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Title: Early Improvement in Coronary Risk Factor Profile with Rimonabant Persists At 2-Year Follow-up: Presented at AHA

"Early Improvement in Coronary Risk Factor Profile with Rimonabant Persists At 2-Year Follow-up: Presented at AHA"

By Jill Stein NEW ORLEANS, LA -- November 9, 2004 -- Two-year results confirm that the investigative endocannabinoid receptor antagonist rimonabant can help patients lose weight more significantly than placebo. "The 2-year results of the Rimonabant in Obesity -- North America trial [RIO-North America] confirm that rimonabant is an innovative and promising tool for the long-term treatment of weight and associated cardiovascular risk factors in abdominally obese patients," said Xavier Pi-Sunyer, MD, chief of the division of endocrinology, St. Luke's-Roosevelt Hospital Center, Columbia University, New York, New York. In his presentation at the American Heart Association Scientific Sessions 2004, Dr. Pi-Sunyer noted that more than 3,000 patients -- 80% of whom were women -- were enrolled in the RIO-North America trial. Patients were divided into 3 treatment arms -- rimonabant 20 mg or 5 mg, or placebo. Patients were encouraged to attempt to reduce their daily diet by 600 calories. The subjects were not encouraged to do anything different as far as daily exercise was concerned. While rimonabant 5 mg resulted in some weight loss, more significant loss was achieved by patients taking the 20 mg dose -- which Dr. Pi-Sunyer suggested would be the one advocated for weight loss when the drug is taken to the US Food and Drug Administration (FDA) for approval. Dr. Pi-Sunyer reported the following findings from this study: -- Patients treated with rimonabant 20 mg reduced waist circumference by 8 centimeters (3.1 inches) compared to 3.8 cm (1.5 inches) in placebo patients (P <.001). -- 62.5% of patients treated with rimonabant 20 mg lost more than 5% of their initial body weight compared to 33.2% of those on placebo (P <.001). -- 32.8% of patients treated with rimonabant 20 mg lost more than 10% of their initial body weight compared to 16.4% of those on placebo (P <.001). -- Levels of high-density lipoprotein cholesterol increased by 24.5% in patients treated with rimonabant 20 mg compared to 13.8% of those on placebo (P <.001). -- Triglyceride levels were reduced by 9.9% in patients treated with rimonabant 20 mg compared to 1.6% of those on placebo (P <.05). -- No differences were noted in the 3 groups with regard to scores measured by the Hospital Anxiety Depression scale. Dr. Pi-Sunyer suggested that because obesity was a chronic disorder he foresaw the use of rimonabant as a long-term treatment. "We didn't see any red flags in safety issues," he said. "To maintain weight loss for 2 years is pretty good," said Robert Bonow, MD, chief of cardiology, Northwestern University, Chicago, Illinois, and a past president of the American Heart Association. "This was also accomplished in a sizeable number of patients." Dr. Bonow said that regulators and physicians should be alert to any long-term toxicity. First-line therapy for weight loss should still include lifestyle modification, he said, while acknowledging that the epidemic of obesity now seen throughout the United States is evidence that those efforts need further attention. He said that before rimonabant is considered for adolescents, long-term safety in adults is needed and then a clinical trial in that age group should be undertaken. Douglas Greene, MD, vice president of corporate medical and regulatory affairs, Sanofi-Aventis, Paris, France, the developer of rimonabant, said the company plans to file for approval with the FDA in the second quarter of 2005. "We have begun discussions with authorities in the United States and Europe about trials with adolescents," Dr. Greene said. He noted that the company has not decided if they will seek registration for both the 5 mg and 20 mg dose of rimonabant. That decision, he said, would follow completion of clinical trials, including those testing rimonabant as a treatment for smoking cessation. Those trials, he said, would be reported next year. [Presentation title: Effect of Rimonabant on Weight Reduction and Weight Maintenance: RIO-North America Trial.]

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