36-week Safety and Tolerability Study of Extended-Release Niacin (ERN) for the T

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36-week Safety and Tolerability Study of Extended-Release Niacin (ERN) for the Treatment of Elevated Triglycerides in HIV

Niacin has proven effective when used for elevated troglycerides in the general population, however, concerns regarding safety , in particular, increased insulin resistance and flushing has led to limited use in HIV. There is also concern that liver enzyme functions tests may become elevated. Souza (abstract 49) and researchers from Hawaii including Celcilia Shikuma reported preliminary information on the safety and tolerability of ERN over 24 weeks when used for elevated triglycerides in individuals on stable HAART. 8 of ten patients have been enrolled and 4 have completed week 24; 1 patient was withdrawn for inability to comply with study visit requirements. Patients with cardiovascular disease, diabetes, or active liver disease were excluded. Patients with mean fasting triglycerides levels of 200 mg/dl by two screening tests one week apart were started on an American Heart Association Step One diet and exercise program. If triglycerides remained elevated after 4 weeks, a Step Two diet and exercise program was started. Patients with persistent elevated triglycerides of 200 mg/dl after 4 weeks were started on ERN, 500 mg once daily, depending on subject tolerability. HOMA was used to assess insulin resistance.

In the backgrounder the authors said current lipodystrophy data suggest increasing triglycerides may be necessary for fat redistribution and controlling triglycerides may be crucial for delaying or inhibiting lipodystrophy.

RESULTS

Dose titration and maintenance to 1500 mg/day were achieved in all treated patients evaluated at week 24. No patient needed dose adjustment. Mild flushing was experienced in all patients. ALT did increase significantly from 22 to 31 (p=.017). Mean triglycerides decreased 388 from about 600 to 220. 9 of 41 venous lactates were equal to or above normsal. 2/6 patients had lactates above 4.1. These levels returned to normal upon retesting and were associated with recent exercising. Mild to moderate flushing was experienced (grade 2 or less): flushing, chills, abdominal pain, diarrhea, edema, fatigue, pain. One patient experienced thrombophebitis.. There were no clinically significant changes in uric acid, total bilirubin or phosporous, howver, 1 patient required supplementation for a grade 3 hypophosphatemia. There were no significant changes in liver function, HOMA index or lipoprotein fractions so far in this small preliminary study. The authors felt that so far ERN dose titration and maintenance up to week 24 was safe and tolerable. CD4 counts increased for all patients in the study, and viral load remained the same for 6 of 7 patients, 1 patient saw viral load go from 53 to 266 copies/ml.

Vergel

Executive Director

Program for Wellness Restoration, PoWeR

www.medibolics.com

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