Ivabradine fails SIGNIFY trial for Stable Angina-Servier
A 19,000-patient study presented at the European Society of Cardiology Congress found a large group of patients with severe activity-limiting angina did worse on ivabradine from Servier. The SIGNIFY trial had been designed to show that adding ivabradine to standard therapy would be beneficial. The negative result in the sub-group of 12,000 patients with severe angina meant it failed.
The increase in the combined risk of cardiovascular death and heart attack in this patient group was small but statistically significant, with 7.6 percent of them suffering an adverse event against 6.5 percent of those on placebo. A commentary in the New England Journal of Medicine, where the results were also published, said more research was needed to understand the finding and in the meantime doctors should "exercise caution" in using the drug in severe angina patients. The European Medicines Agency has launched a review into the safety of the medicine, which is sold under the brand name Procoralan, because of the signal from the SIGNIFY trial.
see-
" Ivabradine in Stable Coronary Artery Disease without Clinical Heart Failure"- Kim Fox, M.D., Ian Ford, Ph.D., Philippe Gabriel Steg, M.D., Jean-Claude Tardif, M.D., Michal Tendera, M.D., and Roberto Ferrari, M.D. for the SIGNIFY Investigators August 31, 2014DOI: 10.1056/NEJMoa1406430.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins