Editorial: Polypill: promise and problems

Published in The Hindu on April 17, 2009

Chronic ‘lifestyle’ diseases cause a huge number of premature deaths round the world. “Preventing Chronic Diseases: a vital investment,” a 2005 report of the World Health Organisation (WHO), estimated that global action to prevent chronic diseases could save 36 million lives by 2015. India is one of the countries most at risk and most in need of preventive action, especially against rising morbidity and mortality from cardiovascular disease. A paper published recently in The Lancet by Yusuf et al presents the findings of the Indian Polycap Study (TIPS), a first step in the testing of a promising hypothesis aimed at reducing morbidity and mortality from cardiovascular disease. In 2001, an international consultation came up with the idea of developing a combination pill to reduce cost and increase adherence in secondary prevention of cardiovascular disease. In 2003, an article in the British Medical Journal boldly argued for a combination of six drugs, five of them of proven efficacy in the secondary prevention of heart attacks, in a “polypill” to be universally prescribed for “primary prevention” of cardiovascular events. TIPS, working not with a polypill but with a “polycap,” which combines in a capsule three blood-pressure-lowering drugs at low doses with a statin and aspirin, was a proof of concept study funded by Cadila Pharmaceuticals, Ahmedabad. The basic interpretation of its findings is that “this Polycap formulation could be conveniently used to reduce multiple risk factors and cardiovascular risk.” The stage now seems set for a large-scale trial.

The polypill hypothesis does pose problems. One challenge will be how to combine different drugs in a way that rules out chemical antagonisms or adverse effects and how to fine-tune dosage adjustments of individual constituent drugs. Another problem, underscored by the 15 per cent non-compliance rate in the TIPS trial, will be acceptance by people for risk factors they do not have. Most crucially, the polypill concept must not be sold at the expense of lifestyle changes. “The polypill definitely has a role in secondary prevention,” suggests Dr. K. Srinath Reddy, eminent cardiologist and physician who is president of the Public Health Foundation of India. “Its role in primary prevention needs to be carefully studied. It may need to be restricted to use in individuals at a high risk of cardiovascular event in the next 10 years. Such individuals often have multiple risk factors, which co-exist and contribute to a high ‘absolute risk.’ Whether single risk factors require a ‘polypill’ is a debatable question. Certainly it would make more sense for a smoker to give up smoking than take a polypill.” The logic of such an approach would seem incontestable.

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