Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients.

Abstract

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. 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. 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. 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.