Miller J, Carr A, Brown D, Cooper DA; Conference on Retroviruses and Opportunistic Infections.

Program Abstr 8th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 8th 2001 Chic Ill. 2001 Feb 4-8; 8: 205 (abstract no. 540).

Natl Ctr in HIV Epidemiology and Clin Res, Univ of New South Wales.

Background: A syndrome of lipodystrophy has been widely described in patients with HIV, especially those taking protease inhibitors (PIs). Hypertriglyceridaemia has been a predominant metabolic feature in these descriptions, frequently observed at levels associated with accelerated cardiac disease. Gemfibrozil is clinically indicated for the treatment of hypertriglyceridaemia. Methods: To explore the safety and efficacy of a potential therapeutic intervention for patients with elevated triglycerides (TGs) we conducted a 16-week, randomised, double-blind, comparative study of low-saturated-fat diet alone versus low-saturated-fat diet with gemfibrozil (GF) 600 mg bid in patients with TGs >3 mmol/L and currently receiving PI therapy. Following a 4-week period of dietary intervention alone, patients were randomised to GF or matching placebo for 12 weeks. Efficacy measures included fasting lipids, free fatty acids, glucose, insulin and c-peptide. Results: 3 6 patients, all male, were randomised into the study (16 GF, 20 placebo). Median baseline TGs were 5.6 mmol/L, cholesterol 6.8 mmol/L, glucose 4.8 mmol/L and insulin 7.4 mU/L. Patients on GF had decreases in TGs over 12 weeks (-1.326 mmol/L) compared to placebo (+0.37 mmol/L) [p = 0.06]; however, only one patient had TGs return to normal range (<2.00 mmol/L). No significant changes in cholesterol, HDL cholesterol, free fatty acids, fasting glucose or insulin were observed. GF was well tolerated and did not appear to induce additional PI toxicity. Conclusions: GF is safe and demonstrates modest efficacy for patients with PI-associated hypertriglyceridaemia. It appears unlikely that it will lower TGs sufficiently in this patient group, at least in the presence of continued PI use, to confer sufficient clinical benefit.

Publication Types:

• Meeting Abstracts

Keywords:

• Case-Control Studies
• Cholesterol
• Cholesterol, HDL
• Diet, Fat-Restricted
• Double-Blind Method
• Fatty Acids, Nonesterified
• Gemfibrozil
• HIV Infections
• HIV Protease Inhibitors
• Humans
• Hypertriglyceridemia
• Insulin
• Lipids
• Male
• Protease Inhibitors
• therapy

Other ID:

• GWAIDS0006827

UI: 102244323

From Meeting Abstracts