Log in to MyACC
Polypill for CV Disease Prevention in an Underserved Population
Study Questions:
What is the value of the “polypill” for reduction in cardiovascular (CV) risk factors in nonwhites with a low socioeconomic status?
Methods:
The randomized, open-labeled, controlled trial was conducted in 303 adults without CV 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 (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 (SBP) and low-density lipoprotein cholesterol (LDL-C) level at 12 months.
Results:
The trial enrolled 303 adults, of whom 96% were black, mean age 56 (6) years, 40% men, mean body mass index (BMI) 30 (8) kg/m2, and 91% completed the trial. Three quarters of the participants had an annual income below $15,000. The mean estimated 10-year CV risk was 12.7%, baseline BP 140/83 mm Hg with 43% stage 2 or higher, and baseline LDL-C 113 mg/dl. At baseline, each had normal potassium renal function, 54% were on 1 or more antihypertensive drugs, and 17% a statin. The monthly cost of the polypill was $26. At 12 months, adherence to the polypill regimen based on pill counts was 86% (interquartile range, 79-93). In the polypill group, clinicians reduced doses of other antihypertensive or lipid-lowering medications or discontinued their use in 44% of the patients, and 10% of the usual-care group had dose escalation. Mean SBP 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). Mean LDL-C decreased by 15 mg/dl in the polypill group, as compared with 4 mg/dl in the usual-care group (difference, −11 mg/dl; 95% CI, −18 to −5; p < 0.001).
Conclusions:
A polypill-based strategy led to greater reductions in SBP and LDL-C level than were observed with usual care in a socioeconomically vulnerable minority population.
Perspective:
Most studies of the polypill have been placebo-controlled. The open-labeled study design in a community sample of patients not at goal and left on medication fits considering the social determinants in this cohort. I was surprised that 54% were on 1 or more antihypertensive drugs and the addition of three antihypertensive drugs (albeit low dose) did not lead to hypotension or symptoms with dropouts and the mean SBP difference between groups was only 7 mm Hg. I would be much more comfortable if subjects were given a $50 BP machine and they, a family member, or neighbor were taught to monitor SBP with parameters to call the clinic for symptoms or BP below a target.
Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins, Novel Agents, Statins
Keywords: Amlodipine, Antihypertensive Agents, Blood Pressure, Body Mass Index, Cardiovascular Diseases, Cholesterol, LDL, Dyslipidemias, Hydrochlorothiazide, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypotension, Losartan, Potassium, Primary Prevention, Risk Factors, Social Class, Vulnerable Populations
< Back to Listings
