New Evidence That Plaque Buildup Shouldn’t Be Ignored

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Thu, 10/10/2024 - 14:32

 

Subclinical disease detected on imaging predicts death, report investigators who show that plaque burden found on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

The work not only highlights the importance of early detection, but it also has clinical implications, said Valentin Fuster, MD, president of the Mount Sinai Fuster Heart Hospital in New York. “It’s going to change things,” he said. “What I believe is going to happen is that we will begin to evaluate people with risk factors at age 30 using imaging. Today, we evaluate people at age 50 using clinical practice guidelines.”

Fuster’s team developed 3D vascular ultrasound to assess plaque burden and applied it in a prospective cohort study known as BioImage. The researchers assessed 6102 patients in Chicago, Illinois, and Fort Lauderdale, Florida, using 3D vascular ultrasound of the carotid artery and another well-established modality — coronary artery calcium, determined by CT.

Participants had no cardiovascular symptoms, yet their plaque burden and calcium scores at the beginning of the study were significantly associated with death during the 15 years of follow-up, even after taking risk factors and medication into account. The results are published in the Journal of the American College of Cardiology.

“Now, there is no question that subclinical disease on imaging predicts mortality,” said Fuster.

David J. Maron, MD, a preventive cardiologist at the Stanford University School of Medicine in California, calls the finding “very important.”

“The presence of atherosclerosis is powerful knowledge to guide the intensity of therapy and to motivate patients and clinicians to treat it,” said Maron, who is the co-author of an accompanying editorial and was not involved in the study.
 

Predicting Risk Early

The research also showed that the risk for death increases if the burden of plaque in the carotid artery increases over time. Both plaque burden shown on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

Maron says recent studies of younger populations, such as Progression of Early Subclinical Atherosclerosis (PESA) and Coronary Artery Risk Development in Young Adults (CARDIA), show that “risk factors at a young age have much more impact on arterial disease than when we measure risk factors at older age.” The CARDIA study showed signs of atherosclerosis in patients as young as in their twenties. This paradigm shift to early detection will now be possible thanks to technological advances like 3D vascular ultrasound.

Maron said he agrees with screening earlier in life. “The risk of having an event is related to the plaque burden and the number of years that a patient has been exposed to that burden. The earlier in life we can identify the burden to slow, arrest, or even reverse the plaque, the better.”

Maron points out that the study looked at an older population and did not include information on cause of death. While a study of younger people and data on cardiac causes of death would be useful, he says the study’s conclusions remain significant.
 

3D Vascular Ultrasound vs Coronary Artery Calcium

While both imaging methods in the study predicted death better than cardiovascular risk factors alone, each option has advantages.

For coronary artery calcium, “there’s a huge amount of literature demonstrating the association with cardiovascular events, there’s a standardized scoring system, there are widespread facilities for computed tomography, and there is not a lot of variability in the measurement — it’s not dependent on the operator,” said Maron.

But there is one drawback. The scoring system –— the Agatston score — can paradoxically go up following aggressive lowering of low-density lipoprotein cholesterol. “Once coronary calcium is present, it is challenging to interpret a repeat scan because we don’t know if the increase in score is due to progression or increasing density of the calcium, which is a sign of healing,” said Maron.

Vascular ultrasound avoids this problem and can also identify early noncalcified plaques and monitor their progression before they would appear on CT. Furthermore, the imaging does not add to lifetime radiation dose, as CT does, Fuster said.

3D ultrasound technology will soon be available in an inexpensive, automated, and easy-to-use format, he explains. Fuster envisions a scenario in which a nurse in a low-income country, using a cell phone app, will be able to assess atherosclerosis in a patient’s femoral artery. “In less than 1 hour, we can predict disease much more rigorously than with risk factors alone,” he said. “I think this is very exciting.”
 

Progression Increases Risk

Finding any atherosclerosis means an increased risk for death, but a greater burden or amount of atherosclerosis increases that risk, said Fuster. Progression of atherosclerosis increases risk even further. 

The study looked at changes in atherosclerosis burden on vascular ultrasound in a subset of 732 patients a median of 8.9 years after their first test. Those with progression had a higher risk for death than those with regression or no atherosclerosis. “Progression is much more significant in predicting mortality than atherosclerosis findings alone,” Fuster said.

Maron said this finding points to “two great values from noninvasive imaging of atherosclerosis.” Not only does imaging detect atherosclerosis, but it can also characterize the burden and any calcification. Further, it allows doctors to monitor the response to interventions such as lifestyle changes and medical therapy. “Serial imaging of plaque burden will really enhance the management of atherosclerosis,” said Maron. “If we discover that someone is progressing rapidly, we can intensify therapy.”

He says imaging results also provide needed motivation for both clinicians and patients to take action that would prevent the deaths that result from atherosclerosis.
 

A version of this article appeared on Medscape.com.

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Subclinical disease detected on imaging predicts death, report investigators who show that plaque burden found on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

The work not only highlights the importance of early detection, but it also has clinical implications, said Valentin Fuster, MD, president of the Mount Sinai Fuster Heart Hospital in New York. “It’s going to change things,” he said. “What I believe is going to happen is that we will begin to evaluate people with risk factors at age 30 using imaging. Today, we evaluate people at age 50 using clinical practice guidelines.”

Fuster’s team developed 3D vascular ultrasound to assess plaque burden and applied it in a prospective cohort study known as BioImage. The researchers assessed 6102 patients in Chicago, Illinois, and Fort Lauderdale, Florida, using 3D vascular ultrasound of the carotid artery and another well-established modality — coronary artery calcium, determined by CT.

Participants had no cardiovascular symptoms, yet their plaque burden and calcium scores at the beginning of the study were significantly associated with death during the 15 years of follow-up, even after taking risk factors and medication into account. The results are published in the Journal of the American College of Cardiology.

“Now, there is no question that subclinical disease on imaging predicts mortality,” said Fuster.

David J. Maron, MD, a preventive cardiologist at the Stanford University School of Medicine in California, calls the finding “very important.”

“The presence of atherosclerosis is powerful knowledge to guide the intensity of therapy and to motivate patients and clinicians to treat it,” said Maron, who is the co-author of an accompanying editorial and was not involved in the study.
 

Predicting Risk Early

The research also showed that the risk for death increases if the burden of plaque in the carotid artery increases over time. Both plaque burden shown on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

Maron says recent studies of younger populations, such as Progression of Early Subclinical Atherosclerosis (PESA) and Coronary Artery Risk Development in Young Adults (CARDIA), show that “risk factors at a young age have much more impact on arterial disease than when we measure risk factors at older age.” The CARDIA study showed signs of atherosclerosis in patients as young as in their twenties. This paradigm shift to early detection will now be possible thanks to technological advances like 3D vascular ultrasound.

Maron said he agrees with screening earlier in life. “The risk of having an event is related to the plaque burden and the number of years that a patient has been exposed to that burden. The earlier in life we can identify the burden to slow, arrest, or even reverse the plaque, the better.”

Maron points out that the study looked at an older population and did not include information on cause of death. While a study of younger people and data on cardiac causes of death would be useful, he says the study’s conclusions remain significant.
 

3D Vascular Ultrasound vs Coronary Artery Calcium

While both imaging methods in the study predicted death better than cardiovascular risk factors alone, each option has advantages.

For coronary artery calcium, “there’s a huge amount of literature demonstrating the association with cardiovascular events, there’s a standardized scoring system, there are widespread facilities for computed tomography, and there is not a lot of variability in the measurement — it’s not dependent on the operator,” said Maron.

But there is one drawback. The scoring system –— the Agatston score — can paradoxically go up following aggressive lowering of low-density lipoprotein cholesterol. “Once coronary calcium is present, it is challenging to interpret a repeat scan because we don’t know if the increase in score is due to progression or increasing density of the calcium, which is a sign of healing,” said Maron.

Vascular ultrasound avoids this problem and can also identify early noncalcified plaques and monitor their progression before they would appear on CT. Furthermore, the imaging does not add to lifetime radiation dose, as CT does, Fuster said.

3D ultrasound technology will soon be available in an inexpensive, automated, and easy-to-use format, he explains. Fuster envisions a scenario in which a nurse in a low-income country, using a cell phone app, will be able to assess atherosclerosis in a patient’s femoral artery. “In less than 1 hour, we can predict disease much more rigorously than with risk factors alone,” he said. “I think this is very exciting.”
 

Progression Increases Risk

Finding any atherosclerosis means an increased risk for death, but a greater burden or amount of atherosclerosis increases that risk, said Fuster. Progression of atherosclerosis increases risk even further. 

The study looked at changes in atherosclerosis burden on vascular ultrasound in a subset of 732 patients a median of 8.9 years after their first test. Those with progression had a higher risk for death than those with regression or no atherosclerosis. “Progression is much more significant in predicting mortality than atherosclerosis findings alone,” Fuster said.

Maron said this finding points to “two great values from noninvasive imaging of atherosclerosis.” Not only does imaging detect atherosclerosis, but it can also characterize the burden and any calcification. Further, it allows doctors to monitor the response to interventions such as lifestyle changes and medical therapy. “Serial imaging of plaque burden will really enhance the management of atherosclerosis,” said Maron. “If we discover that someone is progressing rapidly, we can intensify therapy.”

He says imaging results also provide needed motivation for both clinicians and patients to take action that would prevent the deaths that result from atherosclerosis.
 

A version of this article appeared on Medscape.com.

 

Subclinical disease detected on imaging predicts death, report investigators who show that plaque burden found on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

The work not only highlights the importance of early detection, but it also has clinical implications, said Valentin Fuster, MD, president of the Mount Sinai Fuster Heart Hospital in New York. “It’s going to change things,” he said. “What I believe is going to happen is that we will begin to evaluate people with risk factors at age 30 using imaging. Today, we evaluate people at age 50 using clinical practice guidelines.”

Fuster’s team developed 3D vascular ultrasound to assess plaque burden and applied it in a prospective cohort study known as BioImage. The researchers assessed 6102 patients in Chicago, Illinois, and Fort Lauderdale, Florida, using 3D vascular ultrasound of the carotid artery and another well-established modality — coronary artery calcium, determined by CT.

Participants had no cardiovascular symptoms, yet their plaque burden and calcium scores at the beginning of the study were significantly associated with death during the 15 years of follow-up, even after taking risk factors and medication into account. The results are published in the Journal of the American College of Cardiology.

“Now, there is no question that subclinical disease on imaging predicts mortality,” said Fuster.

David J. Maron, MD, a preventive cardiologist at the Stanford University School of Medicine in California, calls the finding “very important.”

“The presence of atherosclerosis is powerful knowledge to guide the intensity of therapy and to motivate patients and clinicians to treat it,” said Maron, who is the co-author of an accompanying editorial and was not involved in the study.
 

Predicting Risk Early

The research also showed that the risk for death increases if the burden of plaque in the carotid artery increases over time. Both plaque burden shown on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

Maron says recent studies of younger populations, such as Progression of Early Subclinical Atherosclerosis (PESA) and Coronary Artery Risk Development in Young Adults (CARDIA), show that “risk factors at a young age have much more impact on arterial disease than when we measure risk factors at older age.” The CARDIA study showed signs of atherosclerosis in patients as young as in their twenties. This paradigm shift to early detection will now be possible thanks to technological advances like 3D vascular ultrasound.

Maron said he agrees with screening earlier in life. “The risk of having an event is related to the plaque burden and the number of years that a patient has been exposed to that burden. The earlier in life we can identify the burden to slow, arrest, or even reverse the plaque, the better.”

Maron points out that the study looked at an older population and did not include information on cause of death. While a study of younger people and data on cardiac causes of death would be useful, he says the study’s conclusions remain significant.
 

3D Vascular Ultrasound vs Coronary Artery Calcium

While both imaging methods in the study predicted death better than cardiovascular risk factors alone, each option has advantages.

For coronary artery calcium, “there’s a huge amount of literature demonstrating the association with cardiovascular events, there’s a standardized scoring system, there are widespread facilities for computed tomography, and there is not a lot of variability in the measurement — it’s not dependent on the operator,” said Maron.

But there is one drawback. The scoring system –— the Agatston score — can paradoxically go up following aggressive lowering of low-density lipoprotein cholesterol. “Once coronary calcium is present, it is challenging to interpret a repeat scan because we don’t know if the increase in score is due to progression or increasing density of the calcium, which is a sign of healing,” said Maron.

Vascular ultrasound avoids this problem and can also identify early noncalcified plaques and monitor their progression before they would appear on CT. Furthermore, the imaging does not add to lifetime radiation dose, as CT does, Fuster said.

3D ultrasound technology will soon be available in an inexpensive, automated, and easy-to-use format, he explains. Fuster envisions a scenario in which a nurse in a low-income country, using a cell phone app, will be able to assess atherosclerosis in a patient’s femoral artery. “In less than 1 hour, we can predict disease much more rigorously than with risk factors alone,” he said. “I think this is very exciting.”
 

Progression Increases Risk

Finding any atherosclerosis means an increased risk for death, but a greater burden or amount of atherosclerosis increases that risk, said Fuster. Progression of atherosclerosis increases risk even further. 

The study looked at changes in atherosclerosis burden on vascular ultrasound in a subset of 732 patients a median of 8.9 years after their first test. Those with progression had a higher risk for death than those with regression or no atherosclerosis. “Progression is much more significant in predicting mortality than atherosclerosis findings alone,” Fuster said.

Maron said this finding points to “two great values from noninvasive imaging of atherosclerosis.” Not only does imaging detect atherosclerosis, but it can also characterize the burden and any calcification. Further, it allows doctors to monitor the response to interventions such as lifestyle changes and medical therapy. “Serial imaging of plaque burden will really enhance the management of atherosclerosis,” said Maron. “If we discover that someone is progressing rapidly, we can intensify therapy.”

He says imaging results also provide needed motivation for both clinicians and patients to take action that would prevent the deaths that result from atherosclerosis.
 

A version of this article appeared on Medscape.com.

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Trend Toward Higher Mortality in Patients With CF and CVD

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Wed, 10/09/2024 - 15:33

— With the remarkable advances made in therapy over the past decade, many patients with cystic fibrosis (CF) can expect to survive into their 50s and even well beyond. But as patients with CF live longer, they are increasingly likely to develop complications such as cardiovascular diseases (CVDs) that beset many older adults. And as evidence from a new study suggests, there is an increasing need for cardiovascular screening and specialized cardiac care for these patients.

Among more than 83,000 patients with CF hospitalized for any reason from 2016 through 2021, less than 1% of patients had a cardiac cause listed, but in unadjusted analyses, these patients had a more than twofold risk for in-hospital death than those with CF hospitalized for other causes, reported Adnan Bhat, MD, assistant professor of hospital medicine at the University of Florida, Gainesville.

