A tablet designed to prevent cardiovascular disease by combining medicines to lower blood pressure and a statin to lower cholesterol added ammunition to the argument that the “polypill” approach works. Blood pressure and low density lipoprotein (LDL) cholesterol levels dropped as predicted in people 50 years and older who took a daily polypill, according to a study published online July 18 in PLoS One.
Nicholas J. Wald, DSc, director of the Wolfson Institute of Preventive Medicine at University of London, and colleagues conducted the study to quantify the effects of the polypill. The medication consists of half doses of the blood pressure lowering agents amlodipine, losartan and hydrochlorothiazide with a standard dose of the statin simvastatin (Zocor, Merck).
While several trials have shown polypills lower blood pressure and LDL cholesterol levels, the results have been varied. Reception to the concept also has been mixed, with advocates calling the approach bold and worth pursuing and critics questioning its side effects, costs and potential to overtreat healthy people.
The authors highlighted several limitations with the previous trials, included poor adherence in treatment groups and a study design that they wrote led to underestimations of efficacy. For the present study, they recruited 84 participants between December 2010 and March 2011 who were 50 years or older for the randomized, double-blind trial. The study used a crossover design, where participants took the polypill for 12 weeks and a placebo for 12 weeks, making them their own controls.
Participants already were enrolled in a cardiovascular disease prevention program and had no self-reported history of cardiovascular disease. Researchers took blood pressure and LDL cholesterol measurements at the end of each 12-week period.
Polypill usage reduced mean systolic blood pressure, diastolic blood pressure and LDL cholesterol by 12 percent, 11 percent and 39 percent, respectively. “Our results show that the original predictions were accurate and not overestimated as has been suggested,” Wald and colleagues wrote.
The authors argued that these results likely are more accurate than previous findings because of the study design. They also addressed the omission of folic acid and aspirin in the polypill, which had been promoted in some other single-pill multiple-medication regimes, because of their respective lack of clinical efficacy and bleeding risks.
Based on risk factors and risk estimates, they calculated that administering the polypill would reduce ischemic cardiac disease events by 72 percent and stroke by 64 percent. “This Polypill, designed principally for primary prevention, therefore has considerable potential for the prevention of cardiovascular disease,” they concluded.