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Efficacy and Safety of Sucroferric Oxyhydroxide and Calcium Carbonate in Hemodialysis Patients.
Kidney Int Rep. 2018 Jan; 3(1):185-192.KI

Abstract

INTRODUCTION

In this phase III, open-label, single-arm, multi-center 12-week study, we evaluated the efficacy and safety of combination therapy with sucroferric oxyhydroxide (PA21) and calcium carbonate for hemodialysis patients with hyperphosphatemia.

METHODS

We enrolled 35 subjects aged ≥ 20 years with end-stage kidney disease and serum phosphorus 3.5-6.0 mg/dl who were undergoing hemodialysis 3 times weekly and taking calcium carbonate and sevelamer hydrochloride. Patients switched from sevelamer hydrochloride and calcium carbonate to sucroferric oxyhydroxide and calcium carbonate. Sucroferric oxyhydroxide was orally administered 3 times daily within 750 mg/d (250 mg per dose) to 3000 mg/d (1000 mg per dose), immediately before every meal, for 12 weeks. Calcium carbonate was orally administered 3 times daily after every meal. Outcomes were serum phosphorus concentration, safety, and satisfaction with bowel movements.

RESULTS

Mean (SD) serum phosphorus concentrations were 5.01 (0.63) mg/dl at week 0 and 4.89 (1.14) mg/dl at the end of treatment, after patients switched from sevelamer hydrochloride to sucroferric oxyhydroxide. The incidence of adverse drug reactions was 31.4% (11/35), with diarrhea being the most frequent (31.4%). More sucroferric oxyhydroxide-treated patients were satisfied with their bowel movements. More patients with constipation, as well as those who experienced diarrhea, were satisfied with their bowel movements at the end of the study.

CONCLUSION

Combined administration of sucroferric oxyhydroxide and calcium carbonate at low doses was effective in maintaining serum phosphorus concentrations within the target range, and patients' gastrointestinal status improved. Sucroferric oxyhydroxide maintained its serum phosphorus-lowering effect with a decreased pill burden, and its concomitant administration with calcium carbonate was well tolerated.

Authors+Show Affiliations

Division of Nephrology, Department of Internal Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29340330

Citation

Koiwa, Fumihiko, et al. "Efficacy and Safety of Sucroferric Oxyhydroxide and Calcium Carbonate in Hemodialysis Patients." Kidney International Reports, vol. 3, no. 1, 2018, pp. 185-192.
Koiwa F, Yokoyama K, Fukagawa M, et al. Efficacy and Safety of Sucroferric Oxyhydroxide and Calcium Carbonate in Hemodialysis Patients. Kidney Int Rep. 2018;3(1):185-192.
Koiwa, F., Yokoyama, K., Fukagawa, M., & Akizawa, T. (2018). Efficacy and Safety of Sucroferric Oxyhydroxide and Calcium Carbonate in Hemodialysis Patients. Kidney International Reports, 3(1), 185-192. https://doi.org/10.1016/j.ekir.2017.10.003
Koiwa F, et al. Efficacy and Safety of Sucroferric Oxyhydroxide and Calcium Carbonate in Hemodialysis Patients. Kidney Int Rep. 2018;3(1):185-192. PubMed PMID: 29340330.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Sucroferric Oxyhydroxide and Calcium Carbonate in Hemodialysis Patients. AU - Koiwa,Fumihiko, AU - Yokoyama,Keitaro, AU - Fukagawa,Masafumi, AU - Akizawa,Tadao, Y1 - 2017/10/06/ PY - 2017/05/22/received PY - 2017/09/27/revised PY - 2017/10/02/accepted PY - 2018/1/18/entrez PY - 2018/1/18/pubmed PY - 2018/1/18/medline KW - calcium carbonate KW - combination therapy KW - hemodialysis KW - hyperphosphatemia KW - sucroferric oxyhydroxide (PA21) SP - 185 EP - 192 JF - Kidney international reports JO - Kidney Int Rep VL - 3 IS - 1 N2 - INTRODUCTION: In this phase III, open-label, single-arm, multi-center 12-week study, we evaluated the efficacy and safety of combination therapy with sucroferric oxyhydroxide (PA21) and calcium carbonate for hemodialysis patients with hyperphosphatemia. METHODS: We enrolled 35 subjects aged ≥ 20 years with end-stage kidney disease and serum phosphorus 3.5-6.0 mg/dl who were undergoing hemodialysis 3 times weekly and taking calcium carbonate and sevelamer hydrochloride. Patients switched from sevelamer hydrochloride and calcium carbonate to sucroferric oxyhydroxide and calcium carbonate. Sucroferric oxyhydroxide was orally administered 3 times daily within 750 mg/d (250 mg per dose) to 3000 mg/d (1000 mg per dose), immediately before every meal, for 12 weeks. Calcium carbonate was orally administered 3 times daily after every meal. Outcomes were serum phosphorus concentration, safety, and satisfaction with bowel movements. RESULTS: Mean (SD) serum phosphorus concentrations were 5.01 (0.63) mg/dl at week 0 and 4.89 (1.14) mg/dl at the end of treatment, after patients switched from sevelamer hydrochloride to sucroferric oxyhydroxide. The incidence of adverse drug reactions was 31.4% (11/35), with diarrhea being the most frequent (31.4%). More sucroferric oxyhydroxide-treated patients were satisfied with their bowel movements. More patients with constipation, as well as those who experienced diarrhea, were satisfied with their bowel movements at the end of the study. CONCLUSION: Combined administration of sucroferric oxyhydroxide and calcium carbonate at low doses was effective in maintaining serum phosphorus concentrations within the target range, and patients' gastrointestinal status improved. Sucroferric oxyhydroxide maintained its serum phosphorus-lowering effect with a decreased pill burden, and its concomitant administration with calcium carbonate was well tolerated. SN - 2468-0249 UR - https://www.unboundmedicine.com/medline/citation/29340330/Efficacy_and_Safety_of_Sucroferric_Oxyhydroxide_and_Calcium_Carbonate_in_Hemodialysis_Patients_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2468-0249(17)30405-9 DB - PRIME DP - Unbound Medicine ER -
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