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A randomized, double-blind study of gemfibrozil for the treatment of protease inhibitor-associated
John Miller1, Dannae Brown, Janaki Amin
1From St. Vincent's Hospital, Sydney, Australia.
Insights
Gemfibrozil showed modest efficacy in lowering triglycerides for HIV patients on protease inhibitors. While safe, its clinical benefit remains uncertain due to limited triglyceride reduction.
Area of Science:
- Cardiology
- Infectious Diseases
- Pharmacology
Background:
- Hypertriglyceridemia is prevalent in HIV patients, particularly those on protease inhibitors.
- Elevated triglycerides are linked to accelerated cardiovascular disease in this population.
- Lipodystrophy is also a common comorbidity in HIV patients, often associated with dyslipidemia.
Purpose of the Study:
- To evaluate the efficacy of gemfibrozil in managing hypertriglyceridemia in HIV-infected patients.
- To assess the safety profile of gemfibrozil in this patient group.
- To determine if gemfibrozil impacts other metabolic parameters or HIV disease markers.
Main Methods:
- A 16-week, randomized, double-blind, placebo-controlled trial.
- Inclusion criteria: HIV patients with triglycerides >= 3 mmol/l on protease inhibitor therapy.
- Intervention: Low saturated fat diet with or without gemfibrozil 600 mg twice daily after an initial 4-week diet-only period.
Main Results:
- Gemfibrozil group showed a mean triglyceride reduction of -1.22 mmol/l versus +0.35 mmol/l in the placebo group (p=0.08).
- Only one patient achieved desirable triglyceride levels (< or = 2.00 mmol/l).
- Gemfibrozil was well-tolerated, with no significant impact on other metabolic parameters, CD4 counts, or HIV RNA load.
Conclusions:
- Gemfibrozil is safe for HIV patients on protease inhibitors.
- The drug demonstrated modest efficacy in reducing triglyceride levels.
- Clinical benefit of gemfibrozil for hypertriglyceridemia in this population requires further investigation.
Background:
Hypertriglyceridaemia is common in patients with HIV, especially those taking protease inhibitors or with lipodystrophy, frequently observed at levels associated with accelerated cardiac disease. This study aimed to explore the efficacy and safety of gemfibrozil for hypertriglyceridemia in patients with HIV infection.
Methods:
A 16-week, randomized, double-blind, comparative study of low saturated fat diet versus low saturated fat diet with gemfibrozil 600 mg twice daily in patients with triglycerides > or = 3mmol/l receiving protease inhibitor therapy. Following a 4-week period of dietary intervention alone, patients were randomized to gemfibrozil or matching placebo. The primary outcome was the difference in mean change in fasting triglycerides at week 16 between the two groups.
Results:
37 men were randomized (17 gemfibrozil, 20 placebo) with median fasting triglycerides 5.6 mmol/l. Mean changes in triglycerides from week 4 to week 16 were -1.22 mmol/l and +0.35 mmol/l for the gemfibrozil and placebo groups respectively (between-group mean difference of 1.57 mmol/l; 95% confidence interval, -6.7 to 3.5; = 0.08). Only one patient treated had triglycerides return to a desirable range (< or = 2.00 mmol/l). No significant changes in the other metabolic parameters were observed. Gemfibrozil was well tolerated, did not appear to induce additional protease inhibitor toxicity, and did not induce changes in CD4 lymphocyte counts or HIV RNA load.
Conclusions:
Gemfibrozil is safe and demonstrated at most, modest efficacy for hypertriglyceridemia in HIV-infected patients receiving protease inhibitors. Given the level of response, however, it is unclear whether these reductions will confer clinical benefit, at least in the presence of continued protease inhibitor use.
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