GSK Coreg adds mortality claim
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Revised labeling for GlaxoSmithKline's Coreg (carvedilol) cites a 23% risk reduction in all-cause mortality for myocardial infarction patients. FDA approved the beta blocker March 27 for reducing cardiovascular mortality in clinically stable post-MI patients with left ventricular dysfunction. The sNDA was based on GSK's 1,959-patient CAPRICORN study, in which all-cause mortality was 15% for placebo and 12% for Coreg (p=0.03). Labeling does not mention that results did not meet the pre-specified p-value of .004 for statistical significance; FDA's Cardiovascular & Renal Drugs Advisory Committee voted Jan. 7 that other Coreg studies and experience with other beta blockers supported the indication. GSK is promoting Coreg as "the only beta-blocking agent approved to reduce the risk of death in mild, moderate and severe heart failure