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Philadelphia, November 01, 2001 - GlaxoSmithKline (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) approved Coreg® (carvedilol) for the treatment of severe heart failure. Coreg is already approved for the treatment of mild to moderate heart failure. Additionally, Coreg is now the only beta-blocking agent indicated to increase survival in mild, moderate, and severe heart failure patients.
"About a quarter of a million people die each year from heart failure, a condition that has reached epidemic proportions in the U.S.," said David Stout, President, US Pharmaceuticals. "Coreg is the only beta-blocking agent approved by the FDA to treat mild to severe heart failure, and has shown life-saving benefits in this broad spectrum of patients. Coreg, with beta1, beta2 and alpha1 blockade, is truly different from other beta-blocking agents."
The FDA granted marketing approval for Coreg in severe heart failure based on a review of data from the COPERNICUS (CarvedilOl ProspEctive RaNdomIzed CumUlative Survival) trial. The data demonstrated that treatment with Coreg reduced the risk of death in patients with severe heart failure by 35 percent compared to placebo. Further, Coreg was well tolerated in this patient population. Coreg is now the only beta-blocking agent proven effective and also well tolerated in severe heart failure patients.
The COPERNICUS trial was a multicenter, double-blind, randomized controlled trial of Coreg versus placebo in patients with severe heart failure. Patients were already taking ACE inhibitors, diuretics and commonly digoxin. The trial was conducted with over 2,200 patients in over 300 hospitals in 21 countries on six continents. The results from the trial were published in the New England Journal of Medicine in May 2001, and presented at the American College of Cardiology conference in Orlando in March 2001. Coreg, approved in May 1997, was the first drug with beta-blocking properties approved in the U.S. for mild to moderate heart failure.
"The COPERNICUS trial extends the benefits of carvedilol from patients with only mild or moderate symptoms to patients with severe symptoms - physicians should now feel comfortable using this drug across this broader spectrum of the disease," said Milton Packer, MD, Professor of Medicine at Columbia University College of Physicians & Surgeons and lead investigator of the trial.
Coreg Provides Unique Triple Blockade
Beta-blockers work by blocking certain receptors that are used by stress hormones in the body. These hormones are involved in the worsening of heart failure. The unique mechanism of action of Coreg blocks all three receptors believed to play a role in the progression of heart failure. The broad spectrum of the pharmacologic actions of Coreg may account for its favorable effects across a wide range of patients. However, the basis for the beneficial effects (mechanism of action) of Coreg in heart failure is not known.
Some common side effects associated with Coreg 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 fewer tears or have dry eyes. As with any medicine, patients taking Coreg should also first tell their doctor what other medications they are taking.
Heart Failure Is a Growing Epidemic
Heart failure affects nearly five million Americans every year and is the only major cardiovascular disease on the rise. 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. 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 incidence 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 currently estimated that less than 20 percent of patients with heart failure in the U.S. are receiving beta-blockers.
About GlaxoSmithKline
GlaxoSmithKline - 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.
Customer information line: 1-888-825-5249
Web site address: www.gsk.com.
Coreg Web site address: www.Coreginfo.com
Enquiries:
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Holly Russell
Heather Rose |
(919) 483 2839
(212) 798 9746 |
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