Although the excess mortality was no longer statistically significant in analyses adjusted for potential confounding factors, the data highlight a trend that requires further exploration, he said during an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

“There’s a trend for people with cystic fibrosis admitted for cardiac causes to have a higher in-hospital mortality and increased rate of discharge to nursing facilities, especially for patients admitted for heart failure. The clinical implication is that there is an increased need to start screening for cardiovascular risk factors,” he said.
 

National Database Sample

Bhat and colleagues conducted a retrospective study using the National Inpatient Sample database to identify all hospitalizations among patients with CF in the United States from 2016 through 2021.

They included all hospitalizations with a principal diagnosis code for atrial fibrillation, heart failure, or myocardial infarction.

Of 83,250 total hospitalizations during the study period, 415 (0.5%) were for primary cardiac causes. These included 170 hospitalizations for atrial fibrillation, 95 for heart failure, and 150 for myocardial infarction.

Patients hospitalized for cardiac causes had a higher mean age (59.5 vs 34.5 years) and more comorbidities than patients hospitalized for other causes. These comorbidities included hyperlipidemia, chronic kidney disease, obesity, and a family history of coronary artery disease.

In all, 5% of patients hospitalized for cardiac cause died in hospital, compared with 2% of patients hospitalized for other reasons (P = .044).

However, in logistic regression analyses adjusting for age, sex, and race, this difference was no longer significant.

Similarly, an unadjusted analysis showed that patients with cardiac disease were twice as likely to be discharged to a nursing facility (8% vs 4%, respectively), but this difference too disappeared in adjusted analyses.

The risk for in-hospital mortality appeared to be highest among those patients with a primary diagnosis of heart failure, who had an 11% rate of in-hospital death, compared with 2% among patients with CF hospitalized for other causes.

The total number of deaths was too small, however, to allow for regression analysis, Bhat said.

Nonetheless, taken together, the data indicate a trend toward increased mortality from cardiovascular causes among older patients with CF, as well as the need for further research into the cardiovascular health of these patients, Bhat concluded.
 

 

 

Better Nutrition, Higher Risk

In an interview, Yuqing A. Gao, MD, from the Santa Monica Pulmonary Sleep Clinic in California, who was not involved in the study, commented that with the advent of elexacaftor/tezacaftor/ivacaftor modulator therapy, patients with CF tend to have increases in body mass index and improved nutritional intake and absorption, which in turn could increase hyperlipidemia and other factors that might in turn contribute to increased CVD risk.

“It’s really an interesting area of research, and there’s hope that this will bring more focus on how to better screen [for CVD risk] because that’s something that’s very much not known at this time,” she said.

Gao was co-moderator for the session where Bhat presented the data. Bhat did not report a study funding source. Bhat and Gao reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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— With the remarkable advances made in therapy over the past decade, many patients with cystic fibrosis (CF) can expect to survive into their 50s and even well beyond. But as patients with CF live longer, they are increasingly likely to develop complications such as cardiovascular diseases (CVDs) that beset many older adults. And as evidence from a new study suggests, there is an increasing need for cardiovascular screening and specialized cardiac care for these patients.

Among more than 83,000 patients with CF hospitalized for any reason from 2016 through 2021, less than 1% of patients had a cardiac cause listed, but in unadjusted analyses, these patients had a more than twofold risk for in-hospital death than those with CF hospitalized for other causes, reported Adnan Bhat, MD, assistant professor of hospital medicine at the University of Florida, Gainesville.

Although the excess mortality was no longer statistically significant in analyses adjusted for potential confounding factors, the data highlight a trend that requires further exploration, he said during an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

“There’s a trend for people with cystic fibrosis admitted for cardiac causes to have a higher in-hospital mortality and increased rate of discharge to nursing facilities, especially for patients admitted for heart failure. The clinical implication is that there is an increased need to start screening for cardiovascular risk factors,” he said.
 

National Database Sample

Bhat and colleagues conducted a retrospective study using the National Inpatient Sample database to identify all hospitalizations among patients with CF in the United States from 2016 through 2021.

They included all hospitalizations with a principal diagnosis code for atrial fibrillation, heart failure, or myocardial infarction.

Of 83,250 total hospitalizations during the study period, 415 (0.5%) were for primary cardiac causes. These included 170 hospitalizations for atrial fibrillation, 95 for heart failure, and 150 for myocardial infarction.

Patients hospitalized for cardiac causes had a higher mean age (59.5 vs 34.5 years) and more comorbidities than patients hospitalized for other causes. These comorbidities included hyperlipidemia, chronic kidney disease, obesity, and a family history of coronary artery disease.

In all, 5% of patients hospitalized for cardiac cause died in hospital, compared with 2% of patients hospitalized for other reasons (P = .044).

However, in logistic regression analyses adjusting for age, sex, and race, this difference was no longer significant.

Similarly, an unadjusted analysis showed that patients with cardiac disease were twice as likely to be discharged to a nursing facility (8% vs 4%, respectively), but this difference too disappeared in adjusted analyses.

The risk for in-hospital mortality appeared to be highest among those patients with a primary diagnosis of heart failure, who had an 11% rate of in-hospital death, compared with 2% among patients with CF hospitalized for other causes.

The total number of deaths was too small, however, to allow for regression analysis, Bhat said.

Nonetheless, taken together, the data indicate a trend toward increased mortality from cardiovascular causes among older patients with CF, as well as the need for further research into the cardiovascular health of these patients, Bhat concluded.
 

 

 

Better Nutrition, Higher Risk

In an interview, Yuqing A. Gao, MD, from the Santa Monica Pulmonary Sleep Clinic in California, who was not involved in the study, commented that with the advent of elexacaftor/tezacaftor/ivacaftor modulator therapy, patients with CF tend to have increases in body mass index and improved nutritional intake and absorption, which in turn could increase hyperlipidemia and other factors that might in turn contribute to increased CVD risk.

“It’s really an interesting area of research, and there’s hope that this will bring more focus on how to better screen [for CVD risk] because that’s something that’s very much not known at this time,” she said.

Gao was co-moderator for the session where Bhat presented the data. Bhat did not report a study funding source. Bhat and Gao reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

— With the remarkable advances made in therapy over the past decade, many patients with cystic fibrosis (CF) can expect to survive into their 50s and even well beyond. But as patients with CF live longer, they are increasingly likely to develop complications such as cardiovascular diseases (CVDs) that beset many older adults. And as evidence from a new study suggests, there is an increasing need for cardiovascular screening and specialized cardiac care for these patients.

Among more than 83,000 patients with CF hospitalized for any reason from 2016 through 2021, less than 1% of patients had a cardiac cause listed, but in unadjusted analyses, these patients had a more than twofold risk for in-hospital death than those with CF hospitalized for other causes, reported Adnan Bhat, MD, assistant professor of hospital medicine at the University of Florida, Gainesville.

Although the excess mortality was no longer statistically significant in analyses adjusted for potential confounding factors, the data highlight a trend that requires further exploration, he said during an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

“There’s a trend for people with cystic fibrosis admitted for cardiac causes to have a higher in-hospital mortality and increased rate of discharge to nursing facilities, especially for patients admitted for heart failure. The clinical implication is that there is an increased need to start screening for cardiovascular risk factors,” he said.
 

National Database Sample

Bhat and colleagues conducted a retrospective study using the National Inpatient Sample database to identify all hospitalizations among patients with CF in the United States from 2016 through 2021.

They included all hospitalizations with a principal diagnosis code for atrial fibrillation, heart failure, or myocardial infarction.

Of 83,250 total hospitalizations during the study period, 415 (0.5%) were for primary cardiac causes. These included 170 hospitalizations for atrial fibrillation, 95 for heart failure, and 150 for myocardial infarction.

Patients hospitalized for cardiac causes had a higher mean age (59.5 vs 34.5 years) and more comorbidities than patients hospitalized for other causes. These comorbidities included hyperlipidemia, chronic kidney disease, obesity, and a family history of coronary artery disease.

In all, 5% of patients hospitalized for cardiac cause died in hospital, compared with 2% of patients hospitalized for other reasons (P = .044).

However, in logistic regression analyses adjusting for age, sex, and race, this difference was no longer significant.

Similarly, an unadjusted analysis showed that patients with cardiac disease were twice as likely to be discharged to a nursing facility (8% vs 4%, respectively), but this difference too disappeared in adjusted analyses.

The risk for in-hospital mortality appeared to be highest among those patients with a primary diagnosis of heart failure, who had an 11% rate of in-hospital death, compared with 2% among patients with CF hospitalized for other causes.

The total number of deaths was too small, however, to allow for regression analysis, Bhat said.

Nonetheless, taken together, the data indicate a trend toward increased mortality from cardiovascular causes among older patients with CF, as well as the need for further research into the cardiovascular health of these patients, Bhat concluded.
 

 

 

Better Nutrition, Higher Risk

In an interview, Yuqing A. Gao, MD, from the Santa Monica Pulmonary Sleep Clinic in California, who was not involved in the study, commented that with the advent of elexacaftor/tezacaftor/ivacaftor modulator therapy, patients with CF tend to have increases in body mass index and improved nutritional intake and absorption, which in turn could increase hyperlipidemia and other factors that might in turn contribute to increased CVD risk.

“It’s really an interesting area of research, and there’s hope that this will bring more focus on how to better screen [for CVD risk] because that’s something that’s very much not known at this time,” she said.

Gao was co-moderator for the session where Bhat presented the data. Bhat did not report a study funding source. Bhat and Gao reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Use of SGLT2 Inhibitors Associated With Better Survival in PAH

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Changed
Wed, 10/09/2024 - 13:28

— The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.

“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. Group one pulmonary hypertension includes not only the inflammatory cascades but also fibrotic and neurovascularization, and all these different parts of the pathophysiology are linked to each other. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).

At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).

The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.

Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.

Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.

Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.

The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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— The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.

“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. Group one pulmonary hypertension includes not only the inflammatory cascades but also fibrotic and neurovascularization, and all these different parts of the pathophysiology are linked to each other. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).

At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).

The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.

Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.

Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.

Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.

The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

— The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.

“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. Group one pulmonary hypertension includes not only the inflammatory cascades but also fibrotic and neurovascularization, and all these different parts of the pathophysiology are linked to each other. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).

At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).

The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.

Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.

Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.

Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.

The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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Poor Arm Position May Significantly Skew BP Readings

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Changed
Wed, 10/09/2024 - 11:31

Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.

Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million  adults in the United States and more than 1 billion people globally.

This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.
 

Substantial Overestimation

In the crossover, randomized trial of 133 adults, Hairong Liu, MHS, with the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues found that supporting the arm on the lap overestimated systolic BP (SBP) by 3.9 mmHg and diastolic BP (DBP) by 4.0 mm Hg. When the arm hung at the side, readings overestimated SBP by 6.5 mm Hg and DBP by 4.4 mm Hg, with consistent results across subgroups.

Participants were randomly assigned to get a series of BP measurements with the arm positioned in three ways: Supported on a desk; hand supported on lap; and arm unsupported at the side. Because BP readings are intrinsically variable, all had a fourth set of BP measurements with the arm supported on a desk. 

Participants’ mean age was 57 years; 48 participants (36%) had SBP of ≥ 130 mm Hg; and 55 participants (41%) had a body mass index of ≥ 30.

Two researcher team staff members conducted all the measurements. They received standardized training and completed a certification test in BP measurement, administered by a study author. Measurements were taken from 9 am to 6 pm using a validated oscillometric BP device (ProBP 2000 Digital Blood Pressure Device, Welch Allyn). Only the right arms were used unless a specific condition was present, such as an open sore.
 

Study’s Design Sets It Apart

The authors wrote that the design of the study set this work apart. “Earlier studies have shown that unsupported or arm positioning below heart level can overestimate SBP by 4-23 mm Hg and DBP by 3-12 mm Hg.” But the strength of this study is the randomized, crossover design, “which is in contrast to the majority of published studies where the order of arm positions before seated BP measurement was not randomized or not clearly described.”

Dr. DiPette, who says, “I’ve given my career to understanding hypertension,” praised the design as well.

Randomization of which position patients were assigned to first was important because the first reading is often higher than subsequent readings, Dr. DiPette said.

“That makes sense as the person acclimatizes to the environment,” he explained. BP can even vary within the same reading, he noted.
 

 

 

Incorrect Readings for Many Reasons

Incorrect measures are common given the number of settings and number of providers and patients taking blood pressure even with training, certification in the method, and educational materials.

“We recommend taking a blood pressure in any possible setting you can. Because it’s that critical,” he said. “Most of the time it’s taken in busy primary care settings. The pressures are there. Most times it’s only one reading. It’s the medical environment of today.”

He noted that although this study finds overestimation, different arm positions not recommended by guidelines could potentially result in underestimation of hypertension. 

“I liken the BP measurement to a laboratory test that has clear treatment implications. We would want the BP measurement to have the same rigorous accuracy as a blood test or radiologic machine,” he said. 

Dr. DiPette said more education is needed for patients as well as providers as patients may be monitoring their own BP at home. Patients should also know they can ask for a measurement to be repeated, know the correct arm position recommended by guidelines, and the implications of incorrect readings, he said.

This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation. 

Ms. Liu reported grants from Resolve to Save Lives outside the submitted work. One coauthor reported grants from the National Institutes of Health and personal fees from Kowa, RhythmX AI, and Fukuda Denshi outside the submitted work. Dr. DiPette declared no relevant financial relationships. He was part of a leadership team that developed World Health Organization guidelines on hypertension.

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

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Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.

Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million  adults in the United States and more than 1 billion people globally.

This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.
 

Substantial Overestimation

In the crossover, randomized trial of 133 adults, Hairong Liu, MHS, with the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues found that supporting the arm on the lap overestimated systolic BP (SBP) by 3.9 mmHg and diastolic BP (DBP) by 4.0 mm Hg. When the arm hung at the side, readings overestimated SBP by 6.5 mm Hg and DBP by 4.4 mm Hg, with consistent results across subgroups.

Participants were randomly assigned to get a series of BP measurements with the arm positioned in three ways: Supported on a desk; hand supported on lap; and arm unsupported at the side. Because BP readings are intrinsically variable, all had a fourth set of BP measurements with the arm supported on a desk. 

Participants’ mean age was 57 years; 48 participants (36%) had SBP of ≥ 130 mm Hg; and 55 participants (41%) had a body mass index of ≥ 30.

Two researcher team staff members conducted all the measurements. They received standardized training and completed a certification test in BP measurement, administered by a study author. Measurements were taken from 9 am to 6 pm using a validated oscillometric BP device (ProBP 2000 Digital Blood Pressure Device, Welch Allyn). Only the right arms were used unless a specific condition was present, such as an open sore.
 

