase in age, 1.85) vs. those without HCV (aHR, 1.30).
Specifically, compared with those without HCV, the estimated T1MI risk was 17% higher among 50- to 59-year-olds with HCV and 77% higher among those 60 and older; neither association was statistically significant, although the authors suggest this probably was because of the smaller number of participants in the older age categories.
Even without HCV, the risk of T1MI increased in participants who had traditional risk factors. The risk was significantly higher among PWH aged 40-49 with diabetes, hypertension, chronic kidney disease, protease inhibitor (PI) use, and smoking, whereas among PWH aged 50-59, the T1MI risk was significantly greater among those with hypertension, PI use, and smoking.
Among those aged 60 or older, hypertension and low CD4 counts were associated with a significantly increased T1MI risk.
“Clinicians providing health care to people with HIV should know their patients’ HCV status,” Dr. Althoff said, “and provide support regarding HCV treatment and ways to reduce their cardiovascular risk, including smoking cessation, reaching and maintaining a healthy BMI, and substance use treatment.”
Truly additive?
American Heart Association expert volunteer Nieca Goldberg, MD, a clinical associate professor of medicine at New York University and medical director of Atria NY, said the increased T1MI risk with coinfection “makes sense” because both HIV and HCV are linked to inflammation.
However, she said in an interview, “the fact that the authors didn’t control for other, more traditional heart attack risk factors is a limitation. I would like to see a study that takes other risk factors into consideration to see if HCV is truly additive.”
Meanwhile, like Dr. Althoff, she said, “Clinicians should be taking a careful history that includes chronic infections as well as traditional heart risk factors.”
Additional studies are needed, Dr. Althoff agreed. “There are two paths we are keenly interested in pursuing. The first is understanding how metabolic risk factors for MI change after HCV treatment. We are working on this.”
“Ultimately,” she said, “we want to compare MI risk in people with HIV who had successful HCV treatment to those who have not had successful HCV treatment.”
In their current study, they had nearly 2 decades of follow-up, she noted. “Although we don’t need to wait that long, we would like to have close to a decade of potential follow-up time (since 2016, when sofosbuvir/velpatasvir became available) so that we have a large enough sample size to observe a sufficient number of MIs within the first 5 years after successful HCV treatment.”
No commercial funding or relevant disclosures were reported.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Among animal protein foods, low-fat dairy consumption may minimize the risk of developing type 2 diabetes while red meat raises that risk, a new analysis finds.
“A plant-based dietary pattern with limited intake of meat, moderate intake of fish, eggs, and full-fat dairy, and habitual consumption of yogurt, milk, or low-fat dairy, might represent the most feasible, sustainable, and successful population strategy to optimize the prevention of type 2 diabetes,” lead author Annalisa Giosuè, MD, of the University of Naples (Italy) Federico II, told this news organization.
baibaz/iStock/Getty Images
She presented the findings from an umbrella review of 13 dose-response meta-analyses of prospective cohort studies at the annual meeting of the European Association for the Study of Diabetes.
The study is believed to be the first comprehensive overview of the available evidence from all published meta-analyses on the relationship between well-defined amounts of animal-origin foods and the risk of type 2 diabetes.
Dr. Giosuè and colleagues focused on animal-based foods because they represent a gap in most guidelines for type 2 diabetes prevention, she explained.
“The existing evidence and dietary recommendations for type 2 diabetes prevention are mainly based on the appropriate consumption of plant foods: high amounts of the fiber-rich ones and low consumption of the refined ones as well as those rich in free sugars. And also on the adequate choice among fat sources – reduction of saturated fat sources like butter and cream and replacement with plant-based poly- and monounsaturated fat sources like nontropical vegetable oils. But not on the most suitable choices among different animal foods for the prevention of type 2 diabetes,” she explained.
The new findings are in line with the Mediterranean diet in that, while plant based, it also limits red-meat consumption, but not all animal-based foods, and has consistently been associated with a reduced risk of type 2 diabetes. Vegetarian diets have also been associated with a reduced risk of type 2 diabetes, but far less evidence is available for that, she said.
Asked for comment, session moderator Matthias Schulze, MD, head of the department of molecular epidemiology at the German Institute of Human Nutrition, Berlin, said: “Decreasing intake of red and processed meat is already a strong recommendation, and these data support that. You have to make choices for and against [certain] foods. So, if you decide to eat less red meat, then the question is what do you eat instead? This study shows that specifically other animal products, like dairy and ... fish or white meat sources ... are healthy among the animal-based foods. But you could also obviously look at plant-based foods as protein sources as well.”
And Dr. Schulze noted that the data suggest another dimension to type 2 diabetes prevention beyond simply focusing on weight loss.
“You can achieve weight loss with very different diets. Diet quality plays an important role. These data support that if you look at diabetes prevention, then you would focus on people with high intakes of specific animal-based foods, besides looking at overweight and obesity. Then you could intervene to reduce this intake, with potential substitutions with other animal foods like fish or white meat, or plant-based sources of proteins.”
Red meat damages, dairy protects
The 13 meta-analyses included 175 summary risk ratios for type 2 diabetes incidence for the consumption of total meat, red meat, white meat, processed meats, fish, total dairy, full-fat dairy, low-fat dairy, milk, cheese, yogurt, or eggs.
Significant increases in the risk of developing type 2 diabetes were found for consumption of 100 g/day of total meat (SRR, 1.20; 20% increase) and red meat (SRR, 1.22, 22% increase) and with 50 g/day of processed meats (SRR, 1.30; 30% increase). A borderline increased risk was also seen for 50 g/day of white meat (SRR, 1.04; 4% increase).
