FOR IMMEDIATE RELEASE

PATIENTS WITH SEVERE CONGESTIVE HEART FAILURE (CHF) OFFERED NEW HOPE

Coreg® is now approved to treat severe CHF

TORONTO, Ontario (May 30, 2002) - Today, a new treatment advance offers hope for patients with severe congestive heart failure (CHF). Coreg® (carvedilol) is now approved by Health Canada to treat severe CHF and is the first and only beta-blocker in Canada approved to treat mild, moderate and severe CHF. According to the Heart and Stroke Foundation of Canada, CHF is the most rapidly growing cardiovascular condition in the country, and remains the number one reason for hospitalization of people over the age of 65.

"Fifty per cent of heart failure patients are likely to die within three-to-five years of diagnosis," said Dr. Malcolm Arnold, Director of Research Affairs, Division of Cardiology, London Health Sciences Centre, and Chair of the Canadian Congestive Heart Failure Clinics Network. "Coreg has helped transform the treatment of heart failure. This medication will improve the prognosis for many patients, even with severe heart failure. Clinical trials have clearly proven the benefits of Coreg when used to treat mild, moderate and severe heart failure. Coreg slows disease progression, reduces the risk of hospitalization and improves symptoms."

Clinical data from the landmark COPERNICUS (CarvedilOl ProspEctive RaNdomIzed CumUlative Survival) trial, which included more than 2,200 patients with the most severe heart failure yet studied with a beta-blocker, have shown that Coreg reduced the chance of death by 35 per cent in patients with severe heart failure. These positive clinical trial results prompted the ethical committee to recommend the trial be stopped early and all patients be offered treatment with Coreg. In fact, significant results from clinical trials with carvedilol contributed to the Canadian Cardiovascular Society's (CCS) decision to update treatment guidelines to now recommend beta-blockers, such as Coreg, as a mainstay of CHF treatment.

"When I was first diagnosed with congestive heart failure, I wasn't sleeping very well. I would lie down and feel liquid in my lungs; it was like a choking sensation. Night after night I had this problem and I knew something was wrong. And, breathing was quite difficult, especially after climbing stairs," says Laszlo Deak, a 61-year old CHF patient. "Now, I have more energy. I can take long walks and generally my physical stamina has improved a great deal. I can even play some golf."

Before treatment with Coreg, Mr. Deak's heart failure was considered to be NYHA Class III (moderate) and his left ventricular ejection fraction was 17 per cent - well below what is considered normal (> 55 per cent). Today, his heart failure has improved to NYHA Class II (mild), and his ejection fraction has risen to 48 per cent - almost back to normal.

Heart Failure Is a Growing Epidemic

Cardiovascular disease is the leading cause of death in Canada. Congestive heart failure affects 350,000 Canadians and is also the leading cause of hospitalization of people over the age of 65, costing the Canadian healthcare system more than $1 billion per year for in-patient hospitalization alone. Heart failure occurs when the heart is unable to pump enough blood to meet the body's requirements and develops from such causes as hypertension (high blood pressure), myocardial infarction (heart attack), coronary artery disease, and excessive alcohol consumption. Patients with CHF must deal with a debilitating array of symptoms as their disease progresses, such as severe fatigue, persistent cough and shortness of breath, in addition to ongoing and frequent hospital visits.

About Coreg

In addition to the COPERNICUS trial, further landmark trials have shown the life-saving benefits of Coreg. The U.S. Carvedilol Multicenter Program has shown that treatment with Coreg reduced the chance of death by 65 per cent in patients with mild to moderate heart failure. The CAPRICORN (CArvedilol Post-InfaRct SurvIval COntRol in LV DysfunctioN) trial was the first major clinical trial designed to address the role of a beta-blocker on left ventricular function in patients who have suffered a heart attack while receiving current standard therapy. The results showed that treatment with Coreg following a heart attack can reduce the risk of patients having another heart attack by 42 per cent and dying by 23 per cent. Safety and efficacy is still under investigation and marketing authorization has not yet been obtained for Coreg's use in patients who have had a heart attack.

Coreg is generally well-tolerated. Some common side effects associated with the medication include shortness of breath, a slow heartbeat, fatigue, dizziness or faintness. Most side effects are self-limiting and tend to go away with continued treatment. As with any medication, there are some people who should not take Coreg.

About GlaxoSmithKline

GlaxoSmithKline Inc. - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. In Canada, GlaxoSmithKline employs approximately 1,800 people and is a top 20 investor in Canadian research and development, contributing more than $100 million annually. The company is also one of the top 10 corporate charitable donors, investing more than $6.5 million annually and is recognized as one of the 50 best companies to work for in Canada.

NOTE:English and French physicians and patients are available for interviews in London, ON; Montreal and Quebec City, QC.

English and French B-Roll will run consecutively via satellite on ANIK E2C, Transponder 6B Audio Channels 6.8 & 6.2. Toronto stations have been granted a PEGAD at the Toronto TOC on Dome Transmit 1, DPA 18.

  • First Feed: 11:00 - 11:30 a.m. Eastern
  • Second Feed: 14:00 - 14:30 (2:00 - 2:30 p.m.) Eastern

For further information about this news release, please contact:

Sherry Zarins/Janiece Walsh

Edelman Public Relations Canada

Tel: (416) 979-1120

Carlo Mastrangelo/Catherine Jackson

GlaxoSmithKline Inc.

Tel: (905) 819-7129/(905) 814-3527

Coreg® is a registered trademark, used under license by GlaxoSmithKline Inc.