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Diet Drug Acomplia Seen Needing More Testing as Diabetes Treatment

Posted: Thursday, November 02, 2006

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.

Among all patients who entered the RIO-Diabetes study, patients on rimonabant 20 mg once daily achieved an HbA1c reduction of 0.6%versus an increase of 0.1% on placebo from a baseline value of 7.3% and 7.2%respectively (p<0.0001 vs. placebo). Among those patients with a higher HbA1c(>8%), rimonabant 20 mg once daily achieved a reduction of 1.1%, compared with a reduction of 0.3% in the placebo group. Nearly 70% of patients treated with rimonabant 20 mg once daily lowered their HbA1c levels to below 7% as compared to only 48% of patients in the placebo arm (p<0.0001). Even more impressive, 43% of patients on rimonabant 20 mg once daily had HbA1c levels <6.5% at their final visit compared to only 21% in the placebo group(p<0.0001). Approximately 57% of the reduction in HbA1c levels achieved with rimonabant 20 mg once daily was calculated to be independent of the weight loss achieved. The direct peripheral metabolic effects of rimonabant on other cardiometabolic risk factors has been demonstrated throughout the RIOclinical trial program.

Sattar stated that, "The results are encouraging, but they leave a number of key questions unanswered.'' "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.

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

Source: Diabetes In Control