GSK and Flamel Technologies have announced FDA approval of once-a-day Coreg CR (carvedilol phosphate) extended-release capsules, for the treatment of 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.COREG CR will utilize Flamel’s proprietary Micropump® technology, which controls the delivery of carvedilol helping to maintain appropriate amounts of medicine in the body over a 24-hour span. This technology allows COREG CR to be dosed once daily, in contrast to immediate-release COREG (carvedilol) tablets, which patients must take twice daily. GSK plans to begin shipping COREG CR in the first quarter of 2007.”Once-a-day COREG CR will simplify the treatment regimen and offer 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. “The combination of this benefit with the proven effectiveness of COREG offers a treatment advantage for the growing number of heart patients who take multiple medications every day.”COREG CR is a third generation “beta blocker,” which is a class of medicines that work by slowing heart rate and lowering the force with which it pumps. Studies of COREG CR indicate it is generally well tolerated with a low incidence of adverse events. COREG CR, a once-a-day medicine, is approved to treat the same conditions as twice-a-day COREG, which has established a significant role in the treatment of heart disease.Evidence of the treatment benefits of COREG has come from multiple clinical studies. These COREG studies include COMET, published in 2003. This trial of more than 3,000 heart failure patients demonstrated that patients receiving COREG lived 1.4 years longer compared to patients taking the beta blocker metoprolol tartrate.Important insights into the effect of COREG following a heart attack came from the CAPRICORN trial, published in 2001. This study showed that when COREG 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. In addition, patients taking COREG had a significantly reduced risk of having another heart attack.Another study, GEMINI, in 2004, evaluated patients with hypertension and underlying diabetes. Older beta blockers have generally been regarded as having a negative impact on key metabolic parameters. In contrast, the GEMINI study results showed that COREG effectively lowered blood pressure while having a neutral impact on blood-sugar levels, lipids and weight gain.
