Weight loss Tips

It's now official. If diet drug Acomplia (rimonabant) is ultimately approved for sale in the United States, the prescription diet pill will go on the U.S. market not as Acomplia but as Zimulti.

Sanofi-Aventis, developer of rimonabant which is now sold in a number of European countries, Argentina and Mexico as Acomplia, has long been coy about what name it intends to use if the FDA approves the diet drug for U.S. sale.

But the pros-and-cons of rimonabant are cheduled to be aired by an FDA advisory panel on June 13th, and the official notice of the hearing published in the Federal Register says the panel will discuss "the efficacy and safety of new drug application (NDA) 21-888, proposed tradename Zimulti (rimonabant)."

The meeting notice published by the FDA Endocrinologic and Metabolic Drugs Advisory Committee also is interesting in that would appear to dash suggestions made by some of Sanofi's favorite financial analysts that the FDA may now approve Acomplia / Zimulti for treatment of type 2 diabetes.

The published notice says the FDA panel will consider rimonabant "as an adjunct to diet and exercise for obesity management in patients with a body mass index equal to or greater than 30, or a body mass index equal to or greater than 27 if accompanied by at least one cardiovascular risk factor."

This not only does not sound like treatment of diabetes, but it also does not sound like an indication for treatment of "metabolic syndrome," which is a package of cardiometabolic risk factors.

If "obesity management" indeed does become the FDA-approved indication, the question of whether U.S. insurers will agree to pay for the diet drug would appear to be very much up in the air.

In Europe, the German state insurance system has classified Acomplia a life-style drug and has rejected reimbursing patients, and the French government has agreed to provide partial coverage only for obese (not simply overweight) patients who also have inadequately controlled type 2 diabetes.

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Sanofi's highly anticipated diet drug Acomplia (rimonabant) may also be useful in helping obese diabetics control their blood sugar levels, but some respected researchers have expressed skepticism and called for additional testing in the prestigious British medical journal Lancet.

Their analysis of the RIO-Diabetes study, which first appeared in the Acomplia Report when they were presented at the American Diabetes Association meeting in June 2005, accompanied formal publication of the peer-reviewed results in the Lancet.

"The RIO-Diabetes study showed that rimonabant 20 mg significantly improved weight, levels of blood sugar and othercardiometabolic risk factors important in the management of type 2 diabetes,"said Professor Andre Scheen of Belgium's University of Liege who led the clinical trial.

Scheen said the trial results indicated that Acomplia's effect in reducing blood sugar levels was double what could be attributed to weight loss alone.

"Over 50 percent of the improvements in HbA1c (a measure of blood sugar control) and HDL (good) cholesterol were independent of the weight loss achieved, suggesting a direct effect of rimonabant on these parameters," Scheen and his colleagues said.

But Professor Naveed Sattar of the University of Glasgow, in a comment accompanying the report in the Lancet, said as a reviewer he was "not convinced" by this finding, and suggested the improvement in blood sugar levels may have been caused by factors other than Acomplia.

"The results are encouraging, but they leave a number of key questions unanswered,'' Sattar told the Bloomberg news service. "More studies are needed to assess the drug's true position in the treatment of diabetes.''

Sattar said side-effects including depression among some of the patients given the drug, as well as a high dropout rate from the study, also required additional analysis.

In the trial, patients given the highest dose of the drug lost an average 11.7 pounds over a one-year period compared with a weight loss of 3.1 pounds for those receiving a placebo. Rimonabant also lowered the level of HbA1c, a measure of blood sugar, to within a safe range.

"The improved blood sugar control plus weight loss achieved with rimonabant is very encouraging," Scheen said. "Today, most medications for type 2 diabetes are associated with weight gain and it is difficult for people with diabetes to lose weight and keep it off."

Sanofi-Aventis, developer of the drug, clearly is hoping that Acomplia -- which still has not received FDA approval as a weight-loss drug -- ultimately also will be approved for treatment of a variety of medical conditions that would increase the prospects of insurance reimbursement.

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