• Daniel Muñoz, Prince Uzoije, Cassandra Reynolds, Roslynn Miller, David Walkley, Susan Pappalardo, Phyllis Tousey, Heather Munro, Holly Gonzales, Wenliang Song, Charles White, William J Blot, and Thomas J Wang.
• From the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
• N. Engl. J. Med. 2019 Sep 19; 381 (12): 1114-1123.

BackgroundPersons with low socioeconomic status and nonwhite persons in the United States have high rates of cardiovascular disease. The use of combination pills (also called "polypills") containing low doses of medications with proven benefits for the prevention of cardiovascular disease may be beneficial in such persons. However, few data are available regarding the use of polypill therapy in underserved communities in the United States, in which adherence to guideline-based care is generally low.MethodsWe conducted a randomized, controlled trial involving adults without cardiovascular disease. Participants were assigned to the polypill group or the usual-care group at a federally qualified community health center in Alabama. Components of the polypill were atorvastatin (at a dose of 10 mg), amlodipine (2.5 mg), losartan (25 mg), and hydrochlorothiazide (12.5 mg). The two primary outcomes were the changes from baseline in systolic blood pressure and low-density lipoprotein (LDL) cholesterol level at 12 months.ResultsThe trial enrolled 303 adults, of whom 96% were black. Three quarters of the participants had an annual income below $15,000. The mean estimated 10-year cardiovascular risk was 12.7%, the baseline blood pressure was 140/83 mm Hg, and the baseline LDL cholesterol level was 113 mg per deciliter. The monthly cost of the polypill was $26. At 12 months, adherence to the polypill regimen, as assessed on the basis of pill counts, was 86%. The mean systolic blood pressure decreased by 9 mm Hg in the polypill group, as compared with 2 mm Hg in the usual-care group (difference, -7 mm Hg; 95% confidence interval [CI], -12 to -2; P = 0.003). The 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<0.001).ConclusionsA 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. (Funded by the American Heart Association Strategically Focused Prevention Research Network and the National Institutes of Health; ClinicalTrials.gov number, NCT02278471.).Copyright © 2019 Massachusetts Medical Society.

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