Tuesday, July 11, 2006

Sanofi Aventis - Acomplia: cautious prescribing advice in the UK

From Prescribing Advice for GP's:

"The UK launch of Rimonabant (Acomplia) has generated significant media interest. The launch of the product was reported at the BBC and in the Guardian.

Rimonabant is being promoted based upon reductions in weight and waist circumference but also reductions in cardiometabolic risk factors.

Reductions in weight and waist circumference are obviously good outcomes for a medicine licensed for the treatment of obesity, but what are cardiometabolic risk factors?

In the studies of rimonabant versus placebo data were collected on several biological markers, for example HbA1c, HDL-Cholesterol and triglycerides. All of these markers showed improvements compared to placebo that are estimated to be greater than those expected from weight loss alone. It should be noted that there have been no studies published as yet linking these improvements to reductions in cardiovascular morbidity or mortality.

The Journal of the American Medical Association published the RIO-North America Study earlier this year. This paper concluded that the weight reductions achieved with rimonabant were modest and that the longer-term effects require further study. It is also noted that the drop out rate from the study was high.

Action: Clinicians should not prescribe rimonabant solely based on the reductions in cardiometabolic risk factors. Diet and Exercise is key to weight loss before any drug treatment is considered. "

Hmmm. That's not "two thumbs up"!

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