702-T. A Randomized, Double-Blind, Placebo-Controlled, Comparative Study on the Effects of Metformin or Gemfibrozil in Lipodystrophic HIV-1-Infected Patients Receiving Protease Inhibitors (PI)

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Session 92 Poster Session
Switch Studies/Treatment of Lipodystrophy Syndromes
Session Time: 4:30-6:30 pm
Room 4E-F

702-T.

A Randomized, Double-Blind, Placebo-Controlled, Comparative Study on the Effects of Metformin or Gemfibrozil in Lipodystrophic HIV-1-Infected Patients Receiving Protease Inhibitors (PI)
E. Martínez*, P. Domingo, J. B. Pérez-Cuevas, J. A. Arroyo, E. Buira, A. Milinkovic, I. Conget, J. Mallolas, G. Vázquez, and J. M. Gatell
Hosp. Clin. and Hosp. 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 PI-containing HAART, abdominal fat accumulation, and plasma triglycerides >200 mg/dL were randomised to receive blind medication consisting on metformin 850 mg/12h, gemfibrozil 600 mg/12h, or placebo/12h. At least 20 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 (BIA), and measurement of regional fat thickness by sonography were done. Analysis of data has been blind (arms’ names: A, B, or C).
Results: 66 patients (22 A, 23 B, 21 C) included. 1 patient assigned to B never started therapy, and 3 (A, B, and C) were lost at 6 and 1 (C) at 9 months. Baseline characteristics were balanced among the 3 arms. All 3 arms showed slight decreases of weight and body mass index, LDL cholesterol, fat-free mass and fat (BIA), and
subcutaneous and intraabdominal fat (sonography); however, differences in these variables among the 3 arms were not significant. The effects on hypertriglyceridemia and insulin resistance (defined by insulin AUC on OGTT) were not statistically different among the 3 arms. No patient discontinued study medication due to adverse effects.
Conclusion: All 3 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.