Switching hemodialysis patients from sevelamer hydrochloride to bixalomer: a single-center, non-randomized analysis of efficacy and effects on gastrointestinal symptoms and metabolic acidosis

BMC Nephrology

Chikara Ohyama¹  Tomihisa Funyu³  Hisao Saitoh³  Takuya Koie²  Yasuhiro Hashimoto¹  Yusuke Ishibashi²  Ken Fukushi²  Tendo Sato²  Yuta Kojima²  Joutaro Mikami²  Hiromichi Iwamura²  Naoki Fujita²  Masaaki Oikawa²  Takuma Narita²  Hiromi Murasawa³  Shingo Hatakeyama² 

[1] Department of Advanced Transplant and Regenerative Medicine, Graduate School of Medicine, Hirosaki University, 036-8562 Hirosaki, Japan;Department of Urology, Graduate School of Medicine, Hirosaki University, 5 Zaifu-chou, 036-8562 Hirosaki, Japan;Department of Urology, Oyokyo Kidney Research Institute, 036-8243 Hirosaki, Japan

关键词: Metabolic acidosis;    Gastrointestinal disorder;    Hemodialysis;    Hyperphosphatemia;    Bixalomer;   

Others  :  1082817
DOI  :  10.1186/1471-2369-14-222

 received in 2013-07-07, accepted in 2013-10-07,  发布年份 2013

【 摘 要 】

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.

Trial registration

The study was registered as Clinical trial: (UMIN000011150).

【 授权许可】

   
2013 Hatakeyama et al.; licensee BioMed Central Ltd.

【 图 表 】

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