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UPI Correspondent Barcelona, Spain (UPI) Sep 13, 2006 The polypill -- a multi-drug tablet designed to bring First World cardiology treatment to millions of individuals in the Third World -- continues to roll towards development, pushed by a consortium with roots in the United States and Spain. Human trials with the triple-medicine pill will be tested in Spain and then will be introduced in China, said Valentin Fuster, president of the World Heart Federation and director of the Mount Sinai Cardiovascular Institute in New York. "We have been in negotiations with a company here in Spain for about six months, and discussions have been progressing rapidly," Fuster told United Press International. He said that Spain is a good choice for initial marketing because heart disease here has increased markedly as the nation's economy improved in the last two decades. If the pill is successful in trials in Spain, it will be introduced in China, where heart disease is growing exponentially, he said. Fuster unveiled plans for the polypill -- which he said he hopes will be a reality by 2009 -- at the 15th World Congress on Cardiology in Barcelona, Spain. Researchers have long thought a polypill would be desirable because it would reduce the burden on patients, reducing medicine regimens from three tablets to one. The pill will contain a statin, aspirin and an angiotensin-converting enzymes inhibitor, Fuster said. All those drugs are off-patent, meaning they can be produced inexpensively. A cheap pill and a simple regimen are more likely to be accepted by patients around the world as well as being affordable. "It would be used only for secondary prevention and only under the very strict definition of secondary prevention after heart attacks," Fuster said. Sidney Smith Jr., professor of medicine at the University of North Carolina, Chapel Hill, and co-chair of the World Congress of Cardiology, said designing a polypill for primary prevention would be more difficult because it would have to take into account far more variables and options. He also noted that the evidence was clearer on what treatments prevented second heart attacks. Fuster said that if development of the polypill becomes successful in treating heart attack, "it is possible that we would expand to secondary prevention after other events such as stroke or unstable angina." Although Fuster was tight-lipped about which specific drugs would be in the polypill, he did acknowledge that the pills would only contain medicine known to impact secondary prevention. That means the patients who get the pill would already have heart disease. The statin is most likely to be simvastatin -- sold by Merck under the brand name Zocor -- a drug known to lower cholesterol and has demonstrated the ability to reduce the risk of a second heart attack. Simvastatin is now available as a generic product. Aspirin has also been shown in numerous studies to reduce the risk of a second heart attack. It is an anti-platelet drug that, in addition to its pain-reducing qualities, keeps blood cells from sticking together, thereby reducing the risk of clotting. The third component is a blood-pressure controller, known as an angiotensin-converting enzyme (ACE) inhibitor. These blood-pressure-lowering drugs are also known to inhibit harmful molecular inflammatory cascades that have been implicated in heart disease. Several ACE-inhibitors are available in generic formulations. ACE-inhibitors are especially helpful in patients who have heart failure or are at risk of developing this serious and progressive deterioration of the heart muscle. People with documented heart disease are also at risk of progressing to heart failure. Smith, who also chairs the American College of Cardiology/American Heart Association prevention guidelines committee, said the drugs selected would meet strict evidence-based criteria, which would limit the drugs to those that have been shown in randomized clinical trials to reduce recurrent heart attacks and cardiac mortality. The polypill may eventually find its way to the United States and Western Europe, Fuster said, but may find its way back to the industrialized nations after first tackling heart disease in the developing world. He said his organization has had some preliminary discussions with the U.S. Food and Drug Administration, which had "expressed interest."
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