BG Medicine Inc., a company focused on the development and commercialization of novel cardiovascular diagnostics, announced that results from a sub-study of the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) trial were published online in the current issue of the European Heart Journal. Study results demonstrated that patients with blood levels of galectin-3 below 19.0 ng/mL at the start of the trial derived significant clinical benefit from rosuvastatin (statin) treatment. By contrast, no clinical benefit from rosuvastatin treatment was observed among participants with higher levels of galectin-3.
The galectin-3 CORONA study was designed to assess whether baseline galectin-3 levels could distinguish a group of patients with heart failure who would derive a clinical benefit from rosuvastatin treatment. Rosuvastatin, known under the brand name Crestor, is a statin medication indicated for the treatment of high cholesterol and related lipid disorders to reduce the risk of heart attack and stroke.
The sub-study involved 1,462 trial participants (approximately one-third of all CORONA trial subjects). Results demonstrated that patients with plasma levels of galectin-3 less than 19.0 ng/mL derived a 35% reduction in primary adverse cardiovascular events while on rosuvastatin treatment compared to placebo, while no comparable benefit was observed in subjects with plasma levels of galectin-3 above 19.0 ng/mL (p=0.036). The primary endpoint was a composite of cardiovascular mortality, non fatal myocardial infarction and non fatal stroke, which were analyzed as time to first event.
“Heart failure is a leading cause of death, and galectin-3 is increasingly recognized as a factor in promoting cardiac fibrosis and poor clinical outcomes in many heart failure patients,” said Dr. Lars Gullestad, MD, PhD, Professor of Cardiology in the Department of Cardiology at Rikshospitalet University Hospital, Oslo, Norway, who led the study.
“This important study reaffirms a key premise of our galectin-3 research, namely that galectin-3 identifies heart failure patients with a distinct form of the disease,” said Pieter Muntendam, MD, Executive Vice President and Chief Medical Officer of BG Medicine. “We expected that the benefit of certain drugs may be limited to patient groups defined by their level of galectin-3 and this is an excellent example of such differential benefit.”
The original CORONA study was designed to evaluate the utility of rosuvastatin treatment for patients with advanced heart failure. Results from that trial, reported in the New England Journal of Medicine in 2007, demonstrated no rosuvastatin benefit on the primary coronary endpoint or on cardiovascular death.
Date: May 14, 2012
Source: BG Medicine Inc.