Background: Despite potent antiretroviral activity, protease inhibitor-based pharmacological treatment of HIV disease has recently been associated with lipid and glucose metabolism abnormalities (more frequently hypertriglyceridemia and hypercholesterolemia). The aim of our open-label, randomized, prospective study was to evaluate the role of fibrates in the management of HIV-associated hyperlipidemia.
Patients and methods: Plasma lipid levels of 635 HIV-infected patients referred to our tertiary care center and who had been receiving protease inhibitor-based antiretroviral therapy for at least 12 months were evaluated. All patients presenting hypertriglyceridemia (> 300 mg/dl) of at least 6-month duration and unresponsive to a hypolipidemic diet and physical exercise were treated with bezafibrate (400 mg once daily), gemfibrozil (600 mg twice daily) or fenofibrate (200 mg once daily) for 12 months.
Results: 69 (10.9%) of the 635 observed patients received fibrate therapy: bezafibrate was employed in 25 cases, gemfibrozil in 22 and fenofibrate in 22. Hypolipidemic drugs led to a reduction of 41.2% and 23.3% vs baseline triglyceridemia and cholesterolemia, respectively, with a favorable tolerability profile.
Conclusion: All used fibrates showed a similar, significant efficacy in the treatment of diet-resistant hyperlipidemia, but further studies seem necessary in order to establish the most appropriate guidelines for the management of dyslipidemia associated with highly active antiretroviral therapy (HAART).