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New Data Show COREG CR (TM) Reduced Blood Pressure In Patients With Essential Hypertension
Philadelphia - 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 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(R) technology by Flamel Technologies 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(R) (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.