"Patients Keep Smaller Waistline, Less Weight After Two Years on Rimonabant Therapy: Presented at ACC"
By Ed Susman
ORLANDO, FL -- March 8, 2005 -- After 2 years, patients who lost weight using rimonabant maintained their weight loss, researchers reported at the American College of Cardiology 54[th Scientific Sessions 2005.
Luc Van Gaal, MD, professor of diabetology, metabolism and clinical nutrition, University Hospital of Antwerp, Antwerp, Belgium, who is principal investigator of the Rimonabant in Obesity - Europe (RIO-Europe) study.
Dr. Van Gaal and colleagues in 60 centers across Europe and the United States recruited 1,507 overweight patients into the phase 3, randomized, double-blind, and placebo-controlled trial.
The researchers compared two fixed daily doses of rimonabant, a endocannanobid inhibitor, and placebo. All patients were given advice on reducing weight and were asked to try to reduce their dietary intake by 600 calories a day. The objectives of the trial were to assess the effects of rimonabant on weight loss for a period of 1 year and to determine the drug's potential to maintain weight loss during a second year of treatment.
The study also assessed improvement in waist circumference and metabolic risk factors such as dyslipidemia, glucose metabolism, and metabolic syndrome, and evaluated the safety and tolerability profile of rimonabant over the 2-year period.
Previous results of several RIO studies have consistently shown that patients on rimonabant lose weight, especially weight around the waist, which is considered a key improvement for control and prevention of cardiovascular disease and diabetes.
Dr. Van Gaal said that after 2 years, patients on the 20 mg dose of rimonabant had maintained a loss of 7.2 kg (16 lbs) compared with 2.5 kg (5.5 lbs) among patients on placebo, a difference that was significant at the P <.001 level. Patients on the 5 mg dose maintained a loss of 4.6 kg (10 lbs), which also reached statistical significance against placebo (P =.007).
Another key finding was that patients on the 20-mg dose retained a 7.5 cm (3 inch) reduction in waist circumference compared with 3.4 cm (1.3 inches) waist circumference reduction with placebo.
Dr. Van Gaal also reported that 39% of patients on rimonabant were able to reach a goal of losing 10% of their weight compared to 12.4% of patients on placebo after 1 year. After the second year, 32% of patients on rimonabant and 10.9% of patients on placebo had maintained that weight loss, he said.
Dr. Van Gaal said a 10% weight loss has been shown to results in a 50% reduced risk of developing diabetes.
"We can now say that we have robust data that can be replicated that shows rimonabant helps people lose weight and maintain that weight loss," said Dr. Van Gaal in his late breaker presentation. "It appears that for each kilogram lost with rimonabant, a person takes a centimeter off the waistline."
The trial, sponsored by Sanofi-Aventis, based in Paris, France, appeared to mirror 2-year results of the RIO- North America study, reported in November 2004 at the American Heart Association meeting. "The result curves are virtually superimposable," Dr. Van Gaal said.
While applauding the results of the trial, Julius Gardin, MD, chief of cardiology, St. John Hospital, Detroit, Michigan, United States, said, "The question is that we know that the battle against obesity is more than just a 2-year fight. We would like to see if this weight reduction is maintained long term."
[Presentation title: Two-Year Data From RIO Europe Study: Metabolic Effects of Rimonabant in Overweigh/Obese People. Late breaker presentation]
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