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3rd International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV23-26 October 2001, Athens, Greece |
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, COMPARATIVE STUDY ON THE EFFECTS OF METFORMIN OR GEMFIBROZIL IN LIPODYSTROPHIC HIV-1-INFECTED PATIENTS RECEIVING PROTEASE INHIBITORS
Antiviral Therapy 2001; 6(Suppl. 4):21 (abstract no. 29)
E Martinez1, P Domingo2, JB Pérez-Cuevas1, A Arroyo2, E Buira1, A Milinkovic1, M Ruiz1, G Vázquez2 and JM Gatell1
1 Hospital Clinic, Barcelona, Spain; and 2 Hospital de Sant Pau, Barcelona, Spain
BACKGROUND: Hypertriglyceridemia and insulin resistance often accompanies lipodystrophy. The effect of treating those metabolic abnormalities without changing antiretroviral therapy is not known.
METHODS: Patients on stable protease inhibitorcontaining highly active antiretroviral therapy, abdominal fat accumulation, and plasma triglycerides >200 mg/dl were randomized to receive blind medication consisting on metformin 850 mg/12 h, gemfibrozil 600 mg/12 h, or placebo/12 h. At least 15 patients per arm should be included to detect at least a 25% improvement of lipodystrophy in the best arm, assuming that lipodystrophy on placebo would not spontaneously improve. Patients were followed every 3 months for 1 year. At each visit, weight, height, waist, hip, fasting glucose, triglycerides, total and HDL and LDL cholesterol, CD4 cells and HIV-1 RNA were measured. At baseline, 6 and 12 months, oral glucose tolerance test (OGTT), bioimpedance analysis (BrA), and measurement of regional fat thickness by sonography were done. Analysis of data has been blind (arms' names: A, B or C).
RESULTS: Fifty-one patients (17 A, 18 B, 16 C) were included. One patient assigned to B never started therapy, and three (A, B and C) were lost at 6 and 1 (C) at 9 months. Baseline characteristics were balanced among the three arms. All three arms showed slight decreases of weight and body mass index, LDL cholesterol, fat-free mass and fat (BIA), and subcutaneous and intra-abdominal fat (sonography); however, differences in these variables among the three arms were not significant. The effects on hypertriglyceridemia and insulin resistance (defined by insulin AUC on OGTT) were not statistically different among the three arms. No patient discontinued study medication.
CONCLUSIONS: All three arms showed negligible effects not only for treating fat changes in HIV-1-infected patients with lipodystrophy, but also for treating associated metabolic abnormalities. The results of this study do not support the recommendation of either metformin or gemfibrozil to treat lipodystrophy in HIV-1-infected patients.
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