Study’s Design Sets It Apart

The authors wrote that the design of the study set this work apart. “Earlier studies have shown that unsupported or arm positioning below heart level can overestimate SBP by 4-23 mm Hg and DBP by 3-12 mm Hg.” But the strength of this study is the randomized, crossover design, “which is in contrast to the majority of published studies where the order of arm positions before seated BP measurement was not randomized or not clearly described.”

Dr. DiPette, who says, “I’ve given my career to understanding hypertension,” praised the design as well.

Randomization of which position patients were assigned to first was important because the first reading is often higher than subsequent readings, Dr. DiPette said.

“That makes sense as the person acclimatizes to the environment,” he explained. BP can even vary within the same reading, he noted.
 

 

 

Incorrect Readings for Many Reasons

Incorrect measures are common given the number of settings and number of providers and patients taking blood pressure even with training, certification in the method, and educational materials.

“We recommend taking a blood pressure in any possible setting you can. Because it’s that critical,” he said. “Most of the time it’s taken in busy primary care settings. The pressures are there. Most times it’s only one reading. It’s the medical environment of today.”

He noted that although this study finds overestimation, different arm positions not recommended by guidelines could potentially result in underestimation of hypertension. 

“I liken the BP measurement to a laboratory test that has clear treatment implications. We would want the BP measurement to have the same rigorous accuracy as a blood test or radiologic machine,” he said. 

Dr. DiPette said more education is needed for patients as well as providers as patients may be monitoring their own BP at home. Patients should also know they can ask for a measurement to be repeated, know the correct arm position recommended by guidelines, and the implications of incorrect readings, he said.

This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation. 

Ms. Liu reported grants from Resolve to Save Lives outside the submitted work. One coauthor reported grants from the National Institutes of Health and personal fees from Kowa, RhythmX AI, and Fukuda Denshi outside the submitted work. Dr. DiPette declared no relevant financial relationships. He was part of a leadership team that developed World Health Organization guidelines on hypertension.

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

Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.

Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million  adults in the United States and more than 1 billion people globally.

This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.
 

Substantial Overestimation

In the crossover, randomized trial of 133 adults, Hairong Liu, MHS, with the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues found that supporting the arm on the lap overestimated systolic BP (SBP) by 3.9 mmHg and diastolic BP (DBP) by 4.0 mm Hg. When the arm hung at the side, readings overestimated SBP by 6.5 mm Hg and DBP by 4.4 mm Hg, with consistent results across subgroups.

Participants were randomly assigned to get a series of BP measurements with the arm positioned in three ways: Supported on a desk; hand supported on lap; and arm unsupported at the side. Because BP readings are intrinsically variable, all had a fourth set of BP measurements with the arm supported on a desk. 

Participants’ mean age was 57 years; 48 participants (36%) had SBP of ≥ 130 mm Hg; and 55 participants (41%) had a body mass index of ≥ 30.

Two researcher team staff members conducted all the measurements. They received standardized training and completed a certification test in BP measurement, administered by a study author. Measurements were taken from 9 am to 6 pm using a validated oscillometric BP device (ProBP 2000 Digital Blood Pressure Device, Welch Allyn). Only the right arms were used unless a specific condition was present, such as an open sore.
 

Study’s Design Sets It Apart

The authors wrote that the design of the study set this work apart. “Earlier studies have shown that unsupported or arm positioning below heart level can overestimate SBP by 4-23 mm Hg and DBP by 3-12 mm Hg.” But the strength of this study is the randomized, crossover design, “which is in contrast to the majority of published studies where the order of arm positions before seated BP measurement was not randomized or not clearly described.”

Dr. DiPette, who says, “I’ve given my career to understanding hypertension,” praised the design as well.

Randomization of which position patients were assigned to first was important because the first reading is often higher than subsequent readings, Dr. DiPette said.

“That makes sense as the person acclimatizes to the environment,” he explained. BP can even vary within the same reading, he noted.
 

 

 

Incorrect Readings for Many Reasons

Incorrect measures are common given the number of settings and number of providers and patients taking blood pressure even with training, certification in the method, and educational materials.

“We recommend taking a blood pressure in any possible setting you can. Because it’s that critical,” he said. “Most of the time it’s taken in busy primary care settings. The pressures are there. Most times it’s only one reading. It’s the medical environment of today.”

He noted that although this study finds overestimation, different arm positions not recommended by guidelines could potentially result in underestimation of hypertension. 

“I liken the BP measurement to a laboratory test that has clear treatment implications. We would want the BP measurement to have the same rigorous accuracy as a blood test or radiologic machine,” he said. 

Dr. DiPette said more education is needed for patients as well as providers as patients may be monitoring their own BP at home. Patients should also know they can ask for a measurement to be repeated, know the correct arm position recommended by guidelines, and the implications of incorrect readings, he said.

This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation. 

Ms. Liu reported grants from Resolve to Save Lives outside the submitted work. One coauthor reported grants from the National Institutes of Health and personal fees from Kowa, RhythmX AI, and Fukuda Denshi outside the submitted work. Dr. DiPette declared no relevant financial relationships. He was part of a leadership team that developed World Health Organization guidelines on hypertension.

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

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Lifestyle Medicine: Not Just for the Wealthy

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Changed
Wed, 10/09/2024 - 08:35

Primary care clinicians understand that addressing lifestyle-related chronic disease health disparities in minority and lower-income communities is a significant opportunity to alleviate unnecessary suffering. Disparate health outcomes associated with underlying comorbidities during the COVID pandemic exposed the urgency of this problem.

When it comes to delivering evidence-based therapeutic lifestyle behavior interventions to these populations, however, there is a misconception that lifestyle medicine is only for the wealthy. Such a misconception needlessly widens the gap in health disparities because the truth is that everyone deserves access to lifestyle medicine. Fortunately, there are numerous successful examples of delivering these services to underresourced patients. We can all contribute to narrowing health inequities by sourcing increasingly abundant lifestyle medicine resources.

All patients’ lived experiences are unique, and there is a wide range of potential challenges to achieving lifestyle behavior change. Lack of access to nutritious food or transportation, a shortage of safe green spaces, unstable housing, and low health literacy are examples of social determinants of health (SDOH) that affect lifestyle choices. Ignoring these obstacles is a disservice to patients and almost certainly results in treatment failure. Requirements to document SDOH have been a tremendous initial step. 

The next step is to have conversations with every patient about the powerful outcomes of even small lifestyle changes. All too often, clinicians forgo conversations on lifestyle change with patients affected by adverse SDOH and assume that social obstacles automatically mean that patients are neither willing nor able to attempt behavior modification. Instead, it is an opportunity for clinicians, particularly those certified in lifestyle medicine, to meet patients where they are, work with them to identify solutions, and provide referrals to community-based organizations with resources to help.
 

Small Steps to Big Changes

Not all lifestyle behavior interventions need to be programmatic or time intensive. Clinicians can guide patients toward simple but specific actions that can make a difference in health outcomes over time. Small steps, like eating one can of beans or two bags of frozen leafy greens each week, are a good start toward adjusted eating patterns. The American College of Lifestyle Medicine offers a whole-food, plant-predominant meal guide to share with patients. 

Individuals can increase their physical activity in their living rooms by doing sit-to-stands or balancing on one leg. Deep breathing and establishing a sleep routine are other lifestyle behavior changes without a price tag.

It is true that early adopters of lifestyle medicine often had difficulty practicing in underresourced communities. Those practitioners were forced to operate on a cash-pay basis, making access to care cost-prohibitive for many patients. However, board certification has been available since 2017, and lifestyle medicine is being integrated into medical schools and residency programs. Many such board-certified clinicians now work in large health systems and bill under the usual methods. There are also frameworks, such as the community-engaged lifestyle medicine model, showing how to treat patients affected by adverse SDOH effectively.

For example, patients at risk for malnutrition because of illnesses like chronic kidney disease, cancer, and heart failure receive medically tailored meals and access to a registered dietitian through a partnership between UC San Diego Health and Mama’s Kitchen. In Pennsylvania’s Lehigh Valley, where 1 in 10 of the approximately 700,000 residents face food insecurity, the Kellyn Foundation delivers fresh food through the Eat Real Food Mobile Market and offers whole-food, plant-predominant cooking classes, interactive elementary school programs focused on healthy lifestyle choices, and therapeutic lifestyle-change programs in community locations. Three months after launching new mobile market sites in Allentown, 1200 households were utilizing $15 weekly food vouchers through the program. Lifestyle medicine clinicians serve inner-city and rural areas in independent practices, large health systems, and community-based practice activities.

To improve access to lifestyle medicine in underresourced communities, more clinicians trained and certified in lifestyle medicine are needed. The Health Equity Achieved through Lifestyle Medicine Initiative supports a diverse lifestyle medicine workforce by offering scholarships to clinicians underrepresented in medicine and is working to train and certify at least one physician within each of the 1400 federally qualified health centers where clinicians are on the front lines of delivering care to the most underserved populations.

A meaningful first step for clinicians to address health disparities is to screen patients for and document SDOH. The American Academy of Family Physicians offers useful tools to screen patients, identify community-based resources, and help patients create action plans to overcome health risks and improve outcomes. In a promising trend to better support addressing SDOH in clinical care, the 2024 Medicare Physician Fee Schedule final rule included new codes to support this effort. 

Not every patient will be ready or willing to begin a lifestyle medicine treatment plan. Still, all of them will be grateful for the opportunity to decide for themselves. If we are invested in narrowing health inequities, lifestyle medicine and behavior change must be a topic in clinical encounters with all our patients.

Dr. Collings, director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Primary care clinicians understand that addressing lifestyle-related chronic disease health disparities in minority and lower-income communities is a significant opportunity to alleviate unnecessary suffering. Disparate health outcomes associated with underlying comorbidities during the COVID pandemic exposed the urgency of this problem.

When it comes to delivering evidence-based therapeutic lifestyle behavior interventions to these populations, however, there is a misconception that lifestyle medicine is only for the wealthy. Such a misconception needlessly widens the gap in health disparities because the truth is that everyone deserves access to lifestyle medicine. Fortunately, there are numerous successful examples of delivering these services to underresourced patients. We can all contribute to narrowing health inequities by sourcing increasingly abundant lifestyle medicine resources.

All patients’ lived experiences are unique, and there is a wide range of potential challenges to achieving lifestyle behavior change. Lack of access to nutritious food or transportation, a shortage of safe green spaces, unstable housing, and low health literacy are examples of social determinants of health (SDOH) that affect lifestyle choices. Ignoring these obstacles is a disservice to patients and almost certainly results in treatment failure. Requirements to document SDOH have been a tremendous initial step. 

The next step is to have conversations with every patient about the powerful outcomes of even small lifestyle changes. All too often, clinicians forgo conversations on lifestyle change with patients affected by adverse SDOH and assume that social obstacles automatically mean that patients are neither willing nor able to attempt behavior modification. Instead, it is an opportunity for clinicians, particularly those certified in lifestyle medicine, to meet patients where they are, work with them to identify solutions, and provide referrals to community-based organizations with resources to help.
 

Small Steps to Big Changes

Not all lifestyle behavior interventions need to be programmatic or time intensive. Clinicians can guide patients toward simple but specific actions that can make a difference in health outcomes over time. Small steps, like eating one can of beans or two bags of frozen leafy greens each week, are a good start toward adjusted eating patterns. The American College of Lifestyle Medicine offers a whole-food, plant-predominant meal guide to share with patients. 

Individuals can increase their physical activity in their living rooms by doing sit-to-stands or balancing on one leg. Deep breathing and establishing a sleep routine are other lifestyle behavior changes without a price tag.

It is true that early adopters of lifestyle medicine often had difficulty practicing in underresourced communities. Those practitioners were forced to operate on a cash-pay basis, making access to care cost-prohibitive for many patients. However, board certification has been available since 2017, and lifestyle medicine is being integrated into medical schools and residency programs. Many such board-certified clinicians now work in large health systems and bill under the usual methods. There are also frameworks, such as the community-engaged lifestyle medicine model, showing how to treat patients affected by adverse SDOH effectively.

For example, patients at risk for malnutrition because of illnesses like chronic kidney disease, cancer, and heart failure receive medically tailored meals and access to a registered dietitian through a partnership between UC San Diego Health and Mama’s Kitchen. In Pennsylvania’s Lehigh Valley, where 1 in 10 of the approximately 700,000 residents face food insecurity, the Kellyn Foundation delivers fresh food through the Eat Real Food Mobile Market and offers whole-food, plant-predominant cooking classes, interactive elementary school programs focused on healthy lifestyle choices, and therapeutic lifestyle-change programs in community locations. Three months after launching new mobile market sites in Allentown, 1200 households were utilizing $15 weekly food vouchers through the program. Lifestyle medicine clinicians serve inner-city and rural areas in independent practices, large health systems, and community-based practice activities.

To improve access to lifestyle medicine in underresourced communities, more clinicians trained and certified in lifestyle medicine are needed. The Health Equity Achieved through Lifestyle Medicine Initiative supports a diverse lifestyle medicine workforce by offering scholarships to clinicians underrepresented in medicine and is working to train and certify at least one physician within each of the 1400 federally qualified health centers where clinicians are on the front lines of delivering care to the most underserved populations.

A meaningful first step for clinicians to address health disparities is to screen patients for and document SDOH. The American Academy of Family Physicians offers useful tools to screen patients, identify community-based resources, and help patients create action plans to overcome health risks and improve outcomes. In a promising trend to better support addressing SDOH in clinical care, the 2024 Medicare Physician Fee Schedule final rule included new codes to support this effort. 

Not every patient will be ready or willing to begin a lifestyle medicine treatment plan. Still, all of them will be grateful for the opportunity to decide for themselves. If we are invested in narrowing health inequities, lifestyle medicine and behavior change must be a topic in clinical encounters with all our patients.

Dr. Collings, director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Primary care clinicians understand that addressing lifestyle-related chronic disease health disparities in minority and lower-income communities is a significant opportunity to alleviate unnecessary suffering. Disparate health outcomes associated with underlying comorbidities during the COVID pandemic exposed the urgency of this problem.

When it comes to delivering evidence-based therapeutic lifestyle behavior interventions to these populations, however, there is a misconception that lifestyle medicine is only for the wealthy. Such a misconception needlessly widens the gap in health disparities because the truth is that everyone deserves access to lifestyle medicine. Fortunately, there are numerous successful examples of delivering these services to underresourced patients. We can all contribute to narrowing health inequities by sourcing increasingly abundant lifestyle medicine resources.

All patients’ lived experiences are unique, and there is a wide range of potential challenges to achieving lifestyle behavior change. Lack of access to nutritious food or transportation, a shortage of safe green spaces, unstable housing, and low health literacy are examples of social determinants of health (SDOH) that affect lifestyle choices. Ignoring these obstacles is a disservice to patients and almost certainly results in treatment failure. Requirements to document SDOH have been a tremendous initial step. 

