Pharmaceutical issues in the development of a polypill for the treatment of cardiovascular diseases

Cardiovascular diseases (CVDs) are the foremost cause of mortality worldwide. It is estimated that around 20 million people will die from CVDs by 2015. Accordingly, there is a need to develop treatment strategies, which on implementation can substantially reduce the growing burden of CVDs. It has been hypothesized and partly evidenced that CVDs can be prevented if the risk factors, that is, high low-density lipoprotein (LDL) cholesterol, raised blood pressure, increased serum homocysteine level and platelet aggregation, are targeted simultaneously. In that context, a polypill containing combination of a statin, blood pressure lowering agents (among thiazides, beta blockers and angiotensin-converting enzyme inhibitors), aspirin and folic acid has been shown to reduce incidence of CVDs by more than 80%. After the initial results were published, interest has been shown by pharmaceutical industry worldwide to bring such a cocktail in the market. The efforts are on currently. The purpose of this note is to highlight in particular, the issues in the pharmaceutical development of a multidrug product of this kind.

Section editors:Colin H. Macphee – Department of Vascular Biology, GlaxoSmithKline, King of Prussia, PA, USAAlan Daugherty – Cardiovascular Research Center, University of Kentucky, Lexington, KY, USA