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ESC Spokespersons assess the viability of the 'Polypill' for cardiovascular disease prevention

June 27, 2003

ESC Spokespersons speak out on the concept of the 'Polypill', proposed by British scientists as a daily formula of six medications, to be taken by heart patients and all those over 55 years old, to avert more than 80 percent of heart attacks and strokes.

The 'Polypill', proposed by Dr Nicolas Wald and Dr Malcolm Law of the University of London, consists of a statin or simvastatin to lower cholesterol, three blood pressure lowering drugs at standard half dose (e.g. a thiazide, a beta-blocker and an angiotensin converting enzyme inhibitor), folic acid to reduce levels of homocysteine and subsequent atherosclerosis, and aspirin.

Wald and Law suggest that the 'Polypill' could provide combined treatment to reduce four cardiovascular risk factors - low density lipoprotein cholesterol, blood pressure, serum homocysteine and platelet function - regardless of pre-treatment levels, for use in a single daily pill with minimal adverse effects. Wald and Law's paper 'A strategy to reduce cardiovascular disease by more than 80%' is to be published in tomorrow's British Medical Journal (volume 326, 28 June 2003).

The ESC would like to accentuate that the concept of the 'Polypill' is in an early stage and based on meta-analyses and academic calculations rather than clinical studies. Whilst the idea is an excellent in hypothetical terms, further analysis and clinical trials will be required before the 'Polypill' can be supported as a truly viable, effective and cost-cutting option in cardiovascular disease prevention.

Statements from three ESC Spokespersons follow.

ESC Spokespersons give their comments on the issue

Professor Lars Rydén, Karolinska Hospital, Stockholm, Sweden - ESC Spokesperson:

"This is an intriguing idea and perhaps very pragmatic. What the authors are suggesting has a lot of potential and would certainly make life easier and presumably reduce medical costs whilst saving lives and decreasing the incidence of heart attacks and strokes.

"However, there are many other aspects to be addressed. Dosages are not according to what have been tested in trials and the combination as such may have its drawbacks.

"This pill has not been tested thus, although the idea is very interesting, it must be evaluated against optimal evidence based and discrete combinations of the equivalent drugs. It would also be advisable to conduct cost-benefit analyses to see just how much money could be saved".


Professor Denis Clément, University Hospital Gent, Belgium - ESC Spokesperson:

"Many patients are at much higher risk of cardiovascular disease than they anticipate and this can also be true for those who are asymptomatic. Several large-scale studies have shown that prevention with drugs can improve on prognosis. But, to achieve the goals, one needs to take several drugs. Several studies (such as EUROASPIRE) have also shown that the compliance of such patients to drug intake is bad and even worse if they have to take several pills.

"The reasoning to prepare such a 'Polypill', with all the necessary constituents included in one pill, is therefore appropriate in order to address the achievement of treatment goals and improvement of patient compliance. However, only long-term follow up studies will be able to demonstrate whether or not the 'Polypill' can achieve these aims in reality".


Professor John GF Cleland, University of Hull, UK - ESC Spokesperson:

"The concept of the "Polypill" is interesting but a seriously flawed over-simplification for at least 4 reasons, these are as follows:

"1. The evidence base for some of the interventions is weak - aspirin and homocysteine are really just products of meta-analysis rather than based on robust trials so far. The largest recent trial of aspirin (PEP - n =13,356) showed a significant excess of CHD death and non-fatal MI. There is also a lot of publication bias associated with aspirin.

"2. There is the potential for adverse drug interactions and the cumulative side effects may be much worse than the authors imagine. It is possible that some interventions are no longer effective in the context of modern therapy. It is also impossible to believe that once a drug has been shown to work, it will work for eternity - it will be superseded by new developments. Old drugs need periodic reassessment to find out if they remain effective in addition to new treatments.

"3. We have no evidence that these treatments actually prevent disease - they do delay its development but the health-economic consequences of delay and prevention are quite different.

"4. The "Polypill" is clearly an interesting concept but one that needs to be properly tested. This may prove to be very difficult."

European Society of Cardiology (ESC)