The opposite was found for dairy foods. Inverse associations for type 2 diabetes development were found for an intake of 200 g/day of total dairy (SRR, 0.95; 5% reduction), low-fat dairy (SRR, 0.96; 4% reduction), milk (SRR, 0.90; 10% reduction), and for 100 g/day of yogurt (SRR, 0.94, 6% reduction).
Neutral (nonsignificant) effects were found for 200 g/day of full-fat dairy (SRR, 0.98) and for 30 g/day of cheese (SRR, 0.97). Fish consumption also had a neutral association with type 2 diabetes risk (SRR, 1.04 for 100 g/day) as did one egg per day (SRR, 1.07), but evidence quality was low.
And, Dr. Giosuè noted during her presentation, these relationships could change with alterations in the amounts consumed.
Dr. Schulze commented: “Fish is more clearly related to reduced cardiovascular risk than for preventing type 2 diabetes, where we’ve had mixed results. They might not always be the same.”
What are the mechanisms?
The reasons for these positive and negative associations aren’t entirely clear, but Dr. Giosuè noted that dairy products contain several nutrients, vitamins, and other components, such as calcium and vitamin D, that have potential beneficial effects on glucose metabolism.
In particular, she said, “Whey proteins in milk have a well-known beneficial effect on the regulation of the rise of glucose levels in the blood after meals, and also on the control of appetite and body weight.”
Moreover, probiotics found in yogurt have been linked to protective effects against weight gain and obesity, which “may in part [explain] the beneficial role of yogurt in type 2 diabetes prevention.”
Meat, in contrast, is full of cholesterol, saturated fatty acids, and heme iron, which can promote subclinical inflammation and oxidative stress, which may in turn, affect insulin sensitivity, Dr. Giosuè explained. What’s more, “processed meats also contain nitrates, nitrites, and sodium that can contribute to pancreatic cell damage and vascular dysfunction, thus affecting insulin sensitivity.”
And white meat (poultry) has a lower fat content than red meats such as beef, lamb, and pork, as well as a more favorable fatty acid profile and a lower heme-iron content, she said in an interview.
What about vegan diets? The devil is in the details
Asked about the relative health benefits of diets that completely eliminate animal-based foods, Dr. Giosuè replied: “What is important to keep in mind when hearing about the potential of vegan diets to prevent, or manage, or induce the remission of type 2 diabetes, is that the inclusion in the diet of solely foods of plant origin does not mean ‘automatically’ to eat only foods that are good for diabetes prevention.”
“Just like the exclusion of all foods of animal origin is not equivalent to reduce the risk of type 2 diabetes ... Solid evidence has demonstrated that plant foods which are refined and/or rich in free sugars like white bread, biscuits, and sweetened beverages are as harmful as red and processed meats for diabetes incidence and progression.”
Dr. Giosuè and Dr. Schulze have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Among animal protein foods, low-fat dairy consumption may minimize the risk of developing type 2 diabetes while red meat raises that risk, a new analysis finds.
“A plant-based dietary pattern with limited intake of meat, moderate intake of fish, eggs, and full-fat dairy, and habitual consumption of yogurt, milk, or low-fat dairy, might represent the most feasible, sustainable, and successful population strategy to optimize the prevention of type 2 diabetes,” lead author Annalisa Giosuè, MD, of the University of Naples (Italy) Federico II, told this news organization.
baibaz/iStock/Getty Images
She presented the findings from an umbrella review of 13 dose-response meta-analyses of prospective cohort studies at the annual meeting of the European Association for the Study of Diabetes.
The study is believed to be the first comprehensive overview of the available evidence from all published meta-analyses on the relationship between well-defined amounts of animal-origin foods and the risk of type 2 diabetes.
Dr. Giosuè and colleagues focused on animal-based foods because they represent a gap in most guidelines for type 2 diabetes prevention, she explained.
“The existing evidence and dietary recommendations for type 2 diabetes prevention are mainly based on the appropriate consumption of plant foods: high amounts of the fiber-rich ones and low consumption of the refined ones as well as those rich in free sugars. And also on the adequate choice among fat sources – reduction of saturated fat sources like butter and cream and replacement with plant-based poly- and monounsaturated fat sources like nontropical vegetable oils. But not on the most suitable choices among different animal foods for the prevention of type 2 diabetes,” she explained.
The new findings are in line with the Mediterranean diet in that, while plant based, it also limits red-meat consumption, but not all animal-based foods, and has consistently been associated with a reduced risk of type 2 diabetes. Vegetarian diets have also been associated with a reduced risk of type 2 diabetes, but far less evidence is available for that, she said.
Asked for comment, session moderator Matthias Schulze, MD, head of the department of molecular epidemiology at the German Institute of Human Nutrition, Berlin, said: “Decreasing intake of red and processed meat is already a strong recommendation, and these data support that. You have to make choices for and against [certain] foods. So, if you decide to eat less red meat, then the question is what do you eat instead? This study shows that specifically other animal products, like dairy and ... fish or white meat sources ... are healthy among the animal-based foods. But you could also obviously look at plant-based foods as protein sources as well.”
And Dr. Schulze noted that the data suggest another dimension to type 2 diabetes prevention beyond simply focusing on weight loss.
“You can achieve weight loss with very different diets. Diet quality plays an important role. These data support that if you look at diabetes prevention, then you would focus on people with high intakes of specific animal-based foods, besides looking at overweight and obesity. Then you could intervene to reduce this intake, with potential substitutions with other animal foods like fish or white meat, or plant-based sources of proteins.”
Red meat damages, dairy protects
The 13 meta-analyses included 175 summary risk ratios for type 2 diabetes incidence for the consumption of total meat, red meat, white meat, processed meats, fish, total dairy, full-fat dairy, low-fat dairy, milk, cheese, yogurt, or eggs.
