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MAJOR INTERNATIONAL STUDY SHOWS LOWERING HEART RATE LESSENS RISK OF HEART ATTACKS IN PATIENTS WITH CORONARY ARTERY DISEASE AND A HEART RATE ABOVE 70 BEATS PER MINUTE

September 4, 2008
Montreal - For the first time, a major international study has demonstrated that using a medication to lower high heart rate in patients with coronary artery disease and a heart rate above 70 beats per minute can significantly lessen - by 30 percent or more - the risk of those patients suffering major cardiovascular problems such as heart attacks, a finding which could change the medical management of the disease.

The Montreal Heart Institute led the Canadian portion of the study, which involved almost 11,000 patients in 33 countries on four continents. The much-anticipated study results were presented this week at the 2008 European Society of Cardiology Congress in Munich, Germany and published simultaneously in the medical journal The Lancet.

The study, called BEAUTIfUL, followed 10,917 patients who had known heart disease and evaluated whether using a medication, a selective heart rate lowering agent ivabradine, would help prevent them from developing serious cardiovascular events such as heart attacks. All the patients were already receiving the guideline-recommended cardiovascular therapy, including the use of antiplatelet agents (by 94% of the study patients), angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) (91%), beta-blockers (87%), as well as lipid-lowering agents (76%).

The results showed there was a neutral effect overall in the study, but that using the drug to lower heart rate had a significantly positive impact on patients who started with an elevated resting heart rate, defined as greater than 70 beats per minute.

BEAUTIfUL data conclusively demonstrated that these patients with an elevated resting heart rate greater than 70 bpm are more likely to die or suffer another cardiovascular event than patients with a lower resting heart rate. The increase in risk is 34% for cardiovascular death, 46% for myocardial infarction (heart attack), 56% for heart failure and 38% for coronary revascularisation. In those patients, the addition of the heart rate-lowering treatment resulted in a 36 percent lowering of the risk of hospitalization for fatal and non-fatal myocardial infarction (p=0.001) and a 30 percent lowering of the risk of coronary revascularization (p=0.016).

"The results from BEAUTIfUL support the role of selectively reducing heart rate in patients with known coronary heart disease who have a baseline heart rate more than 70," said Dr. Jean-Claude Tardif, the study’s Canadian lead investigator, member of the study steering committee, director of the Montreal Heart Institute Research Centre and professor of medicine at the Universite de Montreal. "What is most interesting about the results is that by lowering heart rate sufficiently in these patients we can indeed have the potential to reduce the incidence of cardiovascular events over and above what we can achieve with the best standard of care we have available right now."

Ivabradine is not yet approved or available in Canada.

PRESS RELEASE - Sept. 3, 2008 - icm-mhi.org

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