Important note: Information in this article was accurate in November 2005. The state of the art may have changed since the publication date.
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HIV Treatment Bulletin - Vol. 6, No. 11-12, November-December 2005
Simon Collins, HIV i-Base
Michael Dubé from Indiana University reported results from a 48 week study looking at whether extended release niacin (ERN), also known as nicotinic acid or vitamin B3, would be safe and effective in dyslipidaemic HIV-positive patients on HAART.
This was a single arm open label study in 33 men (median age 43 years, 67% white). After a 4-week course of diet modification and exercise, ERN was started at 500mg daily for the first 4-6 weeks as tolerated and titrated in 500mg doses until either the target dose of 2000mg/day or improved lipid targets were reached. 23 patients reached the 2000mg dose and eight reached 1500mg, four patients discontinued, one each for flushing, grade 3 ALT, diarrhoea and HIV progression. Three patients had grade 2 and three had grade 3 flushing.
Results are summarised in Table 1 below.
No significant changes in ALT or uric acid were reported. At week 12 fasting glucose increased transiently by 5%, but changes were not significant at week 24 or 48. Fasting insulin was greater than baseline at all time points.
Dubé concluded that extended-release niacin might be considered for treatment of high triglycerides, high non-HDL cholesterol, or low HDL cholesterol without major elevations of low-density lipoprotein cholesterol.
Other commentators however stressed the importance of careful monitoring of glucose regulation and the liver if niacin is used in lipid management for HIV-positive individuals.
Although the study design included using MRI scans to monitor intra-abdominal fat (IAF) these results were not included in the presentation. As part of the discussion after the presentation, it was reported that no change in IAF was seen in this study.
Comment
Side effects from high dose regular niacin include flushing, and rarely, acanthosis nigricans - a black furry rash on the chest and underarms, which can result from insulin resistance, and which resolves after discontinuation/dose reduction.
Diabetes can be exacerbated and require dose adjustments of diabetes medication. Liver function also requires careful monitoring.
Niacin can increase levels of growth hormone and this may explain some of the benefits seen in this study. A previous report form Fessel and colleagues reported reductions in intra-abdominal fat and softening and shrinkage of buffalo hump making the lack of effect on IAF important. [2]
Niacin is reported to appear in human milk and may cause serious side effects in nursing infants.
References
| 1. | Dubé MP, Wu JP, Aberg JA et al. Safety and efficacy of extended release niacin for the treatment of dyslipidaemia in patients with HIV infection: a prospective, multi-centre study (ACTG5148). Antiviral Therapy 2005; 10:L9 (abstract no. 12). |
| 2. | Fessel J - Effects of Niacin upon Fat Expansion in HIV-Positive Patients Who Have the Fat Redistribution Syndrome (FRS). Abstract 703-T. See HIV Treat Bull 2002 Apr;3(3). |
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