The combination of fish oil with fenofibrate was more effective than either treatment alone in reducing triglycerides to desired levels in people living with HIV, according to a study published in the April 1 issue of the Journal of Acquired Immune Deficiency Syndromes.
HIV can cause a blood fat known as triglycerides to become elevated, as can the antiretroviral drugs used to treat HIV. High triglycerides can result in pancreatitis, and a growing body of evidence suggests that they may also increase the risk of heart disease. Though fish oil has been known to reduce triglycerides by as much as 30 percent in a couple of small studies in people with HIV, prior to now, no study has used higher doses of fish oil combined with fenofibrate with the goal of reducing triglycerides to 200 mg/dL or less, the target recommended for optimal heart health by the National Cholesterol Education Project (NCEP).
John Gerber, MD, of the University of Colorado Health Sciences Center in Denver, and his colleagues enrolled 100 people with HIV and high triglycerides into AIDS Clinical Trials Group (ACTG) study A5186. The study was designed with two phases. In phase one, which lasted eight weeks, half the study group received 3 grams of fish oil twice daily, and the other half received 160 mg of fenofibrate once daily. At the end of eight weeks, all the patients who achieved a triglyceride level of 200 mg/dL or less remained on their current treatment, while those failing to meet this target were switched to a combination of both fish oil and fenofibrate.
Of the 100 A5186 study participants, all were on antiretroviral therapy, roughly 95 percent were male, and the average age was 43 years. Fifteen percent were black and nearly 30 percent were Hispanic. The average triglyceride level was high in both groups: 668 mg/dL for those randomized to receive fish oil and 667 mg/dL among those taking fenofibrate.
At the end of the first eight weeks of the study, few people in either group had triglyceride levels of 200 mg/dL or less, with just 8.5 percent of those on fish oil and 16.7 percent of those on fenofibrate reaching this goal. Of the 75 participants who went on to receive the combination of fish oil and fenofibrate, 22.7 percent reached the treatment goal, far higher than the 10 percent that the trial design required for the treatment combination to be considered a success.
Overall, both fish oil and fenofibrate were well tolerated, with only five people discontinuing either treatment due to side effects. Both drugs can increase LDL, often called the “bad” cholesterol, and as expected, this occurred in the study. The authors state that the long-term implications of this increase are unknown.
Previous studies have demonstrated that fish oil could moderately suppress immune function. In this study, however, there was no evidence of an impact on either CD4 total numbers or percentages. Dr. Gerber’s team also examined the potential of fish oil to interact with patients’ antiretrovirals, and found that this did not occur in the study.
The team concluded that the results of this study encourage additional research with higher doses of fish oil to determine whether this would help further reduce triglycerides to the NCEP goal of 200 mg/dL or less.
