Phosphate management success in both real-world and clinical settings

Retrospective analyses and clinical studies have shown that Velphoro significantly improved phosphorus control in patients on dialysis.1-5
 

Real-world results with Velphoro: Daniel Coyne, MD

Professor of Medicine, Division of Nephrology; Medical Director, Chromalloy American Kidney Center, Washington University in St. Louis, MO

Dr Coyne discusses how a switch to Velphoro doubled the percentage of patients who achieved their phosphorus goal in a real-world analysis (03:01)1


*A retrospective analysis of deidentified clinical and prescription data from 818 hemodialysis patients extracted from the Fresenius Kidney Care clinical data warehouse and Fresenius pharmacy database. Clinical and laboratory parameters of 222 patients who continued Velphoro monotherapy for 24 months from baseline beginning between April 1, 2014, and April 1, 2015, were compared to 596 patients who discontinued Velphoro and were switched to alternate phosphate binders within 90 days of baseline. The decision to switch phosphate binders was made on a clinical basis and the reasons underlying this change were not available. Outcomes included achievement of target serum phosphorus of ≤5.5 mg/dL and phosphate binder pill burden.5

A retrospective analysis of deidentified pharmacy data from 1,029 adult in-center hemodialysis patients who were switched to Velphoro during routine care between April 2014 and March 2015. The decision to switch phosphate binders (PBs) was made on a clinical basis and the reasons underlying this change were not available. Outcomes included the proportion of patients with phosphorus levels ≤5.5 mg/dL and the mean prescribed PB pills/day at baseline (3 months prior to Velphoro) and during Velphoro follow-up (6 months after switch to Velphoro, n=424).1

A retrospective analysis of deidentified pharmacy data from 530 adult in-center hemodialysis patients who were switched to Velphoro during routine care between March 2014 and March 2015. The decision to discontinue baseline phosphate binders (PBs) and switch to Velphoro was made on a clinical basis and the reasons underlying this change were not available. Comparisons were made between the 91-day period before Velphoro initiation (ie, baseline) and the 4 consecutive 91-day intervals of Velphoro treatment (Q1–Q4). Main outcome measures included achievement of target phosphorus levels (≤5.5 mg/dL) and mean number of PB pills/day. 2

§A 52-week, open-label, active-controlled, phase 3 study evaluated the safety and efficacy of Velphoro in lowering serum phosphorus levels in patients (N=1,054) with chronic kidney disease on hemodialysis or peritoneal dialysis. In the titration phase (first 24 weeks), patients were randomized to receive either Velphoro or sevelamer carbonate to establish the noninferiority of Velphoro to sevelamer carbonate in lowering serum phosphorus at 12 weeks (secondary endpoint). The following withdrawal phase (weeks 24 to 27, n=93) established the superiority of Velphoro with an effective maintenance dose over a placebo-like low dose (primary endpoint). During a final long-term maintenance phase (weeks 28-52, n=658), patients continued phosphate binder treatment according to their original randomization for the assessment of long-term efficacy, safety, and tolerability.7

Over the course of the 52-week study, patients on Velphoro took an average of 5.4 fewer tablets per day: 5.4 x 365 = 1971.3

References: 1. Coyne DW, Ficociello LH, Parameswaran V, et al. Real-world effectiveness of sucroferric oxyhydroxide in patients on chronic hemodialysis: a retrospective analysis of pharmacy data. Clin Nephrol. 2017;88(2):59-67. 2. Kendrick J, Parameswaran V, Ficociello LH, et al. One-year historical cohort study of the phosphate binder sucroferric oxyhydroxide in patients on maintenance hemodialysis. J Ren Nutr. 2019;29(5):428-437. 3. Floege J, Covic AC, Ketteler M, et al; on behalf of the Sucroferric Oxyhydroxide Study Group. Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrol Dial Transplant. 2015;30(6):1037-1046. 4. Floege J, Covic AC, Ketteler M, et al; on behalf of the PA21 Study Group. A phase III study of the efficacy and safety of a novel iron–based phosphate binder in dialysis patients. Kidney Int. 2014;86(3):638-647. 5. Coyne DW, Ficociello LH, Parameswaran V, et al. Sucroferric oxyhydroxide in maintenance hemodialysis: a retrospective, comparative cohort study. Kidney Med. 2020; doi: https://doi.org/10.1016/j.xkme.2020.01.009. 6. Data on file. Fresenius Medical Care North America. Waltham, MA. 7. Velphoro® [package insert]. Waltham, MA: Fresenius Medical Care North America; 2020.