Testing on Heart Polypill to Start Soon

The eagerly awaited polypill that can help prevent heart attacks will be going into clinical testing phase soon, Spanish researchers report. The researchers hope to launch the three-in-one pill across the world in 2010 for less than $10 a month.

Plans to develop polypills for heart treatment have been in the pipeline for several years now, but fierce competition between major pharmaceutical companies and patent issues have stalled development of these highly anticipated medications. But with several good generic medications coming into the market and smaller companies from developing countries coming forward to take the initiative, the combination drug concept is once again moving forward. The initiative by Spanish researchers now gives new hopes to patients waiting for this form of treatment.

Three tried and tested heart treatment drugs – aspirin, a cholesterol-lowering statin and an ACE inhibitor for reducing blood pressure have been brought together to create the polypill. It is targeted at saving heart attack patients from having a second heart attack. Currently, such patients have to take multiple, often expensive drugs and stick to a strict treatment regimen, which makes their life really tough.

The researchers plan to get the first European patients started on the polypill in July of this year with plans to recruit a total of 600 patients for their trials. Trials on US patients will follow in the first half of 2009. Being low cost, the new combination medication could potentially save millions of lives, especially in developing countries.

While this particular polypill is not meant for people who have no history of heart attacks, the researchers believe there soon might be other polypills that will become available for such patients. Dr. Francisco de Paula Rodriguez Perera, director of the Spanish National Centre of Cardiovascular Research informed that they planned to introduce the medicine in Spain and certain parts of Latin America and then gradually spread it across the world by end of 2010.

“I think in five years we are going to have several different offerings in the market... there will be polypills for different phases of treatment,” he said. He referred to the plans that London’s Wolfson Institute of Preventive Medicine has for testing a five-in-one polypill that can be taken by all over the age of 55 years, whether they have a history of heart disease or not.

Development of the Spanish polypill is a joint venture between Spanish drug maker Ferrer and the Spanish National Centre of Cardiovascular Research. Dr. Rodriguez and team hope to receive approval for their new polypill from both the US Food and Drug Administration and European regulators.

“We expect to finish the clinical studies in the third or fourth quarter of 2009 and be out in market in the first half 2010,” Rodriguez said. Dr. Valentin Fuster, also a member of the research team expressed the opinion that such cheaper medications were extremely important in poorer, developing countries that are facing alarmingly increasing rates of cardiovascular disease.

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