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Polypill

The objective of this project is to save the lives of those severely affected by cardiovascular disease through the successful development of a polypill by 2010. A polypill is a fixed dose combination of anti-hypertensive, lipid lowering and aspirin therapies, for use in secondary prevention of cardiovascular disease in post myocardial infarction (“heart attack”) patients.  This project was launched in partnership with the Spanish National Centre for Cardiovascular Research (CNIC).

It has been proven that appropriate stand-alone medications ranging from anti-hypertensive therapies to statins and including aspirin have had very beneficial effects on premature mortality in Western populations.  Many of these medications are now off patent and as such are available at lower generic prices. However, the complexity of three or more medications would strain developing country health systems both financially and logistically.  Patient compliance would be another complicating factor.

The production of the polypill, which is currently estimated to be one-fifth of the cost of currently available therapies, could save the lives of post myocardial infarction patients as well as high risk individuals in low- and middle-income countries as well as low-income patients in more developed economies who would otherwise have limited treatment options.   

The new concept of the polypill for the prevention of cardiovascular disease was evaluated three years ago through an extensive literature survey of various large meta-analyses of the efficacy and safety of the reduction of four cardiovascular risk factors (cholesterol, arterial blood pressure, platelet aggregation, homocysteine). This research was published1 in June 2003 and concluded that a fixed combination drug (polypill) could reduce coronary heart disease events by 88% and strokes by 80% in individuals who are at risk.

It is expected that the polypill will substantially increase patient adherence as has been shown with other combination drugs, notably for HIV/AIDS patients.

Project schedule:
•    Combination selection 2006
•    Pharmaceutical development 2007
•    Bio equivalence 2008
•    Dossier evaluation 2009
•    Marketing 2010

The World Heart Federation is working towards building knowledge and commitment among physicians, particularly in low- and middle-income countries, to facilitate distribution as of 2010.

Pilot countries are still being identified but will include Spain, China and India.


1 Wald NJ, Law MR. BMJ. 2003 Jun 28;326(7404):1419.