ESC/WCC: World Congress of Cardiology Gets Call for Polypill for Secondary Prevention

BARCELONA, Spain, Sept. 3 -- The concept of a single pill packed with the potency of aspirin, statins, and ACE inhibitors-the triad proven to prevent a recurrent heart attack-got a powerful push at the opening of the World Congress of Cardiology here.

Valentin Fuster, M.D., Ph.D., president of the World Heart Federation, announced that such a polypill would be introduced in Spain in 2009.

If the polypill proves successful here, the World Heart Federation plans to introduce it next in China, where heart disease is growing exponentially, said Valentin Fuster, M.D., Ph.D., who is director of the Mount Sinai Cardiovascular Institute in New York.

In addition to prevention actions such as the polypill, Dr. Fuster said it is time to consider laws to regulate the food industry, particularly serving size. He also backed the proposal by New York's Mayor Michael Bloomberg to ban foods containing trans fatty acids.

Dr. Fuster unveiled plans for the polypill during as a press briefing to open the World Congress of Cardiology. a joint meeting of the European Society of Cardiology and Dr. Fuster's organization.

The idea behind the polypill is simple, that patients would be more willing to take one pill than three pills.

Dr. Fuster said this issue is more important in developing countries, where adherence to multiple drug regimens is even worse than it is in the United States.

Asked for specifics about the polypill, Dr. Fuster said his organization has been "working with a company here in Spain for about six months, and discussions have been progressing rapidly."

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. Heart disease has also risen hand in hand with economic growth in China.

The pill, he said, would contain an off-patent statin and an off-patent ACE-inhibitor in combination with aspirin. "It would be used only for secondary prevention and only under the very strict definition of secondary prevention after myocardial infarction," he said.

But if successful, "it is possible that we would expand to secondary prevention after other events such as stroke or unstable angina."

Dr. Fuster declined to name a specific statin or ACE inhibitor, but Sidney C. Smith, Jr., M.D., who chairs the American College of Cardiology/American Heart Association prevention guidelines committee, said the drugs selected would meet strict evidence-based criteria. This would limit the drugs to those that have been shown in randomized clinical trials to reduce recurrent MI and cardiac mortality.

Using those criteria the most likely off-patent choices are Zocor (simvistatin), which demonstrated a survival benefit in the 4S study (Scandinavian Simvastatin Survival Study), and Altace (ramipril), which demonstrated a post-MI survival benefit in the HOPE (Heart Outcomes Prevention Evaluation) trial.

Asked whether this same low-cost, polypill would be available in the United States, Dr. Fuster said the federation has not targeted the U.S. as an initial market. But he predicted that the polypill would some day be available in America, adding that his organization has had some preliminary discussions with the FDA, which had expressed interest.

As to heart healthy eating, Dr. Fuster said, "it is not just about diet, We also have to teach people to eat less."

Regulation of food, he said, is just as important as "the use of red lights and green lights to regulate traffic."

More than 25,000 cardiologists were expected at the congress, which will conclude on Wednesday. During that time 3,917 abstracts-a record number for a heart meeting-will be presented during podium and poster presentations. Additionally, 60 satellite sessions-again a record for a cardiology meeting-- sponsored by industry and non-profit organization will be presented.