The next step is to have conversations with every patient about the powerful outcomes of even small lifestyle changes. All too often, clinicians forgo conversations on lifestyle change with patients affected by adverse SDOH and assume that social obstacles automatically mean that patients are neither willing nor able to attempt behavior modification. Instead, it is an opportunity for clinicians, particularly those certified in lifestyle medicine, to meet patients where they are, work with them to identify solutions, and provide referrals to community-based organizations with resources to help.
 

Small Steps to Big Changes

Not all lifestyle behavior interventions need to be programmatic or time intensive. Clinicians can guide patients toward simple but specific actions that can make a difference in health outcomes over time. Small steps, like eating one can of beans or two bags of frozen leafy greens each week, are a good start toward adjusted eating patterns. The American College of Lifestyle Medicine offers a whole-food, plant-predominant meal guide to share with patients. 

Individuals can increase their physical activity in their living rooms by doing sit-to-stands or balancing on one leg. Deep breathing and establishing a sleep routine are other lifestyle behavior changes without a price tag.

It is true that early adopters of lifestyle medicine often had difficulty practicing in underresourced communities. Those practitioners were forced to operate on a cash-pay basis, making access to care cost-prohibitive for many patients. However, board certification has been available since 2017, and lifestyle medicine is being integrated into medical schools and residency programs. Many such board-certified clinicians now work in large health systems and bill under the usual methods. There are also frameworks, such as the community-engaged lifestyle medicine model, showing how to treat patients affected by adverse SDOH effectively.

For example, patients at risk for malnutrition because of illnesses like chronic kidney disease, cancer, and heart failure receive medically tailored meals and access to a registered dietitian through a partnership between UC San Diego Health and Mama’s Kitchen. In Pennsylvania’s Lehigh Valley, where 1 in 10 of the approximately 700,000 residents face food insecurity, the Kellyn Foundation delivers fresh food through the Eat Real Food Mobile Market and offers whole-food, plant-predominant cooking classes, interactive elementary school programs focused on healthy lifestyle choices, and therapeutic lifestyle-change programs in community locations. Three months after launching new mobile market sites in Allentown, 1200 households were utilizing $15 weekly food vouchers through the program. Lifestyle medicine clinicians serve inner-city and rural areas in independent practices, large health systems, and community-based practice activities.

To improve access to lifestyle medicine in underresourced communities, more clinicians trained and certified in lifestyle medicine are needed. The Health Equity Achieved through Lifestyle Medicine Initiative supports a diverse lifestyle medicine workforce by offering scholarships to clinicians underrepresented in medicine and is working to train and certify at least one physician within each of the 1400 federally qualified health centers where clinicians are on the front lines of delivering care to the most underserved populations.

A meaningful first step for clinicians to address health disparities is to screen patients for and document SDOH. The American Academy of Family Physicians offers useful tools to screen patients, identify community-based resources, and help patients create action plans to overcome health risks and improve outcomes. In a promising trend to better support addressing SDOH in clinical care, the 2024 Medicare Physician Fee Schedule final rule included new codes to support this effort. 

Not every patient will be ready or willing to begin a lifestyle medicine treatment plan. Still, all of them will be grateful for the opportunity to decide for themselves. If we are invested in narrowing health inequities, lifestyle medicine and behavior change must be a topic in clinical encounters with all our patients.

Dr. Collings, director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Which Medication Is Best? VA Genetic Tests May Have the Answer

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Fri, 10/04/2024 - 08:54

The US Department of Veterans Affairs (VA) now has a permanent pharmacogenomics service that provides genetic tests to give clinicians insight into the best medication options for their patients.

The tests, which have no extra cost, are available to all veterans, said pharmacist Jill S. Bates, PharmD, MS, executive director of the VA National Pharmacogenomics Program, who spoke in an interview and a presentation at the annual meeting of the Association of VA Hematology/Oncology.

Genetic testing is “a tool that can help optimize care that we provide for veterans,” she said. “Pharmacogenomics is additional information to help the clinician make a decision. We know that most veterans—greater than 90%—carry a variant in a pharmacogenomics gene that is actionable.”

The genetic tests can provide insight into the optimal medication for multiple conditions such as mental illness, gastrointestinal disorders, cancer, pain, and heart disease. According to a 2019 analysis of over 6 years of data, more than half of the VA patient population used medications whose efficacy may have been affected by detectable genetic variants.

For instance, Bates said tests can let clinicians know whether patients are susceptible to statin-associated muscle adverse effects if they take simvastatin, the cholesterol medication. An estimated 25.6% of the VA population has this variant.

Elsewhere on the cardiac front, an estimated 58.3% of the VA population has a genetic variant that increases sensitivity to the blood thinner warfarin.

Testing could help psychiatrists determine whether certain medications should not be prescribed—or should be prescribed at lower doses—in patients who’ve had adverse reactions to antidepressants, Bates said.

In cancer, Bates said, genetic testing can identify patients who have a genetic variant that boosts toxicity from fluoropyrimidine chemotherapy treatments, which include capecitabine, floxuridine, and fluorouracil. Meanwhile, an estimated 0.9% will have no reaction or limited reaction to capecitabine and fluorouracil, and 4.8% will have hypersensitivity to carbamazepine and oxcarbazepine. 

Tests can also identify a genetic variant that can lead to poor metabolism of the chemotherapy drug irinotecan, which is used to treat colon cancer. “In those patients, you’d want to reduce the dose by 20%,” Bates said. In other cases, alternate drugs may be the best strategy to address genetic variations.

Prior to 2019, clinicians had to order pharmacogenomic tests outside of the VA system, according to Bates. That year, a donation from Sanford Health brought VA pharmacogenomics to 40 pilot sites. Since then, more than 88,000 tests have been performed.

The VA has now made its pharmacogenomic program permanent, Bates said. As of early September, testing was available at 139 VA sites and is coming soon to 4 more. It’s not available at another 23 sites that are scattered across the country.

A tool in the VA electronic health record now reminds clinicians about the availability of genetic testing and allows them to order tests. However, testing isn’t available for patients who have had liver transplants or certain bone marrow transplants.

The VA is working on developing decision-making tools to help clinicians determine when the tests are appropriate, Bates said. It typically takes 2 to 3 weeks to get results, she said, adding that external laboratories provide results. “We eventually would like to bring in all pharmacogenomics testing to be conducted within the VA enterprise.”

 

Bates reported that she had no disclosures.

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The US Department of Veterans Affairs (VA) now has a permanent pharmacogenomics service that provides genetic tests to give clinicians insight into the best medication options for their patients.

The tests, which have no extra cost, are available to all veterans, said pharmacist Jill S. Bates, PharmD, MS, executive director of the VA National Pharmacogenomics Program, who spoke in an interview and a presentation at the annual meeting of the Association of VA Hematology/Oncology.

Genetic testing is “a tool that can help optimize care that we provide for veterans,” she said. “Pharmacogenomics is additional information to help the clinician make a decision. We know that most veterans—greater than 90%—carry a variant in a pharmacogenomics gene that is actionable.”

The genetic tests can provide insight into the optimal medication for multiple conditions such as mental illness, gastrointestinal disorders, cancer, pain, and heart disease. According to a 2019 analysis of over 6 years of data, more than half of the VA patient population used medications whose efficacy may have been affected by detectable genetic variants.

For instance, Bates said tests can let clinicians know whether patients are susceptible to statin-associated muscle adverse effects if they take simvastatin, the cholesterol medication. An estimated 25.6% of the VA population has this variant.

Elsewhere on the cardiac front, an estimated 58.3% of the VA population has a genetic variant that increases sensitivity to the blood thinner warfarin.

Testing could help psychiatrists determine whether certain medications should not be prescribed—or should be prescribed at lower doses—in patients who’ve had adverse reactions to antidepressants, Bates said.

In cancer, Bates said, genetic testing can identify patients who have a genetic variant that boosts toxicity from fluoropyrimidine chemotherapy treatments, which include capecitabine, floxuridine, and fluorouracil. Meanwhile, an estimated 0.9% will have no reaction or limited reaction to capecitabine and fluorouracil, and 4.8% will have hypersensitivity to carbamazepine and oxcarbazepine. 

Tests can also identify a genetic variant that can lead to poor metabolism of the chemotherapy drug irinotecan, which is used to treat colon cancer. “In those patients, you’d want to reduce the dose by 20%,” Bates said. In other cases, alternate drugs may be the best strategy to address genetic variations.

Prior to 2019, clinicians had to order pharmacogenomic tests outside of the VA system, according to Bates. That year, a donation from Sanford Health brought VA pharmacogenomics to 40 pilot sites. Since then, more than 88,000 tests have been performed.

The VA has now made its pharmacogenomic program permanent, Bates said. As of early September, testing was available at 139 VA sites and is coming soon to 4 more. It’s not available at another 23 sites that are scattered across the country.

A tool in the VA electronic health record now reminds clinicians about the availability of genetic testing and allows them to order tests. However, testing isn’t available for patients who have had liver transplants or certain bone marrow transplants.

The VA is working on developing decision-making tools to help clinicians determine when the tests are appropriate, Bates said. It typically takes 2 to 3 weeks to get results, she said, adding that external laboratories provide results. “We eventually would like to bring in all pharmacogenomics testing to be conducted within the VA enterprise.”

 

Bates reported that she had no disclosures.

The US Department of Veterans Affairs (VA) now has a permanent pharmacogenomics service that provides genetic tests to give clinicians insight into the best medication options for their patients.

The tests, which have no extra cost, are available to all veterans, said pharmacist Jill S. Bates, PharmD, MS, executive director of the VA National Pharmacogenomics Program, who spoke in an interview and a presentation at the annual meeting of the Association of VA Hematology/Oncology.

Genetic testing is “a tool that can help optimize care that we provide for veterans,” she said. “Pharmacogenomics is additional information to help the clinician make a decision. We know that most veterans—greater than 90%—carry a variant in a pharmacogenomics gene that is actionable.”

The genetic tests can provide insight into the optimal medication for multiple conditions such as mental illness, gastrointestinal disorders, cancer, pain, and heart disease. According to a 2019 analysis of over 6 years of data, more than half of the VA patient population used medications whose efficacy may have been affected by detectable genetic variants.

For instance, Bates said tests can let clinicians know whether patients are susceptible to statin-associated muscle adverse effects if they take simvastatin, the cholesterol medication. An estimated 25.6% of the VA population has this variant.

Elsewhere on the cardiac front, an estimated 58.3% of the VA population has a genetic variant that increases sensitivity to the blood thinner warfarin.

Testing could help psychiatrists determine whether certain medications should not be prescribed—or should be prescribed at lower doses—in patients who’ve had adverse reactions to antidepressants, Bates said.

In cancer, Bates said, genetic testing can identify patients who have a genetic variant that boosts toxicity from fluoropyrimidine chemotherapy treatments, which include capecitabine, floxuridine, and fluorouracil. Meanwhile, an estimated 0.9% will have no reaction or limited reaction to capecitabine and fluorouracil, and 4.8% will have hypersensitivity to carbamazepine and oxcarbazepine. 

Tests can also identify a genetic variant that can lead to poor metabolism of the chemotherapy drug irinotecan, which is used to treat colon cancer. “In those patients, you’d want to reduce the dose by 20%,” Bates said. In other cases, alternate drugs may be the best strategy to address genetic variations.

Prior to 2019, clinicians had to order pharmacogenomic tests outside of the VA system, according to Bates. That year, a donation from Sanford Health brought VA pharmacogenomics to 40 pilot sites. Since then, more than 88,000 tests have been performed.

The VA has now made its pharmacogenomic program permanent, Bates said. As of early September, testing was available at 139 VA sites and is coming soon to 4 more. It’s not available at another 23 sites that are scattered across the country.

A tool in the VA electronic health record now reminds clinicians about the availability of genetic testing and allows them to order tests. However, testing isn’t available for patients who have had liver transplants or certain bone marrow transplants.

The VA is working on developing decision-making tools to help clinicians determine when the tests are appropriate, Bates said. It typically takes 2 to 3 weeks to get results, she said, adding that external laboratories provide results. “We eventually would like to bring in all pharmacogenomics testing to be conducted within the VA enterprise.”

 

Bates reported that she had no disclosures.

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New Hypertension Approach Hits Multiple Targets at Low Dose

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Tue, 10/01/2024 - 15:25

Single-pill combinations that include three or four antihypertensive medications are the way forward for the management of patients with elevated blood pressure, according to experts evaluating the new approach.

This multidrug strategy — in which ultralow-dose triple combinations can be used as a starting treatment and four full-dose combinations can be used to treat resistant hypertension — has shown an impressive ability to lower blood pressure in several new studies.

But will it catch on as a routine treatment recommendation in current practice?

Studies of treatment strategies that involve an ultralow quarter dose of three drugs that lower blood pressure and then escalation to a half-dose triple combination and then to a full-dose triple combination, all given as a single pill, were presented at the European Society of Cardiology (ESC) Congress 2024. Another strategy presented involves a four-drug full-dose combination in patients with resistant hypertension.
 

Start With Low Doses of Three Drugs

The triple-combination pill contains telmisartan (an angiotensin blocker), amlodipine (a calcium channel blocker), and indapamide (a diuretic). The three medications are used at three doses: Quarter, half, and standard.

“The idea is to start treatment with a little bit of the three main drug classes instead of the full dose of one drug and then to increase the triple-combination doses as required to get to blood pressure goal,” said Anthony Rodgers, PhD, from the team at The George Institute for Global Health, Sydney, Australia, that is developing this triple-combination product.

“Using three different mechanisms right from the beginning covers all the bases and leads to improved blood pressure reduction while just using very small doses of each agent. This represents a completely new approach that could transform the management of hypertension,” he reported.

Single-pill triple-combination antihypertensive formulations exist already, but the component drugs are all at standard doses. Such combinations were designed to improve adherence in patients with hard-to-control blood pressure who need more than two full-dose medications, he explained.

“We are suggesting a completely different concept using much lower doses of the triple combination right from the beginning of treatment,” Dr. Rodgers explained. “Convenience and adherence will be an added advantage, but there’s more to it than that. It’s about combining the different mechanisms of three separate drug classes to get a better antihypertensive effect and being able to do this right from the start of treatment in patients with mildly elevated blood pressure, as well as those with higher levels.”

Proof-of-concept trials of this approach have been conducted, but no commercial low-dose triple-combination product has been available.

The George Institute is now developing such a product — through George Medicines, its commercial arm — with the aim of bringing the triple-combination pill to market in both high- and low-income countries. An approval submission has been filed in the United States.

Dr. Rodgers presented two studies that assessed the triple combination. One showed that the quarter dose reduced blood pressure significantly better than placebo in patients with mildly elevated blood pressure. The second showed that half and standard doses of the three medications were more effective at lowering blood pressure than three dual combinations at the same doses.
 

