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

Hatakeyama S, Murasawa H, Narita T, Oikawa M, Fujita N, Iwamura H, Mikami J, Kojima Y, Sato T, Fukushi K, Ishibashi Y, Hashimoto Y, Koie T, Saitoh H, Funyu T, Ohyama C - BMC Nephrol (2013)

Bottom Line: 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.Mean satisfaction score was 3.1 ± 0.7, with 64% of patients reporting they were "neither satisfied nor dissatisfied" after switching.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Urology, Graduate School of Medicine, Hirosaki University, 5 Zaifu-chou, 036-8562 Hirosaki, Japan. shingorilla2@gmail.com.

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.

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

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Study design and disposition of subjects. A total of 112 patients were enrolled in this study. Questionnaires were administered and blood biochemistry and blood gas were assessed at 0 (baseline), 4, 8, and 12 weeks after the switch in the switch group. In the control group, questionnaires were administered at 0 and 12 weeks, and blood biochemistry assessed at 0, 4, 8, and 12 weeks. Blood gas analysis was not performed in the control group.
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Figure 1: Study design and disposition of subjects. A total of 112 patients were enrolled in this study. Questionnaires were administered and blood biochemistry and blood gas were assessed at 0 (baseline), 4, 8, and 12 weeks after the switch in the switch group. In the control group, questionnaires were administered at 0 and 12 weeks, and blood biochemistry assessed at 0, 4, 8, and 12 weeks. Blood gas analysis was not performed in the control group.

Mentions: The study design is illustrated in Figure 1. A total of 530 patients on maintenance hemodialysis were treated in our clinic during June 2012, including 32 with hyperphosphatemia who were taking oral sevelamer hydrochloride. Of these, 28 provided consent to switch from sevelamer hydrochloride to BXL (1:1 dose) from July to October 2012 (switch group). The control group consisted of 84 stable hemodialysis patients not taking sevelamer hydrochloride, randomly selected by random number tables using patient identification number. Patients were included if they (1) were aged 20 to 80 years; (2) were stable on hemodialysis sessions started at least 1 year before study entry; (3) provided written informed consent to participate; (4) had not changed their regimen of phosphate-lowering drugs, cinacalcet hydrochloride (if used), and other medications that could affect serum phosphorus levels for at least 28 days before study entry; (5) had not changed their dialysis regimens for at least 28 days before study entry; (6) had not changed other factors, including dietary therapy and concomitant drugs, during the study period; and (7) were in good general health, with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) grade of 0 or 1 [10].


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

Hatakeyama S, Murasawa H, Narita T, Oikawa M, Fujita N, Iwamura H, Mikami J, Kojima Y, Sato T, Fukushi K, Ishibashi Y, Hashimoto Y, Koie T, Saitoh H, Funyu T, Ohyama C - BMC Nephrol (2013)

Study design and disposition of subjects. A total of 112 patients were enrolled in this study. Questionnaires were administered and blood biochemistry and blood gas were assessed at 0 (baseline), 4, 8, and 12 weeks after the switch in the switch group. In the control group, questionnaires were administered at 0 and 12 weeks, and blood biochemistry assessed at 0, 4, 8, and 12 weeks. Blood gas analysis was not performed in the control group.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3852730&req=5

Figure 1: Study design and disposition of subjects. A total of 112 patients were enrolled in this study. Questionnaires were administered and blood biochemistry and blood gas were assessed at 0 (baseline), 4, 8, and 12 weeks after the switch in the switch group. In the control group, questionnaires were administered at 0 and 12 weeks, and blood biochemistry assessed at 0, 4, 8, and 12 weeks. Blood gas analysis was not performed in the control group.
Mentions: The study design is illustrated in Figure 1. A total of 530 patients on maintenance hemodialysis were treated in our clinic during June 2012, including 32 with hyperphosphatemia who were taking oral sevelamer hydrochloride. Of these, 28 provided consent to switch from sevelamer hydrochloride to BXL (1:1 dose) from July to October 2012 (switch group). The control group consisted of 84 stable hemodialysis patients not taking sevelamer hydrochloride, randomly selected by random number tables using patient identification number. Patients were included if they (1) were aged 20 to 80 years; (2) were stable on hemodialysis sessions started at least 1 year before study entry; (3) provided written informed consent to participate; (4) had not changed their regimen of phosphate-lowering drugs, cinacalcet hydrochloride (if used), and other medications that could affect serum phosphorus levels for at least 28 days before study entry; (5) had not changed their dialysis regimens for at least 28 days before study entry; (6) had not changed other factors, including dietary therapy and concomitant drugs, during the study period; and (7) were in good general health, with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) grade of 0 or 1 [10].

Bottom Line: 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.Mean satisfaction score was 3.1 ± 0.7, with 64% of patients reporting they were "neither satisfied nor dissatisfied" after switching.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Urology, Graduate School of Medicine, Hirosaki University, 5 Zaifu-chou, 036-8562 Hirosaki, Japan. shingorilla2@gmail.com.

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.

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

Show MeSH
Related in: MedlinePlus