Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients.
Floege, Jurgen 1; Covic, Adrian C. 2; Ketteler, Markus 3; Mann, Johannes F.E. 4; Rastogi, Anjay 5; Spinowitz, Bruce 6; Chong, Edward M.F. 7; Gaillard, Sylvain 7; Lisk, Laura J. 7; Sprague, Stuart M. 8
[Article]
Nephrology Dialysis Transplantation.
30(6):1037-1046, June 2015.
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Background: Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients. Long-term efficacy and tolerability of the iron-based phosphate binder, sucroferric oxyhydroxide (previously known as PA21), was compared with that of sevelamer carbonate (sevelamer) in an open-label Phase III extension study.
Methods: In the initial Phase III study, hemo- or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive sucroferric oxyhydroxide 1.0-3.0 g/day (2-6 tablets/day; n = 710) or sevelamer 2.4-14.4 g/day (3-18 tablets/day; n = 349) for 24 weeks. Eligible patients could enter the 28-week extension study, continuing the same treatment and dose they were receiving at the end of the initial study.
Results: Overall, 644 patients were available for efficacy analysis (n = 384 sucroferric oxyhydroxide; n = 260 sevelamer). Serum phosphorus concentrations were maintained during the extension study. Mean /- standard deviation (SD) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02 /- 0.52 mmol/L with sucroferric oxyhydroxide and 0.09 /- 0.58 mmol/L with sevelamer. Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range (1.13-1.78 mmol/L) for both treatment groups. Mean (SD) daily tablet number over the 28-week extension study was lower for sucroferric oxyhydroxide (4.0 /- 1.5) versus sevelamer (10.1 /- 6.6). Patient adherence was 86.2% with sucroferric oxyhydroxide versus 76.9% with sevelamer. Mean serum ferritin concentrations increased over the extension study in both treatment groups, but transferrin saturation (TSAT), iron and hemoglobin concentrations were generally stable. Gastrointestinal-related adverse events were similar and occurred early with both treatments, but decreased over time.
Conclusions: The serum phosphorus-lowering effect of sucroferric oxyhydroxide was maintained over 1 year and associated with a lower pill burden, compared with sevelamer. Sucroferric oxyhydroxide was generally well tolerated long-term and there was no evidence of iron accumulation.
(C) European Renal Association - European Dialysis and Transplant Association 2015. Published by Oxford University Press. All rights reserved.
