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Investigative Drug Rimonabant Helps Obese Subjects Lose Weight and Reduce Waist Size: Presented at ESC(CARD)2004

By Ed Susman

MUNICH, GERMANY -- August 30, 2004 -- Studies with rimonabant continue to show that the investigative drug -- when combined with a diet and exercise program -- results in reductions in weight and abdominal girth, and a decrease in metabolic syndrome.

"We are still involved in a number of clinical studies with rimonabant," said Luc Van Gaal, MD, Professor of Medicine, Antwerp University, Antwerp, Belgium. "But I believe the company -- Sanofi-Aventis -- will file for regulatory approval in the first quarter of 2005."

The Phase III Rimonabant in Obesity – Europe (RIO-Europe) study found that the endocannabinoid type 1 blocker rimonabant in its 20 mg dose was significantly better than placebo in getting patients to stay on programs that help them diet and lose weight.

"Rimonabant breaks the vicious circle by cutting the desire to eat by inhibiting the endocannabinoid activation by receptors in the brain and in adipose tissue," Dr. Van Gaal said here August 29th at the European Society of Cardiology ESC2004 meeting.

In the study, doctors assigned 1,507 overweight patients to rimonabant 5 mg or 20 mg or to a control group, who was encouraged to lose weight but did not receive the new treatment. Patients needed to have a body mass index greater than 27 and a co-morbidity such as a dyslipidemia to be eligible for the 2-year study.

In reporting the results after 1 year of treatment, Dr. Van Gaal said of the 599 individuals on the 20 mg of rimonabant, the average person lost 8.6 kg or about 19 pounds compared to an average of about 3.6 kg for the 305 patients on placebo. The difference reached significance at the p<0.001 level. The 603 patients on the lower dose of rimonabant also lost more weight than placebo patients, about 4.8 kg. That difference was also significant versus placebo at the p=0.038 level.

Nearly 70% of patients treated with rimonabant 20 mg/day lost more than 5% of their initial body weight, compared to 44.2% of patients in the rimonabant 5 mg/day group and 30.5% in the placebo group. In addition, 39% of patients on rimonabant 20 mg/day lost more than 10% of their initial body weight compared to 15.3% of those on rimonabant 5 mg/day and 12.4% of those on placebo.

Patients on rimonabant 20 mg/day also had an average decrease in their waist circumference of 8.5 cm or about 3.5 inches that reached statistical significance versus placebo. Those patients lost 5.3 cm or about two inches.

Dr. Van Gaal said the number of patients diagnosed as having metabolic syndrome at baseline -- 42.2% of those assigned to rimonabant 20 mg-- decreased by more than half to 19.6%. About 39.9% of the placebo patients were diagnosed with metabolic syndrome at baseline. After treatment 31% of these patients still had the condition. The difference in reduction was significant to the p<.001 level, he said.


[Abstract title: "Hot Line 1: RIO-EUROPE: A Randomised Double-Blind Study of Weight Reducing Effect and Safety of Rimonabant in Obese Patients With or Without Comorbidities." Abstract 106]

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