PMID- 28194884
OWN - NLM
STAT- MEDLINE
DCOM- 20171102
LR  - 20171102
IS  - 1744-9987 (Electronic)
IS  - 1744-9979 (Linking)
VI  - 21
IP  - 2
DP  - 2017 Apr
TI  - Long-Term Safety and Efficacy of Bixalomer in Hyperphosphatemic Patients With 
      Chronic Kidney Disease Not on Dialysis.
PG  - 173-179
LID - 10.1111/1744-9987.12502 [doi]
AB  - Bixalomer, a metal-free, nonabsorbable phosphate binder, is approved in Japan to 
      treat hyperphosphatemia in dialysis patients. Bixalomer is effective and has a 
      favorable safety profile in predialysis patients with hyperphosphatemia. This 
      study examined the long-term effectiveness and safety of bixalomer in predialysis 
      patients with hyperphosphatemia. This was a 48-week, multicenter, open-label, 
      phase 3 study in Japanese predialysis patients with hyperphosphatemia. Patients 
      received bixalomer at an initial dose of 1500 mg/day, which was titrated to a 
      maximum of 7500 mg/day depending on patients' serum phosphorus responses to 
      bixalomer. A total of 105 patients received bixalomer treatment, and 39 completed 
      the study. The most common reason for discontinuation was initiation of dialysis. 
      Mean serum phosphorus concentrations decreased from 5.15 mg/dL at baseline to 
      4.67 mg/dL at Week 12 and then fluctuated slightly around this level until it 
      reached 4.58 mg/dL at Week 48. The proportion of total patients achieving the 
      target serum phosphorus concentration (>/=2.5 to <4.6 mg/dL) increased after 
      treatment to a maximum of 66.2% at Week 20 and subsequently decreased to 51.3% by 
      Week 48. Most adverse events (AEs) occurred in the first 12 weeks of treatment. 
      The incidence of AEs did not increase with long-term treatment. Common AEs 
      reported included nasopharyngitis (29.5%), constipation (19%), and upper 
      respiratory tract inflammation (12.4%). These findings suggest that long-term 
      treatment with bixalomer is effective, well tolerated, and has no new safety 
      concerns. Bixalomer may be an alternative treatment option for the long-term 
      management of hyperphosphatemia in patients with chronic kidney diseases.
CI  - (c) 2017 International Society for Apheresis, Japanese Society for Apheresis, and 
      Japanese Society for Dialysis Therapy.
FAU - Akizawa, Tadao
AU  - Akizawa T
AD  - Division of Nephrology, Department of Medicine, Showa University School of 
      Medicine, Tokyo, Japan.
FAU - Tsukada, Junko
AU  - Tsukada J
AUID- ORCID: 0000-0003-1635-9408
AD  - Global Development, Astellas Pharma Inc., Tokyo, Japan.
FAU - Kameoka, Chisato
AU  - Kameoka C
AD  - Global Development, Astellas Pharma Inc., Tokyo, Japan.
FAU - Kuroishi, Kentarou
AU  - Kuroishi K
AD  - Global Development, Astellas Pharma Inc., Tokyo, Japan.
FAU - Yamaguchi, Yusuke
AU  - Yamaguchi Y
AD  - Global Development, Astellas Pharma Inc., Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170214
PL  - Australia
TA  - Ther Apher Dial
JT  - Therapeutic apheresis and dialysis : official peer-reviewed journal of the 
      International Society for Apheresis, the Japanese Society for Apheresis, the 
      Japanese Society for Dialysis Therapy
JID - 101181252
RN  - 0 (Polyamines)
RN  - 3160WY51LV (bixalomer)
SB  - IM
MH  - Female
MH  - Humans
MH  - Hyperphosphatemia/*complications/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Polyamines/adverse effects/*therapeutic use
MH  - Renal Insufficiency, Chronic/*complications
MH  - Time
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Bixalomer
OT  - Chronic kidney disease
OT  - Hyperphosphatemia
OT  - Phosphate binder
OT  - Predialysis
EDAT- 2017/02/15 06:00
MHDA- 2017/11/03 06:00
CRDT- 2017/02/15 06:00
PHST- 2016/06/22 00:00 [received]
PHST- 2016/08/25 00:00 [revised]
PHST- 2016/08/28 00:00 [accepted]
PHST- 2017/02/15 06:00 [pubmed]
PHST- 2017/11/03 06:00 [medline]
PHST- 2017/02/15 06:00 [entrez]
AID - 10.1111/1744-9987.12502 [doi]
PST - ppublish
SO  - Ther Apher Dial. 2017 Apr;21(2):173-179. doi: 10.1111/1744-9987.12502. Epub 2017 
      Feb 14.