Significant increases in the risk of developing type 2 diabetes were found for consumption of 100 g/day of total meat (SRR, 1.20; 20% increase) and red meat (SRR, 1.22, 22% increase) and with 50 g/day of processed meats (SRR, 1.30; 30% increase). A borderline increased risk was also seen for 50 g/day of white meat (SRR, 1.04; 4% increase).
The opposite was found for dairy foods. Inverse associations for type 2 diabetes development were found for an intake of 200 g/day of total dairy (SRR, 0.95; 5% reduction), low-fat dairy (SRR, 0.96; 4% reduction), milk (SRR, 0.90; 10% reduction), and for 100 g/day of yogurt (SRR, 0.94, 6% reduction).
Neutral (nonsignificant) effects were found for 200 g/day of full-fat dairy (SRR, 0.98) and for 30 g/day of cheese (SRR, 0.97). Fish consumption also had a neutral association with type 2 diabetes risk (SRR, 1.04 for 100 g/day) as did one egg per day (SRR, 1.07), but evidence quality was low.
And, Dr. Giosuè noted during her presentation, these relationships could change with alterations in the amounts consumed.
Dr. Schulze commented: “Fish is more clearly related to reduced cardiovascular risk than for preventing type 2 diabetes, where we’ve had mixed results. They might not always be the same.”
What are the mechanisms?
The reasons for these positive and negative associations aren’t entirely clear, but Dr. Giosuè noted that dairy products contain several nutrients, vitamins, and other components, such as calcium and vitamin D, that have potential beneficial effects on glucose metabolism.
In particular, she said, “Whey proteins in milk have a well-known beneficial effect on the regulation of the rise of glucose levels in the blood after meals, and also on the control of appetite and body weight.”
Moreover, probiotics found in yogurt have been linked to protective effects against weight gain and obesity, which “may in part [explain] the beneficial role of yogurt in type 2 diabetes prevention.”
Meat, in contrast, is full of cholesterol, saturated fatty acids, and heme iron, which can promote subclinical inflammation and oxidative stress, which may in turn, affect insulin sensitivity, Dr. Giosuè explained. What’s more, “processed meats also contain nitrates, nitrites, and sodium that can contribute to pancreatic cell damage and vascular dysfunction, thus affecting insulin sensitivity.”
And white meat (poultry) has a lower fat content than red meats such as beef, lamb, and pork, as well as a more favorable fatty acid profile and a lower heme-iron content, she said in an interview.
What about vegan diets? The devil is in the details
Asked about the relative health benefits of diets that completely eliminate animal-based foods, Dr. Giosuè replied: “What is important to keep in mind when hearing about the potential of vegan diets to prevent, or manage, or induce the remission of type 2 diabetes, is that the inclusion in the diet of solely foods of plant origin does not mean ‘automatically’ to eat only foods that are good for diabetes prevention.”
“Just like the exclusion of all foods of animal origin is not equivalent to reduce the risk of type 2 diabetes ... Solid evidence has demonstrated that plant foods which are refined and/or rich in free sugars like white bread, biscuits, and sweetened beverages are as harmful as red and processed meats for diabetes incidence and progression.”
Dr. Giosuè and Dr. Schulze have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Among animal protein foods, low-fat dairy consumption may minimize the risk of developing type 2 diabetes while red meat raises that risk, a new analysis finds.
“A plant-based dietary pattern with limited intake of meat, moderate intake of fish, eggs, and full-fat dairy, and habitual consumption of yogurt, milk, or low-fat dairy, might represent the most feasible, sustainable, and successful population strategy to optimize the prevention of type 2 diabetes,” lead author Annalisa Giosuè, MD, of the University of Naples (Italy) Federico II, told this news organization.
baibaz/iStock/Getty Images
She presented the findings from an umbrella review of 13 dose-response meta-analyses of prospective cohort studies at the annual meeting of the European Association for the Study of Diabetes.
The study is believed to be the first comprehensive overview of the available evidence from all published meta-analyses on the relationship between well-defined amounts of animal-origin foods and the risk of type 2 diabetes.
Dr. Giosuè and colleagues focused on animal-based foods because they represent a gap in most guidelines for type 2 diabetes prevention, she explained.
“The existing evidence and dietary recommendations for type 2 diabetes prevention are mainly based on the appropriate consumption of plant foods: high amounts of the fiber-rich ones and low consumption of the refined ones as well as those rich in free sugars. And also on the adequate choice among fat sources – reduction of saturated fat sources like butter and cream and replacement with plant-based poly- and monounsaturated fat sources like nontropical vegetable oils. But not on the most suitable choices among different animal foods for the prevention of type 2 diabetes,” she explained.
The new findings are in line with the Mediterranean diet in that, while plant based, it also limits red-meat consumption, but not all animal-based foods, and has consistently been associated with a reduced risk of type 2 diabetes. Vegetarian diets have also been associated with a reduced risk of type 2 diabetes, but far less evidence is available for that, she said.
Asked for comment, session moderator Matthias Schulze, MD, head of the department of molecular epidemiology at the German Institute of Human Nutrition, Berlin, said: “Decreasing intake of red and processed meat is already a strong recommendation, and these data support that. You have to make choices for and against [certain] foods. So, if you decide to eat less red meat, then the question is what do you eat instead? This study shows that specifically other animal products, like dairy and ... fish or white meat sources ... are healthy among the animal-based foods. But you could also obviously look at plant-based foods as protein sources as well.”
And Dr. Schulze noted that the data suggest another dimension to type 2 diabetes prevention beyond simply focusing on weight loss.
“You can achieve weight loss with very different diets. Diet quality plays an important role. These data support that if you look at diabetes prevention, then you would focus on people with high intakes of specific animal-based foods, besides looking at overweight and obesity. Then you could intervene to reduce this intake, with potential substitutions with other animal foods like fish or white meat, or plant-based sources of proteins.”
