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

Abstract

Hyperphosphatemia is a common complication in dialysis-dependent patients with chronic kidney disease. Most dialysis-dependent patients need oral phosphate binder therapy to control serum phosphorus concentrations. Most phosphate binders have a high daily pill burden, which may reduce treatment adherence and impair phosphorus control. Sucroferric oxyhydroxide is a potent iron-based phosphate binder approved for use in dialysis-dependent patients in 2013. A randomized controlled trial of sucroferric oxyhydroxide demonstrated its efficacy for reduction of serum phosphorus with a lower pill burden than sevelamer carbonate. Clinical trials carefully select patients, monitor adherence, and routinely titrate medications to a protocol-defined goal. Consequently, trials may not reflect real-world use of medications. Since its approval, we and others have performed retrospective and prospective analyses of sucroferric oxyhydroxide in real-world clinical practice in > 6400 hemodialysis and approximately 500 peritoneal dialysis patients in the USA and Europe. Consistent with the clinical trial data, real-world observational studies have demonstrated that sucroferric oxyhydroxide can effectively reduce serum phosphorus with a lower daily pill burden than most other phosphate binders. These studies have also shown sucroferric oxyhydroxide provides effective serum phosphorus control in different treatment settings, including as monotherapy in phosphate binder-naïve patients, in patients switching from other phosphate binders, or when used in combination with other phosphate binders. These observational studies indicate a favorable safety and tolerability profile, and minimal, if any, systemic iron absorption. This article reviews the key results from these observational studies of sucroferric oxyhydroxide and evaluates its role in the management of hyperphosphatemia in clinical practice.

Sucroferric oxyhydroxide use in patients on haemodialysis – real-world experience from an Asian cohort

“…The efficacy of SO in different clinical treatment settings was demonstrated in a recent review of real-world evidence of its use. 17 We found no significant difference in serum calcium levels in short term use of SO, but a slight reduction was observed in longer term use. This could be attributed to the sizeable proportion of patients (76.7%) in our audit cohort who switched from calcium-based phosphate binders to SO or took a combination of calcium-based phosphate binders with SO (with reduced dosage of calcium-based binders, presumably).…”

A 6-Month clinical practice pilot study of sucroferric oxyhydroxide on nutritional status in patients on peritoneal dialysis

“…In this larger study, withdrawal from SO from adverse events occurred in only 8.2% of participants. Recent real-world studies of SO have also shown that it is effective and well-tolerated [ 21 ]. We did not obtain information beyond the 6-month time period in our study, so we do not know if patients were able to continue on SO and thus do not have longer data regarding effectiveness or side effects.…”

Serum Phosphorus Management with Sucroferric Oxyhydroxide as a First-Line Phosphate Binder within the First Year of Hemodialysis

“…Sucroferric oxyhydroxide (SO, 500 mg per tablet; Velphoro ® , Fresenius Medical Care Renal Therapies Group, Waltham, MA, USA) is a non-calcium, chewable, iron-based PB that effectively lowers sP while reducing pill burden relative to other PBs. To date, studies have largely examined the effects of SO in prevalent hemodialysis populations previously treated with other PBs [14][15][16][17][18][19][20][21]. This study aimed to explore the role of SO as a first-line PB among patients in their first year of dialysis.…”