Limits...
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).

Show MeSH

Related in: MedlinePlus

Satisfaction survey for bixalomer. Satisfaction with BXL was assessed by a 5-level rating, including “very dissatisfied (score 1)”, “somewhat dissatisfied (score 2)”, “neither satisfied nor dissatisfied (score 3)”, “somewhat satisfied (score 4)”, and “very satisfied (score 5)”. The most frequent answer after switching (64%) was “neither satisfied nor dissatisfied”, with only seven patients (25%) reporting being “somewhat satisfied” after the switch. The mean score was 3.1 ± 0.7.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC3852730&req=5

Figure 4: Satisfaction survey for bixalomer. Satisfaction with BXL was assessed by a 5-level rating, including “very dissatisfied (score 1)”, “somewhat dissatisfied (score 2)”, “neither satisfied nor dissatisfied (score 3)”, “somewhat satisfied (score 4)”, and “very satisfied (score 5)”. The most frequent answer after switching (64%) was “neither satisfied nor dissatisfied”, with only seven patients (25%) reporting being “somewhat satisfied” after the switch. The mean score was 3.1 ± 0.7.

Mentions: Satisfaction with BXL was assessed by a 5-level rating, including “very dissatisfied”, “somewhat dissatisfied”, “neither satisfied nor dissatisfied”, “somewhat satisfied”, and “very satisfied” in all 28 switched patients. The mean satisfaction score was 3.1 ± 0.7, with most patients (64%) reporting that they were “neither satisfied nor dissatisfied” after the switch (Figure 4).


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)

Satisfaction survey for bixalomer. Satisfaction with BXL was assessed by a 5-level rating, including “very dissatisfied (score 1)”, “somewhat dissatisfied (score 2)”, “neither satisfied nor dissatisfied (score 3)”, “somewhat satisfied (score 4)”, and “very satisfied (score 5)”. The most frequent answer after switching (64%) was “neither satisfied nor dissatisfied”, with only seven patients (25%) reporting being “somewhat satisfied” after the switch. The mean score was 3.1 ± 0.7.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 4: Satisfaction survey for bixalomer. Satisfaction with BXL was assessed by a 5-level rating, including “very dissatisfied (score 1)”, “somewhat dissatisfied (score 2)”, “neither satisfied nor dissatisfied (score 3)”, “somewhat satisfied (score 4)”, and “very satisfied (score 5)”. The most frequent answer after switching (64%) was “neither satisfied nor dissatisfied”, with only seven patients (25%) reporting being “somewhat satisfied” after the switch. The mean score was 3.1 ± 0.7.
Mentions: Satisfaction with BXL was assessed by a 5-level rating, including “very dissatisfied”, “somewhat dissatisfied”, “neither satisfied nor dissatisfied”, “somewhat satisfied”, and “very satisfied” in all 28 switched patients. The mean satisfaction score was 3.1 ± 0.7, with most patients (64%) reporting that they were “neither satisfied nor dissatisfied” after the switch (Figure 4).

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