Rimonabant cut Hb[A.sub.1c] in type 2 diabetic patients.
In treatment-naive patients with type 2 diabetes, 6 months of rimonabant therapy produced significantly greater improvements than did placebo in Hb[A.sub.1c] levels, body weight, and cardiometabolic measures, according to clinical trial results presented in Cape Town, South Africa, at the International Diabetes Federation World Diabetes Congress.
In the double-blind, placebo-controlled Study Evaluating Rimonabant Efficacy in Drug-Naive Diabetic Patients (SERENADE), 138 patients receiving rimonabant 20 mg/day were compared with 140 patients on placebo. All patients were at least 18 years old, had a history of type 2 diabetes diagnosed 2 months to 3 years prior to the study, and had no previous insulin therapy, other than insulin for gestational diabetes or for short-term hospitalization. None had taken oral antidiabetic drugs beyond 4 months, and such drugs were discontinued at least 6 months prior to the study. All had a stable weight, and Hb[A.sub.1c] levels of at least 7% but no greater than 10%.
The patients were treated at any of 56 centers in the United States, Argentina, Chile, Germany, Hungary, the Netherlands, and Poland. The study's primary end point was reduction in Hb[A.sub.1c] level.
At baseline, both study arms had a mean Hb[A.sub.1c] of 7.9%; at 6 months, this measure had dropped to a mean of 7.1% in the rimonabant group, compared with 7.5% in the placebo group, Dr. Julio Rosenstock said at a press briefing during the congress.
In a subgroup of patients with baseline Hb[A.sub.1c] levels of at least 8.5%, the difference between the groups was even more pronounced, with the rimonabant group's mean level dropping to 7.0% at 6 months, compared with 8.3% for the placebo group.
Overall, the portion of the treatment population achieving an Hb[A.sub.1c] level of less than 7% was 51% in the rimonabant group and 35% in the placebo group.
Rimonabant also helped patients achieve significant reductions in body weight and waist circumference, said Dr. Rosenstock, clinical professor of medicine at the University of Texas Southwestern Medical Center, Dallas. Patients taking the study drug saw a mean 6.7-kg reduction, compared with a mean 2.8-kg reduction for those taking placebo. Waist size was reduced by a mean of 6 cm for those on rimonabant, vs. 2 cm for those on placebo. (All data were based on intent to treat, with the last observation carried forward.)
The effect on Hb[A.sub.1c] appears to be independent of weight loss, Dr. Rosenstock said, noting that according to analysis of variance, 57% of the drop in Hb[A.sub.1c] was a direct effect of rimonabant.
Rimonabant also was associated with significantly greater improvements in cardiometabolic measures, compared with placebo. Serum levels of adiponectin rose by a mean of 1.6 mcg/mL in the treatment group, compared with a 0.2-mcg/mL decrease in placebo patients. Insulin resistance levels (known as HOMA-IR levels) rose by a mean of 0.33 units in the placebo group and dropped by a mean of 1.89 units in the rimonabant arm. The mean HDL cholesterol level was increased by 10% on rimonabant vs. by 3% on placebo, while mean triglyceride levels fell by 16% on the drug, vs. 4% on placebo.
The most common side effects associated with rimonabant were dizziness (11%), nausea (9%), upper respiratory tract infection (7%), anxiety (6%), and depressed mood (6%). In the treatment group, there were 13 discontinuations (9%), vs. 3 (2%) in the control group.
Sanofi-Aventis, which markets rimonabant (Acomplia) in Europe as a weight-loss drug, sponsored the study. In February 2006, the U.S. Food and Drug Administration issued an "approvable letter" for that indication--but not for use as a diabetes drug. The company submitted its response in October.
BY JOHN R. BELL
|Printer friendly Cite/link Email Feedback|
|Author:||Bell, John R.|
|Publication:||Internal Medicine News|
|Date:||Jan 1, 2007|
|Previous Article:||Rosiglitazone has lower treatment failure rate.|
|Next Article:||Radioiodine-131 overused in low-risk thyroid ca.|