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Take forward the polypill idea, concludes expert committee
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     The idea that whole populations might be treated with a polypill made up of several active drugs to prevent heart disease and stroke was generally supported at a meeting of experts organised just before Christmas by the US Centers for Disease Control in Atlanta.

    They also gave general agreement that a series of trials would be needed—at least in the United States and Europe—before it would be possible to give the polypill to whole populations without any screening, as was proposed when the idea of the pill was first advanced in the BMJ by Nick Wald and Malcolm Law of London抯 Wolfson Institute of Preventive Medicine (2003;326:1419).

    The polypill proposed by Professors Wald and Law in their paper would have six ingredients: a statin, aspirin, folic acid, and three antihypertensives (a thiazide, a ?blocker, and an angiotensin converting enzyme inhibitor), all at half dose. It would be given to everybody at age 55 without any screening and to everyone with existing cardiovascular disease. The combination, the authors said, would prevent heart disease and stroke by reducing four different risk factors—blood pressure, lipid concentration, homocysteine concentration, and platelet function. The authors calculated that ischaemic heart disease events would be reduced by 88% and stroke by 80%. Side effects would be minimal.

    The Atlanta meeting agreed that the present methods for reducing heart disease and stroke are not working. Changing lifestyle is hard to achieve in current social and political environments, and the medical response is inadequate, in that many patients at risk are not identified, many who are recognised are not treated, and many who are treated are not treated adequately.

    Something different is needed, the meeting agreed, and the polypill idea represents a completely new strategy. It would not replace but would supplement other treatments and attempts to change lifestyle. The excitement of the idea, the meeting agreed, is not just in the polypill but in the concept of delivering health care in a wholly new way. Some people at the meeting had little doubt that a daily polypill would reduce heart disease and stroke. The research questions, they argued, were whether it would be possible to get large numbers of people to take the pill for long periods and what the best methods of delivering the pill were.

    Others said that the evidence of efficacy of the treatment in people at low risk of heart disease and stroke was inadequate and that not enough was known about safety. Furthermore, the US Food and Drug Administration would need evidence of efficacy in populations at low risk—as well, perhaps, as evidence that each component of the polypill added something important. The meeting also recognised that three powerful groups are threatened by the polypill idea: the drug industry, doctors, and the public health lobby, which generally favours lifestyle change over mass drug treatment.

    Despite dissent the meeting generally thought that it would be necessary to start with a rigorous, placebo controlled trial of the polypill in people at intermediate risk of heart disease and stroke. About 6000 participants would be needed. More adventurous, cluster randomised studies of different ways of delivering the polypill could follow. The first trial has already been designed and may well happen. Meanwhile, the meeting heard, a version of the polypill is likely to appear on the market in India by the end of 2005.

    Competing interest: RS was a member of the expert committee and had his expenses paid. He was also editor of the BMJ when the polypill paper was published.(Atlanta Richard Smith)