 

 

The VERONICA Trial

The triple combination was also assessed in the VERONICA study, which showed that among Black adults in Nigeria with uncontrolled hypertension, blood pressure was lower and control was better with the low-dose triple-combination pill than with standard care, and tolerability was good.

In VERONICA, recently published in JAMA, 300 patients with a mean baseline blood pressure of 151/97 mm Hg at home and 156/97 mm Hg in the clinic were randomly assigned to receive the triple-combination pill or standard care.

In the triple-combination group, patients started with the quarter-dose pill, then accelerated, as necessary, to the half-dose and standard-dose pills.

In the standard care group, patients started with amlodipine (5 mg), which was stepped up at monthly intervals so patients could achieve a target blood pressure < 140/90 mm Hg as follows: Amlodipine (5 mg) plus losartan (50 mg); then amlodipine (10 mg) plus losartan (100 mg); then amlodipine (10 mg), losartan (100 mg), plus hydrochlorothiazide (25 mg); and finally referral to a specialist if the target blood pressure was still not achieved.

At month 6, mean home systolic blood pressure was, on average, 31 mm Hg lower in the triple-combination group and 26 mm Hg lower in the standard care group (adjusted difference, −5.8 mm Hg; P < .001).

More patients in the triple-combination group than in the standard care group achieved clinic blood pressure control, defined as blood pressure < 140/90 mm Hg (82% vs 72%), and more patients achieved home blood pressure control, defined as blood pressure below 130/80 mm Hg (62% vs 28%).

No participants discontinued treatment due to adverse events, and adverse events of special interest were reported by just 2% and 3% patients in the triple-combination and standard care groups, respectively.

At month 6, however, more participants in the triple-combination group than in the standard care group had serum potassium levels < 3.5 mmol/L (34% vs 18%), although fewer participants in both the groups had potassium levels < 3.0 mmol/L (10% vs 5%).

Hypokalemia may be the consequence of low dietary potassium intake in Africa, and co-administration with potassium-enriched salt substitution should be evaluated, said Dike Ojji, MBBS, PhD, University of Abuja, Nigeria, who was the lead investigator of VERONICA.

“These findings have broad clinical and public health implications, given that improved hypertension control is a priority in Africa and globally. The results underscore the need for combination therapy to be the cornerstone of effective treatment regimens,” Dr. Ojji said.
 

Missed Targets

“It has taken a long time for the penny to drop as to why the existing antihypertensive treatment paradigm does not work so well,” Dr. Rodgers pointed out. “What tends to happen in clinical practice is that people start on one drug and blood pressure falls a bit, then no further action is taken. But this is not usually enough to get to target. With our approach of using three drugs at low doses straight away, we can often get the blood pressure controlled to target much more quickly with one tablet.”

Low doses of the triple-combination pill should also have a favorable adverse-effect profile and fewer drug interactions, as these issues are generally seen much more frequently with higher doses of drugs, he explained.

This low-dose triple-combination approach could help manage the current epidemic of hypertension and cardiometabolic disease, said Pam Taub, MD, director of preventive cardiology at UC San Diego Health System.

“We are in a new era of cardiometabolic disease, and one of the fundamental drivers of atherosclerotic cardiovascular disease is hypertension, which is prevalent in patients with diabetes, in those with obesity, and is a contributor to chronic kidney disease,” she said.

“We really need to be addressing hypertension very early to prevent this end-organ damage, but because hypertension tends to occur alongside multiple other comorbidities, patients are often on many different medications and are overwhelmed by the burden of polypharmacy.”

Dr. Taub described this triple-combination approach as “looking at hypertension treatment through a new lens.”

“We’ve always been taught to maximize the dose of one agent before we go to a new agent,” she said. “These studies are fundamentally challenging that paradigm. From a pathophysiological and mechanistic perspective, we are seeing that lower doses of different medications can really harness some unique synergistic mechanisms, which can be beneficial for patients.”

But not all experts are convinced that this approach will be a popular option in all countries.

Although this approach makes sense, in that the different agents work synergistically to give a better antihypertensive effect, many physicians could be uncomfortable with the idea of giving multiple medications straight off as the first step of treatment, said Eugene Yang, MD, from the University of Washington in Seattle.

If the patient develops a side effect, it will not be clear which medication is causing it, making it difficult to know which one to stop, he pointed out.

“These studies confirm that a low-dose multidrug-combination pill is effective at lowering blood pressure, but we already have previous studies showing this,” he added. “The issue is how we translate this into patient care. It would be great if we could get people to use it, but I think concerns from both clinicians and patients about identifying the source of any side effects may be a stumbling block.”

The approach is more likely to be adopted in low- to middle-income countries, where there is limited access to healthcare and where the population-wide control of blood pressure makes sense, said Dr. Yang.

Most current guidelines now recommend initiating therapy with two agents, ideally, as a single-pill combination product. “We have finally acknowledged that the vast majority of patients need two drugs. That’s a good starting point. This low-dose triple combination could be an interesting new approach,” said Neil Poulter, MD, professor of preventive cardiovascular medicine at Imperial College London, England.

This approach is in line with the idea that single-pill combinations are the way forward for hypertension therapy, he added.

“The triple combination is attractive, in that you are never quite sure which particular mechanism is driving an individual’s elevated blood pressure, so if you can target three different mechanisms at the same time, you’ve got more chance of a good hit,” Dr. Poulter said.

“The VERONICA trial showed a very good result on lowering BP using this low-dose triple combination as a starting point and increasing quickly to single-pill combinations of triple half doses, then triple full doses, as required. But I think we need more evidence on how this compares to current practice than just this one study in Africa to make this an acceptable routine approach on a global level,” he said.
 

 

 

QUADRO: Four-Drug Combo in Resistant Hypertension

Another scenario in which single-pill antihypertensive combinations could be particularly useful is at the other end of the spectrum: The treatment of patients with resistant hypertension.

The QUADRO study showed that a single pill containing perindopril, indapamide, amlodipine, and bisoprolol is better at lowering blood pressure than the triple combination of perindopril, indapamide, and amlodipine.

The primary endpoint — office sitting systolic blood pressure at 16 weeks — was 8 mm Hg lower with the quadruple combination than with the triple combination. And mean ambulatory 24-hour systolic blood pressure was 7.5 mm Hg lower with the four-drug combination.

This was the first study of a single-pill quadruple combination in patients with resistant hypertension, which is a “difficult-to-treat condition demanding a high number of pills with not enough safe and practical options,” said Stefano Taddei, MD, from the University of Pisa, Italy, when he presented the study at the ESC meeting.

Using “four well-established drugs in a single-combination pill may improve adherence and should be an innovative solution for resistant and difficult-to-treat hypertensive patients,” he said.

Nonadherence is a big problem in patients with resistant hypertension. “It is really difficult to get patients to take three or four antihypertensive agents along with all the other medications they have for other comorbidities,” Dr. Taub pointed out. “We really need to think about combination formulations that reduce the pill burden for our patients.”

Around 10% patients with hypertension may require a fourth drug, so a four-drug single-pill combination therefore makes good sense, said Dr. Poulter.

But the choice of the fourth drug is the subject of debate. The PATHWAY trial showed spironolactone to be the most effective fourth agent, but it can cause side effects, such as gynecomastia and hyperkalemia.

“The beta-blocker in the four-drug combination product used in the QUADRO study may not be as effective as spironolactone at lowering blood pressure,” Dr. Poulter explained, noting that beta-blockers have known side effects. However, “they are often already recommended for patients with very common comorbidities, such as arrhythmias, history of MI, heart failure, angina. In that regard, it makes sense to have a beta-blocker in there.”

The four-drug combination used in the QUADRO study led to a bigger reduction — by 8 mm Hg — than the three-drug combination. “That’s pretty good. I thought this was a very useful and interesting study,” he said.

There could be a role for a four-drug combination product in resistant hypertension. “Whatever we can do to improve adherence and reduce blood pressure is good thing,” said Dr. Yang.

However, a mineralocorticoid receptor antagonist (such as spironolactone) might be better as the fourth drug; that is what is recommended in the resistant hypertension algorithm.
 

Lower Blood Pressure, Better Outcomes

“What we are seeing in these trials is that across a wide spectrum of patients with hypertension or resistant hypertension, combination pills are superior to standard practice for BP lowering, and that will lead to improved outcomes,” said Dr. Taub.

“For years, such single-pill combinations have been viewed as ‘bad medicine’ in hypertension,” Dr. Poulter added. “That is clearly not the case, as these studies are showing. And single-pill combination therapies are used extensively in practically every other area of medicine. We are starting to accept them now in the blood pressure community, and I think the use of triple and quadruple combinations, as in these studies, has a real logic to it. But for this approach to be useful, these single-pill combinations must be made available, cheaply, across the world, especially in low- and middle-income countries where hypertension rates are a particular problem.”
 

A version of this article appeared on Medscape.com.

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Single-pill combinations that include three or four antihypertensive medications are the way forward for the management of patients with elevated blood pressure, according to experts evaluating the new approach.

This multidrug strategy — in which ultralow-dose triple combinations can be used as a starting treatment and four full-dose combinations can be used to treat resistant hypertension — has shown an impressive ability to lower blood pressure in several new studies.

But will it catch on as a routine treatment recommendation in current practice?

Studies of treatment strategies that involve an ultralow quarter dose of three drugs that lower blood pressure and then escalation to a half-dose triple combination and then to a full-dose triple combination, all given as a single pill, were presented at the European Society of Cardiology (ESC) Congress 2024. Another strategy presented involves a four-drug full-dose combination in patients with resistant hypertension.
 

Start With Low Doses of Three Drugs

The triple-combination pill contains telmisartan (an angiotensin blocker), amlodipine (a calcium channel blocker), and indapamide (a diuretic). The three medications are used at three doses: Quarter, half, and standard.

“The idea is to start treatment with a little bit of the three main drug classes instead of the full dose of one drug and then to increase the triple-combination doses as required to get to blood pressure goal,” said Anthony Rodgers, PhD, from the team at The George Institute for Global Health, Sydney, Australia, that is developing this triple-combination product.

“Using three different mechanisms right from the beginning covers all the bases and leads to improved blood pressure reduction while just using very small doses of each agent. This represents a completely new approach that could transform the management of hypertension,” he reported.

Single-pill triple-combination antihypertensive formulations exist already, but the component drugs are all at standard doses. Such combinations were designed to improve adherence in patients with hard-to-control blood pressure who need more than two full-dose medications, he explained.

“We are suggesting a completely different concept using much lower doses of the triple combination right from the beginning of treatment,” Dr. Rodgers explained. “Convenience and adherence will be an added advantage, but there’s more to it than that. It’s about combining the different mechanisms of three separate drug classes to get a better antihypertensive effect and being able to do this right from the start of treatment in patients with mildly elevated blood pressure, as well as those with higher levels.”

Proof-of-concept trials of this approach have been conducted, but no commercial low-dose triple-combination product has been available.

The George Institute is now developing such a product — through George Medicines, its commercial arm — with the aim of bringing the triple-combination pill to market in both high- and low-income countries. An approval submission has been filed in the United States.

Dr. Rodgers presented two studies that assessed the triple combination. One showed that the quarter dose reduced blood pressure significantly better than placebo in patients with mildly elevated blood pressure. The second showed that half and standard doses of the three medications were more effective at lowering blood pressure than three dual combinations at the same doses.
 

 

 

The VERONICA Trial

The triple combination was also assessed in the VERONICA study, which showed that among Black adults in Nigeria with uncontrolled hypertension, blood pressure was lower and control was better with the low-dose triple-combination pill than with standard care, and tolerability was good.

In VERONICA, recently published in JAMA, 300 patients with a mean baseline blood pressure of 151/97 mm Hg at home and 156/97 mm Hg in the clinic were randomly assigned to receive the triple-combination pill or standard care.

In the triple-combination group, patients started with the quarter-dose pill, then accelerated, as necessary, to the half-dose and standard-dose pills.

In the standard care group, patients started with amlodipine (5 mg), which was stepped up at monthly intervals so patients could achieve a target blood pressure < 140/90 mm Hg as follows: Amlodipine (5 mg) plus losartan (50 mg); then amlodipine (10 mg) plus losartan (100 mg); then amlodipine (10 mg), losartan (100 mg), plus hydrochlorothiazide (25 mg); and finally referral to a specialist if the target blood pressure was still not achieved.

At month 6, mean home systolic blood pressure was, on average, 31 mm Hg lower in the triple-combination group and 26 mm Hg lower in the standard care group (adjusted difference, −5.8 mm Hg; P < .001).

More patients in the triple-combination group than in the standard care group achieved clinic blood pressure control, defined as blood pressure < 140/90 mm Hg (82% vs 72%), and more patients achieved home blood pressure control, defined as blood pressure below 130/80 mm Hg (62% vs 28%).

No participants discontinued treatment due to adverse events, and adverse events of special interest were reported by just 2% and 3% patients in the triple-combination and standard care groups, respectively.

At month 6, however, more participants in the triple-combination group than in the standard care group had serum potassium levels < 3.5 mmol/L (34% vs 18%), although fewer participants in both the groups had potassium levels < 3.0 mmol/L (10% vs 5%).

Hypokalemia may be the consequence of low dietary potassium intake in Africa, and co-administration with potassium-enriched salt substitution should be evaluated, said Dike Ojji, MBBS, PhD, University of Abuja, Nigeria, who was the lead investigator of VERONICA.

“These findings have broad clinical and public health implications, given that improved hypertension control is a priority in Africa and globally. The results underscore the need for combination therapy to be the cornerstone of effective treatment regimens,” Dr. Ojji said.
 

Missed Targets

“It has taken a long time for the penny to drop as to why the existing antihypertensive treatment paradigm does not work so well,” Dr. Rodgers pointed out. “What tends to happen in clinical practice is that people start on one drug and blood pressure falls a bit, then no further action is taken. But this is not usually enough to get to target. With our approach of using three drugs at low doses straight away, we can often get the blood pressure controlled to target much more quickly with one tablet.”

Low doses of the triple-combination pill should also have a favorable adverse-effect profile and fewer drug interactions, as these issues are generally seen much more frequently with higher doses of drugs, he explained.

This low-dose triple-combination approach could help manage the current epidemic of hypertension and cardiometabolic disease, said Pam Taub, MD, director of preventive cardiology at UC San Diego Health System.

“We are in a new era of cardiometabolic disease, and one of the fundamental drivers of atherosclerotic cardiovascular disease is hypertension, which is prevalent in patients with diabetes, in those with obesity, and is a contributor to chronic kidney disease,” she said.

“We really need to be addressing hypertension very early to prevent this end-organ damage, but because hypertension tends to occur alongside multiple other comorbidities, patients are often on many different medications and are overwhelmed by the burden of polypharmacy.”

Dr. Taub described this triple-combination approach as “looking at hypertension treatment through a new lens.”

