Monday, June 23, 2008 Dumaguing: Polypill reaches clinical testing phase By Dr. Victor Dumaguing To Your Health
(WORLD Congress of Cardiology, Buenos Aires, 19th May 2008) -- Two years from the announcement of its intention to advocate for the development of the polypill for post myocardial infarction (heart attack) patients, the World Heart Federation (WHF) can report that the polypill has now reached the clinical testing phase.
Led by Dr. Valentin Fuster, immediate past president of the WHF, it is the result of collaboration between the Spanish National Centre for Cardiovascular Research (Cnic), of which Dr. Fuster is Scientific President, and the Ferrer laboratory in Spain.
It is hoped in dollar terms that the new pill, a combination of aspirin, statin and ACE inhibitor, will be available for a single-figure monthly outlay. It has already been reviewed by the Food and Drug Administration (FDA) and now moves forward to the clinical trial phase to test further parameters related with pharmacodynamics and pharmacokinetics.
In September last year Dr. Fuster, head of clinical and research cardiology at Mount Sinai Medical Center in the USA, chaired a meeting of 20 scientists and corporate representatives for the purpose of sharing information on the various initiatives to develop a polypill. 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 behaviors," said Dr. Fuster.
"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 prevent heart attack patients suffering from a recurrence. It is not intended for primary prevention or daily use by people with no history of heart attack."
The potential value of applying the polypill strategy just for high-risk patients has recently been recognized by the World Health Organization (WHO), and the WHF will continue to stimulate the scientific debate and advocate for the production and delivery of the polypill.