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New labeling for beta-blocker Coreg 

FDA approves updated labeling for Coreg® showing benefits for heart attack patients with damaged hearts and heart failure patients


Philadelphia, May 24, 2005: GlaxoSmithKline announced today that the U.S. Food and Drug Administration approved the addition of important clinical data to the labeling for its beta-blocker Coreg® (carvedilol). One of the updates to the label is based on a study showing that patients taking Coreg who had a recent heart attack that damaged their heart had a 40 percent reduced risk of suffering another heart attack when given to patients who received modern-day therapy, including ACE inhibitors, thrombolytics, cholesterol-lowering agents and aspirin. In addition, the label, also known as the prescribing information, notes similar reductions in the risk of heart attack in heart failure patients taking Coreg based on a meta-analysis of placebo-controlled trials. The label also now includes additional data further supporting the ability of Coreg to increase survival among heart failure patients .

“These label updates reinforce the benefits of Coreg for patients with heart failure and patients who experienced a recent heart attack that damaged their heart,” said Mary Ann Lukas, M.D., senior director, Cardiovascular Medicine Centre, GlaxoSmithKline. “Our hope is that this new information will help guide healthcare professionals as they choose the right beta-blocker for these cardiac patients.”

The new prescribing information includes data from the landmark CAPRICORN (CArvedilol Post InfaRction SurvIval COntRol in Left Ventricular DysfunctioN) trial. The trial showed that when Coreg was initiated within 21 days and maintained long term in patients following a heart attack that damaged their heart, the risk of dying was reduced by 23 percent. In addition, patients participating in the trial experienced a 40 percent reduction in fatal or non-fatal myocardial infarction (p="0.01)."

Additionally, results from the Carvedilol or Metoprolol European Trial (COMET) trial, the longest and largest beta-blocker trial ever conducted in heart failure, are included in the updated prescribing information for Coreg. In the COMET trial, 3,029 patients with NYHA class II — IV heart failure (left ventricular ejection fraction of ≤ 35 percent) were randomized to receive either Coreg or immediate-release metoprolol tartrate. Patients participating in the double-blind trial were evaluated for a mean duration of 4.8 years. Results of the study found that all-cause mortality was 34 percent in the patients treated with Coreg compared to 40 percent in the metoprolol tartrate group (p="0.0017)." The composite endpoint of mortality or all-cause hospital admission was 74 percent in the group treated with Coreg and 76 percent in the group treated with metoprolol tartrate. In addition, the estimated mean survival was 8.0 years among patients taking Coreg and 6.6 years with metoprolol tartrate.

The COMET trial compared carvedilol (target dose 25 mg bid) to metoprolol tartrate (target dose 50 mg bid). It is not known whether this formulation of metoprolol at any dose or this low dose of metoprolol in any formulation has any effect on survival or hospitalization in patients with heart failure. Metoprolol tartrate is not indicated in the United Statesfor heart failure. COMET did not compare carvedilol to metoprolol succinate (Toprol XL®*). The efficacy of carvedilol versus metoprolol succinate in heart failure has not been established in a head-to-head outcomes study. The target dose of metoprolol succinate in heart failure is 200 mg qd.

“Heart failure and heart attacks affect millions of Americans and their families,” said Mary Ann Lukas, M.D., senior director, Cardiovascular Medicine Centre, GlaxoSmithKline. “We are proud to provide medicines like Coreg that can help these patients.”

About Heart Attacks

Each year in the United States, nearly one million people suffer from heart attacks, known medically as myocardial infarction, which occurs when the blood supply to part of the heart muscle is severely reduced or blocked. This narrowing of the coronary vessels is often linked with risk factors such as smoking, diabetes, high blood pressure, high blood cholesterol, physical inactivity and obesity. There also may be risk factors associated with family history.

* Toprol XL is a registered trademark of the Astra Zeneca Group of Companies

About Heart Failure

Heart failure is a progressive condition in which the heart muscle weakens and gradually loses its ability to pump enough blood to supply the body’s needs. Heart failure affects nearly 5 million Americans, and, as more people are surviving heart attacks but being left with weakened hearts, heart failure is the only major cardiovascular disorder on the rise. More than 500,000 patients are newly diagnosed with heart failure each year -- exceeding the number of new diagnosed cases for AIDS, breast cancer or Alzheimer’s disease. In addition, the number of deaths in the U.S.from this condition as a primary or contributory cause has increased steadily despite advances in treatment options, averaging nearly 300,000 patient deaths each year. In 2005, the estimated direct and indirect cost of heart failure in the U.S.is $27.9 billion. While there is currently no known cure for heart failure, new treatment approaches may help patients live more normal and fulfilling lives and benefit from a decreased risk of hospitalization.

About Coreg

Coreg is marketed by GlaxoSmithKline in the United Statesand is the only beta-blocking agent FDA approved to improve survival in mild to severe heart failure and is the only beta-blocker approved for reducing cardiovascular mortality in heart attack survivors with damaged hearts. Specific indications are:

§ In Heart Attack Survivors With Damaged Hearts:Coreg is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of <="40" percent (with or without symptomatic heart failure).

§ Congestive Heart Failure: Coregis indicated for the treatment of mild to severe heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitor, and digitalis to increase survival and, also, to reduce the risk of hospitalization.

§ Hypertension:Coreg is indicated for the management of essential hypertension. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

Patients taking Coreg should avoid stopping therapy abruptly. With certain beta-blocking agents, stopping therapy abruptly has led to chest pain, and in some cases, heart attack. The dosage of Coreg should be reduced gradually over a 1- to 2-week period, and the patient should be carefully monitored.

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.

Some common side effects associated with Coreg include shortness of breath, a slow heartbeat, weight gain, fatigue, hypotension, 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. 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. 


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