Statins and fibrates both relatively effective for PI-induced hyperlipidemia
Brian Boyle MD, for HIVandHepatitis.com
Hyperlipidemia occurs in some patients treated with highly active antiretroviral therapy (HAART), especially when a protease inhibitor (PI), is included in the regimen. These hyperlipidemias have proved to be quite difficult to treat, at least if the goal is the return of the patient to the cholesterol and triglyceride levels recommended in the (US) National Cholesterol Education Program guidelines.
In a study published in AIDS, investigators from Italy evaluated the use of two groups of agents used in the treatment of HAART-induced hyperlipidemias, the statins and fibrates. The study was an open-label, randomized, prospective study with 106 evaluable patients who had been on PI-based HAART for at least 12 months, had a viral load <50 copies/mL, and had hypertriglyceridemia of at least six months duration that was unresponsive to dietary changes. The patients were treated with bezafibrate, gemfibrozil, fenofibrate, pravastatin, or fluvastatin for at least 12 months.
The investigators found that after 12 months of follow-up, the fibrate-treated patients had reductions in triglycerides and cholesterol of 40.7% and 21.9%, respectively (P < 0.001), while the patients treated with statins had reductions of 34.8% and 25.2%, respectively (P < 0.001). Comparing the efficacy of the fibrates and statins, no significant differences were found regarding the reductions in hyperlipidemia. All regimens were relatively well tolerated and there were no unexpected adverse events.
The authors conclude, “All administered statins and fibrates revealed a similar, significant efficacy in the treatment of diet-resistant hyperlipidemia, and showed a favourable tolerability profile.” These data support the conclusion that although some patients may not return to levels of lipids recommended by the National Cholesterol Education Program guidelines, significant improvements in both triglycerides and cholesterol can be achieved by the use of either fibrates or statins in patients with HAART-induced hyperlipidemia.
Calza L et al. Statins and fibrates for the treatment of hyperlipidemia in HIV-infected patients receiving HAART. AIDS 2003;17(6):851-859.
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It has been shown previously that lipid lowering agents lower lipids in hyperlipidemia associated with antiretroviral therapy. The crucial question, however, is how much is enough to achieve a clinical benefit. Given the modest success of statins and fibrates in primary and secondary prevention of myocardial infarction or stroke (no effect on overall mortality reported in up to seven trial years, decrease in MI <30%) the number to be treated to save a life may even be higher in the antiretroviral setting. Significant changes in laboratory markers may not translate into survival benefits.