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Efficacy and Safety of a Novel Nicotinamide Modified-Release Formulation in the Treatment of Refractory Hyperphosphatemia in Patients Receiving Hemodialysis-A Randomized Clinical Trial.
- Source :
-
Kidney international reports [Kidney Int Rep] 2020 Dec 19; Vol. 6 (3), pp. 594-604. Date of Electronic Publication: 2020 Dec 19 (Print Publication: 2021). - Publication Year :
- 2020
-
Abstract
- Introduction: Despite widespread use of phosphate binders (PBs), phosphate control is insufficient in many hemodialysis patients. Preliminary clinical observations suggest that nicotinamide may act synergistically with PBs to improve phosphate control.<br />Methods: This multinational, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of nicotinamide modified release (NAMR) in combination with oral PB in a large cohort of hemodialysis patients with abnormal serum phosphate concentration (>4.5 mg/dl) despite treatment with PB. Patients entered a proof-of-efficacy phase (12 weeks [W12]) in which adjustments of relevant comedication were not permitted, followed by a safety extension phase for up to 52 weeks. Here, we report the results of the first phase.<br />Results: The intention-to-treat (ITT) population consisted of 539 patients in the NAMR and 183 patients in the placebo group. NAMR and placebo were orally administered once daily (250-1500 mg/d). Mean age of patients was 61.8 years, and 63.0% were men. In the confirmatory analysis that estimated the difference in serum phosphate concentration after 12 weeks, NAMR proved superior over placebo with a significant difference of -0.51 mg/dl (95% confidence interval [CI] -0.72, -0.29; P  < 0.0001). This effect was associated with significantly lower intact parathyroid hormone (iPTH) values (NAMR: 292.4±300.4 pg/ml vs. placebo: 337.0±302.7 pg/ml; P  = 0.04) and an improved calcification propensity (T50 time; NAMR: 23.8±97.1 minutes vs. placebo: 2.3±100.7 minutes; P  = 0.02). Diarrhea and pruritus were more frequent in the NAMR group.<br />Conclusion: NAMR combined with oral PB significantly improved phosphate control in hemodialysis patients.<br /> (© 2021 Published by Elsevier, Inc., on behalf of the International Society of Nephrology.)
Details
- Language :
- English
- ISSN :
- 2468-0249
- Volume :
- 6
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Kidney international reports
- Publication Type :
- Academic Journal
- Accession number :
- 33732974
- Full Text :
- https://doi.org/10.1016/j.ekir.2020.12.012