GlaxoSmithKline announced that the Cardiovascular and Renal Drugs Advisory Committee of the United States Food and Drug Administration (FDA) unanimously supported the use of the beta-blocking agent Coreg (carvedilol) in patients who have had a heart attack and who have left ventricular dysfunction. This recommendation is based on data from the landmark CAPRICORN (CArvedilol Post InfaRction Survival ContRol in Left Ventricular DysfunctioN) trial, which showed that early long-term treatment with Coreg following a heart attack in patients with left ventricular dysfunction could reduce the risk of dying by 23 per cent.
According to the National Institute of Health, each year 1.1 million Americans suffer a heart attack -- of which approximately 40 per cent are recurrent attacks -- and nearly 500,000 die. Coreg is the only beta-blocking agent approved for the treatment of mild, moderate and severe heart failure and is the only beta-blocking agent with an approved indication to reduce the risk of dying in heart failure. Coreg is also indicated for essential hypertension.
"GlaxoSmithKline is dedicated to developing medicines that truly improve lives, and our commitment to the Coreg clinical program is another example of this," said Bonnie Rossello, Vice President, GlaxoSmithKline. "We are pleased with the Advisory Committee's decision to recommend the use of Coreg in patients who have had a heart attack and who have left ventricular dysfunction, further acknowledging the life-saving benefits across a broad spectrum of patients."
CAPRICORN, a placebo-controlled, randomized trial designed to evaluate the effect of Coreg compared with placebo in patients with left ventricular dysfunction following an acute myocardial infarction (MI), enrolled over 1,900 patients at over 160 sites in 17 countries. Clinically stable patients were randomized to receive either long-term treatment with Coreg or placebo (ACE inhibitors and many other proven life-saving therapies) following a proven MI with left ventricular ejection fraction of < 40 percent. Patients were required to have been taking ACE inhibitors and were followed for a mean of 15 months (up to a maximum of 2.7 years from time of randomization to time of last visit). Treatment with Coreg was shown to reduce the risk of death for any reason by 23 per cent (p=0.031).
"The CAPRICORN trial is the first major study designed specifically to assess the efficacy of beta-blocking agents when added to current therapy of ACE inhibitors, thrombolytics, statins and aspirin in patients who have suffered a heart attack and who have left ventricular dysfunction," said Henry J. Dargie, Chairman of the CAPRICORN Steering Committee and Professor of Cardiology at the Western Infirmary, Glasgow, Scotland. "If approved, this new indication for carvedilol fills an important gap, allowing clinicians to offer these patients effective treatment. In the study, patients received current standard of care medications and carvedilol as early as three days and up to 21 days following a heart attack."
CAPRICORN is the first major trial designed specifically to address the role of a beta-blocking agent in patients who have suffered a heart attack when given on-top of modern day therapy of ACE inhibitors, thrombolytics, statins and aspirin. Previous studies involving post-MI patients with other beta-blockers were conducted during the 1970s and 1980s, when patients infrequently received such beneficial therapies. CAPRICORN is also unique in that all patients had depressed left ventricular dysfunction after their MI -- such patients are at considerably higher risk and had been excluded in previous beta-blocker heart attack trials.