Key result
Extended-release niacin improves flow-mediated dilation by ~3.6 percentage points over control in HIV patients.
Why the study?
Low HDL-c levels in HIV-infected patients on stable ART are associated with endothelial dysfunction, but the effects of niacin on endothelial function in this population have not been investigated.
RCT (n=19)
Open-label
Computer-generated single-block randomized treatment list
No
Absolute Event Rate: 6.36% vs 2.73%
p-value: p=0.048
Hypothesis-generating for niacin in HIV endothelial dysfunction; leaves open effects on clinical outcomes.
OBJECTIVE: To assess the short-term effects of extended-release niacin (ERN) on endothelial function in HIV-infected patients with low high-density lipoprotein-cholesterol (HDL-c) levels. METHODS: Randomized controlled study to determine the short-term effects of ERN on endothelial function, measured by flow-mediated vasodilation (FMD) of the brachial artery, in HIV-infected adults with low HDL-c. Participants on stable HAART with fasting HDL-c less than 40 mg/dl and low-density lipoprotein-cholesterol less than 130 mg/dl were randomized to ERN or control arms. ERN treatment started at 500 mg/night and titrated to 1500 mg/night for 12 weeks. Controls received the same follow-up but were not given ERN (no placebo). Participants were excluded if they had a history of cardiac disease, uncontrolled hypertension, diabetes mellitus, or were on lipid-lowering medications such as statins and fibrates. Change in FMD was compared between arms with respect to baseline HDL-c. RESULTS: Nineteen participants were enrolled: 89% men, median age 50 years, 53% white/non-Hispanic, median CD4 cell count 493 cells/microl, and 95% of them had HIV RNA below 50 copies/ml. Participants receiving ERN had a median HDL-c (interquartile range) increase of 3.0 mg/dl (0.75 to 5.0) compared with -1.0 mg/dl in controls (-6.0 to 2.5), a P value is equal to 0.04. The median change in FMD was 0.91% (-2.95 to 2.21) for ERN and -0.48% (-2.65 to 0.98) for controls (P = 0.67). However, end of study FMD for ERN was significantly different from controls after adjusting for baseline differences in FMD and HDL-c, 6.36% (95% confidence interval 4.85-7.87) and 2.73% (95% confidence interval 0.95-4.51) respectively, a P value is equal to 0.048. CONCLUSION: This pilot study demonstrated that short-term niacin therapy could improve endothelial function in HIV-infected patients with low HDL-c.
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Chow et al. (2010) conducted an RCT in HIV infection with low HDL-cholesterol (n=19). Extended-release niacin (ERN) vs. Standard care (no placebo/no ERN) was evaluated on Change in flow-mediated vasodilation (FMD) of the brachial artery (adjusted end of study FMD) (p=0.048). Extended-release niacin significantly improved adjusted flow-mediated vasodilation compared to control (6.36% vs 2.73%, p=0.048) in HIV-infected adults with low HDL-cholesterol.
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