SANOFI-AVENTIS PUBLISHES RESULTS OF RIO-DIABETES STUDY
Sanofi-aventis announced that the results of the RIO-Diabetes trial have been posted on The Lancet online edition. The one-year trial showed that rimonabant 20 mg once daily significantly improved several cardiometabolic risk factors including weight, HbA1c (a measure of blood sugar control), HDL cholesterol (good cholesterol) and triglycerides (fats in the blood), systolic blood pressure as well as waist circumference (a marker of intra-abdominal adiposity), in overweight and obese patients with Type 2 diabetes uncontrolled with metformin or sulfonylurea. More than 50 percent of the improvements in HbA1c and HDL cholesterol were independent of the weight loss achieved, suggesting a direct effect of rimonabant on these parameters.
Among all patients who entered the RIO-Diabetes study, a Phase III, multinational, multicenter, randomized, double-blind and placebo-controlled trial, patients on rimonabant 20 mg once daily achieved an HbA1c reduction of 0.6 percent versus an increase of 0.1 percent on placebo from a baseline value of 7.3 percent and 7.2 percent, respectively. Among those patients with a higher HbA1c, rimonabant 20 mg once daily achieved a reduction of 1.1 percent percent compared with a reduction of 0.3 percent in the placebo group. Nearly 70 percent of patients treated with rimonabant 20 mg once daily lowered their HbA1c levels to below 7 percent as compared to only 48 percent of patients in the placebo arm. And 43 percent of patients on rimonabant 20 mg once daily had HbA1c levels less than 6.5 percent at their final visit compared with only 21 percent in the placebo group.
Patients treated with rimonabant 20 mg once daily benefited from a reduction in weight of 5.3 kg versus 1.4 kg for patients in the placebo group. Waist circumference was reduced by 5.2 cm in patients in the rimonabant 20 mg group versus 1.9 cm observed in the placebo group.
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