First CV polypill to enter US clinical testing

25 May 2008

The first polypill aimed at combating heart attacks has reached the clinical testing phase. Part of a collaboration between the Spanish National Center for Cardiovascular Research and the Ferrer laboratory in Spain, the pill is a fixed-dose combination of aspirin, a statin and angiotensin-converting enzyme inhibitor that will be available for a single-figure monthly outlay.

The three-in-one pill has already been reviewed by the US Food and Drug Administration and now moves forward to the clinical trial phase to define parameters related with pharmacodynamics and pharmacokinetics. One of the senior scientists championing the polypill concept is Valentin Fuster, head of clinical and research cardiology at Mount Sinai Medical Center in the USA. Dr Fuster noted that, "today, within one year of a myocardial infarction, between a third and half of all patients are not taking the three drugs they need and are not correcting their risk factors. There are a variety of explanations for this behavior, but the polypill will be more affordable, more available and a more convenient method of treatment."

"However it should be stressed that the FDA will only accept the pill if each individual ingredient is critical for the prolongation of life. Therefore, the polypill is aimed only at secondary prevention, helping to stop heart attack patients suffering a recurrence. It is not intended for primary prevention or daily use by people with no history of heart attack," he stressed.

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