Red meat damages, dairy protects
The 13 meta-analyses included 175 summary risk ratios for type 2 diabetes incidence for the consumption of total meat, red meat, white meat, processed meats, fish, total dairy, full-fat dairy, low-fat dairy, milk, cheese, yogurt, or eggs.
Significant increases in the risk of developing type 2 diabetes were found for consumption of 100 g/day of total meat (SRR, 1.20; 20% increase) and red meat (SRR, 1.22, 22% increase) and with 50 g/day of processed meats (SRR, 1.30; 30% increase). A borderline increased risk was also seen for 50 g/day of white meat (SRR, 1.04; 4% increase).
The opposite was found for dairy foods. Inverse associations for type 2 diabetes development were found for an intake of 200 g/day of total dairy (SRR, 0.95; 5% reduction), low-fat dairy (SRR, 0.96; 4% reduction), milk (SRR, 0.90; 10% reduction), and for 100 g/day of yogurt (SRR, 0.94, 6% reduction).
Neutral (nonsignificant) effects were found for 200 g/day of full-fat dairy (SRR, 0.98) and for 30 g/day of cheese (SRR, 0.97). Fish consumption also had a neutral association with type 2 diabetes risk (SRR, 1.04 for 100 g/day) as did one egg per day (SRR, 1.07), but evidence quality was low.
And, Dr. Giosuè noted during her presentation, these relationships could change with alterations in the amounts consumed.
Dr. Schulze commented: “Fish is more clearly related to reduced cardiovascular risk than for preventing type 2 diabetes, where we’ve had mixed results. They might not always be the same.”
What are the mechanisms?
The reasons for these positive and negative associations aren’t entirely clear, but Dr. Giosuè noted that dairy products contain several nutrients, vitamins, and other components, such as calcium and vitamin D, that have potential beneficial effects on glucose metabolism.
In particular, she said, “Whey proteins in milk have a well-known beneficial effect on the regulation of the rise of glucose levels in the blood after meals, and also on the control of appetite and body weight.”
Moreover, probiotics found in yogurt have been linked to protective effects against weight gain and obesity, which “may in part [explain] the beneficial role of yogurt in type 2 diabetes prevention.”
Meat, in contrast, is full of cholesterol, saturated fatty acids, and heme iron, which can promote subclinical inflammation and oxidative stress, which may in turn, affect insulin sensitivity, Dr. Giosuè explained. What’s more, “processed meats also contain nitrates, nitrites, and sodium that can contribute to pancreatic cell damage and vascular dysfunction, thus affecting insulin sensitivity.”
And white meat (poultry) has a lower fat content than red meats such as beef, lamb, and pork, as well as a more favorable fatty acid profile and a lower heme-iron content, she said in an interview.
What about vegan diets? The devil is in the details
Asked about the relative health benefits of diets that completely eliminate animal-based foods, Dr. Giosuè replied: “What is important to keep in mind when hearing about the potential of vegan diets to prevent, or manage, or induce the remission of type 2 diabetes, is that the inclusion in the diet of solely foods of plant origin does not mean ‘automatically’ to eat only foods that are good for diabetes prevention.”
“Just like the exclusion of all foods of animal origin is not equivalent to reduce the risk of type 2 diabetes ... Solid evidence has demonstrated that plant foods which are refined and/or rich in free sugars like white bread, biscuits, and sweetened beverages are as harmful as red and processed meats for diabetes incidence and progression.”
Dr. Giosuè and Dr. Schulze have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Higher consumption of whole grains, fish, fiber, and omega-3 polyunsaturated fatty acids reduces deaths from all causes in people with type 2 diabetes, show new data.
Results from the systematic review and meta-analysis were presented at the annual meeting of the European Association for the Study of Diabetes by lead author Janett Barbaresko, PhD, a researcher from the German Diabetes Center in Düsseldorf.
Lisovskaya/iStock/Getty Images Plus
Adding just one serving (around 20 g/day) of whole grains from foods such as brown bread, brown rice, or breakfast cereals was associated with about a 16% reduction in all-cause mortality, and each portion of fish consumed per week was associated with a 5% lower risk of all-cause mortality. In addition, eating 5 g/day of fiber was associated with a 14% reduction in all-cause mortality, and 0.1 g/day of omega-3 polyunsaturated fatty acids with a 13% reduction.
Diet also has role in improving survival in those with type 2 diabetes
Dr. Barbaresko explained that most dietary recommendations for people with type 2 diabetes are not evidence based or are derived from studies of the general population, and that the degree to which different components of diet are associated with all-cause mortality, or indeed the prevention of morbidity and mortality, remains unknown.
By way of example, she noted the American Diabetes Association 2022 guidelines for the prevention and management of diabetes complications advises limited intake of saturated and trans fatty acids, higher intake of polyunsaturated fatty acids, and following the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets.
“Our findings show that dietary factors not only play a role in the prevention of type 2 diabetes, but also seem to be relevant for improving survival in people with diagnosed diabetes,” she said, adding that, “in particular, we found some key aspects of a healthy diet such as higher intakes of whole grains, fiber, fish, and omega-3 polyunsaturated fatty acids may improve survival of individuals with type 2 diabetes.”
She noted that individuals with type 2 diabetes are known to be more prone to circulatory diseases, dementia, cancer, and bone fractures, and that lifestyle modifications, including diet – with or without medications – underpin most management strategies.
“For the first time, we have provided a summary of all published studies on any dietary factor in association to all-cause mortality in individuals with type 2 diabetes,” said Dr. Barbaresko. “Moreover, the certainty of evidence has been evaluated for the first time.”
Matthias Schulze, MD, head of the German Institute of Human Nutrition, Berlin, moderated the session.
