SERENADE: effects of monotherapy with rimonabant, the first selective CB1 receptor antagonist, on glycemic control, body weight, and lipid profile in drug-naive type 2 diabetes.

Description

The SERENADE study assessed the glucose-lowering efficacy of a 6-month rimonabant therapy (20 mg/day), a selective CB1 receptor antagonist, in 278 drug-naive type 2 diabetic patients who were exposed to treatment. The change in HbA1c was greater in rimonabant- than in placebo-treated patients (mean difference: -0.51%, p=0.0002). Moreover, rimonabant also induced greater improvements in body weight, waist circumference, fasting glucose, insulin resistance (homeostasis model of assessment of insulin resistance), proinsulin/insulin ratio, adiponectin, HDL cholesterol, triglycerides, non-HDL cholesterol, and LDL particle size than did placebo. Adverse events occurring more frequently in rimonabant-treated patients were dizziness, nausea, anxiety, depressed mood, and paresthesia. Although this class of drugs has been shown to produce meaningful improvements in several cardiometabolic risk factors, its safety and benefit/risk ratio remains subject to debate. In addition, rimonabant is no longer available for use in clinical practice.