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Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients.
Hemodial Int. 2018 10; 22(4):480-491.HI

Abstract

INTRODUCTION

Sucroferric oxyhydroxide (SFOH) is a non-calcium, iron-based phosphate binder that demonstrated sustained serum phosphorus (sP) control, good tolerability, and lower pill burden, vs. sevelamer carbonate ("sevelamer"), in a Phase 3 study conducted in dialysis patients with hyperphosphatemia. This analysis evaluates the efficacy and safety of SFOH and sevelamer among African American (AA) patients participating in the trial.

METHODS

Post hoc analysis of a 24-week, Phase 3, open-label trial (NCT01324128) and its 28-week extension study (NCT01464190). Patients were randomized 2:1 to SFOH (1.0-3.0 g/day) or sevelamer (2.4-14.4 g/day) for up to 52 weeks.

FINDINGS

Of 549 patients who completed the Phase 3 study and extension, 100 (18.2%) AA patients were eligible for efficacy analysis (SFOH, n = 48; sevelamer, n = 52). sP concentrations decreased rapidly and comparably with both treatments by Week 8 (mean ± standard deviation change from baseline: -1.9 ± 1.9 mg/dL for SFOH and -2.2 ± 1.8 mg/dL for sevelamer). These reductions were maintained for 52 weeks (-2.1 ± 2.6 and -2.1 ± 1.6 mg/dL) and achieved with a lower mean pill burden (3.4 ± 1.4 vs. 7.6 ± 2.9 tablets/day) with SFOH vs. sevelamer. Treatment adherence rates (adherence within 70%-120% of expected medication intake) were 79.2% with SFOH and 59.6% with sevelamer. The proportion of patients reporting serious adverse events (AEs) was 27.7% with SFOH and 30.7% with sevelamer. More patients withdrew due to treatment-emergent AEs with SFOH vs. sevelamer (18.5% vs. 8.0%). The most common AEs with both treatments were gastrointestinal-related: diarrhea and discolored feces with SFOH, and nausea, vomiting, and constipation with sevelamer.

DISCUSSION

SFOH is an efficacious and well-tolerated treatment for hyperphosphatemia in AA dialysis patients, with a lower pill burden and an improved adherence rate vs. sevelamer. These findings were consistent with the wider US patient population and the overall study population.

Authors+Show Affiliations

NorthShore University HealthSystem, Chicago, Illinois, USA.Coburg Clinic and KfH-Dialysis Center, Coburg, Germany.'Gr.T. Popa' University of Medicine and Pharmacy, Iasi, Romania.RWTH University Hospital Aachen, Aachen, Germany.Vifor Pharma, Glattbrugg, Switzerland.Vifor Pharma, Glattbrugg, Switzerland.University of California, Los Angeles, California, USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29656600

Citation

Sprague, Stuart M., et al. "Long-term Efficacy and Safety of Sucroferric Oxyhydroxide in African American Dialysis Patients." Hemodialysis International. International Symposium On Home Hemodialysis, vol. 22, no. 4, 2018, pp. 480-491.
Sprague SM, Ketteler M, Covic AC, et al. Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients. Hemodial Int. 2018;22(4):480-491.
Sprague, S. M., Ketteler, M., Covic, A. C., Floege, J., Rakov, V., Walpen, S., & Rastogi, A. (2018). Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients. Hemodialysis International. International Symposium On Home Hemodialysis, 22(4), 480-491. https://doi.org/10.1111/hdi.12663
Sprague SM, et al. Long-term Efficacy and Safety of Sucroferric Oxyhydroxide in African American Dialysis Patients. Hemodial Int. 2018;22(4):480-491. PubMed PMID: 29656600.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients. AU - Sprague,Stuart M, AU - Ketteler,Markus, AU - Covic,Adrian C, AU - Floege,Jürgen, AU - Rakov,Viatcheslav, AU - Walpen,Sebastian, AU - Rastogi,Anjay, Y1 - 2018/04/15/ PY - 2017/11/27/received PY - 2018/02/21/revised PY - 2018/4/16/pubmed PY - 2019/4/19/medline PY - 2018/4/16/entrez KW - Phosphate binder KW - chronic kidney disease KW - hemodialysis KW - hyperphosphatemia KW - sucroferric oxyhydroxide SP - 480 EP - 491 JF - Hemodialysis international. International Symposium on Home Hemodialysis JO - Hemodial Int VL - 22 IS - 4 N2 - INTRODUCTION: Sucroferric oxyhydroxide (SFOH) is a non-calcium, iron-based phosphate binder that demonstrated sustained serum phosphorus (sP) control, good tolerability, and lower pill burden, vs. sevelamer carbonate ("sevelamer"), in a Phase 3 study conducted in dialysis patients with hyperphosphatemia. This analysis evaluates the efficacy and safety of SFOH and sevelamer among African American (AA) patients participating in the trial. METHODS: Post hoc analysis of a 24-week, Phase 3, open-label trial (NCT01324128) and its 28-week extension study (NCT01464190). Patients were randomized 2:1 to SFOH (1.0-3.0 g/day) or sevelamer (2.4-14.4 g/day) for up to 52 weeks. FINDINGS: Of 549 patients who completed the Phase 3 study and extension, 100 (18.2%) AA patients were eligible for efficacy analysis (SFOH, n = 48; sevelamer, n = 52). sP concentrations decreased rapidly and comparably with both treatments by Week 8 (mean ± standard deviation change from baseline: -1.9 ± 1.9 mg/dL for SFOH and -2.2 ± 1.8 mg/dL for sevelamer). These reductions were maintained for 52 weeks (-2.1 ± 2.6 and -2.1 ± 1.6 mg/dL) and achieved with a lower mean pill burden (3.4 ± 1.4 vs. 7.6 ± 2.9 tablets/day) with SFOH vs. sevelamer. Treatment adherence rates (adherence within 70%-120% of expected medication intake) were 79.2% with SFOH and 59.6% with sevelamer. The proportion of patients reporting serious adverse events (AEs) was 27.7% with SFOH and 30.7% with sevelamer. More patients withdrew due to treatment-emergent AEs with SFOH vs. sevelamer (18.5% vs. 8.0%). The most common AEs with both treatments were gastrointestinal-related: diarrhea and discolored feces with SFOH, and nausea, vomiting, and constipation with sevelamer. DISCUSSION: SFOH is an efficacious and well-tolerated treatment for hyperphosphatemia in AA dialysis patients, with a lower pill burden and an improved adherence rate vs. sevelamer. These findings were consistent with the wider US patient population and the overall study population. SN - 1542-4758 UR - https://www.unboundmedicine.com/medline/citation/29656600/Long_term_efficacy_and_safety_of_sucroferric_oxyhydroxide_in_African_American_dialysis_patients_ L2 - https://doi.org/10.1111/hdi.12663 DB - PRIME DP - Unbound Medicine ER -