Philadelphia, PA - The US Food and Drug Administration has approved additions to the labeling for carvedilol (Coreg, GlaxoSmithKline [GSK]), which now outlines additional results from several major clinical trials that had aided the drug's prior approval for heart failure and patients with post-MI LV dysfunction, the company announced this week. The drug is also approved for hypertension.

The agency approved the post-MI-LV-dysfunction indication in March 2003, based primarily on survival outcomes from the Carvedilol Post Infarction Survival Control in Left Ventricular Dysfunction (CAPRICORN) trial. The drug was associated with a 23% mortality reduction in such patients. Now the labeling can mention the accompanying 40% reduction in reinfarction, according to GSK.

As heartwire reported at the time, the preapproval advisory panel was less convinced by the reinfarction data and had strongly recommended against that indication for the drug.

The new information for the HF indication comes from various sources, the company said, including the Carvedilol or Metoprolol EuropeanTrial (COMET), in which carvedilol was associated with a significant 15% reduction in five-year all-cause mortality compared with immediate-release metoprolol among patients in NYHA functional class 2-4.