One-year efficacy and safety of the iron-based phosphate binder sucroferric oxyhydroxide in patients on peritoneal dialysis.
BACKGROUND
Sucroferric oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of sucroferric oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population.


METHODS
The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing sucroferric oxyhydroxide (1.0-3.0 g/day) with sevelamer (2.4-14.4 g/day) in dialysis patients over 52 weeks in total.


RESULTS
In the overall study, 84/1055 (8.1%) patients received PD and were eligible for efficacy analysis (sucroferric oxyhydroxide, n = 56; sevelamer, n = 28). The two groups were broadly comparable to each other and to the overall study population. Serum phosphorus concentrations decreased comparably with both phosphate binders by week 12 (mean change from baseline - 0.6 mmol/L). Over 52 weeks, sucroferric oxyhydroxide effectively reduced serum phosphorus concentrations to a similar extent as sevelamer; 62.5% and 64.3% of patients, respectively, were below the Kidney Disease Outcomes Quality Initiative target range (≤1.78 mmol/L). This was achieved with a lower pill burden (3.4 ± 1.3 versus 8.1 ± 3.7 tablets/day) with sucroferric oxyhydroxide compared with sevelamer. Treatment adherence rates were 91.2% with sucroferric oxyhydroxide and 79.3% with sevelamer. The proportion of patients reporting at least one treatment-emergent adverse event was 86.0% with sucroferric oxyhydroxide and 93.1% with sevelamer. The most common adverse events with both treatments were gastrointestinal: diarrhea and discolored feces with sucroferric oxyhydroxide and nausea, vomiting and constipation with sevelamer.


CONCLUSIONS
Sucroferric oxyhydroxide is noninferior to sevelamer for controlling serum phosphorus in patients undergoing PD, while providing a relatively low pill burden and a high rate of adherence.
RWTH University Hospital Aachen, Germany.
Jürgen
J
Floege
Gr.T. Popa University of Medicine and Pharmacy, Iasi, Romania.
Adrian C
AC
Covic
Coburg Clinic and KfH-Dialysis Center, Coburg, Germany.
Markus
M
Ketteler
Munich General Hospital, Munich, Germany.
Johannes
J
Mann
University of California, Los Angeles, CA, USA.
Anjay
A
Rastogi
New York-Presbyterian Hospital Queens, Flushing, NY, USA.
Bruce
B
Spinowitz
Vifor Pharma, Glattbrugg, Switzerland.
Viatcheslav
V
Rakov
Vifor Pharma, Glattbrugg, Switzerland.
Laura J
LJ
Lisk
NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Evanston, IL, USA.
Stuart M
SM
Sprague
D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D004338:Drug Combinations; D005260:Female; D005290:Ferric Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010530:Peritoneal Dialysis; D010710:Phosphates / Q000097:blood; D013395:Sucrose / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D004338:Drug Combinations; D005290:Ferric Compounds; D010710:Phosphates; C000599459:sucroferric oxyhydroxide; D013395:Sucrose
chronic kidney disease; hemodialysis; peritoneal dialysis; phosphate binder; sevelamer carbonate; sucroferric oxyhydroxide