The new work “summarizes the available evidence, providing important dietary advice for patients with diabetes, for example, recommending whole grains,” he remarked. “However, the study also points to gaps in knowledge, so for many diet factors, we have either no or few studies, or study quality considered to be low, which calls for more research to fill the gap.”
High versus low intake of various dietary factors
The researchers performed meta-analyses based on published studies of all-cause mortality in individuals with type 2 diabetes aged 18 years and over, as associated with dietary patterns, macronutrients (carbohydrates, protein, fat), micronutrients (vitamins and minerals), secondary plant compounds (for example, polyphenols), and supplements.
Studies were conducted mainly in the United States and Europe with a mean follow-up of 10 years. Low and high intake were compared, and a dose-response relationship between different dietary factors and all-cause mortality was explored to generate summary risk ratios. The researchers also explored how the certainty of evidence was determined.
Decreased mortality from any cause was found for a higher intake of fish (SRR per serving/week, 0.95; over six studies); whole grain (SRR per 20 g/day, 0.84; two studies); fiber (SRR per 5 g/day, 0.86; three studies), and omega-3 polyunsaturated fatty acids (SRR per 0.1 g/day, 0.87; two studies).
A low certainty of evidence was found for an inverse association between all-cause mortality and vegetable consumption (SRR per 100 g/day, 0.88; two studies) and plant protein intake (SRR per 10 g/day, 0.91; three studies).
Eggs were associated with an increased risk of all-cause mortality (SRR per 10 g/day, 1.05; seven studies), as was dietary cholesterol (SRR per 300 mg/day, 1.19; two studies).
Regarding other dietary patterns, including the Mediterranean diet and low-carbohydrate diet, either no association was found and/or the evidence was very uncertain. Likewise, evidence was uncertain for foods including nuts, dairy, meat, sugar and sweets; macronutrients, including carbohydrates; and micronutrients, such as caffeine and vitamin D.
“With the Mediterranean diet, we saw an inverse association [with all-cause mortality] comparing high adherence with low adherence to the Mediterranean diet, but the certainty of evidence was very low, indicating a really uncertain meta-evidence,” remarked Dr. Barbaresko.
She concluded that a greater number of studies is needed to investigate the association of dietary factors with all-cause mortality in type 2 diabetes to strengthen the evidence for several other dietary factors. She also cautioned that meta-analyses are affected by unmeasured and residual confounding.
Dr. Barbaresko and Dr. Schulze reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Higher consumption of whole grains, fish, fiber, and omega-3 polyunsaturated fatty acids reduces deaths from all causes in people with type 2 diabetes, show new data.
Results from the systematic review and meta-analysis were presented at the annual meeting of the European Association for the Study of Diabetes by lead author Janett Barbaresko, PhD, a researcher from the German Diabetes Center in Düsseldorf.
Lisovskaya/iStock/Getty Images Plus
Adding just one serving (around 20 g/day) of whole grains from foods such as brown bread, brown rice, or breakfast cereals was associated with about a 16% reduction in all-cause mortality, and each portion of fish consumed per week was associated with a 5% lower risk of all-cause mortality. In addition, eating 5 g/day of fiber was associated with a 14% reduction in all-cause mortality, and 0.1 g/day of omega-3 polyunsaturated fatty acids with a 13% reduction.
Diet also has role in improving survival in those with type 2 diabetes
Dr. Barbaresko explained that most dietary recommendations for people with type 2 diabetes are not evidence based or are derived from studies of the general population, and that the degree to which different components of diet are associated with all-cause mortality, or indeed the prevention of morbidity and mortality, remains unknown.
By way of example, she noted the American Diabetes Association 2022 guidelines for the prevention and management of diabetes complications advises limited intake of saturated and trans fatty acids, higher intake of polyunsaturated fatty acids, and following the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets.
“Our findings show that dietary factors not only play a role in the prevention of type 2 diabetes, but also seem to be relevant for improving survival in people with diagnosed diabetes,” she said, adding that, “in particular, we found some key aspects of a healthy diet such as higher intakes of whole grains, fiber, fish, and omega-3 polyunsaturated fatty acids may improve survival of individuals with type 2 diabetes.”
She noted that individuals with type 2 diabetes are known to be more prone to circulatory diseases, dementia, cancer, and bone fractures, and that lifestyle modifications, including diet – with or without medications – underpin most management strategies.
“For the first time, we have provided a summary of all published studies on any dietary factor in association to all-cause mortality in individuals with type 2 diabetes,” said Dr. Barbaresko. “Moreover, the certainty of evidence has been evaluated for the first time.”
Matthias Schulze, MD, head of the German Institute of Human Nutrition, Berlin, moderated the session.
The new work “summarizes the available evidence, providing important dietary advice for patients with diabetes, for example, recommending whole grains,” he remarked. “However, the study also points to gaps in knowledge, so for many diet factors, we have either no or few studies, or study quality considered to be low, which calls for more research to fill the gap.”
High versus low intake of various dietary factors
The researchers performed meta-analyses based on published studies of all-cause mortality in individuals with type 2 diabetes aged 18 years and over, as associated with dietary patterns, macronutrients (carbohydrates, protein, fat), micronutrients (vitamins and minerals), secondary plant compounds (for example, polyphenols), and supplements.
Studies were conducted mainly in the United States and Europe with a mean follow-up of 10 years. Low and high intake were compared, and a dose-response relationship between different dietary factors and all-cause mortality was explored to generate summary risk ratios. The researchers also explored how the certainty of evidence was determined.
Decreased mortality from any cause was found for a higher intake of fish (SRR per serving/week, 0.95; over six studies); whole grain (SRR per 20 g/day, 0.84; two studies); fiber (SRR per 5 g/day, 0.86; three studies), and omega-3 polyunsaturated fatty acids (SRR per 0.1 g/day, 0.87; two studies).
