Fish oil and fenofibrate for the treatment of hypertriglyceridemia in HIV-infected subjects on antiretroviral therapy: results of ACTG A5186.
BACKGROUND
Fish oil has been shown to reduce serum triglyceride (TG) concentrations. In HIV-infected patients on antiretroviral therapy, high TG concentrations likely contribute to increased risk of cardiovascular disease. AIDS Clinical Trials Group A5186 examined the safety and efficacy of fish oil plus fenofibrate in subjects not achieving serum TG levels < or =200 mg/dL with either agent alone.


METHODS
One hundred subjects on highly active antiretroviral therapy with serum TG concentrations > or =400 mg/dL and low-density lipoprotein cholesterol < or =160 mg/dL were randomized to 3 g of fish oil twice daily or 160 mg of fenofibrate daily for 8 weeks. Subjects with a fasting TG level >200 mg/dL at week 8 received a combination of fish oil and fenofibrate in the same doses from week 10 to week 18.


RESULTS
Median baseline TG was 662 mg/dL in the fish oil group and 694 mg/dL in the fenofibrate group (P = not significant). Fish oil reduced TG levels by a median of 283 mg/dL (46%), fenofibrate reduced them by 367 mg/dL (58%), and combination therapy reduced them by 65.5%. Combination therapy achieved TG levels of < or =200 mg/dL in 22.7% subjects. Fish oil had no measurable effect on immunologic parameters or the pharmacokinetics of lopinavir.


CONCLUSIONS
Fish oil was safe when administered alone or combined with fenofibrate and significantly reduced TG levels in HIV-infected subjects with hypertriglyceridemia.
Gerber
John G
JG
Department of Medicine, University of Colorado Health Sciences Center, Denver, CO, USA.
Kitch
Douglas W
DW
Fichtenbaum
Carl J
CJ
Zackin
Robert A
RA
Charles
Stéphannie
S
Hogg
Evelyn
E
Acosta
Edward P
EP
Connick
Elizabeth
E
Wohl
David
D
Kojic
E Milu
EM
Benson
Constance A
CA
Aberg
Judith A
JA
D000328:Adult; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D011345:Fenofibrate / Q000627:therapeutic use*; D005395:Fish Oils / Q000627:therapeutic use*; D015658:HIV Infections / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D015228:Hypertriglyceridemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D005395:Fish Oils; D000960:Hypolipidemic Agents; D014280:Triglycerides; D011345:Fenofibrate