Polypill: lights and shadows.

The idea of packaging and formulating several drugs commonly used in cardiovascular disease prevention into a single polypill is appealing. It is believed that the polypill would have several advantages over the separate use of several medications, enhancing acceptability and long-term adherence, with lower cost and easier accessibility. However, there are few data available on the efficacy and safety of polypill preparations for preventive purposes. The Indian Polycap Study (TIPS) was the first to systematically test the clinical application of the polypill; it included ramipril, hydrochlorothiazide, atenolol, aspirin, and simvastatin. Blood pressure and LDL levels were effectively lowered and antiplatelet function was demonstrated, but the effect of simvastatin was reduced because of an unexpected drug interaction. The polypill was well tolerated. Challenges to be resolved include the need to demonstrate conclusively the safety and efficacy of the polypill in large clinical end point trials.