A low certainty of evidence was found for an inverse association between all-cause mortality and vegetable consumption (SRR per 100 g/day, 0.88; two studies) and plant protein intake (SRR per 10 g/day, 0.91; three studies).
Eggs were associated with an increased risk of all-cause mortality (SRR per 10 g/day, 1.05; seven studies), as was dietary cholesterol (SRR per 300 mg/day, 1.19; two studies).
Regarding other dietary patterns, including the Mediterranean diet and low-carbohydrate diet, either no association was found and/or the evidence was very uncertain. Likewise, evidence was uncertain for foods including nuts, dairy, meat, sugar and sweets; macronutrients, including carbohydrates; and micronutrients, such as caffeine and vitamin D.
“With the Mediterranean diet, we saw an inverse association [with all-cause mortality] comparing high adherence with low adherence to the Mediterranean diet, but the certainty of evidence was very low, indicating a really uncertain meta-evidence,” remarked Dr. Barbaresko.
She concluded that a greater number of studies is needed to investigate the association of dietary factors with all-cause mortality in type 2 diabetes to strengthen the evidence for several other dietary factors. She also cautioned that meta-analyses are affected by unmeasured and residual confounding.
Dr. Barbaresko and Dr. Schulze reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Higher consumption of whole grains, fish, fiber, and omega-3 polyunsaturated fatty acids reduces deaths from all causes in people with type 2 diabetes, show new data.
Results from the systematic review and meta-analysis were presented at the annual meeting of the European Association for the Study of Diabetes by lead author Janett Barbaresko, PhD, a researcher from the German Diabetes Center in Düsseldorf.
Lisovskaya/iStock/Getty Images Plus
Adding just one serving (around 20 g/day) of whole grains from foods such as brown bread, brown rice, or breakfast cereals was associated with about a 16% reduction in all-cause mortality, and each portion of fish consumed per week was associated with a 5% lower risk of all-cause mortality. In addition, eating 5 g/day of fiber was associated with a 14% reduction in all-cause mortality, and 0.1 g/day of omega-3 polyunsaturated fatty acids with a 13% reduction.
Diet also has role in improving survival in those with type 2 diabetes
Dr. Barbaresko explained that most dietary recommendations for people with type 2 diabetes are not evidence based or are derived from studies of the general population, and that the degree to which different components of diet are associated with all-cause mortality, or indeed the prevention of morbidity and mortality, remains unknown.
By way of example, she noted the American Diabetes Association 2022 guidelines for the prevention and management of diabetes complications advises limited intake of saturated and trans fatty acids, higher intake of polyunsaturated fatty acids, and following the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets.
“Our findings show that dietary factors not only play a role in the prevention of type 2 diabetes, but also seem to be relevant for improving survival in people with diagnosed diabetes,” she said, adding that, “in particular, we found some key aspects of a healthy diet such as higher intakes of whole grains, fiber, fish, and omega-3 polyunsaturated fatty acids may improve survival of individuals with type 2 diabetes.”
She noted that individuals with type 2 diabetes are known to be more prone to circulatory diseases, dementia, cancer, and bone fractures, and that lifestyle modifications, including diet – with or without medications – underpin most management strategies.
“For the first time, we have provided a summary of all published studies on any dietary factor in association to all-cause mortality in individuals with type 2 diabetes,” said Dr. Barbaresko. “Moreover, the certainty of evidence has been evaluated for the first time.”
Matthias Schulze, MD, head of the German Institute of Human Nutrition, Berlin, moderated the session.
The new work “summarizes the available evidence, providing important dietary advice for patients with diabetes, for example, recommending whole grains,” he remarked. “However, the study also points to gaps in knowledge, so for many diet factors, we have either no or few studies, or study quality considered to be low, which calls for more research to fill the gap.”
High versus low intake of various dietary factors
The researchers performed meta-analyses based on published studies of all-cause mortality in individuals with type 2 diabetes aged 18 years and over, as associated with dietary patterns, macronutrients (carbohydrates, protein, fat), micronutrients (vitamins and minerals), secondary plant compounds (for example, polyphenols), and supplements.
Studies were conducted mainly in the United States and Europe with a mean follow-up of 10 years. Low and high intake were compared, and a dose-response relationship between different dietary factors and all-cause mortality was explored to generate summary risk ratios. The researchers also explored how the certainty of evidence was determined.
Decreased mortality from any cause was found for a higher intake of fish (SRR per serving/week, 0.95; over six studies); whole grain (SRR per 20 g/day, 0.84; two studies); fiber (SRR per 5 g/day, 0.86; three studies), and omega-3 polyunsaturated fatty acids (SRR per 0.1 g/day, 0.87; two studies).
A low certainty of evidence was found for an inverse association between all-cause mortality and vegetable consumption (SRR per 100 g/day, 0.88; two studies) and plant protein intake (SRR per 10 g/day, 0.91; three studies).
Eggs were associated with an increased risk of all-cause mortality (SRR per 10 g/day, 1.05; seven studies), as was dietary cholesterol (SRR per 300 mg/day, 1.19; two studies).
Regarding other dietary patterns, including the Mediterranean diet and low-carbohydrate diet, either no association was found and/or the evidence was very uncertain. Likewise, evidence was uncertain for foods including nuts, dairy, meat, sugar and sweets; macronutrients, including carbohydrates; and micronutrients, such as caffeine and vitamin D.
“With the Mediterranean diet, we saw an inverse association [with all-cause mortality] comparing high adherence with low adherence to the Mediterranean diet, but the certainty of evidence was very low, indicating a really uncertain meta-evidence,” remarked Dr. Barbaresko.
