A single pill containing low doses of three medications to treat high blood pressure and one to lower cholesterol reduced the estimated risk of cardiovascular disease by 25% in a study published today in the New England Journal of Medicine (NEJM).
"Polypills" for prevention of cardiovascular disease have previously been studied in low- and middle-income countries where other health care barriers exist, according to senior author Thomas Wang, MD, chief of the Division of Cardiovascular Medicine at Vanderbilt University Medical Center (VUMC).
But the U.S. study released today of mostly low income, primarily black adults from a community health center in Mobile, Alabama, sets up a conversation about how to extend these findings to other settings.
"The pill may address some of the barriers that contribute to disparities in health based on geography, socioeconomic class and other parameters that we know have existed in this country and other countries for a while now," Wang said. "Despite advances in the prevention and treatment of cardiovascular disease, it remains the No. 1 global killer of both men and women."
The randomized, controlled trial of adults without cardiovascular disease enrolled 303 adults - 96% black, 60% female and 75% with an annual income below $15,000 - with half assigned to take a daily polypill for 12 months and the other half assigned to continue their usual routine medical care. Half of the study participants came from the Southern Community Cohort Study, co-led by William Blot, PhD, a research professor of Medicine at VUMC and co-senior author of this study. Adherence was 86% after one year, based on pill counts.
Participants underwent a standard medical exam, blood pressure measurement, and blood cholesterol testing during their initial visit, a two-month visit, and a 12-month visit.
At the end of the year, study participants who had taken the polypill had decreased blood pressure by an average of 7 mm Hg and reduced LDL cholesterol levels as compared with participants in the usual care group, translating to an estimated 25% reduction in the risk of experiencing a cardiovascular event.
"Patients seeking care at community health centers have traditionally been under-represented in clinical trials. We need to better understand what works and what doesn't in these settings so we can improve outcomes for our fellow citizens who may be the most vulnerable," said lead author Daniel Muñoz, MD, a cardiologist at VUMC.
"We think there are advantages to combining population-based strategies like the polypill with all of the virtues of precision medicine. It is a running start for people who need access to some medical care, but precision medicine should still be used to add therapy and adjust therapy."
The study was funded by the American Heart Association Strategically Focused Prevention Research Network and the National Institutes of Health; ClinicalTrials.gov number NCT02278471.
New England Journal of Medicine