Nashville, TN—Using a polypill containing low doses of three medications to reduce blood pressure and cholesterol instead of separate prescriptions reduced the risk of cardiovascular disease by 25% in a cohort of mostly low income, primarily African American adults.

The report, published in the New England Journal of Medicine (NEJM), focused on the benefits of “polypills” for prevention of cardiovascular disease. The combination medications previously were studied in low- and middle-income countries where other healthcare barriers exist, according to the authors.

Vanderbilt University Medical Center–led researchers measured the benefits in participants from a community health center in Mobile, Alabama. Researchers said they posited that a polypill would be beneficial for three reasons:
• The simplicity of using a daily pill might improve adherence to therapy
• The elimination of requirements for dose adjustment might be useful in settings in which frequent follow-up visits are impractical
• For blood-pressure control, the combination of multiple low-dose medications rather than the use of one or two higher-dose medications might improve the safety profile because side effects are often dose-dependent.

“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,” explained senior author Thomas Wang, MD, chief of the Division of Cardiovascular Medicine at Vanderbilt University Medical Center (VUMC).

Background information in the article notes that, in the United States, rates of cardiovascular disease are higher in those with low socioeconomic status and in those who are nonwhite, yet little data are available on the use of polypill therapy in underserved communities where adherence to guideline-based care is generally low.

To see if they could remedy that, researchers conducted a randomized, controlled trial involving adults without cardiovascular disease. Participants were assigned to the polypill group—receiving a combination of atorvastatin (at a dose of 10 mg), amlodipine (2.5 mg), losartan (25 mg), and hydrochlorothiazide (12.5 mg) at a cost of $26 a month—or the usual-care group. Defined as the two primary outcomes were the changes from baseline in systolic blood pressure and LDL cholesterol level at 12 months.

Nearly all, 96%, of the patients were black, and three-quarters of them had an annual income below $15,000. The authors note that, among the group, the mean estimated 10-year cardiovascular risk was 12.7%, the baseline blood pressure was 140/83 mmHg, and the baseline LDL cholesterol level was 113 mg per deciliter.

Results indicate that at 12 months, adherence to the polypill regimen, measured based on pill counts, was 86%, which led to a range of benefits. Among those, according to the study team, was that mean systolic blood pressure decreased by 9 mmHg in the polypill group versus 2 mmHg in the usual-care group (difference, -7 mmHg; 95% CI, -12 to -2; P = .003), and mean LDL cholesterol level decreased by 15 mg per deciliter in the polypill group, as compared with 4 mg per deciliter in the usual-care group (difference, -11 mg per deciliter; 95% CI, -18 to -5; P <.001).

“A polypill-based strategy led to greater reductions in systolic blood pressure and LDL cholesterol level than were observed with usual care in a socioeconomically vulnerable minority population,” the authors conclude. “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.”

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