New data from the Carvedilol or Metoprolol European Trial (COMET) study were announced today by the study Steering Committee because of a significant mortality benefit in favor of carvedilol (marketed as Dilatrend in Europe and as Coreg in the U.S.). COMET was designed to determine whether a newer, comprehensive beta-blocking agent, carvedilol results in a greater survival benefit than metoprolol tartrate, a selective beta-blocking agent. COMET demonstrated that carvedilol saved significantly more lives than metoprolol tartrate.

"COMET is the longest and largest study ever conducted in chronic heart failure with more than 10,000 patient years of follow-up," commented Professor Philip Poole-Wilson, Chairman of the COMET Steering Committee. Commenting further on the COMET results, Professor Philip Poole-Wilson stated, "The significant survival benefits of carvedilol demonstrate a clear difference between the agents."

COMET is the first and only head-to-head mortality study in heart failure comparing two drugs in the same class. The principal results will be presented in detail for the first time at the Heart Failure 2003 meeting organized by the European Society of Cardiology, June 21-24, in Strasbourg, France.

The results of COMET add even more weight to what is already a wealth of data demonstrating the important benefits of carvedilol. In Europe, Dilatrend (carvedilol) is licensed to Roche and is approved for congestive heart failure, angina pectoris and hypertension. In the U.S., Coreg (carvedilol) is licensed to GlaxoSmithKline and is the only beta-blocking agent FDA approved to improve survival in heart failure. Coreg is also approved for mild, moderate and severe heart failure, and 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, 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.