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.

Conclusion: 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.