A Randomized, Double-Blind, Placebo-Controlled Study of Benfluorex in HIV-Infected Patients with Insulin Resistance or Impaired Glucose Tolerance

Abstract

Purpose: We previously reported a beneficial effect of benfluorex (BFL) on oral glucose tolerance test (OGTT) and visceral fat mass in an open-label study conducted in 60 HIV-infected patients. The objective of this study was to assess whether administration of BFL compared to placebo (PBO) improves insulin resistance (IR) in HIV+ patients with HAART- induced lipodystrophy. Method: 22 HIV-infected patients with IR or impaired glucose tolerance were double-blind randomly assigned to receive BFL 3 tablets/day or PBO for 24 weeks. Efficacy assessments included OGTT, abdominal computed tomography, and the measurement of fasting lipids. Results: Change of median insulin AUC was –53.0 μIU/mL (IQR, –126.0 to –12.7) in the BFL group vs. +33.6 μIU/mL (IQR, 7.0 to 115.6) (p = .01) in PBO group. Weight decreased significantly in the BFL group (–2 kg ± 2.6; IQR, –6.8 to 2.0) compared to the PBO group (0.8 kg ± 1.7; IQR, –2.0 to 0.5) (p = .02). No significant changes in visceral or subcutaneous fat mass and plasma lipid level were observed between the two groups. Conclusion: Added to antiretroviral therapy, a 6-month therapy with BFL improved insulin sensitivity but is not sufficient to reduce significantly visceral fat mass.

Keywords:

• HIV lipodystrophy
• insulin resistance
• visceral fat mass