“We’ve always been taught to maximize the dose of one agent before we go to a new agent,” she said. “These studies are fundamentally challenging that paradigm. From a pathophysiological and mechanistic perspective, we are seeing that lower doses of different medications can really harness some unique synergistic mechanisms, which can be beneficial for patients.”

But not all experts are convinced that this approach will be a popular option in all countries.

Although this approach makes sense, in that the different agents work synergistically to give a better antihypertensive effect, many physicians could be uncomfortable with the idea of giving multiple medications straight off as the first step of treatment, said Eugene Yang, MD, from the University of Washington in Seattle.

If the patient develops a side effect, it will not be clear which medication is causing it, making it difficult to know which one to stop, he pointed out.

“These studies confirm that a low-dose multidrug-combination pill is effective at lowering blood pressure, but we already have previous studies showing this,” he added. “The issue is how we translate this into patient care. It would be great if we could get people to use it, but I think concerns from both clinicians and patients about identifying the source of any side effects may be a stumbling block.”

The approach is more likely to be adopted in low- to middle-income countries, where there is limited access to healthcare and where the population-wide control of blood pressure makes sense, said Dr. Yang.

Most current guidelines now recommend initiating therapy with two agents, ideally, as a single-pill combination product. “We have finally acknowledged that the vast majority of patients need two drugs. That’s a good starting point. This low-dose triple combination could be an interesting new approach,” said Neil Poulter, MD, professor of preventive cardiovascular medicine at Imperial College London, England.

This approach is in line with the idea that single-pill combinations are the way forward for hypertension therapy, he added.

“The triple combination is attractive, in that you are never quite sure which particular mechanism is driving an individual’s elevated blood pressure, so if you can target three different mechanisms at the same time, you’ve got more chance of a good hit,” Dr. Poulter said.

“The VERONICA trial showed a very good result on lowering BP using this low-dose triple combination as a starting point and increasing quickly to single-pill combinations of triple half doses, then triple full doses, as required. But I think we need more evidence on how this compares to current practice than just this one study in Africa to make this an acceptable routine approach on a global level,” he said.
 

 

 

QUADRO: Four-Drug Combo in Resistant Hypertension

Another scenario in which single-pill antihypertensive combinations could be particularly useful is at the other end of the spectrum: The treatment of patients with resistant hypertension.

The QUADRO study showed that a single pill containing perindopril, indapamide, amlodipine, and bisoprolol is better at lowering blood pressure than the triple combination of perindopril, indapamide, and amlodipine.

The primary endpoint — office sitting systolic blood pressure at 16 weeks — was 8 mm Hg lower with the quadruple combination than with the triple combination. And mean ambulatory 24-hour systolic blood pressure was 7.5 mm Hg lower with the four-drug combination.

This was the first study of a single-pill quadruple combination in patients with resistant hypertension, which is a “difficult-to-treat condition demanding a high number of pills with not enough safe and practical options,” said Stefano Taddei, MD, from the University of Pisa, Italy, when he presented the study at the ESC meeting.

Using “four well-established drugs in a single-combination pill may improve adherence and should be an innovative solution for resistant and difficult-to-treat hypertensive patients,” he said.

Nonadherence is a big problem in patients with resistant hypertension. “It is really difficult to get patients to take three or four antihypertensive agents along with all the other medications they have for other comorbidities,” Dr. Taub pointed out. “We really need to think about combination formulations that reduce the pill burden for our patients.”

Around 10% patients with hypertension may require a fourth drug, so a four-drug single-pill combination therefore makes good sense, said Dr. Poulter.

But the choice of the fourth drug is the subject of debate. The PATHWAY trial showed spironolactone to be the most effective fourth agent, but it can cause side effects, such as gynecomastia and hyperkalemia.

“The beta-blocker in the four-drug combination product used in the QUADRO study may not be as effective as spironolactone at lowering blood pressure,” Dr. Poulter explained, noting that beta-blockers have known side effects. However, “they are often already recommended for patients with very common comorbidities, such as arrhythmias, history of MI, heart failure, angina. In that regard, it makes sense to have a beta-blocker in there.”

The four-drug combination used in the QUADRO study led to a bigger reduction — by 8 mm Hg — than the three-drug combination. “That’s pretty good. I thought this was a very useful and interesting study,” he said.

There could be a role for a four-drug combination product in resistant hypertension. “Whatever we can do to improve adherence and reduce blood pressure is good thing,” said Dr. Yang.

However, a mineralocorticoid receptor antagonist (such as spironolactone) might be better as the fourth drug; that is what is recommended in the resistant hypertension algorithm.
 

Lower Blood Pressure, Better Outcomes

“What we are seeing in these trials is that across a wide spectrum of patients with hypertension or resistant hypertension, combination pills are superior to standard practice for BP lowering, and that will lead to improved outcomes,” said Dr. Taub.

“For years, such single-pill combinations have been viewed as ‘bad medicine’ in hypertension,” Dr. Poulter added. “That is clearly not the case, as these studies are showing. And single-pill combination therapies are used extensively in practically every other area of medicine. We are starting to accept them now in the blood pressure community, and I think the use of triple and quadruple combinations, as in these studies, has a real logic to it. But for this approach to be useful, these single-pill combinations must be made available, cheaply, across the world, especially in low- and middle-income countries where hypertension rates are a particular problem.”
 

A version of this article appeared on Medscape.com.

Single-pill combinations that include three or four antihypertensive medications are the way forward for the management of patients with elevated blood pressure, according to experts evaluating the new approach.

This multidrug strategy — in which ultralow-dose triple combinations can be used as a starting treatment and four full-dose combinations can be used to treat resistant hypertension — has shown an impressive ability to lower blood pressure in several new studies.

But will it catch on as a routine treatment recommendation in current practice?

Studies of treatment strategies that involve an ultralow quarter dose of three drugs that lower blood pressure and then escalation to a half-dose triple combination and then to a full-dose triple combination, all given as a single pill, were presented at the European Society of Cardiology (ESC) Congress 2024. Another strategy presented involves a four-drug full-dose combination in patients with resistant hypertension.
 

Start With Low Doses of Three Drugs

The triple-combination pill contains telmisartan (an angiotensin blocker), amlodipine (a calcium channel blocker), and indapamide (a diuretic). The three medications are used at three doses: Quarter, half, and standard.

“The idea is to start treatment with a little bit of the three main drug classes instead of the full dose of one drug and then to increase the triple-combination doses as required to get to blood pressure goal,” said Anthony Rodgers, PhD, from the team at The George Institute for Global Health, Sydney, Australia, that is developing this triple-combination product.

“Using three different mechanisms right from the beginning covers all the bases and leads to improved blood pressure reduction while just using very small doses of each agent. This represents a completely new approach that could transform the management of hypertension,” he reported.

Single-pill triple-combination antihypertensive formulations exist already, but the component drugs are all at standard doses. Such combinations were designed to improve adherence in patients with hard-to-control blood pressure who need more than two full-dose medications, he explained.

“We are suggesting a completely different concept using much lower doses of the triple combination right from the beginning of treatment,” Dr. Rodgers explained. “Convenience and adherence will be an added advantage, but there’s more to it than that. It’s about combining the different mechanisms of three separate drug classes to get a better antihypertensive effect and being able to do this right from the start of treatment in patients with mildly elevated blood pressure, as well as those with higher levels.”

Proof-of-concept trials of this approach have been conducted, but no commercial low-dose triple-combination product has been available.

The George Institute is now developing such a product — through George Medicines, its commercial arm — with the aim of bringing the triple-combination pill to market in both high- and low-income countries. An approval submission has been filed in the United States.

Dr. Rodgers presented two studies that assessed the triple combination. One showed that the quarter dose reduced blood pressure significantly better than placebo in patients with mildly elevated blood pressure. The second showed that half and standard doses of the three medications were more effective at lowering blood pressure than three dual combinations at the same doses.
 

 

 

The VERONICA Trial

The triple combination was also assessed in the VERONICA study, which showed that among Black adults in Nigeria with uncontrolled hypertension, blood pressure was lower and control was better with the low-dose triple-combination pill than with standard care, and tolerability was good.

In VERONICA, recently published in JAMA, 300 patients with a mean baseline blood pressure of 151/97 mm Hg at home and 156/97 mm Hg in the clinic were randomly assigned to receive the triple-combination pill or standard care.

In the triple-combination group, patients started with the quarter-dose pill, then accelerated, as necessary, to the half-dose and standard-dose pills.

In the standard care group, patients started with amlodipine (5 mg), which was stepped up at monthly intervals so patients could achieve a target blood pressure < 140/90 mm Hg as follows: Amlodipine (5 mg) plus losartan (50 mg); then amlodipine (10 mg) plus losartan (100 mg); then amlodipine (10 mg), losartan (100 mg), plus hydrochlorothiazide (25 mg); and finally referral to a specialist if the target blood pressure was still not achieved.

At month 6, mean home systolic blood pressure was, on average, 31 mm Hg lower in the triple-combination group and 26 mm Hg lower in the standard care group (adjusted difference, −5.8 mm Hg; P < .001).

More patients in the triple-combination group than in the standard care group achieved clinic blood pressure control, defined as blood pressure < 140/90 mm Hg (82% vs 72%), and more patients achieved home blood pressure control, defined as blood pressure below 130/80 mm Hg (62% vs 28%).

No participants discontinued treatment due to adverse events, and adverse events of special interest were reported by just 2% and 3% patients in the triple-combination and standard care groups, respectively.

At month 6, however, more participants in the triple-combination group than in the standard care group had serum potassium levels < 3.5 mmol/L (34% vs 18%), although fewer participants in both the groups had potassium levels < 3.0 mmol/L (10% vs 5%).

Hypokalemia may be the consequence of low dietary potassium intake in Africa, and co-administration with potassium-enriched salt substitution should be evaluated, said Dike Ojji, MBBS, PhD, University of Abuja, Nigeria, who was the lead investigator of VERONICA.

“These findings have broad clinical and public health implications, given that improved hypertension control is a priority in Africa and globally. The results underscore the need for combination therapy to be the cornerstone of effective treatment regimens,” Dr. Ojji said.
 

Missed Targets

“It has taken a long time for the penny to drop as to why the existing antihypertensive treatment paradigm does not work so well,” Dr. Rodgers pointed out. “What tends to happen in clinical practice is that people start on one drug and blood pressure falls a bit, then no further action is taken. But this is not usually enough to get to target. With our approach of using three drugs at low doses straight away, we can often get the blood pressure controlled to target much more quickly with one tablet.”

Low doses of the triple-combination pill should also have a favorable adverse-effect profile and fewer drug interactions, as these issues are generally seen much more frequently with higher doses of drugs, he explained.

This low-dose triple-combination approach could help manage the current epidemic of hypertension and cardiometabolic disease, said Pam Taub, MD, director of preventive cardiology at UC San Diego Health System.

“We are in a new era of cardiometabolic disease, and one of the fundamental drivers of atherosclerotic cardiovascular disease is hypertension, which is prevalent in patients with diabetes, in those with obesity, and is a contributor to chronic kidney disease,” she said.

“We really need to be addressing hypertension very early to prevent this end-organ damage, but because hypertension tends to occur alongside multiple other comorbidities, patients are often on many different medications and are overwhelmed by the burden of polypharmacy.”

Dr. Taub described this triple-combination approach as “looking at hypertension treatment through a new lens.”

“We’ve always been taught to maximize the dose of one agent before we go to a new agent,” she said. “These studies are fundamentally challenging that paradigm. From a pathophysiological and mechanistic perspective, we are seeing that lower doses of different medications can really harness some unique synergistic mechanisms, which can be beneficial for patients.”

But not all experts are convinced that this approach will be a popular option in all countries.

Although this approach makes sense, in that the different agents work synergistically to give a better antihypertensive effect, many physicians could be uncomfortable with the idea of giving multiple medications straight off as the first step of treatment, said Eugene Yang, MD, from the University of Washington in Seattle.

If the patient develops a side effect, it will not be clear which medication is causing it, making it difficult to know which one to stop, he pointed out.

“These studies confirm that a low-dose multidrug-combination pill is effective at lowering blood pressure, but we already have previous studies showing this,” he added. “The issue is how we translate this into patient care. It would be great if we could get people to use it, but I think concerns from both clinicians and patients about identifying the source of any side effects may be a stumbling block.”

The approach is more likely to be adopted in low- to middle-income countries, where there is limited access to healthcare and where the population-wide control of blood pressure makes sense, said Dr. Yang.

Most current guidelines now recommend initiating therapy with two agents, ideally, as a single-pill combination product. “We have finally acknowledged that the vast majority of patients need two drugs. That’s a good starting point. This low-dose triple combination could be an interesting new approach,” said Neil Poulter, MD, professor of preventive cardiovascular medicine at Imperial College London, England.

This approach is in line with the idea that single-pill combinations are the way forward for hypertension therapy, he added.

“The triple combination is attractive, in that you are never quite sure which particular mechanism is driving an individual’s elevated blood pressure, so if you can target three different mechanisms at the same time, you’ve got more chance of a good hit,” Dr. Poulter said.

“The VERONICA trial showed a very good result on lowering BP using this low-dose triple combination as a starting point and increasing quickly to single-pill combinations of triple half doses, then triple full doses, as required. But I think we need more evidence on how this compares to current practice than just this one study in Africa to make this an acceptable routine approach on a global level,” he said.
 

 

 

QUADRO: Four-Drug Combo in Resistant Hypertension

Another scenario in which single-pill antihypertensive combinations could be particularly useful is at the other end of the spectrum: The treatment of patients with resistant hypertension.

The QUADRO study showed that a single pill containing perindopril, indapamide, amlodipine, and bisoprolol is better at lowering blood pressure than the triple combination of perindopril, indapamide, and amlodipine.

The primary endpoint — office sitting systolic blood pressure at 16 weeks — was 8 mm Hg lower with the quadruple combination than with the triple combination. And mean ambulatory 24-hour systolic blood pressure was 7.5 mm Hg lower with the four-drug combination.

This was the first study of a single-pill quadruple combination in patients with resistant hypertension, which is a “difficult-to-treat condition demanding a high number of pills with not enough safe and practical options,” said Stefano Taddei, MD, from the University of Pisa, Italy, when he presented the study at the ESC meeting.

Using “four well-established drugs in a single-combination pill may improve adherence and should be an innovative solution for resistant and difficult-to-treat hypertensive patients,” he said.

Nonadherence is a big problem in patients with resistant hypertension. “It is really difficult to get patients to take three or four antihypertensive agents along with all the other medications they have for other comorbidities,” Dr. Taub pointed out. “We really need to think about combination formulations that reduce the pill burden for our patients.”

Around 10% patients with hypertension may require a fourth drug, so a four-drug single-pill combination therefore makes good sense, said Dr. Poulter.

