title: Switching hemodialysis patients from sevelamer hydrochloride to bixalomer: a single-center, non-randomized analysis of efficacy and effects on gastrointestinal symptoms and metabolic acidosis.
abstract: BACKGROUND
  Bixalomer (BXL) was developed to improve gastrointestinal symptoms and reduce constipation, relative to sevelamer hydrochloride, in hemodialysis patients. We prospectively evaluated the safety and effectiveness of switching maintenance dialysis patients from sevelamer hydrochloride to BXL.
  
  
  METHODS
  Twenty-eight patients were switched from sevelamer hydrochloride to BXL (1:1 dose) from July to October 2012, whereas 84 randomly selected patients not treated with sevelamer hydrochloride were enrolled as a control group. The primary endpoint was improvement of gastrointestinal symptoms; secondary endpoints included improvement in metabolic acidosis, changes in blood biochemistry, and safety 12 weeks after the switch. We also surveyed patient satisfaction with switching to BXL 12 weeks after the switch.
  
  
  RESULTS
  Before switching, symptoms of epigastric fullness were significantly worse in the switch than in the control group. Twelve weeks after the switch, reflux, epigastric fullness, and constipation had improved significantly in the switch group. Other factors, including stomach ache, diarrhea, and form of stool, did not change significantly. Blood gas analysis showed that metabolic acidosis was significantly improved by switching. Four patients (14%) experienced grade 1 adverse events, all of which improved immediately after stopping BXL. Major adverse events were diarrhea and abdominal discomfort. Mean satisfaction score was 3.1 ± 0.7, with 64% of patients reporting they were "neither satisfied nor dissatisfied" after switching.
  
  
  CONCLUSIONS
  A switch from sevelamer hydrochloride to BXL improved symptoms of reflux, epigastric fullness, constipation, and metabolic acidosis in hemodialysis patients.
  
  
  BACKGROUND
  The study was registered as Clinical trial: (UMIN000011150).
authors.affiliation: Department of Urology, Graduate School of Medicine, Hirosaki University, 5 Zaifu-chou, 036-8562 Hirosaki, Japan. shingorilla2@gmail.com.
authors.forename: Shingo
authors.initials: S
authors.lastname: Hatakeyama
authors.forename: Hiromi
authors.initials: H
authors.lastname: Murasawa
authors.forename: Takuma
authors.initials: T
authors.lastname: Narita
authors.forename: Masaaki
authors.initials: M
authors.lastname: Oikawa
authors.forename: Naoki
authors.initials: N
authors.lastname: Fujita
authors.forename: Hiromichi
authors.initials: H
authors.lastname: Iwamura
authors.forename: Joutaro
authors.initials: J
authors.lastname: Mikami
authors.forename: Yuta
authors.initials: Y
authors.lastname: Kojima
authors.forename: Tendo
authors.initials: T
authors.lastname: Sato
authors.forename: Ken
authors.initials: K
authors.lastname: Fukushi
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Ishibashi
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Hashimoto
authors.forename: Takuya
authors.initials: T
authors.lastname: Koie
authors.forename: Hisao
authors.initials: H
authors.lastname: Saitoh
authors.forename: Tomihisa
authors.initials: T
authors.lastname: Funyu
authors.forename: Chikara
authors.initials: C
authors.lastname: Ohyama
mesh_terms: D000138:Acidosis / Q000139:chemically induced / Q000175:diagnosis / Q000517:prevention & control*; D002614:Chelating Agents / Q000009:adverse effects / Q000627:therapeutic use*; D057915:Drug Substitution; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000175:diagnosis / Q000517:prevention & control*; D015312:Hemodialysis Solutions / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D054559:Hyperphosphatemia / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011073:Polyamines / Q000009:adverse effects* / Q000627:therapeutic use*; D006435:Renal Dialysis; D000069603:Sevelamer; D016896:Treatment Outcome
chemical_list: D002614:Chelating Agents; D015312:Hemodialysis Solutions; D011073:Polyamines; C000589735:bixalomer; D000069603:Sevelamer