RIO LIPIDS FINDINGS

A multi-center, double-blind, placebo-controlled study, RIO-Lipids enrolled 1,036 obese patients with dyslipidemia and a BMI between 27 and 40 kg/m2. Patients were randomized into three treatment groups receiving either a daily, fixed dose of 5mg or 20mg of rimonabant or placebo along with a reduced calorie diet for one year.

Patients treated for one year with rimonabant 20mg lost almost 20 lbs (8.6 kg) vs. a loss of only 5 lbs (2.4 kg) on placebo (p<0.001). Nearly three-fourths (72.9%) of these patients treated for a year with rimonabant 20mg lost more than 5% of their body weight vs. placebo (p<0.001) while nearly half (44.3%) lost in excess of 10% of their body weight vs. placebo (p<0.001). While weight loss was the primary endpoint, a waist circumference reduction of 3.4 inches (9.1 cm) in patients completing a year of treatment on rimonabant 20 mg was statistically significant (p<0.001 vs. placebo).

Researchers also designed the RIO-Lipids study to determine if rimonabant, in a group of overweight/obese patients at risk for cardiovascular disease, could improve important factors such as lipid profile, glucose metabolism and other features of the metabolic syndrome. Results show that both the 5 mg and 20 mg doses of rimonabant significantly improved two important indicators of cardiovascular risk, HDL-cholesterol and triglycerides vs. placebo. The patients treated for a year in the 20 mg group achieved an average 23% increase (p<0. 001 vs. placebo) in HDL-cholesterol and a reduction of 15% in triglycerides (p<9x10-5 vs. placebo).

No difference in LDL-cholesterol was observed between rimonabant and placebo. However, rimonabant 20mg delivered positive changes in LDL particle size, a known indicator of atherogenic risk. In patient
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Contact: Glenn Lehrman
glenn.lehrman@ketchum.com
917-533-5998
Ketchum
9-Mar-2004