Polypill for cardiovascular disease prevention in an underserved population

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, Thomas J. Wang

Research output: Contribution to journalArticlepeer-review

41 Scopus citations

Abstract

BACKGROUND Persons 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. METHODS We 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. RESULTS The 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). CONCLUSIONS 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.

Original languageEnglish (US)
Pages (from-to)1114-1123
Number of pages10
JournalNew England Journal of Medicine
Volume381
Issue number12
DOIs
StatePublished - Sep 19 2019
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

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