Investor Update
Basel, 13 May 2003
Dramatic New Trial
Results Settle Controversy in Chronic Heart Failure
Dilatrend® proven to save significantly
more lives than metoprolol
The results of the COMET study, the first-ever head-to-head mortality comparison of two beta blocking agents in patients with chronic heart failure (CHF) were announced today by the COMET Steering Committee. They demonstrate that Dilatrend® (carvedilol), a comprehensive beta blocking agent, saves significantly more lives than metoprolol, a conventional beta blocker. Patients receiving Dilatrend® had a significant survival benefit as compared to patients on metoprolol.
The Carvedilol or Metoprolol European Trial (COMET), sponsored by F. Hoffmann-La Roche, was designed to resolve the controversy as to whether comprehensive or selective beta blockade is superior in reducing mortality in patients with CHF.
“COMET is the longest and largest beta blocker 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. “The significant survival benefits of carvedilol demonstrate a clear difference between the agents.”
“The COMET results confirm that Dilatrend® is the superior choice to metoprolol in the treatment of chronic heart failure,’’ said William M. Burns, Head of the Pharmaceutical Division at Roche. “COMET adds to the extensive body of evidence on Dilatrend®, the most studied beta blocking agent in chronic heart failure demonstrating Dilatrend®’s efficacy, safety and tolerability across the whole spectrum of patients.’’
COMET’s principal results will first be presented during the official Hot Line session on 23rd June at the Heart Failure 2003 meeting, organised by the European Society of Cardiology, Strasbourg, France.
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 Dilatrend®
In contrast to
conventional beta blocker agents which block only the beta1 adrenergic receptor, Dilatrend® is a comprehensive
beta1, beta2 and alpha1 receptor blocker. The alpha1 blocking capability of Dilatrend® causes peripheral
blood vessels to dilate, and for this reason, Dilatrend® is also classified as a ‘vasodilating’ beta
blocker. This feature of Dilatrend® offers unique benefits for haemodynamic balance in hypertension,
heart failure and ischaemic heart disease. Dilatrend® also has anti-oxidant and anti-proliferative properties
that further differentiate it from other beta blocking agents.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche
is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and
a leader in virology and transplantation medicine. As a supplier of products and services for the prevention,
diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s
health and quality of life. Roche employs roughly 62,000 people in 150 countries. The Group has alliances
and research and development agreements with numerous partners, including majority ownership interests
in Genentech and Chugai.
All trademarks used or mentioned in this release are legally protected.
Notes to Editors
About COMET
COMET
was a double-blind, randomised parallel group study designed to compare the effects of Dilatrend® with
those of metoprolol on the risk of death and hospitalisations in patients with CHF1.
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 UK.) All patients were followed up for 46 – 74 months adding up to a total database of more than 10,000 patient years, making COMET the longest and largest beta blocker study ever conducted in CHF.
COMET’s principal results will first be presented during an official Hot Line session on 23rd June at the Heart Failure 2003 meeting, organised by the European Society of Cardiology, Strasbourg, France.
COMET was jointly sponsored by F. Hoffmann-La Roche and GlaxoSmithKline. Dilatrend® is marketed worldwide by Roche under the additional trade names Cardiol®, Coreg®, Coropres®, Dilbloc®, Dimitone®, Eucardic® and Kredex® with the exception of North America where it is marketed by GlaxoSmithKline under the trade name of Coreg® and Japan where it is marketed by Daiichi under the trade name of Artist®.
1 Poole-Wilson, P et al. Rationale and design of the carvedilol or metoprolol European trial in patients with chronic heart failure: COMET. European Journal of Heart Failure 4 (2002) 321-329.