Healthcare Industry News: Coreg
News Release - May 17, 2006
New Data Show COREG CR (TM) Reduced Blood Pressure in Patients With Essential HypertensionStudy Presented at American Society for Hypertension Meeting Reports Once-Daily Formulation Well-Tolerated and Provided Continuous 24-hour Blood Pressure Reduction
PHILADELPHIA, May 17 (HSMN NewsFeed) -- Coreg CR(TM) (carvedilol phosphate controlled-release capsules), a controlled-release beta blocker, reduced blood pressure over a full 24-hour dosing interval, according to data presented today at the American Society for Hypertension 21st Annual Scientific Meeting and Exposition in New York. Additionally, the data show that Coreg CR was well-tolerated with no significant difference in incidence of adverse events among patients taking Coreg CR as compared to those taking the placebo. GlaxoSmithKline (NYSE: GSK ) announced in March that the U.S. Food and Drug Administration (FDA) has accepted and is currently reviewing the new drug application (NDA) for Coreg CR.
According to the Heart Disease and Stroke Statistics 2006, nearly one in three Americans suffers from elevated blood pressure (hypertension). An earlier study found that only 29 percent of those diagnosed with hypertension achieve adequate control (<140/90 mmHg) with treatment; nearly half receive no treatment at all. Research shows that patients cite side effects as a major reason for not taking medication.
"Hypertension is a condition that increases the risk of heart attacks and stroke," said Michael A. Weber, M.D., professor of medicine, at the SUNY Downstate Medical College of Medicine, Brooklyn, New York. "We believe that to be fully effective, an antihypertensive agent should provide 24 hour blood pressure reduction with a low incidence of side effects. These Coreg CR findings are encouraging."
Coreg CR was developed with Micropump® technology by Flamel Technologies (Nasdaq: FLML ) and is designed to control dissolution and absorption of carvedilol in the body, allowing for once-a-day dosing. Once approved, Coreg CR will be available to patients in a once-a-day dose. GSK currently markets Coreg® (carvedilol), the immediate release version of carvedilol, which is dosed twice a day.
The data presented at ASH is based on a double-blind, randomized, placebo-controlled, parallel group, multi-center study. Patients were randomized to receive once-daily doses of Coreg CR 20 mg, 40 mg, 80 mg or placebo for six weeks. Participants entered the study with a mean 12-hour daytime diastolic blood pressure by ambulatory blood pressure monitoring (ABPM) of greater than or equal to 90 mmHg, but less than or equal to 109 mmHg.
Coreg CR significantly reduced systolic blood pressure by 6.8 mmHg, 10.1 mmHg and 12.5 mmHg in the Coreg CR 20, 40 and 80 mg treatment groups, respectively. The effects on blood pressure of Coreg CR were evaluated using 24-hour ABPM.
Diastolic blood pressure was significantly lowered by 4.4 mmHg, 7.9 mmHg and 9.6 mmHg in the Coreg CR 20, 40 and 80 mg treatment groups, respectively, using 24-hour ABPM.
The immediate-release formulation of carvedilol, COREG, is marketed by GlaxoSmithKline in the United States. Coreg is the only beta-blocker that is FDA approved to improve survival in mild to severe heart failure and is the only beta-blocker approved for patients who had a heart attack that reduced how well the heart pumps.
Specific indications for Coreg are:
* Coreg is approved for the treatment of hypertension, which is also known as high blood pressure.
* Coreg is approved to reduce the risk of death in patients who had a heart attack that reduced how well the heart pumps.
* Coreg is approved to increase survival in mild to severe heart failure patients.
Important Coreg Safety Information It is important for patients to take their medicine every day as directed by their doctors or health care providers. 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. If their doctor decides that they should stop taking COREG, their doctor or health care provider may slowly reduce their doses over a period of time before stopping it completely.
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. Beta-blockers may mask the symptoms of low blood sugar or 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 should first tell their doctor what other medications they are taking.
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 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. For more information on COREG, visit http://www.coreg.com.
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