Compared with usual care, a polypill regimen led to greater reductions in systolic blood pressure and low-density lipoprotein cholesterol (LDL-C) level in socioeconomically vulnerable minority patients, according to study results published in The New England Journal of Medicine.
The study included adult participants without cardiovascular disease (N=303). Participants were randomly assigned to the polypill group or to usual care at a community health center in Alabama. The polypill consisted of 10 mg atorvastatin, 2.5 mg amlodipine, 25 mg losartan, and 12.5 mg hydrochlorothiazide. The study’s primary outcomes were the changes from baseline in systolic blood pressure and LDL-C level at 12 months.
Of 303 participants, 96% were black and 75% had an annual household income <$15,000. At baseline, overall mean estimated 10-year cardiovascular risk was 12.7%, blood pressure was 140/83 mm Hg, and LDL-C level was 113 mg/dL.
Using pill counts, the researchers found that adherence to the polypill regimen was 86% at 12 months. The monthly cost of the regimen was $26 per patient.
At follow-up, the polypill group had a 9-mm Hg decrease in mean systolic blood pressure compared with a 2-mm Hg decrease for the usual care group (difference, -7 mm Hg; 95% CI, -12 to -2 mm Hg; P =.003).
In the polypill group, the mean LDL-C level decreased by 15 mg/dL vs 4 mg/dL in the usual care group (difference, -11 mg/dL; 95% CI, -18 to -5 mg/dL; P <.001).
The study included several limitations, included its open-label design and its setting in a single community health center.
“We recognize that a “one size fits all” approach to cardiovascular disease prevention runs counter to current trends in precision medicine… Although the precision approach has clear virtues, a broader approach may benefit patients who face barriers to accessing the full advantages of precision medicine,” the researchers wrote.
Muñoz D, Uzoije P, Reynolds C, et al. Polypill for cardiovascular disease prevention in an underserved population. N Engl J Med. 2019;381:1114-1123.