A randomized, double-blind, placebo-controlled study of benfluorex in HIV-infected patients with insulin resistance or impaired glucose tolerance.
OBJECTIVE
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.


METHODS
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 microIU/mL (IQR, -126.0 to -12.7) in the BFL group vs. +33.6 microIU/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.


CONCLUSIONS
Added to antiretroviral therapy, a 6-month therapy with BFL improved insulin sensitivity but is not sufficient to reduce significantly visceral fat mass.
Poizot-Martin
I
I
CISIH-SUD Clinical Research Department, Pôle Oncologie Spécialités Médicales et Chirurgicales, CHU Sainte-Marguerite, APHM, Marseille, France. isabelle.poizot@mail.ap-hm.fr
Drogoul-Vey
M P
MP
Di Stefano
D
D
Jouve
E
E
Fabre
G
G
Saout
A
A
Gastaut
J A
JA
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005277:Fenfluramine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018149:Glucose Intolerance / Q000188:drug therapy*; D015497:HIV-1; D039682:HIV-Associated Lipodystrophy Syndrome / Q000139:chemically induced / Q000188:drug therapy*; D006801:Humans; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000960:Hypolipidemic Agents; D007328:Insulin; D005277:Fenfluramine; C001584:benfluorex