In the Journals

Polypill strategy effective in US socioeconomically disadvantaged population

Among a U.S. population of socioeconomically disadvantaged adults, a polypill-based strategy was associated with greater reductions in systolic BP and LDL compared with the usual care, according to findings published in The New England Journal of Medicine.

According to the study background, while the polypill strategy has been researched in low-income countries, there are few data on its effectiveness in underserved U.S. communities, which tend to have low adherence to guideline-based therapies and high rates of CVD.

“Patients face a variety of barriers to getting the care they need,” Daniel Muñoz, MD, MPA, assistant professor of cardiology at Vanderbilt University Medical Center in Nashville, Tennessee, said in a press release. “Those barriers can include cost and complexity of medication regimens, so innovative strategies are needed to improve the delivery of preventive care, especially when it comes to socioeconomically vulnerable individuals.”

Muñoz and colleagues performed a randomized controlled trial funded by the American Heart Association Strategically Focused Prevention Research Network and the NIH in which 303 adults without CVD (mean age, 56 years; 40% men; 96% black) from the Southern Community Cohort Study living within 50 miles of the Franklin Primary Health Center in Mobile, Alabama, were assigned a polypill consisting of atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg and hydrochlorothiazide 12.5 mg or the usual care.

The primary outcomes were changes in systolic BP and LDL at 12 months.

According to the researchers, three-quarters of the cohort had an annual income of less than $15,000, the mean estimated 10-year CVD risk was 12.7%, baseline BP was 140/83 mm Hg and baseline LDL was 113 mg/dL. The polypill cost $26 per month and its adherence rate was 86%.

The polypill group had a decrease in systolic BP of 9 mm Hg at 12 months vs. a decrease of 2 mm Hg for the control group (difference, –7 mm Hg; 95% CI, –12 to –2), Muñoz and colleagues wrote.

Mean LDL fell 15 mg/dL in the polypill group at 12 months compared with a drop of 4 mg/dL in the control group (difference, –11 mg/dL; 95% CI, –18 to –5), according to the researchers.

A sensitivity analysis using multiple imputation did not change the results.

“On the basis of meta-analyses of cardiovascular outcomes trials in primary prevention, we estimate that such changes, if sustained, would lead to an approximately 25% reduction in the incidence of cardiovascular events,” Muñoz and colleagues wrote.

Muñoz said in the release that “simple strategies like the polypill may offer key advantages for patients who face barriers to accessing medical care. Simplicity is a big advantage of the polypill. It’s once daily; easy to understand; and doesn’t require adjustment. Patients are more likely to take their medications as prescribed, which is good for them and their front-line providers.” – by Erik Swain

Disclosures: Muñoz reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

Among a U.S. population of socioeconomically disadvantaged adults, a polypill-based strategy was associated with greater reductions in systolic BP and LDL compared with the usual care, according to findings published in The New England Journal of Medicine.

According to the study background, while the polypill strategy has been researched in low-income countries, there are few data on its effectiveness in underserved U.S. communities, which tend to have low adherence to guideline-based therapies and high rates of CVD.

“Patients face a variety of barriers to getting the care they need,” Daniel Muñoz, MD, MPA, assistant professor of cardiology at Vanderbilt University Medical Center in Nashville, Tennessee, said in a press release. “Those barriers can include cost and complexity of medication regimens, so innovative strategies are needed to improve the delivery of preventive care, especially when it comes to socioeconomically vulnerable individuals.”

Muñoz and colleagues performed a randomized controlled trial funded by the American Heart Association Strategically Focused Prevention Research Network and the NIH in which 303 adults without CVD (mean age, 56 years; 40% men; 96% black) from the Southern Community Cohort Study living within 50 miles of the Franklin Primary Health Center in Mobile, Alabama, were assigned a polypill consisting of atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg and hydrochlorothiazide 12.5 mg or the usual care.

The primary outcomes were changes in systolic BP and LDL at 12 months.

According to the researchers, three-quarters of the cohort had an annual income of less than $15,000, the mean estimated 10-year CVD risk was 12.7%, baseline BP was 140/83 mm Hg and baseline LDL was 113 mg/dL. The polypill cost $26 per month and its adherence rate was 86%.

The polypill group had a decrease in systolic BP of 9 mm Hg at 12 months vs. a decrease of 2 mm Hg for the control group (difference, –7 mm Hg; 95% CI, –12 to –2), Muñoz and colleagues wrote.

Mean LDL fell 15 mg/dL in the polypill group at 12 months compared with a drop of 4 mg/dL in the control group (difference, –11 mg/dL; 95% CI, –18 to –5), according to the researchers.

A sensitivity analysis using multiple imputation did not change the results.

“On the basis of meta-analyses of cardiovascular outcomes trials in primary prevention, we estimate that such changes, if sustained, would lead to an approximately 25% reduction in the incidence of cardiovascular events,” Muñoz and colleagues wrote.

Muñoz said in the release that “simple strategies like the polypill may offer key advantages for patients who face barriers to accessing medical care. Simplicity is a big advantage of the polypill. It’s once daily; easy to understand; and doesn’t require adjustment. Patients are more likely to take their medications as prescribed, which is good for them and their front-line providers.” – by Erik Swain

Disclosures: Muñoz reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.