Rimonabant-induced weight loss and improvements in high-density lipoprotein cholesterol and triglycerides are sustained through at least two years of drug use, according to an article in the February 15 issue of the Journal of the American Medical Association.

F. Xavier Pi-Sunyer, MD, and his American colleagues evaluated the efficacy and safety of rimonabant in conjunction with diet and exercise in promoting reductions in body weight and waist circumference, long-term weight maintenance, and reduction of cardiometabolic risk factors in obese and higher risk overweight patients.

The randomized, double-blind, placebo-controlled study, conducted from August 2001 to April 2004, included 3,045 adults who were obese (body mass index 30 or greater) or overweight (body mass index greater than 27) and had treated or untreated hypertension or dyslipidemia.

Patients were randomized to receive placebo, 5 mg daily rimonabant, or 20 mg daily rimonabant for Year 1. Rimonabant-treated patients were re-randomized to receive placebo or continue to receive the same rimonabant dose, whereas the placebo group continued to receive placebo during Year 2.Year 1 of the study was completed by 51 percent of patients in the placebo group, 51 percent in the 5 mg rimonabant group, and 55 percent in the 20 mg rimonabant group.

After randomization, weight loss from baseline to end of Year 1 was significantly greater in patients receiving 5 or 20 mg rimonabant than in patients receiving placebo. The percentage of patients achieving a 5 percent or greater weight loss through Year 1 was 26.1 percent for 5 mg rimonabant, 48.6 percent for 20 mg rimonabant, and 20.0 percent for placebo.

Compared with the placebo group, 20 mg rimonabant produced greater average reductions in weight, waist circumference, and level of triglycerides, as well as a greater increase in level of high-density lipoprotein cholesterol.

Patients who were switched from 20 mg rimonabant group to placebo during Year 2 experienced weight regain while those who continued to receive 20 mg rimonabant maintained weight loss and favorable changes in risk factors. Rimonabant was generally well tolerated; the most common drug-related adverse event was nausea (11.2 percent for the 20 mg group vs. 5.8 percent for the placebo group).