The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysis

Abstract

Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), demonstrated its effectiveness for lowering serum phosphate levels, with low daily pill burden, in clinical trials of dialysis patients with hyperphosphatemia. This retrospective database analysis evaluated the real-world effectiveness of SFOH for controlling serum phosphate in European hemodialysis patients. Methods De-identified patient data were extracted from a clinical database (EuCliD®) for adult hemodialysis patients from France, Italy, Portugal, Russia and Spain who were newly prescribed SFOH for up to 1 year as part of routine clinical care. Serum phosphate and pill burden were compared between baseline (3-month period before starting SFOH) and four consecutive quarterly periods of SFOH therapy (Q1−Q4; 12 months) in the overall cohort and three subgroups: PB-naïve patients treated with SFOH monotherapy (mSFOH), and PB-pretreated patients who were either switched to SFOH monotherapy (PB → mSFOH), or received SFOH in addition to another PB (PB + SFOH). Results 1096 hemodialysis patients (mean age: 60.6 years; 65.8% male) were analyzed, including 796, 188 and 53 patients in, respectively, the PB + SFOH, mSFOH, and PB → mSFOH groups. In the overall cohort, serum phosphate decreased significantly from 1.88 mmol/L at baseline to 1.77–1.69 mmol/L during Q1–Q4, and the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased from 41.3% at baseline to 56.2–62.7% during SFOH treatment. Mean PB pill burden decreased from 6.3 pills/day at baseline to 5.0–5.3 pills/day during Q1–Q4. The subgroup analysis found the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased significantly from baseline during SFOH treatment in the PB + SFOH group (from 38.1% up to 60.9% [Q2]) and the mSFOH group (from 49.5% up to 75.2% [Q2]), but there were no significant changes in the PB → mSFOH group. For the PB + SFOH group, serum phosphate reductions were achieved with a similar number of PB pills prescribed at baseline prior to SFOH treatment (6.5 vs 6.2 pills/day at Q4). SFOH daily pill burden was low across all 3 subgroups (2.1–2.8 pills/day). Conclusion In this real-world study of European hemodialysis patients, prescription of SFOH as monotherapy to PB-naïve patients, or in addition to existing PB therapy, was associated with significant improvements in serum phosphate control and a low daily pill burden.

Sucroferric oxyhydroxide for hyperphosphatemia: a review of real-world evidence

“…Retrospective observational studies of both hemodialysis and peritoneal patients have also reported small but significant initial increases in ferritin and TSAT during treatment with SO [33][34][35][36][41][42][43]. The findings are consistent with the minimal iron absorption from SO reported in the Phase 3 trial and its extension [30].…”

“…A retrospective study evaluated the real-world effectiveness of SO in European hemodialysis patients, utilizing data from the EuCliD ® database to analyze a cohort of hemodialysis patients from five European countries who were prescribed SO for up to 1 year [ 42 ]. Serum phosphorus and PB pill burden of the overall cohort ( n = 1,096) were compared between a 3-month baseline period prior to SO initiation and four quarterly periods of SO therapy (Q1 − Q4).…”

“…In the overall cohort, serum phosphorus decreased significantly from 5.83 mg/dl at baseline to 5.48–5.24 mg/dl during Q1–Q4 ( p < 0.0001 vs baseline) [ 42 ]. The proportion of patients with serum phosphorus ≤ 5.5 mg/dl increased from 41.3% at baseline to between 56.2 and 62.7% during Q1–Q4 ( p < 0.0001 vs baseline).…”

“…In the subgroup analysis, the proportion of patients achieving serum phosphorus ≤ 5.5 mg/dl increased to the greatest extent in the SO subgroup (from 49.5% at baseline to 62.5–75.2% during Q1–Q4; p < 0.0001 for Q1, Q2, Q3) and in the PB + SO subgroup (from 38.1% at baseline to 53.9–60.9% during Q1–Q4; p < 0.0001 for all quarters) [ 42 ]. There were no statistically significant changes in the proportion of patients achieving serum phosphorus ≤ 5.5 mg/dl in the PB → SO group.…”

“…Overall, the EuCliD ® database analysis indicated that administration of SO either as monotherapy to PB-naïve patients or as add-on therapy to an existing PB therapy regimen was associated with improvements in serum phosphorus control and a low daily pill burden [ 42 ].…”