She concluded that a greater number of studies is needed to investigate the association of dietary factors with all-cause mortality in type 2 diabetes to strengthen the evidence for several other dietary factors. She also cautioned that meta-analyses are affected by unmeasured and residual confounding.
Dr. Barbaresko and Dr. Schulze reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
When I worked as a scribe prior to starting medical school, it was commonplace for patients to have fasting labs. I always felt terrible for the patients we saw late in the afternoon that had somehow fasted all day. For many other patients, there was the challenge of finding a time when they could return to have fasting labs drawn.
While in medical school, I have seen the transition of my preceptors’ recommendations, where it seems patients can now have nonfasting labs. However, I have still observed instances when patients need to have fasting labs. We can look at an example case to better understand when and why patients do and do not need to fast prior to having their lipids checked.
Kendall Ervin
Case
A 57-year-old woman presents for an annual wellness visit. She has been healthy this past year with no new concerns. Her blood pressure has been well controlled, and she continues on a statin for hyperlipidemia. She is due for annual labs. She ate breakfast this morning. Which of the following do you recommend?
A. Obtain lipids with her other blood work now.
B. Have her return tomorrow to obtain fasting labs.
In this situation, A is the correct answer. The patient is due for routine screening labs and there are no current indications that fasting labs are necessary.
Studies of fasting vs. nonfasting lipids
Sidhu and Naugler performed a cross-sectional analysis comparing lipid values at fasting intervals of 1 hour to 16 hours.1 They found the mean total cholesterol and HDL cholesterol values differed by greater than 2%. For LDL cholesterol, the values differed by less than 10% and triglycerides values differed by less than 20%. With this information, the researchers concluded fasting for routine lipids is generally unnecessary.
Mora and colleagues performed a post hoc prospective follow-up of a randomized control
Dr. Douglas S. Paauw
trial to assess if nonfasting lipid measurements could cause misclassification of cardiovascular risk assessment.2 Based on 8,270 participants, coronary events associated with fasting vs. nonfasting lipid values were similar when adjusted hazard ratios were compared. They also found an agreement of 94.8% when classifying participants into ASCVD risk categories for fasting and nonfasting lipid values. These outcomes led them to support the use of nonfasting lipid labs for routine cardiovascular risk assessment.
Rahman and colleagues performed a systematic review and found the use of nonfasting lipid values can reliably determine statin management in most situations.3 Circumstances where fasting labs should be used are if patients have a genetic dyslipidemia, if patients have severe hypertriglyceridemia (greater than 500 mg/dL), and if patients have pancreatitis. Triglyceride values fluctuate the most between the fasting and nonfasting state as seen above from Sidhu and Naugler. This could impact triglyceride disorder management and the accuracy of LDL cholesterol estimation (calculated by the Friedewald equation: LDL cholesterol = total cholesterol – HDL cholesterol – triglycerides/5 in mg/dL).3
Benefits of nonfasting lipid labs
There are many benefits of nonfasting labs. For the patients, they do not have to come to their appointments hungry, we can reduce the risk of hypoglycemia for those with diabetes, and they do not have to come back at a later date if they ate something earlier in the day.
For the lab, we can improve efficiency and decrease early morning congestion when patients typically come in for fasting labs.
Lastly, for the provider, nonfasting labs can improve workflow and help decrease the number of patients lost to follow-up who were unable to complete fasting labs the same day as their appointment.
Summary
Patients do not need to fast prior to having lipid levels drawn for routine screening. Fasting labs should be considered for patients who have a genetic dyslipidemia or if there is concern for hypertriglyceridemia.
Per the ACC/AHA guidelines, nonfasting lipids can be used to assess ASCVD risk and to establish a baseline LDL cholesterol in adults 20 years and older. If a patient has nonfasting triglycerides greater than 400 mg/dL, repeat fasting lipids should be drawn to assess fasting triglycerides and to establish a baseline LDL cholesterol.4
Ms. Ervin is a fourth-year medical student at the University of Washington, Seattle. She has no conflicts to disclose. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, and he serves as third-year medical student clerkship director at the university. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
When I worked as a scribe prior to starting medical school, it was commonplace for patients to have fasting labs. I always felt terrible for the patients we saw late in the afternoon that had somehow fasted all day. For many other patients, there was the challenge of finding a time when they could return to have fasting labs drawn.
While in medical school, I have seen the transition of my preceptors’ recommendations, where it seems patients can now have nonfasting labs. However, I have still observed instances when patients need to have fasting labs. We can look at an example case to better understand when and why patients do and do not need to fast prior to having their lipids checked.
Kendall Ervin
Case
A 57-year-old woman presents for an annual wellness visit. She has been healthy this past year with no new concerns. Her blood pressure has been well controlled, and she continues on a statin for hyperlipidemia. She is due for annual labs. She ate breakfast this morning. Which of the following do you recommend?
A. Obtain lipids with her other blood work now.
B. Have her return tomorrow to obtain fasting labs.
In this situation, A is the correct answer. The patient is due for routine screening labs and there are no current indications that fasting labs are necessary.
Studies of fasting vs. nonfasting lipids
Sidhu and Naugler performed a cross-sectional analysis comparing lipid values at fasting intervals of 1 hour to 16 hours.1 They found the mean total cholesterol and HDL cholesterol values differed by greater than 2%. For LDL cholesterol, the values differed by less than 10% and triglycerides values differed by less than 20%. With this information, the researchers concluded fasting for routine lipids is generally unnecessary.
Mora and colleagues performed a post hoc prospective follow-up of a randomized control
Dr. Douglas S. Paauw
trial to assess if nonfasting lipid measurements could cause misclassification of cardiovascular risk assessment.2 Based on 8,270 participants, coronary events associated with fasting vs. nonfasting lipid values were similar when adjusted hazard ratios were compared. They also found an agreement of 94.8% when classifying participants into ASCVD risk categories for fasting and nonfasting lipid values. These outcomes led them to support the use of nonfasting lipid labs for routine cardiovascular risk assessment.
