Abstract
BackgroundThe 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.MethodsDe-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).Results1096 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).ConclusionIn 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.
Highlights
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
Patient disposition and baseline characteristics From a total of 1523 patients with recorded SFOH prescriptions that were captured in the EuCLiD® database, 1096 patients were eligible for inclusion in the final analysis (Fig. 1)
The proportion of patients receiving Erythropoiesis-stimulating agent (ESA) decreased progressively during SFOH follow-up, from 80.5% at baseline to 74.6% by Q4 (p ≤ 0.0126 at Q3 and Q4 vs baseline), and was accompanied by a significant decrease in the mean dose of ESA therapy from 6618 units/week at baseline to 5665–6126 units/week during Q1–Q4 (p ≤ 0.0448 for Q1–Q4 vs baseline). This retrospective database analysis of > 1000 European hemodialysis patients showed that treatment with SFOH was associated with an improvement in serum phosphate control when prescribed as part of routine practice for up to 1 year
Summary
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. Many phosphate binders are associated with a high daily pill burden (which may account for ~ 50% of oral medications taken by dialysis patients) [8], and adverse effects, gastrointestinal intolerance [6]. These factors may reduce treatment adherence and contribute towards increased serum phosphate levels [7, 9]. Despite the availability of oral phosphate binder therapy, data from COSMOS (Current Management of Secondary hyperparathyroidism – a Multicenter Observational Study) [10] show that approximately 40% of European hemodialysis patients have serum phosphate above the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (KDOQI) target range (3.5–5.5 mg/dL [1.13–1.78 mmol/L]) [11]
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