Patients live longer on Caredilol

Results from the longest and largest trial ever conducted in heart failure - the Carvedilol or Metoprolol European Trial (COMET) have shown that heart failure patients live longer on carvedilol than on metoprolol

The trial showed that carvedilol, a newer, comprehen-sive beta-blocking medication reduced mortality by 17 percent (p=0.0017) and prolonged median survival by 1.4 years more than metoprolol tartrate, a traditional selective beta-blocking medication. Carvedilol is marketed by GlaxoSmithKline (GSK) as Coreg in the U.S. and Dilatrend 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. The study results were presented today at the Heart Failure 2003 meeting orga-nized by the European Society of Cardiology, in Strasbourg, France.

'For years, physicians have wondered if there are important differences among beta blockers used for the treatment of heart failure,' said Milton Packer, M.D., Director, Heart Failure Center and Professor of Medicine, Columbia University College of Physicians and Surgeons in New York, N.Y. 'The results of the COMET study suggest that the additional properties of carvedilol beyond beta-one blockade do influence sur-vival.'

The results of the COMET study add even more weight to what is already a wealth of data demon-strating the important benefits of carvedilol. In the US, Coreg (carvedilol) is marketed by GSK and is the only beta-blocking agent FDA approved 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, Dila-trend (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 endpoints were all-cause mortality and the composite endpoint 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-recognised 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.