The US Food and Drug Administration has approved a label update for GlaxoSmithKline’s Coreg (carvedilol), meaning that the beta-blocker is now available to reduce the risk of suffering a heart attack.
The UK firm says that the update is based on a clinical trial showing that patients taking Coreg in addition to standard therapy, including ACE inhibitors and aspirin, who had a recent heart attack that damaged their heart had a 40% reduced risk of suffering another heart attack. The label also includes data from the so-called Capricorn trial, which showed a 23% reduced risk of dying in patients that took Coreg within 21 days following a heart attack and maintained treatment over the long-term.
In addition, the label, also known as the prescribing information, notes similar reductions in the risk of heart attack in heart failure patients taking Coreg based on a meta-analysis of placebo-controlled trials. The label also now includes additional data further supporting the ability of Coreg to increase survival among heart failure patients. Data from the 3,029-patient Comet study are also included, in which Coreg was pitted against AstraZeneca’s blockbuster heart drug, Toprol XL (metoprolol). Results found that all-cause mortality was 34% in the Coreg group compared to 40% for those receiving Toprol XL.