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COMET Study Shows Carvedilol Saves Significantly More Lives than Metoprolol

LONDON, ENGLAND -- May 12, 2003 -- New data from the Carvedilol or Metoprolol European Trial (COMET) study show the newer, comprehensive beta-blocking agent, carvedilol, results in a greater survival benefit than metoprolol tartrate, a selective beta-blocking agent.

The new data were announced today by the study Steering Committee because of a significant mortality benefit in favor of carvedilol (marketed as Dilatrend(R) in Europe and as Coreg(R) in the U.S.).

"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 approved by the Food and Drug Administration 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.

* U.S. Coreg (carvedilol) Indications:

Congestive Heart Failure: Coreg is indicated for the treatment of mild to severe heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitor, and digitalis to increase survival and, also, to reduce the risk of hospitalization.

Left Ventricular Dysfunction Following Myocardial Infarction: Coreg is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of <=40% (with or without symptomatic heart failure).

Hypertension: Coreg is indicated for the management of essential hypertension.

Important Safety Information

Patients taking Coreg should avoid stopping therapy abruptly. With certain beta-blocking agents, stopping therapy abruptly has led to chest pain, and in some cases, heart attack. The dosage of Coreg should be reduced gradually over a 1- to 2-week period, and the patient should be carefully monitored.

As with any medicine, there are some people who should not take Coreg. The people who should not take Coreg include those with severe heart failure who are hospitalized in the intensive care unit. Also, people who require certain intravenous medications that help support their circulation (inotropic medications) should not receive Coreg. Other people who should not take Coreg are those with asthma or other breathing problems, those with a very slow heartbeat or heart that skips a beat (irregular heartbeat), those with liver disease and those who are allergic to Coreg. People with diabetes should report any changes in blood sugar levels to their physician. Contact lens wearers may produce fewer tears or have dry eyes.

Some common side effects associated with Coreg include shortness of breath, a slow heartbeat, weight gain, fatigue, hypotension, dizziness or faintness. People taking Coreg who have any of these symptoms should call their doctor. Additionally, if patients experience fatigue or dizziness, they should sit or lie down and avoid driving or hazardous tasks. As with any medicine, patients taking Coreg should also first tell their doctor what other medications they are taking.

COMET was jointly sponsored by GlaxoSmithKline and F. Hoffmann-La Roche.


SOURCE: GlaxoSmithKline

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