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.

Keywords: Chronic kidney disease; End-stage renal disease; Hemodialysis; Hyperphosphatemia; Phosphate binder; Sucroferric oxyhydroxide.

Fig. 1

Patient disposition. Abbreviations: EuCliD®, European Clinical Database; FME, Fresenius Medical Care; RRT, renal replacement therapy; SFOH, sucroferric oxyhydroxide

Fig. 2

Number of patients analyzed at each assessment period and reasons for exclusion. ^aPatients with missing serum phosphate values in the previous quarter who could not be analyzed despite receiving SFOH therapy

Fig. 3

Serum phosphate concentrations during baseline and sucroferric oxyhydroxide follow-up (Q1−Q4). a Mean ± SD serum phosphate concentrations. b Proportion of patients achieving target serum phosphate of ≤1.78 mmol/L and ≤ 1.45 mmol/L. ***p < 0.0001 (vs baseline). Mean values are shown in the table. Abbreviations: PB, phosphate binder; SD, standard deviation; SFOH, sucroferric oxyhydroxide

Fig. 4

Proportion of patients achieving target serum phosphate (≤ 1.78 mmol/L) by country. *p < 0.05; **p < 0.001; ***p < 0.0001 (vs baseline); ^aThe serum phosphate data for Russia for Q3 and Q4 are not shown because the number of patients with follow-up data available was too low for meaningful analysis (Q3, n = 7; Q4, n = 0)

Fig. 5

Serum phosphate and phosphate binder pill burden during baseline and sucroferric oxyhydroxide follow-up (Q1–4). Abbreviations: mSFOH, PB-naïve patients treated with SFOH monotherapy; PB, phosphate binder; PB + SFOH, PB-pretreated patients who added SFOH to another PB; PB → SFOH, PB-pretreated patients switched to SFOH monotherapy; pts, patients; SFOH, sucroferric oxyhydroxide; sP, serum phosphate. Mean values are shown in the table. *p < 0.05; ***p < 0.0001 (vs baseline)