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Title: Heart Failure Patients Live Longer on Carvedilol than on Metoprolol

"Heart Failure Patients Live Longer on Carvedilol than on Metoprolol"

LONDON, UK -- July 4, 2003 -- The first and only head-to-head survival study in heart failure patients to comparing two beta-blocking agents reveals significantly better survival with carvedilol than with metoprolol. The results from the longest and largest trial ever conducted in heart failure -- the Carvedilol or Metoprolol European Trial (COMET) -- will be published in the Saturday, July 5, 2003 issue of The Lancet. The study results also were presented on June 23 at the Heart Failure 2003 meeting organized by the European Society of Cardiology, in Strasbourg, France. The study showed that carvedilol, a newer, comprehensive beta-blocking medication, reduced all cause mortality by 17% (P=0.0017), cardiovascular mortality by 20% (P=0.0004) and prolonged median survival by 1.4 years more than metoprolol tartrate, a traditional selective beta-blocking medication. Carvedilol is marketed as Coreg(R) in the U.S. and Dilatrend(R) in Europe. "The results of COMET provide clear evidence of the survival benefits of carvedilol over metoprolol in the treatment of chronic heart failure and suggest that carvedilol prolongs the life of patients by 1.4 years compared to metoprolol," commented Professor Philip Poole-Wilson, Chairman of the COMET Steering Committee. "Carvedilol's significant survival benefit could mean thousands of lives saved each year." The COMET investigators wanted to determine whether carvedilol, which has properties beyond those of traditional beta blockers, would reduce mortality and morbidity more than a beta-one selective blocker in patients with heart failure. They concluded that carvedilol has a significantly greater beneficial impact on survival than metoprolol. Carvedilol Saved More Lives Than Metoprolol (Tartrate) "For years, physicians have wondered if there are important differences among beta blockers used for the treatment of heart failure," said Milton Packer, MD, Director of the Heart Failure Center and a professor of medicine at Columbia University College of Physicians and Surgeons, in New York. "The results of the COMET study suggest that the additional properties of carvedilol beyond beta-one blockade do influence survival." The results of the COMET study add even more weight to what is already a wealth of data demonstrating the important benefits of carvedilol. In the U.S., Coreg (carvedilol)* is marketed by GlaxoSmithKline and is the only beta-blocking agent approved by the Food and Drug Administration to improve survival in mild to severe heart failure. Coreg is also approved for use in left ventricular dysfunction following a heart attack (with or without symptomatic heart failure) where it also significantly improves survival. Coreg also is indicated for the treatment of essential hypertension. In Europe, Dilatrend (carvedilol) is marketed by Roche and is approved for congestive heart failure, angina pectoris and hypertension. In Europe, metoprolol tartrate, which was used in the COMET study, is approved for indications that include the following: hypertension, angina pectoris, arrhythmias, myocardial infarction, migraine, hyperthyroidism, and is marketed by AstraZeneca as Betaloc and by Novartis as Lopresor. Study Design COMET was initiated in 1996, with 3,029 patients from 15 European countries and 317 centers enrolled in a multi-center, double-blind, and randomized parallel group trial. In the study, 1,511 patients with chronic heart failure were assigned carvedilol and 1,518 to metoprolol. Patients were required to have chronic heart failure, a previous hospital admission for a cardiovascular reason, an ejection fraction of less than or equal to 0.35 and to be treated optimally with diuretics and angiotensin converting enzyme inhibitors unless not tolerated. The co-primary end points were all-cause mortality and the composite end point of all-cause mortality or all-cause hospital admission. All patients were followed up for more than 45 months (175,447 patient months) following the trial, and follow up was concluded on November 15, 2002. The trial accumulated over 1,000 deaths. About Chronic Heart Failure Nearly five million Americans are now living with heart failure and 550,000 people are newly diagnosed with the condition each year. Heart failure is a progressive condition in which the heart muscle becomes weakened after being injured from a health episode, such as a heart attack or high blood pressure, and gradually loses the ability to pump enough blood to supply the body sufficiently. Heart failure is common but under-recognized and often misdiagnosed. Although heart failure may strike at any age, it is more common in people over the age of 65. Heart failure risk factors include: high blood pressure; prior heart attack; history of heart murmurs; enlarged heart; diabetes; and family history of enlarged heart. SOURCE: GlaxoSmithKline

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