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European Heart Journal Advance Access published online on April 7, 2006
European Heart Journal, doi:10.1093/eurheartj/ehi841
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European Heart Journal © The European Society of Cardiology 2006; all rights reserved
Received August 29, 2005
Revised March 3, 2006
Accepted March 9, 2006

Review

Benefits, challenges, and registerability of the polypill

Peter Sleight 1 *, Hubert Pouleur 1, and Faiez Zannad 1

1 Cardiac Department, John Radcliffe Hospital, Headington, Oxford OX3 9DU, UK

* To whom correspondence should be addressed.
Peter Sleight, E-mail: peter.sleight{at}attglobal.net


  Abstract

Guidelines for the management of cardiovascular disease (CVD) stress the importance of treating global risk, rather than individual risk, factors. Patients at high cardiovascular (CV) risk, for example, benefit from a combination of aspirin, antihypertensive agents, lipid-lowering drugs, and possibly folic acid. As the number of medications that a patient requires increases, adherence and compliance to therapy are likely to decrease. The use of affordable, multiple-target, fixed-combination ‘polypills’, which concomitantly reduce multiple risk factors without increasing the pill burden or the risk of adverse effects, has the potential to improve CV risk factor management, thereby reducing the incidence of CVD. This review discusses the benefits of the polypill and the challenges and requirements for its success and registerability. Discussions with regulatory bodies are required in order to obtain some ‘balance’ between an overcautious registration approach and the potentially large public health benefits that are likely to arise from the use of polypills.

Keywords: Cardiovascular disease; Polypill; Hypertension; Dyslipidaemia; Registration.
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