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2015 ; 30
(6
): 1037-46
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Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide,
in dialysis patients
#MMPMID25691681
Floege J
; Covic AC
; Ketteler M
; Mann JF
; Rastogi A
; Spinowitz B
; Chong EM
; Gaillard S
; Lisk LJ
; Sprague SM
Nephrol Dial Transplant
2015[Jun]; 30
(6
): 1037-46
PMID25691681
show ga
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.