Weight loss sustainable with rimonabant, 2-year results show.(News)

ORLANDO, FLA. -- The outstanding weight loss and cardiovascular-risk reduction previously reported after 1 year of rimonabant therapy were maintained after 2 years of treatment in the phase III Rimonabant in Obesity-Europe trial, Luc Van Gaal, M.D., reported at the annual meeting of the American College of Cardiology.

The safety and tolerability profiles of rimonabant, first in a new class of selective endocannabinoid type 1-receptor blockers, also remained reassuring after 2 years' treatment, added Dr. Van Gaal, professor of diabetology, metabolism, and clinical nutrition at the University of Antwerp (Belgium) and principal investigator for Rimonabant in Obesity (RIO)-Europe.

The new 2-year study results are virtually superimposable on the 2-year outcomes of the phase III RIO-North America trial presented last fall at the annual scientific sessions of the American Heart Association (OB.GYN. NEWS, Jan. 1, 2005, p. 36).

Armed with data from more than 6,600 overweight and obese participants in these two trials plus two Sanofi-Aventis-sponsored 1-year phase III trials, the company plans to file before midyear for Food and Drug Administration and European Commission approval of rimonabant 20 mg/day for weight loss, a spokesman told this newspaper. Simultaneously, Sanofi-Aventis will file for a smoking cessation indication, the subject of another extensive phase III rimonabant clinical trials program.

RIO-Europe was a randomized, double-blind, placebo-controlled study involving 1,507 overweight or obese patients with a mean baseline body mass index of 37 kg/[m.sup.2] and a mean age of 45 years. As is typical in weight loss trials, 80% were women. Participants were strongly encouraged by dietitians and counselors to adopt a 600-kcal/day-deficit diet and increase their physical activity.

In RIO-Europe, 20 mg/day of rimonabant resulted in a mean 7.2-kg weight loss among those who completed 2 years of treatment, compared with a mean 2.5-kg loss in those on placebo. In an intent-to-treat analysis, the mean weight loss was 5.5 kg in the rimonabant arm and 1.2 kg with placebo.

At baseline, more than 42% of study participants met National Cholesterol Education Program criteria for metabolic syndrome. After 2 years on rimonabant 20 mg/day, the prevalence of metabolic syndrome fell by 57%, compared with a 34% drop with placebo.