1. In this randomized, controlled trial, patients without cardiovascular disease randomized to receive a polypill containing atorvastatin, amlodipine, losartan, and hydrochlorothiazide experienced greater reductions in systolic blood pressure and low-density lipoprotein (LDL) cholesterol over 12 months compared to patients who received usual-care.
2. Polypill patients reported increased rates of myalgia, hypotension, and lightheadedness.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Disadvantaged patients, including those with low socioeconomic status and minority populations, experience high rates of cardiovascular disease. Polypill-based therapy has not been well-studied in these underserved populations. This trial evaluated two primary endpoints: change in systolic blood pressure and change in LDL cholesterol. Compared to patients treated with usual care, patients on polypill therapy experienced greater decreases in both systolic blood pressure and in LDL cholesterol over 12 months of follow-up. Secondary endpoints, including change in diastolic blood pressure and total cholesterol, were also found to have greater decreases in polypill patients compared to usual-care patients. Compared to the usual-care group, the polypill group experienced higher rates of myalgia, hypotension, and lightheadedness.
This randomized, controlled trial provides evidence that polypill therapy may improve cardiovascular outcomes in underserved patients. Limitations include the study’s open-label design and selection of participants from one community health center.
In-Depth [randomized controlled trial]: This open-label, randomized, controlled trial enrolled 303 participants (96% black; ¾ of participants with annual household income <$15,000) near Mobile, Alabama between December 2015 and July 2017. Eligible patients were 45-75 years of age, had no cardiovascular disease, and took ≤2 antihypertensive medications. Patients who did not complete a clinical questionnaire or clinical examination were excluded. Patients who were randomized to the polypill group (n=148) received 90-day refillable supplies of a polypill consisting of atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg. Those randomized to the usual-care group (n=155) received routine care at the study’s health center in addition to continued care from their primary care physicians. Patients were followed-up at 2 months and 12 months for clinical and laboratory evaluations, with 275 participants (91%) completing the study. Adherence was measured using pill counts. Overall baseline blood pressure was 140/83 mm Hg, and overall baseline LDL cholesterol was 113 mg/dL. The polypill group experienced a decrease of 9 mm Hg in mean systolic blood pressure, compared to 2 mm Hg in the usual-care group (difference, -7 mm Hg; 95% confidence interval [CI], -12 to -2; P=0.003). Polypill patients experienced a decrease of 15 mg/dL in mean LDL cholesterol, compared to 4 mg/dL in the usual-care group (difference, -11 mg/dL; 95% CI, -18 to -5; P<0.001). Secondary outcomes included changes in diastolic blood pressure and changes in total cholesterol. Polypill patients experienced a -3 mm Hg greater decrease in diastolic blood pressure (95% CI, -5 to -1) and a -11 mg/dL greater decrease in total cholesterol (95% CI, -19 to -3) compared to usual-care patients. Median polypill adherence was found to be 86%. All five reported serious adverse events were found to be unrelated to the trial. The polypill group experienced a 1% rate of myalgias and a 1% rate of hypotension or lightheadedness.
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