Healthcare Industry News:  Coreg  

Biopharmaceuticals Cardiology

 News Release - March 22, 2007

GSK Announces Nationwide Availability of Once-A-Day COREG CR(TM) for the Treatment of Three Key Cardiovascular Conditions

PHILADELPHIA, March 22 (HSMN NewsFeed) -- GlaxoSmithKline (NYSE: GSK ) announced today that Coreg CR(TM) (carvedilol phosphate) extended- release capsules, a once-a-day beta-blocker, is now available at pharmacies nationwide. Coreg CR is FDA-approved to treat three cardiovascular conditions:

- High blood pressure, also known as hypertension.

- A heart attack that has reduced how well the heart pumps (known medically as post-myocardial infarction left ventricular dysfunction).

- Mild to severe heart failure.

The availability of once-a-day Coreg CR eases the pill burden for patients who previously had to take Coreg® (carvedilol) twice-a-day. Coreg CR is bioequivalent to the original formulation of COREG, which has established a significant role in the treatment of heart disease.

"The once-a-day dosing of Coreg CR simplifies the treatment regimen and offers the potential for improved compliance for patients with heart disease," said Michael A. Weber, M.D., professor of medicine, at the SUNY Downstate Medical College of Medicine, Brooklyn, New York. "Studies with other older beta blockers show that heart-attack survivors who take less than 75 percent of their beta blocker regimen in the year after an event are more likely to die than compliant patients; we also know that noncompliance is linked to heart-failure hospitalizations."

About Carvedilol

Coreg CR is a once-a-day formulation of carvedilol, a medication that has established a significant role in the treatment of heart disease. Key evidence of carvedilol treatment benefits comes from multiple landmark clinical trials.

Major carvedilol studies include COMET (the Carvedilol or Metoprolol European Trial). According to COMET investigators, the study results suggested that the use of carvedilol in patients with heart failure extended median survival by 1.4 years (95% CI, 0.5-2.3).* A retrospective analysis of this trial, just published in the March 6, 2007 issue of The Journal of the American College of Cardiology, detailed that patients with heart failure who received carvedilol suffered fewer heart attacks and strokes and were less likely to die of these and other vascular events than patients prescribed another beta blocker, metoprolol tartrate.

Important insights into the effect of carvedilol following a heart attack came from the CAPRICORN trial, published in 2001. This study showed that when carvedilol was maintained long term in patients following a heart attack that reduced how well the heart pumps, the risk of dying was reduced by 23 percent (95% CI, 2% to 40%, p = 0.031). Patients taking carvedilol had a significantly reduced risk of having another heart attack.

Another study, GEMINI, in 2004, evaluated patients with hypertension and underlying diabetes. Other older beta blockers have generally been regarded as having a negative impact on key metabolic parameters. In contrast, the GEMINI study results showed that carvedilol effectively lowered blood pressure while having a neutral impact on blood-sugar levels, lipids and weight gain.**

About Coreg CR

Coreg CR is available in four dosage strengths: 10 mg, 20 mg, 40 mg and 80 mg. Coreg CR also is the first FDA-approved medication utilizing Flamel Technologies' (Nasdaq: FLML ) proprietary Micropump® technology, which is designed to control the delivery of carvedilol to help maintain appropriate amounts of medicine in the body over a 24-hour span.

A "third-generation" beta blocker, Coreg CR works by comprehensively blocking neurohormonal activity that can damage a weakened heart. The use of certain beta blockers such as Coreg CR is supported by evidence-based guidelines, such as the American College of Cardiology and American Heart Association (ACC/AHA) Joint Heart Failure Guidelines and the American Association of Clinical Endocrinologists (AACE) Hypertension Task Force's Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Hypertension.

* The Carvedilol Or Metoprolol European Trial (COMET) 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 States for 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. Thus this trial extends the time over which carvedilol manifests benefits on survival in heart failure, but it is not evidence that carvedilol improves outcome over the formulation of metoprolol (Toprol-XL) with benefits in heart failure.

** The COMET, CAPRICORN, and GEMINI studies were conducted with Coreg Tablets. Coreg CR Extended-Release Capsules have been shown to be bioequivalent to Coreg Tablets. Coreg CR should be taken once daily in the morning with food. Coreg CR should be swallowed as a whole capsule. Coreg CR and/or its contents should not be crushed, chewed, or taken in divided doses. The administration of Coreg CR with alcohol (including prescription and over- the-counter medications that contain ethanol) should be separated by at least 2 hours.

Important Coreg and Coreg CR Safety Information

It is important for patients to take their medicine every day as directed by their doctor or health care provider. If patients stop taking Coreg CR or Coreg suddenly, they could have chest pain and/or a heart attack. If the doctor decides that a patient should stop taking Coreg CR or COREG, the doctor may slowly lower the dose over a period of time before stopping it completely.

Some common side effects associated with Coreg CR and Coreg include shortness of breath, a slow heartbeat, weight gain, fatigue, hypotension, dizziness, faintness, or runny nose/sore throat. People taking Coreg CR or 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. Beta-blockers may mask the symptoms of an overactive thyroid or low blood sugar, or may alter blood sugar levels. 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 CR or Coreg should first tell their doctor what other medications they are taking. Coreg CR and Coreg should be taken with food.

There are some people who should not take Coreg CR or COREG, including 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 CR or COREG. Other people who should not take Coreg CR or Coreg are those who are prone to asthma or other breathing problems, those with a very slow heartbeat or heart that skips a beat (irregular heartbeat) and those with liver problems. Complete prescribing information can be found at COREG.COM or COREGCR.COM.

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. Additional information about GlaxoSmithKline can be found online at http://www.gsk.com. Additional information about Coreg CR can be found online at http://www.coregcr.com.


Source: GlaxoSmithKline

Issuer of this News Release is solely responsible for its content.
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