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Published On September 22, 2009

CLINICAL RESEARCH

In the First Polypill Trial, Compelling Results

An all-in-one medication reduced such cardiovascular risk factors as blood pressure and heart rate.

In the Winter 2007 issue of Proto, I wrote about a miracle drug, albeit one not yet invented. Four years earlier, Nick Wald and Malcolm Law of the University of London had hypothesized that a drug they called the Polypill could eliminate 88% of heart attacks and 80% of strokes if taken by everyone age 55 and older. The drug would include a statin to lower cholesterol, three drugs to lower blood pressure and aspirin to prevent blood clots. Yet no one knew whether the pill would lower cardiovascular risk in healthy people or whether the combined side effects would stop the project.

The findings of the first Polypill clinical trial, published in the April 18 issue of the journal The Lancetseem to suggest both concerns were unfounded. In a Phase II, double-blind, randomized trial, researchers in India tested Wald and Law’s theory in patients ages 45 to 80. None of the patients had cardiovascular disease, but all had one risk factor (such as a smoking habit). The 412 subjects who took the pill for 12 weeks tolerated the Polycap (the Indian version of the Polypill) as well as they tolerated various other combinations of the drugs (the study examined 2,053 individuals in nine different drug groups). The Polycap reduced such cardiovascular risk factors as blood pressure and heart rate by amounts equivalent to the reduction produced by each drug taken alone (or additively, for blood pressure).

In a study published in the British Medical Journal on May 19, Wald and Law added support to their theory: In a meta-analysis of 147 randomized trials on blood pressure medications, they found that the drugs lowered the risk of a heart attack or stroke even in people with normal blood pressure. Wald and Law contend that this means all people above a certain age should take such drugs.

Still, the Indian team doesn’t think the Polycap will save as many lives as Wald and Law predict, instead estimating a 62% reduction in heart attacks and a 48% drop in strokes. Only a longer, larger trial can answer that question definitively.

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