Coreg® first beta blocking agent to demonstrate a survival benefit in patients with advanced heart failure
AMSTERDAM, August 29, 2000 -- Landmark study results reported by researchers showed that the beta blocking agent Coreg® (carvedilol) decreased mortality rates by 35 percent in patients with the most advanced stage of heart failure who were already taking standard therapy. Coreg is the first beta blocking agent to show a significant survival benefit in this patient population. These results were presented today at the European Society of Cardiologists (ESC) 22nd Annual Congress in Amsterdam.
COPERNICUS (CarvedilOl ProspEctive RaNdomIzed CUmulative Survival Trial) -- the first major international study of the use of an agent with beta blockade in advanced heart failure -- was halted earlier this year by its Steering Committee due to the significant survival benefit seen with the drug. This action was taken upon the unanimous recommendation of the study's Data and Safety Monitoring Board (DSMB), an international committee whose purpose is to oversee the study and ensure patient safety. Based on the size and consistency of the mortality benefit, the committee believed that it would be inappropriate for physicians to further withhold treatment with Coreg.
"Until recently, most of the trials that had been conducted with beta blockers were in patients who had mild to moderate disease. There was a lot of fear that these drugs would not work in patients with advanced disease," said Milton Packer, M.D., Director, Heart Failure Center and Professor of Medicine, Columbia University College of Physicians and Surgeons in New York, NY and Chairman of the Steering Committee. "The COPERNICUS trial is so important because the results tell us that carvedilol can reduce the risk of death in a much broader range of patients than we previously thought possible for agents with beta blocking activity."
Study Results Demonstrate Survival Benefit in Advanced Heart Failure This study involving Coreg was conducted in over 300 medical centers in 21 countries and enrolled over 2,200 patients with advanced heart failure who had symptoms at rest or on minimal exertion, but not requiring intensive care unit care or intravenous treatments to support their heart's function. Half of the patients received Coreg and half received a placebo (sugar pill), which were both added to the heart failure medications the patients were already taking (ACE inhibitors, diuretics, and commonly digoxin). Patients were evaluated for up to 29 months. Patients treated with Coreg showed a significantly lower mortality rate compared to those treated with placebo (11.4 percent vs. 18.5 percent, respectively). Additionally, serious adverse effects were more common in the placebo group.
Coreg, approved in May 1997, is the only drug with beta blocking properties approved in the U.S. for heart failure. It is presently indicated for the treatment of mild or moderate heart failure. The COPERNICUS data will be filed with the FDA for their review and approval. SmithKline Beecham and Roche Pharmaceuticals are seeking to broaden Coreg's current indication to include patients with advanced heart failure.
Heart Failure Is a Growing Epidemic
Heart failure develops when the heart is weakened and unable to pump
blood efficiently through the body. It commonly results from damage to
the heart after a heart attack, high blood pressure, or diabetes.
Heart failure currently affects nearly 5 million Americans, and is the
only major cardiovascular disorder on the rise. An estimated 400,000
to 700,000 new cases of heart failure are diagnosed each year and the
number of deaths in the U.S. from this condition has more than doubled
since 1979, averaging 250,000 annually.
The impact of heart failure has grown despite the use of digitalis, diuretics and ACE inhibitors. Despite compelling evidence about their benefits from previous studies, beta blocking agents are dramatically under-utilized in the treatment of heart failure. It is estimated that less than 15 percent of patients with heart failure in the U.S. are receiving beta blockers.
Some common side effects associated with Coreg (carvedilol) include shortness of breath, a slow heartbeat, weight gain, fatigue, 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, 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 less tears or have dry eyes. As with any medicine, patients taking Coreg should also first tell their doctor what other medications they are taking.
About SmithKline Beecham Pharmaceuticals and Roche
SmithKline Beecham-one of the world's leading healthcare companies
-discovers, develops, manufactures and markets pharmaceuticals,
vaccines, over-the-counter medicines and health-related consumer
products. For company information, visit SmithKline Beecham on the
World Wide Web at http://www.sb.com.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well being and quality of life. Among the company's areas of therapeutic interest are: virology, including HIV/AIDS and hepatitis C; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation; dermatology and metabolic diseases including obesity and diabetes. For more information on the Roche pharmaceuticals business in the United States, visit the company's web site at: http://www.rocheusa.com.