title: Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients.
abstract: 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.
authors.affiliation: RWTH University Hospital Aachen, Aachen, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Floege
authors.affiliation: Gr.T. Popa University of Medicine and Pharmacy, Iasi, Romania.
authors.forename: Adrian C
authors.initials: AC
authors.lastname: Covic
authors.affiliation: Coburg Clinic and KfH-Dialysis Center, Coburg, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Ketteler
authors.affiliation: Munich General Hospital, Munich, Germany.
authors.forename: Johannes F E
authors.initials: JF
authors.lastname: Mann
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Anjay
authors.initials: A
authors.lastname: Rastogi
authors.affiliation: New York Hospital Queens, Flushing, NY, USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Spinowitz
authors.affiliation: Vifor Pharma, Glattbrugg, Switzerland.
authors.forename: Edward M F
authors.initials: EM
authors.lastname: Chong
authors.affiliation: Vifor Pharma, Glattbrugg, Switzerland.
authors.forename: Sylvain
authors.initials: S
authors.lastname: Gaillard
authors.affiliation: Vifor Pharma, Glattbrugg, Switzerland.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Lisk
authors.affiliation: NorthShore University Health System University of Chicago Pritzker School of Medicine, Evanston, IL, USA.
authors.forename: Stuart M
authors.initials: SM
authors.lastname: Sprague
mesh_terms: D004338:Drug Combinations; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy*; D007501:Iron / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000378:metabolism*; D011379:Prognosis; D006435:Renal Dialysis / Q000009:adverse effects*; D013395:Sucrose / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D004338:Drug Combinations; D005290:Ferric Compounds; C000599459:sucroferric oxyhydroxide; D010758:Phosphorus; D013395:Sucrose; D007501:Iron
keywords: hemodialysis; peritoneal dialysis; sucroferric oxyhydroxide