Rimonabant Fda

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• A few days after the latest clinical results with rimonabant were published in the Feb. 15 issue of the Journal of the American Medical Association, the Food and Drug Administration declined to approve this widely anticipated new drug, according to the February 18 issue of the Wall Street Journal. Rimonabant (Sanofi-Aventis) has been causing excitement among physicians and patients alike during the past several years. Over that time, randomized clinical trials have shown that the drug can help with both sustainable weight loss and with smoking cessation.

• According to company spokesmen, the FDA last week issued an “approvable” lettter for the weight loss indication, but a “non-approvable” letter for smoking cessation.

• Early trials with rimonabant were very promising, and while many have cautioned that it’s way too early to get very excited about this drug, such cautions have been largely ignored. People have been chomping at the bit to get at rimonabant.

• Rimonabant is the first of a class of drugs, called CB1 blockers, that act on the endocannabinoid system (the EC system), a natural system that modulates the body’s energy balance and nicotine dependence. An over-stimulated EC system is thought to play a role both in obesity and in tobacco dependence, and CB1 blockers are supposed to reduce this overstimulation.

• The latest published clinical trial with rimonabant Fda, the RIO-North America study, showed that in 3040 patients treated for two years, 20 mg of rimonabant produced a significant reduction in weight, waist circumference, triglycerides, and in the percentage of patients with metabolic syndrome, as well as a significant increase in HDL levels, compared to placebo. Disturbingly, however, 50% of patients in both the rimonabant and placebo groups (and patients did not know which group they were in) dropped out before the study was finished. Furthermore, to maintain the favorable results, chronic therapy with rimonabant online- which will be a very expensive drug - appears necessary. In addition, while the weight loss and reduction in waist circumference were statistically significant as compared to placebo, they were not of impressive magnitude. The average weight loss over 2 years was about 15 pounds, and the average reduction in waist size was 2 - 4 inches. And finally, about 6% of patients on rimonabant reported anxiety, and 5% reported feeling depressed.

• Now might be a good time to write down the main points covered above. The act of putting it down on paper will help you remember what’s important about RimonabantFda.