“An International Randomized Placebo-Controlled Trial of a Four-Component Combination Pill (“Polypill”) in People with Raised Cardiovascular Risk”

There is widespread interest in the potential for combination cardiovascular medications consisting of aspirin and other agents to lower blood pressure and cholesterol (polypills) to reduce cardiovascular diseases (CVDs). However, no reliable placebocontrolled data are available on both efficacy and tolerability. We conducted a randomized, double-blind placebo-controlled trial of a polypill (aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg and simvastatin 20 mg) in 378 individuals with no indications for any component of the polypill, whose estimated five-year CVD risks were over 7.5%. The primary outcomes were systolic blood pressure (SBP), LDL-cholesterol and tolerability (proportion discontinued randomized therapy) at 12 weeks followup.