Rimonabant improves cardiovascular risk profile.(Clinical Rounds)

NEW ORLEANS -- Evidence is mounting that rimonabant, shown effective for weight loss and smoking cessation, independently improves patients' cardiovascular risk profiles, reported F. Xavier Pi-Sunyer, M.D, at the annual scientific sessions of the American Heart Association.

In the wake of the highly favorable results of the Rimonabant In Obesity--North America (RIO-NA) trial presented the company plans to file for marketing approval for the investigational drug in the second quarter of 2005, a Sanofi-Synthelabo spokesman told this newspaper.

A total of 3,040 obese patients participated in RIO-NA, a 2-year randomized double-blind trial conducted at 72 U.S. and Canadian centers. Participants were randomized to rimonabant at 20 or 5 mg/day or to placebo in a 2:2:1 ratio for the first year. Those on rimonabant were then rerandomized to the same dose of the drug or to placebo for the second year. All patients were also prescribed a mildly hypocaloric diet designed to create a 600 kcal/day deficit relative to energy requirements.

Patients on rimonabant at 20 mg/day experienced significant reductions in body weight and abdominal fat well in excess of what can be achieved with currently available weight-loss medications. They also developed an improved cardiovascular risk profile and a sharply decreased prevalence of the metabolic syndrome, said Dr. Pi-Sunyer, professor of medicine at Columbia University and chief of the department of endocrinology, diabetes, and nutrition at St. Luke's-Roo-sevelt Hospital, New York City.

Mean weight loss at 1 year was 8.7 kg in the rimonabant 20 mg/day group, compared with 2.8 kg with placebo. At 2 years the rimonabant group weighed a mean of 7.4 kg less than at baseline; the placebo group weighed 2.3 kg less. Fully 62.5% of patients on high-dose ...