Rahman and colleagues performed a systematic review and found the use of nonfasting lipid values can reliably determine statin management in most situations.3 Circumstances where fasting labs should be used are if patients have a genetic dyslipidemia, if patients have severe hypertriglyceridemia (greater than 500 mg/dL), and if patients have pancreatitis. Triglyceride values fluctuate the most between the fasting and nonfasting state as seen above from Sidhu and Naugler. This could impact triglyceride disorder management and the accuracy of LDL cholesterol estimation (calculated by the Friedewald equation: LDL cholesterol = total cholesterol – HDL cholesterol – triglycerides/5 in mg/dL).3
Benefits of nonfasting lipid labs
There are many benefits of nonfasting labs. For the patients, they do not have to come to their appointments hungry, we can reduce the risk of hypoglycemia for those with diabetes, and they do not have to come back at a later date if they ate something earlier in the day.
For the lab, we can improve efficiency and decrease early morning congestion when patients typically come in for fasting labs.
Lastly, for the provider, nonfasting labs can improve workflow and help decrease the number of patients lost to follow-up who were unable to complete fasting labs the same day as their appointment.
Summary
Patients do not need to fast prior to having lipid levels drawn for routine screening. Fasting labs should be considered for patients who have a genetic dyslipidemia or if there is concern for hypertriglyceridemia.
Per the ACC/AHA guidelines, nonfasting lipids can be used to assess ASCVD risk and to establish a baseline LDL cholesterol in adults 20 years and older. If a patient has nonfasting triglycerides greater than 400 mg/dL, repeat fasting lipids should be drawn to assess fasting triglycerides and to establish a baseline LDL cholesterol.4
Ms. Ervin is a fourth-year medical student at the University of Washington, Seattle. She has no conflicts to disclose. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, and he serves as third-year medical student clerkship director at the university. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
When I worked as a scribe prior to starting medical school, it was commonplace for patients to have fasting labs. I always felt terrible for the patients we saw late in the afternoon that had somehow fasted all day. For many other patients, there was the challenge of finding a time when they could return to have fasting labs drawn.
While in medical school, I have seen the transition of my preceptors’ recommendations, where it seems patients can now have nonfasting labs. However, I have still observed instances when patients need to have fasting labs. We can look at an example case to better understand when and why patients do and do not need to fast prior to having their lipids checked.
Kendall Ervin
Case
A 57-year-old woman presents for an annual wellness visit. She has been healthy this past year with no new concerns. Her blood pressure has been well controlled, and she continues on a statin for hyperlipidemia. She is due for annual labs. She ate breakfast this morning. Which of the following do you recommend?
A. Obtain lipids with her other blood work now.
B. Have her return tomorrow to obtain fasting labs.
In this situation, A is the correct answer. The patient is due for routine screening labs and there are no current indications that fasting labs are necessary.
Studies of fasting vs. nonfasting lipids
Sidhu and Naugler performed a cross-sectional analysis comparing lipid values at fasting intervals of 1 hour to 16 hours.1 They found the mean total cholesterol and HDL cholesterol values differed by greater than 2%. For LDL cholesterol, the values differed by less than 10% and triglycerides values differed by less than 20%. With this information, the researchers concluded fasting for routine lipids is generally unnecessary.
Mora and colleagues performed a post hoc prospective follow-up of a randomized control
Dr. Douglas S. Paauw
trial to assess if nonfasting lipid measurements could cause misclassification of cardiovascular risk assessment.2 Based on 8,270 participants, coronary events associated with fasting vs. nonfasting lipid values were similar when adjusted hazard ratios were compared. They also found an agreement of 94.8% when classifying participants into ASCVD risk categories for fasting and nonfasting lipid values. These outcomes led them to support the use of nonfasting lipid labs for routine cardiovascular risk assessment.
Rahman and colleagues performed a systematic review and found the use of nonfasting lipid values can reliably determine statin management in most situations.3 Circumstances where fasting labs should be used are if patients have a genetic dyslipidemia, if patients have severe hypertriglyceridemia (greater than 500 mg/dL), and if patients have pancreatitis. Triglyceride values fluctuate the most between the fasting and nonfasting state as seen above from Sidhu and Naugler. This could impact triglyceride disorder management and the accuracy of LDL cholesterol estimation (calculated by the Friedewald equation: LDL cholesterol = total cholesterol – HDL cholesterol – triglycerides/5 in mg/dL).3
Benefits of nonfasting lipid labs
There are many benefits of nonfasting labs. For the patients, they do not have to come to their appointments hungry, we can reduce the risk of hypoglycemia for those with diabetes, and they do not have to come back at a later date if they ate something earlier in the day.
For the lab, we can improve efficiency and decrease early morning congestion when patients typically come in for fasting labs.
Lastly, for the provider, nonfasting labs can improve workflow and help decrease the number of patients lost to follow-up who were unable to complete fasting labs the same day as their appointment.
Summary
Patients do not need to fast prior to having lipid levels drawn for routine screening. Fasting labs should be considered for patients who have a genetic dyslipidemia or if there is concern for hypertriglyceridemia.
Per the ACC/AHA guidelines, nonfasting lipids can be used to assess ASCVD risk and to establish a baseline LDL cholesterol in adults 20 years and older. If a patient has nonfasting triglycerides greater than 400 mg/dL, repeat fasting lipids should be drawn to assess fasting triglycerides and to establish a baseline LDL cholesterol.4
Ms. Ervin is a fourth-year medical student at the University of Washington, Seattle. She has no conflicts to disclose. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, and he serves as third-year medical student clerkship director at the university. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].