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Secondary COMET Data Reveal Reductions in Mortality, Stroke Associated With Carvedilol

VIENNA, Austria, Sept. 2 /PRNewswire/ -- The latest analyses of the landmark Carvedilol or Metoprolol European Trial (COMET) have shown further significant benefits for chronic heart failure (CHF) patients treated with the non-selective beta blocking agent carvedilol compared to those treated with the beta-1 selective beta blocker, metoprolol(1). Today's COMET data reveal that compared to metoprolol, carvedilol is associated with a significantly greater risk reduction of:

Today's COMET results also show that patients treated with carvedilol had a reduced risk for new onset diabetes (22%, p=0.04) compared to metoprolol, which might be attributed to the difference in pharmacological properties of the two drugs.

The data, presented today at the European Society of Cardiology annual meeting, detail the outcomes of COMET's predefined secondary endpoints and add further weight to the highly significant 17 percent survival benefit (p=0.0017) demonstrated by carvedilol over metoprolol, which was presented on 23 June, 2003 at the Heart Failure 2003 meeting(2) and published in the Lancet(3) on 5 July, 2003.

"COMET's secondary endpoint data provide further evidence of the significant benefits of carvedilol over metoprolol in the treatment of chronic heart failure," commented Professor Philip Poole-Wilson, Chairman of the COMET Steering Committee. "Today's data, added to the highly significant survival benefit demonstrated by the study's primary endpoint, show that treating patients with carvedilol can save lives. We expect that COMET's results will have a major impact on clinical practice."

With more than 14,000 patient years of follow up, COMET is the longest and largest ever beta blocker study in CHF and the first head-to-head survival study comparing two beta blocking agents in patients with CHF. It was designed to investigate whether carvedilol was superior to metoprolol tartrate in the treatment of people with CHF. These two drugs, although both classified as beta blockers, have different properties, notably that carvedilol provides not only beta-1 receptor blockade, but also blocks beta-2 and alpha-1 receptors and displays additional ancillary properties, that might explain the benefits beyond survival.

Beta blocking agents are recommended in the guidelines of major international societies such as the European Society of Cardiology (ESC)(4) the American Heart Association (AHA) and the American College of Cardiology (ACC)(5) for the treatment of mild, moderate and severe CHF, and have been clinically proven in a number of landmark clinical trials. (6),(7),(8)

Notes to Editors About Chronic Heart Failure

Experts suggest that there may be more than 10 million people with CHF in Europe alone. There are approximately 2-3 new cases of CHF per 1,000 of the population per year in Europe, whilst in the US there are 400,000 new cases diagnosed annually. Prognosis for CHF is generally poor, with around half of all patients diagnosed dying within 3-5 years -- a death rate similar to that of patients with lung cancer. Quality of life for patients, especially with more severe disease, is low.

About Stroke

Stroke (of all types) is the third leading cause of death in the United States, Western Europe, and Japan, and is the most common cause of disability worldwide. An estimated 85% of all strokes are classified as ischemic, with the remaining 15% hemorrhagic in nature. Stroke occurs in all age groups, but incidence rates increase markedly among those aged 55 or older, doubling with each successive decade.(9)

About Diabetes

It is estimated that there are at least 150 million people in the world with diabetes and that type 2 diabetes accounts for 90 per cent of all cases. Diabetes is one of the leading co-morbitities in CHF.

About COMET

COMET was a double-blind, randomised parallel group study designed to compare the effects of carvedilol with those of metoprolol on the risk of death and hospitalisations in patients with CHF(3).

The trial enrolled 3029 patients with mild to moderate to severe (NYHA class II-IV) CHF from 15 European countries (Austria, Belgium, Denmark, Germany, Finland, France, Hungary, Italy, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom). All patients were followed up for more than 45 months adding up to a total database of more than 14,000 patient years.

The COMET trial was jointly sponsored by F. Hoffmann-La Roche and GlaxoSmithKline. Carvedilol (Dilatrend), is marketed worldwide by Roche under several trade names such as Cardiol®, Coropres®, Dilbloc®, Dimitone®, Eucardic® and Kredex®. In North America it is marketed by GlaxoSmithKline under the trade name of Coreg® and in Japan it is marketed by Daiichi under the trade name of Artist®.

About the COMET Steering Committee

The trial was conducted by an independent Steering Committee comprised of leading experts in CHF: Professor Philip Poole-Wilson (Chairman), London, UK; Professor Karl Swedberg (Vice-Chairman), Gothenburg, Sweden; Professor John Cleland, Kingston upon Hull, UK; Professor Andrea Di Lenarda, Trieste, Italy; Professor Peter Hanrath, Aachen, Germany; Professor Michel Komajda, Paris, France; Professor Marco Metra, Brescia, Italy; Professor Willem Remme, Rhoon, The Netherlands and Professor Christian Torp-Pedersen, Copenhagen, Denmark.

About the Data and Safety Monitoring Board (DSMB)

The trial was overseen by an independent DSMB comprising of: Professor Jacobus Lubsen (Chairman), Switzerland; Professor Lars Wilhelmsen, Sweden; Professor Hansjorg Just, Germany.

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