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4th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV22-25 September 2002, San Diego, CA, USA |
A 36-WEEK SAFETY AND TOLERABILITY STUDY OF EXTENDED-RELEASE NIACIN FOR THE TREATMENT OF HYPERTRIGLYCERIDEMIA IN SUBJECTS WITH HIV
Antiviral Therapy 2002; 7:L33 (abstract 49)
S Souza1,2,3, D Chow1,2,3, E Walsh2, D Ishimitsu2, D Ogata-Arakaki2,3 and C Shikuma2,3
1Queen’s Medical Center, Honolulu, HI, USA; 2Hawaii AIDS Clinical Research Program, Honolulu, HI, USA; 3University of Hawaii, HI, USA
BACKGROUND: Niacin has proven efficacious when used for hypertriglyceridemia in the general population. However, concerns regarding safety, in particular increased insulin resistance, has led to limited use in the HIV-infected population. We report preliminary information on the safety and tolerability of extended-release niacin (ERN) over 24 weeks when used for hypertriglyceridemia (HT) in individuals treated with stable highly active antiretroviral therapy (HAART).
DESIGN: Prospective, open-label, 36-week study
METHODS: Eight of 10 subjects have been enrolled, four have completed week 24, one was withdrawn for inability to comply with study visit requirements. HIV-infected individuals with cardiovascular disease, diabetes or active liver disease were excluded. Subjects with mean fasting TG levels ≥200 mg/dl by two serial screening blood tests 1 week apart were started on an American Heart Association (AHA) Step-One diet and exercise program. If TG levels remained elevated after 4 weeks, a Step-Two diet was initiated. Subjects with persistent elevation of TG levels (≥200 mg/dl) after 4 weeks were started on ERN, 500 mg once daily, with continuation of the diet and exercise recommendations until the end of the study. ERN dosage was increased by 500 mg every 4 weeks, to a maximum of 1500 mg/day, depending on subject tolerability. Subjects were evaluated by physical examinations and laboratory assessments. Homeostasis Model Assessment (HOMA) method was used to assess insulin resistance. Quantification and severity of adverse events including gastrointestinal and cutaneous flushing were documented.
RESULTS: Dose titration and maintenance to 1500 mg/day were achieved in all treated subjects evaluated at week 24. No subject required dose adjustment. Mild flushing was experienced in all subjects. Laboratory comparisons between baseline to week 24 are as follows: Mean (SD) HOMA 3.6 (±1.2) vs 2.4 (±1.5), not significant (NS); ALT 22.3 IU/l (±4.7) vs 31.0 IU/l (±9.4), P=0.017); Mean change TG (–388.2 mg/dl, P=0.03), LDL-c (+0.3 mg/dl, NS), HDL-c (+10.5 mg/dl, NS), TC (+27.7 mg/dl, P=0.045). There were no statistically significant changes in uric acid, total bilirubin or phosphorus; however, one subject required supplementation for a grade 3 hypophosphatemia.
CONCLUSION: There were no clinically significant changes in liver. ERN dose titration and maintenance up to 24 weeks were safe, well tolerated and resulted in a reduction in serum TG.
Supported by Queen Emma Foundation, Kos Pharmaceuticals
Presenting author: S Souza
2002-09-22
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