Pilot study on the safety and tolerability of extended release niacin for HIV-infected patients with hypertriglyceridemia.
BACKGROUND
To determine the safety and tolerability of extended release niacin (ERN) in HIV-infected patients.


METHODS
This was a pilot, open-label, 36 week study evaluating the safety and tolerability of ERN in HIV-infected patients with hypertriglyceridemia. Subjects with cardiovascular disease, diabetes or liver disease were excluded. Subjects with persistent elevation of triglyceride (TG) > 200 after 8 weeks on American Heart Association Step One and Two Diets were started on ERN 500 mg once daily, with continuation of the diet and exercise recommendations until the end of the study. ERN was increased by 500 mg every 4 weeks, to a maximum of 1500 mg/day, depending on subject tolerability. Safety and tolerability of ERN were assessed.


RESULTS
Ten subjects enrolled received ERN. Dose titration and maintenance to 1500 mg/day were achieved in all 10 subjects. No subject required dose adjustment. Mild flushing was experienced in 8 subjects. Asymptomatic hypophosphotemia was noted in 4 subjects; all resolved with oral phosphate supplementation. Median TG was reduced by 254 mg/dL (p < 0.05). Non-significant changes were noted in liver enzymes, HDL, LDL, and total cholesterol. Fasting insulin and glucose levels did not change with treatment.


CONCLUSIONS
In this pilot study ERN was well-tolerated and resulted in reduction of TG. Although the results of this study are promising, the study is limited in the small number of subjects. Further investigation is warranted.
Souza
Scott A
SA
Hawai'i Center for AIDS, Department of Medicine, University of Hawai'i, John A Burns School of Medicine, Leahi Hospital, Honolulu, HI 96816-2333, USA.
Chow
Dominic C
DC
Walsh
Erica J
EJ
Ford
Shippey
S
Shikuma
Cecilia
C
D000328:Adult; D003692:Delayed-Action Preparations; D005947:Glucose / Q000378:metabolism; D006679:HIV Seropositivity; D006801:Humans; D015228:Hypertriglyceridemia / Q000188:drug therapy*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D009525:Niacin; D005947:Glucose