But the choice of the fourth drug is the subject of debate. The PATHWAY trial showed spironolactone to be the most effective fourth agent, but it can cause side effects, such as gynecomastia and hyperkalemia.

“The beta-blocker in the four-drug combination product used in the QUADRO study may not be as effective as spironolactone at lowering blood pressure,” Dr. Poulter explained, noting that beta-blockers have known side effects. However, “they are often already recommended for patients with very common comorbidities, such as arrhythmias, history of MI, heart failure, angina. In that regard, it makes sense to have a beta-blocker in there.”

The four-drug combination used in the QUADRO study led to a bigger reduction — by 8 mm Hg — than the three-drug combination. “That’s pretty good. I thought this was a very useful and interesting study,” he said.

There could be a role for a four-drug combination product in resistant hypertension. “Whatever we can do to improve adherence and reduce blood pressure is good thing,” said Dr. Yang.

However, a mineralocorticoid receptor antagonist (such as spironolactone) might be better as the fourth drug; that is what is recommended in the resistant hypertension algorithm.
 

Lower Blood Pressure, Better Outcomes

“What we are seeing in these trials is that across a wide spectrum of patients with hypertension or resistant hypertension, combination pills are superior to standard practice for BP lowering, and that will lead to improved outcomes,” said Dr. Taub.

“For years, such single-pill combinations have been viewed as ‘bad medicine’ in hypertension,” Dr. Poulter added. “That is clearly not the case, as these studies are showing. And single-pill combination therapies are used extensively in practically every other area of medicine. We are starting to accept them now in the blood pressure community, and I think the use of triple and quadruple combinations, as in these studies, has a real logic to it. But for this approach to be useful, these single-pill combinations must be made available, cheaply, across the world, especially in low- and middle-income countries where hypertension rates are a particular problem.”
 

A version of this article appeared on Medscape.com.

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Modified Sleep Apnea Index Score Associated With CV Risk

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Tue, 10/01/2024 - 15:08

Use of a modified sleep apnea index can identify cardiovascular risk factors in adults with moderate to severe obstructive sleep apnea (OSA), according to results from a new study presented at the American Academy of Otolaryngology–Head and Neck Surgery 2024 Annual Meeting.

The modified sleep apnea severity index (mSASI) combines patient anatomy, weight, sleep study metrics, and symptoms, to provide a more nuanced measure of OSA than the standard apnea-hypopnea index (AHI), said Jennifer A. Goldfarb, MHS, a medical student at Thomas Jefferson University, Philadelphia, Pennsylvania, who presented the findings.

OSA has an association with many negative cardiovascular comorbidities; however, “the AHI provides only a single metric and does not provide a holistic assessment of the individual patient’s disease severity,” said senior author Colin T. Huntley, MD, also of Thomas Jefferson University. 

“OSA is very complex, and having a robust system to assess the disease may be a better predictor of overall severity,” he told this news organization. 

Previous research has shown a correlation between mSASI and mean arterial pressure and serum C-reactive protein in OSA patients, but the connection with cardiovascular risk factors has not been well studied, Ms. Goldfarb noted. 

In the retrospective cohort study, Ms. Goldfarb and colleagues looked at mSASI scores from 260 CPAP-intolerant patients with OSA who underwent upper airway stimulation, maxillomandibular advancement, or expansion sphincter pharyngoplasty at a single sleep surgery clinic between 2014 and 2021. The mSASI uses a score of 1-3, with 3 as the highest level of OSA severity.

Cardiovascular risk factors were assessed at the patient’s initial evaluation by the sleep surgery team. They included coronary artery diseasetype 2 diabetesatrial fibrillationcongestive heart failurehypertension, and cerebrovascular accident

A total of 142 patients (55%) had an mSASI of 1; 91 (35%) had an mSASI of 2; and 27 (10%) had an mSASI of 3. At least one cardiovascular risk factor was present in 58%, 68%, and 63% of these groups, respectively (P = .3). 

Stratifying participants by mSASI scores, the researchers found that patients with an mSASI of 2 or 3 were significantly more likely than those with an mSASI of 1 to have more cardiovascular risk factors on initial presentation, and were significantly more likely to be diagnosed with hypertension (P = .02 for both). 

Using the AHI, however, patients with moderate to severe OSA (AHI > 15) had a similar number of cardiovascular risk factors as those with mild OSA (P > .05). 

“A higher mSASI score, which represents worse disease, was associated with a higher Framingham risk score, which supported our hypothesis; however, the AHI was not found to be associated with an increased Framingham score,” Dr. Huntley told this news organization.
 

Takeaways and Next Steps

These results suggest that the AHI, while a good metric, might not be the best tool for assessment of overall disease severity, given the complexity of OSA, the impact of the disease on patient quality of life, and the risk for downstream cardiovascular disease, said Dr. Huntley. 

The findings were limited by the retrospective design and use of data from a single center. 

Population-level data are needed to identify variables that may be meaningful to create a future tool that provides the best picture of the individual patient’s disease, he added. Additional prospective data are also needed to assess the impact of the scoring system on long-term treatment outcomes. 

“The current study is especially interesting as we are just beginning to understand the factors that predict cardiovascular risk for patients with obstructive sleep apnea,” Megan Durr, MD, of the University of California, San Francisco, said in an interview.

“For a long time, we primarily looked at the AHI and/or oxygen levels during sleep as risk factors, and we haven’t looked as much at other factors.” said Dr. Durr, who served as a moderator for the session in which the study was presented.

The current findings provide a more comprehensive look at cardiovascular risk; the inclusion of patient anatomy and symptoms add to the knowledge of this topic, and will lead to further work in this area, she added. 

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Huntley disclosed receiving research support from Nyxoah and Inspire, and serving as a consultant for Nyxoah, Inspire, and Avivomed. 

Dr. Durr had no financial conflicts to disclose. 
 

A version of this article appeared on Medscape.com.

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Use of a modified sleep apnea index can identify cardiovascular risk factors in adults with moderate to severe obstructive sleep apnea (OSA), according to results from a new study presented at the American Academy of Otolaryngology–Head and Neck Surgery 2024 Annual Meeting.

The modified sleep apnea severity index (mSASI) combines patient anatomy, weight, sleep study metrics, and symptoms, to provide a more nuanced measure of OSA than the standard apnea-hypopnea index (AHI), said Jennifer A. Goldfarb, MHS, a medical student at Thomas Jefferson University, Philadelphia, Pennsylvania, who presented the findings.

OSA has an association with many negative cardiovascular comorbidities; however, “the AHI provides only a single metric and does not provide a holistic assessment of the individual patient’s disease severity,” said senior author Colin T. Huntley, MD, also of Thomas Jefferson University. 

“OSA is very complex, and having a robust system to assess the disease may be a better predictor of overall severity,” he told this news organization. 

Previous research has shown a correlation between mSASI and mean arterial pressure and serum C-reactive protein in OSA patients, but the connection with cardiovascular risk factors has not been well studied, Ms. Goldfarb noted. 

In the retrospective cohort study, Ms. Goldfarb and colleagues looked at mSASI scores from 260 CPAP-intolerant patients with OSA who underwent upper airway stimulation, maxillomandibular advancement, or expansion sphincter pharyngoplasty at a single sleep surgery clinic between 2014 and 2021. The mSASI uses a score of 1-3, with 3 as the highest level of OSA severity.

Cardiovascular risk factors were assessed at the patient’s initial evaluation by the sleep surgery team. They included coronary artery diseasetype 2 diabetesatrial fibrillationcongestive heart failurehypertension, and cerebrovascular accident

A total of 142 patients (55%) had an mSASI of 1; 91 (35%) had an mSASI of 2; and 27 (10%) had an mSASI of 3. At least one cardiovascular risk factor was present in 58%, 68%, and 63% of these groups, respectively (P = .3). 

Stratifying participants by mSASI scores, the researchers found that patients with an mSASI of 2 or 3 were significantly more likely than those with an mSASI of 1 to have more cardiovascular risk factors on initial presentation, and were significantly more likely to be diagnosed with hypertension (P = .02 for both). 

Using the AHI, however, patients with moderate to severe OSA (AHI > 15) had a similar number of cardiovascular risk factors as those with mild OSA (P > .05). 

“A higher mSASI score, which represents worse disease, was associated with a higher Framingham risk score, which supported our hypothesis; however, the AHI was not found to be associated with an increased Framingham score,” Dr. Huntley told this news organization.
 

Takeaways and Next Steps

These results suggest that the AHI, while a good metric, might not be the best tool for assessment of overall disease severity, given the complexity of OSA, the impact of the disease on patient quality of life, and the risk for downstream cardiovascular disease, said Dr. Huntley. 

The findings were limited by the retrospective design and use of data from a single center. 

Population-level data are needed to identify variables that may be meaningful to create a future tool that provides the best picture of the individual patient’s disease, he added. Additional prospective data are also needed to assess the impact of the scoring system on long-term treatment outcomes. 

“The current study is especially interesting as we are just beginning to understand the factors that predict cardiovascular risk for patients with obstructive sleep apnea,” Megan Durr, MD, of the University of California, San Francisco, said in an interview.

“For a long time, we primarily looked at the AHI and/or oxygen levels during sleep as risk factors, and we haven’t looked as much at other factors.” said Dr. Durr, who served as a moderator for the session in which the study was presented.

The current findings provide a more comprehensive look at cardiovascular risk; the inclusion of patient anatomy and symptoms add to the knowledge of this topic, and will lead to further work in this area, she added. 

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Huntley disclosed receiving research support from Nyxoah and Inspire, and serving as a consultant for Nyxoah, Inspire, and Avivomed. 

Dr. Durr had no financial conflicts to disclose. 
 

A version of this article appeared on Medscape.com.

Use of a modified sleep apnea index can identify cardiovascular risk factors in adults with moderate to severe obstructive sleep apnea (OSA), according to results from a new study presented at the American Academy of Otolaryngology–Head and Neck Surgery 2024 Annual Meeting.

The modified sleep apnea severity index (mSASI) combines patient anatomy, weight, sleep study metrics, and symptoms, to provide a more nuanced measure of OSA than the standard apnea-hypopnea index (AHI), said Jennifer A. Goldfarb, MHS, a medical student at Thomas Jefferson University, Philadelphia, Pennsylvania, who presented the findings.

OSA has an association with many negative cardiovascular comorbidities; however, “the AHI provides only a single metric and does not provide a holistic assessment of the individual patient’s disease severity,” said senior author Colin T. Huntley, MD, also of Thomas Jefferson University. 

“OSA is very complex, and having a robust system to assess the disease may be a better predictor of overall severity,” he told this news organization. 

Previous research has shown a correlation between mSASI and mean arterial pressure and serum C-reactive protein in OSA patients, but the connection with cardiovascular risk factors has not been well studied, Ms. Goldfarb noted. 

In the retrospective cohort study, Ms. Goldfarb and colleagues looked at mSASI scores from 260 CPAP-intolerant patients with OSA who underwent upper airway stimulation, maxillomandibular advancement, or expansion sphincter pharyngoplasty at a single sleep surgery clinic between 2014 and 2021. The mSASI uses a score of 1-3, with 3 as the highest level of OSA severity.

Cardiovascular risk factors were assessed at the patient’s initial evaluation by the sleep surgery team. They included coronary artery diseasetype 2 diabetesatrial fibrillationcongestive heart failurehypertension, and cerebrovascular accident

A total of 142 patients (55%) had an mSASI of 1; 91 (35%) had an mSASI of 2; and 27 (10%) had an mSASI of 3. At least one cardiovascular risk factor was present in 58%, 68%, and 63% of these groups, respectively (P = .3). 

Stratifying participants by mSASI scores, the researchers found that patients with an mSASI of 2 or 3 were significantly more likely than those with an mSASI of 1 to have more cardiovascular risk factors on initial presentation, and were significantly more likely to be diagnosed with hypertension (P = .02 for both). 

Using the AHI, however, patients with moderate to severe OSA (AHI > 15) had a similar number of cardiovascular risk factors as those with mild OSA (P > .05). 

“A higher mSASI score, which represents worse disease, was associated with a higher Framingham risk score, which supported our hypothesis; however, the AHI was not found to be associated with an increased Framingham score,” Dr. Huntley told this news organization.
 

Takeaways and Next Steps

These results suggest that the AHI, while a good metric, might not be the best tool for assessment of overall disease severity, given the complexity of OSA, the impact of the disease on patient quality of life, and the risk for downstream cardiovascular disease, said Dr. Huntley. 

The findings were limited by the retrospective design and use of data from a single center. 

Population-level data are needed to identify variables that may be meaningful to create a future tool that provides the best picture of the individual patient’s disease, he added. Additional prospective data are also needed to assess the impact of the scoring system on long-term treatment outcomes. 

“The current study is especially interesting as we are just beginning to understand the factors that predict cardiovascular risk for patients with obstructive sleep apnea,” Megan Durr, MD, of the University of California, San Francisco, said in an interview.

“For a long time, we primarily looked at the AHI and/or oxygen levels during sleep as risk factors, and we haven’t looked as much at other factors.” said Dr. Durr, who served as a moderator for the session in which the study was presented.

The current findings provide a more comprehensive look at cardiovascular risk; the inclusion of patient anatomy and symptoms add to the knowledge of this topic, and will lead to further work in this area, she added. 

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Huntley disclosed receiving research support from Nyxoah and Inspire, and serving as a consultant for Nyxoah, Inspire, and Avivomed. 

Dr. Durr had no financial conflicts to disclose. 
 

A version of this article appeared on Medscape.com.

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Walking App Works Only if Users Think It Does

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Fri, 09/27/2024 - 11:37

 

TOPLINE:

Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.

METHODOLOGY:

  • Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
  • Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
  • SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
  • The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
  • Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.

TAKEAWAY:

  • Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
  • The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
  • Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
  • Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.

IN PRACTICE:

“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.

SOURCE:

The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.

LIMITATIONS:

The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.

DISCLOSURES:

The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.

METHODOLOGY:

  • Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
  • Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
  • SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
  • The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
  • Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.

TAKEAWAY:

  • Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
  • The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
  • Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
  • Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.

IN PRACTICE:

“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.

SOURCE:

The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.

LIMITATIONS:

The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.

DISCLOSURES:

The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.

METHODOLOGY:

  • Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
  • Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
  • SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
  • The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
  • Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.

TAKEAWAY:

  • Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
  • The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
  • Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
  • Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.

IN PRACTICE:

“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.

SOURCE:

The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.

LIMITATIONS:

The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.

DISCLOSURES:

The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Environmental, Metabolic Factors Driving Global Rise in Stroke

Article Type
Changed
Mon, 09/23/2024 - 13:39

Air pollution, high temperatures, and metabolic risk factors are driving global increases in stroke, contributing to 12 million cases and more than 7 million deaths from stroke each year, new data from the Global Burden of Disease (GBD) study showed.

