The Slo-Niacin Trial: A Randomized Double-Blind Placebo-Controlled Cross-Over Trial of Extended Release Niacin for Phosphate Lowering in Haemodialysis Patients
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Aim: Is once daily low dose extended release niacin effective at lowering phosphate? Background: Serum phosphate levels correlate with mortality in dialysis patients. Current phosphate binders often cause side-effects leading to poor compliance. Niacin has previously been shown to lower serum phosphate in patients with kidney disease. However, at doses previously used (≥ 1 g daily), it is poorly tolerated. Slo-niacin® is a extended release formulation taken once daily. Methods: The study was a single-centre double-blind placebo-controlled randomised cross-over trial in haemodialysis patients. All patients received both active treatment (500 mg Slo-niacin® daily) and matching placebo for 8 weeks each with intervening 2 week washout phase. All patients continued usual phosphate binders and Cinacalcet/vitamin D analogues, although no dose adjustments were permitted. Patients were recruited if they were >18yo, not pregnant and serum phosphate 4 weeks prior to commencement was ≥ 1.8 mmol/L. All gave informed consent. Results: 33 patients were recruited. 1 patient died following emergency cardiac surgery during placebo phase & 3 patients withdrew (2 niacin, 1 placebo, p=NS) leaving 29 for analysis. Extended release niacin significantly reduced serum phosphate compared to placebo (p<0.0014, t-test and ANOVA). Mean absolute difference between groups was -0.35 mmol/L (95% CI -0.62 mmol/L to -0.08 mmol/L) in favour of niacin (p ~ 0.01, t-test). Neither treatment altered calcium levels. Extended release niacin was well tolerated apart from early mild flushing which improved with time. Conclusion: Once daily low dose extended-release niacin is effective at lowering serum phosphate.
Journal of Nephrology & Therapeutics
Copyright 2014 Tan KS, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Medical and Health Sciences