The
elevated triglyceride levels that may occur in HIV positive individuals taking
antiretroviral therapy are a concern
because hypertriglyceridemia is associated with an increased risk of cardiovascular
disease, and very high levels can lead to pancreatitis (inflammation of the pancreas).
Several adjunct
therapies have been explored for managing blood lipids. Fish oil, which is rich
in omega-3 fatty acids, had been shown to reduce serum triglycerides in HIV negative
individuals.
As reported in the April 1, 2008 Journal of Acquired Immune
Deficiency Syndromes, the AIDS Clinical Trials Group (ACTG) A5186 team examined
the safety and efficacy of fish oil plus fenofibrate (sold under several names
including Tricor) in patients who had not achieved a triglyceride level of 200
mg/dL or lower -- the target recommended by the National Cholesterol Education
Project (NCEP) -- with either agent alone.
In this study, 100 participants
on HAART with a baseline serum triglyceride level of 400 mg/dL or more and a low-density
lipoprotein (LDL or "bad") cholesterol level of 160 mg/dL or less were
randomly assigned to receive 3 grams of fish oil twice daily or 160 mg of fenofibrate
once daily for 8 weeks. Almost all (95%) were men, the mean age was 43 years,
15% were black, and about 30% were Hispanic. Median baseline triglyceride levels
were similar in the fish oil and fenofibrate groups.
Participants who still
had a fasting triglyceride level above 200 mg/dL at week 8 received both fish
oil and fenofibrate at the same doses from week 10 through week 18. The remainder
stayed on their initially assigned therapy. Results
•
After 8 weeks,
8.5% in the fish oil only group and 16.7% in the fenofibrate only group achieved
the triglyceride target of 200 mg/dL or less.
•
Fish oil alone
reduced triglyceride levels by a median of 283 mg/dL, or 46.0%.
•
Fenofibrate
alone reduced triglycerides by 367 mg/dL, or 58.0%.
•
Combination
therapy reduced triglycerides the most, by 65.5%.
•
Combination
therapy produced triglyceride levels of 200 mg/dL or less in 22.7% of the participants.
•
Overall, both
single therapies and the combination were well tolerated.
•
However, LDL
cholesterol levels increased across the board.
•
Fish oil had
no measurable effect on immunological parameters (CD4 count and percentage) or
lopinavir pharmacokinetics.
Conclusion
Based
on these findings, the investigators concluded, "Fish oil was safe when administered
alone or combined with fenofibrate and significantly reduced triglyceride levels
in HIV-infected subjects with hypertriglyceridemia."
University
of Colorado Health Sciences Center, Denver, CO; Harvard School of Public Health,
Boston, MA; University of Cincinnati Medical Center, Cincinnati, OH; Frontier
Science and Technical Research Foundation, Amherst, NY; Social and Scientific
Systems, Silver Spring, MD; University of Alabama at Birmingham, Birmingham, AL;
University of North Carolina at Chapel Hill, Chapel Hill, NC; Brown Medical School,
Providence, RI; University of California, San Diego, San Diego, CA; New York University,
New York, NY.
4/18/08
Reference JG Gerber, DW Kitch,
CJ Fichtenbaum, and others (AIDS Clinical Trial Group A5186 Team). Fish Oil and
Fenofibrate for the Treatment of Hypertriglyceridemia in HIV-Infected Subjects
on Antiretroviral Therapy: Results of ACTG A5186. Journal of Acquired Immune
Deficiency Syndromes 47(4): 459-466.
The
elevated triglyceride levels that may occur in HIV positive individuals taking
Results
