Increased levels of blood lipids caused by the administration of antiretroviral drugs can be decreased by fish oil capsules, according to the results of a randomised controlled trial presented on Wednesday at the Twelfth Annual Retrovirus Conference in Boston.
Maxepa is a formulation of fish oils rich in omega-3 fatty acids that has been shown to reduce low density lipoprotein (LDL) cholesterol and triglyceride levels in adults without HIV infection. This study was carried out to assess whether it could also reduce triglyceride levels and the risk of heart disease in HIV-positive patients taking antiretroviral therapy.
Researchers in France randomised 122 HIV-positive individuals on highly active antiretroviral therapy to receive either two 1g capsules of Maxepa three times a day or placebo for eight weeks, followed by eight weeks of open-label Maxepa treatment for all patients.
All participants had baseline triglyceride levels above 2g/l after four weeks of diet intended to reduce triglyceride levels, and the mean baseline triglyceride level was 4.5g/l.
After eight weeks of treatment, the 58 patients randomised to receive Maxepa had experienced a median 26% reduction in triglyceride levels, compared to a 1% increase in the placebo group (p = 0.003). Triglyceride levels normalised in 22% of Maxepa recipients, but in only 7% of the placebo group (p = 0.012). The reduction in triglyceride levels was sustained during the open label treatment period among those originally randomised to Maxepa, whilst median levels fell by 21% during this phase among those who originally received placebo.
There were no changes in total or high density lipoprotein (HDL) cholesterol over the course of the study in either group.
Ten patients with baseline triglycerides above 10g/l were given open label Maxepa treatment. These patients also experienced a 44% reduction in triglycerides after eight weeks’ treatment, demonstrating that Maxepa is even effective in patients with severe elevations in blood lipids.
Pierre de Truchis, presenting, said that the treatment was well tolerated, with no significant differences between the Maxepa and placebo groups in reported adverse events. The researchers suggest that Maxepa treatment, despite the high pill burden and dosing frequency, may represent an attractive option for first-line treatment of elevated triglycerides because of a lack of drug interactions and good efficacy.
De Truchis P et al. Treatment of hypertriglyceridemia in HIV-infected patients under HAART, by (n-3)polyunsaturated fatty acids: a double-blind randomized prospective trial in 122 patients. Twelfth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 39, 2005.