Between 1990 and 2021, the number of people who experienced a stroke increased to 11.9 million (up by 70% since 1990), while the number of stroke survivors rose to 93.8 million (up by 86%), and stroke-related deaths rose to 7.3 million (up by 44%), making stroke the third leading cause of death worldwide after ischemic heart disease and COVID-19, investigators found.

Stroke is highly preventable, the investigators noted, with 84% of the stroke burden in 2021 attributable to 23 modifiable risk factors, including air pollution, excess body weight, high blood pressure, smoking, and physical inactivity.

This means there are “tremendous opportunities to alter the trajectory of stroke risk for the next generation,” Catherine O. Johnson, MPH, PhD, co-author and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, said in a news release.

The study was published online in The Lancet Neurology.
 

Top Risk Factor for Subarachnoid Hemorrhage

Since 1990, the contribution of high temperatures to poor health and early death due to stroke has risen 72%, a trend likely to increase in the future — underscoring the impact of environmental factors on the growing stroke burden, the authors said.

“Given that ambient air pollution is reciprocally linked with ambient temperature and climate change, the importance of urgent climate actions and measures to reduce air pollution cannot be overestimated,” Dr. Johnson said.

Mitchell S.V. Elkind, MD, MS, chief clinical science officer for the American Heart Association, who wasn’t involved in the study, told this news organization that environmental factors such as air pollution, particulate matter from wildfires and other sources, and excessive heat are now recognized as major contributors to the risk for stroke. “This should not be surprising as we have long recognized the risks of stroke associated with toxins in cigarette smoke, which likely share mechanisms for vascular damage with pollutants,” Dr. Elkind said.

The data also reveal for the first time that ambient particulate matter air pollution is a top risk factor for subarachnoid hemorrhage, contributing to 14% of the death and disability caused by this serious stroke subtype, on a par with smoking.

Dr. Elkind noted that smoking is “a major risk factor for subarachnoid hemorrhage. It makes sense that particulate air pollution would therefore similarly be a risk factor for subarachnoid hemorrhage, which similarly damages blood vessels. Prior studies were likely too small or did not assess the role of air pollution in subarachnoid hemorrhage.”

The analysis also showed substantial increases between 1990 and 2021 in the global stroke burden linked to high body mass index (up by 88%), high blood sugar (up 32%), a diet high in sugar-sweetened drinks (up 23%), low physical activity (up 11%), high systolic blood pressure (up 7%), and a diet low in omega-6 polyunsaturated fatty acids (up 5%).

“And with increasing exposure to risk factors such as high blood sugar and diet high in sugar-sweetened drinks, there is a critical need for interventions focused on obesity and metabolic syndromes,” Dr. Johnson said.

“Identifying sustainable ways to work with communities to take action to prevent and control modifiable risk factors for stroke is essential to address this growing crisis,” she added.
 

 

 

Prevention Strategies Fall Short

The data also showed that stroke-related disability-adjusted life-years rose from around 121.4 million years of healthy life lost in 1990 to 160.5 million years in 2021, making stroke the fourth leading cause of health loss worldwide after COVID-19, ischemic heart disease, and neonatal disorders.

“The global growth of the number of people who develop stroke and died from or remain disabled by stroke is growing fast, strongly suggesting that currently used stroke prevention strategies are not sufficiently effective,” lead author Valery L. Feigin, MD, PhD, from Auckland University of Technology, Auckland, New Zealand, and affiliate professor at IHME, said in the release.

“New, proven effective population-wide and motivational individual prevention strategies that could be applied to all people at risk of having a stroke, regardless of the level of risk, as recommended in the recent Lancet Neurology Commission on Stroke should be implemented across the globe urgently,” said Dr. Feigin.

Dr. Elkind said the AHA supports research on the effects of air quality on risk for vascular injury and stroke and has “long advocated for policies to mitigate the adverse health impacts of air pollutants, including reduction of vehicle emissions and renewable portfolio standards, taking into account racial, ethnic, and economic disparities.”

“AHA, and the healthcare sector more broadly, must take a leadership role in recommending policies to improve environmental air quality and in working with the private sector and industry to improve air quality,” Dr. Elkind said.

In an accompanying commentary, Ming Liu, MD, and Simiao Wu, MD, PhD, West China Hospital, Sichuan University, Chengdu, China, wrote that “pragmatic solutions to the enormous and increasing stroke burden include surveillance, prevention, acute care, and rehabilitation.”

“Surveillance strategies include establishing a national-level framework for regular monitoring of stroke burden, risk factors, and healthcare services via community-based surveys and health records,” they noted.

“Artificial intelligence and mobile technologies might not only facilitate the dissemination of evidence-based health services but also increase the number of data sources and encourage participation of multidisciplinary collaborators, potentially improving the validity and accuracy of future GBD estimates,” they added.

This study was funded by the Bill & Melinda Gates Foundation. Author disclosures are listed with the original article.

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

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Air pollution, high temperatures, and metabolic risk factors are driving global increases in stroke, contributing to 12 million cases and more than 7 million deaths from stroke each year, new data from the Global Burden of Disease (GBD) study showed.

Between 1990 and 2021, the number of people who experienced a stroke increased to 11.9 million (up by 70% since 1990), while the number of stroke survivors rose to 93.8 million (up by 86%), and stroke-related deaths rose to 7.3 million (up by 44%), making stroke the third leading cause of death worldwide after ischemic heart disease and COVID-19, investigators found.

Stroke is highly preventable, the investigators noted, with 84% of the stroke burden in 2021 attributable to 23 modifiable risk factors, including air pollution, excess body weight, high blood pressure, smoking, and physical inactivity.

This means there are “tremendous opportunities to alter the trajectory of stroke risk for the next generation,” Catherine O. Johnson, MPH, PhD, co-author and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, said in a news release.

The study was published online in The Lancet Neurology.
 

Top Risk Factor for Subarachnoid Hemorrhage

Since 1990, the contribution of high temperatures to poor health and early death due to stroke has risen 72%, a trend likely to increase in the future — underscoring the impact of environmental factors on the growing stroke burden, the authors said.

“Given that ambient air pollution is reciprocally linked with ambient temperature and climate change, the importance of urgent climate actions and measures to reduce air pollution cannot be overestimated,” Dr. Johnson said.

Mitchell S.V. Elkind, MD, MS, chief clinical science officer for the American Heart Association, who wasn’t involved in the study, told this news organization that environmental factors such as air pollution, particulate matter from wildfires and other sources, and excessive heat are now recognized as major contributors to the risk for stroke. “This should not be surprising as we have long recognized the risks of stroke associated with toxins in cigarette smoke, which likely share mechanisms for vascular damage with pollutants,” Dr. Elkind said.

The data also reveal for the first time that ambient particulate matter air pollution is a top risk factor for subarachnoid hemorrhage, contributing to 14% of the death and disability caused by this serious stroke subtype, on a par with smoking.

Dr. Elkind noted that smoking is “a major risk factor for subarachnoid hemorrhage. It makes sense that particulate air pollution would therefore similarly be a risk factor for subarachnoid hemorrhage, which similarly damages blood vessels. Prior studies were likely too small or did not assess the role of air pollution in subarachnoid hemorrhage.”

The analysis also showed substantial increases between 1990 and 2021 in the global stroke burden linked to high body mass index (up by 88%), high blood sugar (up 32%), a diet high in sugar-sweetened drinks (up 23%), low physical activity (up 11%), high systolic blood pressure (up 7%), and a diet low in omega-6 polyunsaturated fatty acids (up 5%).

“And with increasing exposure to risk factors such as high blood sugar and diet high in sugar-sweetened drinks, there is a critical need for interventions focused on obesity and metabolic syndromes,” Dr. Johnson said.

“Identifying sustainable ways to work with communities to take action to prevent and control modifiable risk factors for stroke is essential to address this growing crisis,” she added.
 

 

 

Prevention Strategies Fall Short

The data also showed that stroke-related disability-adjusted life-years rose from around 121.4 million years of healthy life lost in 1990 to 160.5 million years in 2021, making stroke the fourth leading cause of health loss worldwide after COVID-19, ischemic heart disease, and neonatal disorders.

“The global growth of the number of people who develop stroke and died from or remain disabled by stroke is growing fast, strongly suggesting that currently used stroke prevention strategies are not sufficiently effective,” lead author Valery L. Feigin, MD, PhD, from Auckland University of Technology, Auckland, New Zealand, and affiliate professor at IHME, said in the release.

“New, proven effective population-wide and motivational individual prevention strategies that could be applied to all people at risk of having a stroke, regardless of the level of risk, as recommended in the recent Lancet Neurology Commission on Stroke should be implemented across the globe urgently,” said Dr. Feigin.

Dr. Elkind said the AHA supports research on the effects of air quality on risk for vascular injury and stroke and has “long advocated for policies to mitigate the adverse health impacts of air pollutants, including reduction of vehicle emissions and renewable portfolio standards, taking into account racial, ethnic, and economic disparities.”

“AHA, and the healthcare sector more broadly, must take a leadership role in recommending policies to improve environmental air quality and in working with the private sector and industry to improve air quality,” Dr. Elkind said.

In an accompanying commentary, Ming Liu, MD, and Simiao Wu, MD, PhD, West China Hospital, Sichuan University, Chengdu, China, wrote that “pragmatic solutions to the enormous and increasing stroke burden include surveillance, prevention, acute care, and rehabilitation.”

“Surveillance strategies include establishing a national-level framework for regular monitoring of stroke burden, risk factors, and healthcare services via community-based surveys and health records,” they noted.

“Artificial intelligence and mobile technologies might not only facilitate the dissemination of evidence-based health services but also increase the number of data sources and encourage participation of multidisciplinary collaborators, potentially improving the validity and accuracy of future GBD estimates,” they added.

This study was funded by the Bill & Melinda Gates Foundation. Author disclosures are listed with the original article.

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

Air pollution, high temperatures, and metabolic risk factors are driving global increases in stroke, contributing to 12 million cases and more than 7 million deaths from stroke each year, new data from the Global Burden of Disease (GBD) study showed.

Between 1990 and 2021, the number of people who experienced a stroke increased to 11.9 million (up by 70% since 1990), while the number of stroke survivors rose to 93.8 million (up by 86%), and stroke-related deaths rose to 7.3 million (up by 44%), making stroke the third leading cause of death worldwide after ischemic heart disease and COVID-19, investigators found.

Stroke is highly preventable, the investigators noted, with 84% of the stroke burden in 2021 attributable to 23 modifiable risk factors, including air pollution, excess body weight, high blood pressure, smoking, and physical inactivity.

This means there are “tremendous opportunities to alter the trajectory of stroke risk for the next generation,” Catherine O. Johnson, MPH, PhD, co-author and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, said in a news release.

The study was published online in The Lancet Neurology.
 

Top Risk Factor for Subarachnoid Hemorrhage

Since 1990, the contribution of high temperatures to poor health and early death due to stroke has risen 72%, a trend likely to increase in the future — underscoring the impact of environmental factors on the growing stroke burden, the authors said.

“Given that ambient air pollution is reciprocally linked with ambient temperature and climate change, the importance of urgent climate actions and measures to reduce air pollution cannot be overestimated,” Dr. Johnson said.

Mitchell S.V. Elkind, MD, MS, chief clinical science officer for the American Heart Association, who wasn’t involved in the study, told this news organization that environmental factors such as air pollution, particulate matter from wildfires and other sources, and excessive heat are now recognized as major contributors to the risk for stroke. “This should not be surprising as we have long recognized the risks of stroke associated with toxins in cigarette smoke, which likely share mechanisms for vascular damage with pollutants,” Dr. Elkind said.

The data also reveal for the first time that ambient particulate matter air pollution is a top risk factor for subarachnoid hemorrhage, contributing to 14% of the death and disability caused by this serious stroke subtype, on a par with smoking.

Dr. Elkind noted that smoking is “a major risk factor for subarachnoid hemorrhage. It makes sense that particulate air pollution would therefore similarly be a risk factor for subarachnoid hemorrhage, which similarly damages blood vessels. Prior studies were likely too small or did not assess the role of air pollution in subarachnoid hemorrhage.”

The analysis also showed substantial increases between 1990 and 2021 in the global stroke burden linked to high body mass index (up by 88%), high blood sugar (up 32%), a diet high in sugar-sweetened drinks (up 23%), low physical activity (up 11%), high systolic blood pressure (up 7%), and a diet low in omega-6 polyunsaturated fatty acids (up 5%).

“And with increasing exposure to risk factors such as high blood sugar and diet high in sugar-sweetened drinks, there is a critical need for interventions focused on obesity and metabolic syndromes,” Dr. Johnson said.

“Identifying sustainable ways to work with communities to take action to prevent and control modifiable risk factors for stroke is essential to address this growing crisis,” she added.
 

 

 

Prevention Strategies Fall Short

The data also showed that stroke-related disability-adjusted life-years rose from around 121.4 million years of healthy life lost in 1990 to 160.5 million years in 2021, making stroke the fourth leading cause of health loss worldwide after COVID-19, ischemic heart disease, and neonatal disorders.

“The global growth of the number of people who develop stroke and died from or remain disabled by stroke is growing fast, strongly suggesting that currently used stroke prevention strategies are not sufficiently effective,” lead author Valery L. Feigin, MD, PhD, from Auckland University of Technology, Auckland, New Zealand, and affiliate professor at IHME, said in the release.

“New, proven effective population-wide and motivational individual prevention strategies that could be applied to all people at risk of having a stroke, regardless of the level of risk, as recommended in the recent Lancet Neurology Commission on Stroke should be implemented across the globe urgently,” said Dr. Feigin.

Dr. Elkind said the AHA supports research on the effects of air quality on risk for vascular injury and stroke and has “long advocated for policies to mitigate the adverse health impacts of air pollutants, including reduction of vehicle emissions and renewable portfolio standards, taking into account racial, ethnic, and economic disparities.”

“AHA, and the healthcare sector more broadly, must take a leadership role in recommending policies to improve environmental air quality and in working with the private sector and industry to improve air quality,” Dr. Elkind said.

In an accompanying commentary, Ming Liu, MD, and Simiao Wu, MD, PhD, West China Hospital, Sichuan University, Chengdu, China, wrote that “pragmatic solutions to the enormous and increasing stroke burden include surveillance, prevention, acute care, and rehabilitation.”

“Surveillance strategies include establishing a national-level framework for regular monitoring of stroke burden, risk factors, and healthcare services via community-based surveys and health records,” they noted.

“Artificial intelligence and mobile technologies might not only facilitate the dissemination of evidence-based health services but also increase the number of data sources and encourage participation of multidisciplinary collaborators, potentially improving the validity and accuracy of future GBD estimates,” they added.

This study was funded by the Bill & Melinda Gates Foundation. Author disclosures are listed with the original article.

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

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