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SAN DIEGO — The investigational drug rimonabant produces highly significant cardiovascular and metabolic benefit in patients with type 2 diabetes, Andre Scheen, M.D., reported at the annual scientific sessions of the American Diabetes Association.
Earlier this year, Sanofi-Aventis filed for U.S. and European licensure of the selective endocannabinoid type 1–receptor blocker, based on data from a series of phase III trials involving more than 6,600 overweight and obese individuals in North America and Europe showing that the agent promotes sustained weight loss, improved cardiovascular risk profiles, and reversal of the metabolic syndrome.

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The latest of these trials, the Rimonabant in Obesity (RIO)–Diabetes study, suggests similar benefit among overweight and obese patients with type 2 diabetes.
“Patients with type 2 diabetes often have multiple cardiovascular risk factors. Current [glucose-lowering] therapies are often associated with weight gain, which can have a deleterious effect on overall cardiometabolic risk. Therefore, a new approach is needed.” said RIO-Diabetes principal investigator Dr. Scheen, head of the Division of Diabetes, Nutrition, and Metabolic Disorders at the University of Liege, Belgium.
The 1-year, randomized, double-blind, controlled trial enrolled a total of 1,045 overweight or obese patients (body mass indexes [kg/[m.sup.2]] of 27-40) with type 2 diabetes who were aged 18-70 years, and who had already been taking either metformin or a sulfonylurea for at least 6 months.
They were randomized to receive either 5 mg or 20 mg/day of rimonabant or placebo, and all were advised to reduce their daily caloric intake by 600 kilocalories. Two-thirds of the patients completed the 1-year trial.
The three groups were similar at baseline, with a mean age of 56 years, hemoglobin [A.sub.1c] of 7.5%, BMI of 34, and waist circumference of 110 cm. About 60% had hypertension, 55% had dyslipidemia, and 80% met criteria for metabolic syndrome. About two-thirds were taking metformin; one-third were taking sulfonylureas. They continued taking those medications throughout the study.
In the intent-to-treat analysis of the original 1,045 patients with the last observation carried forward, those randomized to 20 mg/day of rimonabant lost a mean of 5.3 kg, compared with 1.4 kg in the placebo group, a highly significant difference. Among the completers, the difference was 6.0 kg vs. 1.9 kg.
Similarly, waist circumference in the 20-mg rimonabant group was reduced by 5.2 cm, compared with 1.9 cm in the placebo group in the initial cohort; the reductions were 6.0 cm vs. 2.4 cm among the completers. More modest results were seen with 5-mg rimonabant, Dr. Scheen noted.
A total of 55.9% of the completers in the 20-mg group lost 5% or more of their initial body weight, compared with 19.5% of the placebo group (49.4% vs. 14.5% in the intent-to-treat analysis), whereas 21.4% and 3.0% of the completers, respectively, and 16.4% and 2.0% of the entire initial group lost 10% or more of their initial body weight. These results are similar to those seen among the nondiabetics in the other RIO trials, “which is remarkable, taking into account the well-known difficulty of diabetics to lose weight,” he said.
Hemoglobin [A.sub.1c], already relatively good at baseline, was improved further with rimonabant at 1 year in the intent-to-treat analysis.
In the 20-mg arm, mean Hb[A.sub.1c] dropped from 7.3% to 6.7%, while remaining unchanged–7.2% to 7.3%–in the placebo group. Here, the difference from placebo was significant for both the 5-mg arm (a 0.2 percentage point drop) and the 20-mg group (a 0.7 percentage point drop). The drop in Hb[A.sub.1c] was identical for those taking metformin and sulfonylureas, he added.
The proportion of patients achieving Hb[A.sub.1c] values of 6.5% or lower (the American Association of Clinical Endocrinologists’ target) was 42.9% with 20-mg rimonabant and 20.8% with placebo, which was a doubling of the success rate. A statistical analysis using a covariance method determined that the weight loss accounted for just 0.3 of the 0.7 percentage point drop in Hb[A.sub.1c] among the patients in the 20-mg arm. It could not explain the other 0.4, suggesting an intrinsic weight-independent metabolic effect of rimonabant.
Lipid improvements also occurred with rimonabant in the intent-to-treat analysis, similar to what was seen among nondiabetics in the other RIO trials.
Levels of HDL cholesterol increased by 15.4% from baseline with 20-mg rimonabant, compared with 9.2% with 5 mg and 7.1% with placebo. As in the other trials, more than half of the increase in HDL cholesterol could not be attributed to weight loss.
All four RIO trials–RIO-Europe, RIO-North America, RIO-Lipids, and now RIO-Diabetes–have shown similarly consistent improvements in components of the metabolic syndrome, Dr. Scheen pointed out.
Safety and tolerability of rimonabant in RIO-Diabetes were also similar to those seen in the previous trials.