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e-Article

A Randomized, Double-Blind, Placebo-Controlled Study of Benfluorex in HIV-Infected Patients with Insulin Resistance or Impaired Glucose Tolerance
Document Type
Academic Journal
Source
HIV Clinical Trials. Jan 01, 2009 10(1):33-40
Subject
Language
English
ISSN
1528-4336
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.