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Rimonabant (Accomplia) to Treat Obesity and Improve Glycemic Control Approved in Mexico

Posted: Wednesday, November 22, 2006

Accomplia is now approved in Europe and Mexico, US next?

On November 1, Mexico's Ministry of Health (via the Federal Commission for Sanitary Risks Prevention) approved rimonabant (Accomplia 20-mg tablets, made by Sanofi-Aventis) for use as an adjunct to diet and exercise in the treatment of obese or overweight (BMI >27 kg/m2) patients with associated cardiometabolic risk factors such as type 2 diabetes or dyslipidemia. A second indication allows its use with metformin or a sulfonylurea to improve glycemic control in type 2 diabetic patients with overweight.

Rimonabant is the first in a new class of drugs called cannabinoid subtype 1 (CB1) blockers, which work by selectively blocking receptors in the brain and peripheral organs that play a key role in glucose and lipid metabolism (eg, adipose tissue, the liver, gastrointestinal tract, and muscle). CB1 blockade decreases endocannabinoid hyperactivity, which has been recently characterized as playing an important role in regulating body weight, controlling energy balance, and glucose and lipid metabolism.

The approval was based on a review of data from the Rimonabant In Obesity/Overweight (RIO) clinical trial in more than 6600 patients worldwide, of which 4500 were followed for up to 2 years.

Results showed that administration of 20 mg of rimonabant daily significantly decreased weight and waist circumference, HbA1c levels, and triglyceride levels while increasing high-density lipoprotein (HDL) cholesterol levels. Approximately 50% of the improvements in HbA1c, triglyceride, and HDL cholesterol levels were beyond that expected from weight loss alone.

In placebo-controlled studies, the most common adverse events leading to discontinuation of therapy included nausea, mood alteration with depressive disorders, anxiety, and dizziness. Rimonabant should not be used in patients with hepatic or renal impairment, or in patients with uncontrolled serious psychiatric illnesses such as major depression.

Rimonabant was previously approved by the European Commission in June 2006 for use as an adjunct to diet and exercise in the treatment of obese or overweight patients with cardiometabolic risk factors.

Source: Diabetes In Control