Polypill strategy may help improve outcomes, adherence in underserved populations
The researchers said that the observed reductions in systolic blood pressure and LDL cholesterol level were clinically and statistically significant and, if sustained, would lead to an estimated 25% reduction in cardiovascular event incidence.
A polypill-based strategy led to greater reductions in systolic blood pressure and LDL cholesterol levels than usual care in a study of patients at a federally qualified community health center in Alabama.
In the randomized, controlled trial, researchers assigned adults without cardiovascular disease to a control group of usual care or to a polypill group that received a pill containing atorvastatin, 10 mg; amlodipine, 2.5 mg; losartan, 25 mg; and hydrochlorothiazide, 12.5 mg. The trial's two primary outcomes were changes from baseline in systolic blood pressure and LDL cholesterol level at 12 months.
From December 2015 through July 2017, 303 participants were randomized, 148 to the polypill group and 155 to a usual care group. Ninety-six percent of participants were black, 60% were women, and the mean age was 56 years. Three-quarters of participants had an annual income below $15,000. Mean estimated 10-year cardiovascular risk was 12.7%, baseline blood pressure was 140/83 mm Hg, and baseline LDL cholesterol level was 113 mg/dL. Monthly cost of the polypill was $26, and adherence was assessed by pill counts. Results of the study were published by the New England Journal of Medicine on Sept. 19.
At 12 months, adherence to the polypill regimen was 86%. Mean systolic blood pressure decreased by 9 mm Hg in the polypill group and by 2 mm Hg in the usual care group (difference, −7 mm Hg; 95% CI, −12 to −2 mm Hg; P=0.003). Mean LDL cholesterol level decreased by 15 mg/dL in the polypill group versus 4 mg/dL in the usual care group (difference, −11 mg/dL; 95% CI, −18 to −5 mg/dL; P<0.001). Net difference in diastolic blood pressure between the polypill group and the usual care group was −3 mm Hg (95% CI, −5 to −1 mm Hg), and net difference in total cholesterol level was −11 mg/dL (95% CI, −19 to −3 mg/dL).
The researchers said that the observed reductions in systolic blood pressure and LDL cholesterol level were clinically and statistically significant and estimated that such changes, if sustained, would lead to a 25% reduction in the incidence of cardiovascular events. “We recognize that a ‘one size fits all’ approach to cardiovascular disease prevention runs counter to current trends in precision medicine, in which clinical, genomic, and lifestyle factors are used for the development of individualized treatment strategies,” they wrote. However, they countered that a broader approach may benefit patients who face barriers to accessing the full advantages of precision medicine due to lack of income, underinsurance, and other factors.
“Thus, the simplicity and low cost of the polypill regimen make this approach attractive when such barriers are common,” the researchers wrote. “It is important to emphasize that use of the polypill does not preclude individualized, add-on therapies for residual elevations in blood-pressure or cholesterol levels, as judged by a patient's physician.”