*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 = 1,971.
†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.1
‡Study to assess the association of phosphate binder pill burden and adherence with phosphorus goal attainment. Adherence was estimated by the medication possession ratio (MPR), defined as the proportion of time a patient had sufficient medication to have taken it as prescribed. Using pharmacy management program data, hemodialysis patients on phosphate binder monotherapy were tracked from first phosphate binder prescription fill for 1 year or until patients were censored. Censoring occurred if patients switched phosphate binder type, received prescriptions for multiple phosphate binders, enrolled in the automatic refill management system, had a gap of 180 days between fills of all medications in the pharmacy management program, had two consecutive serum phosphorus levels <3.0 mg/dL, discontinued hemodialysis, or died.3
1. Velphoro® [package insert]. Waltham, MA: Fresenius Medical Care North America; 2014. 2. 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. 3. Wang S, Alfieri T, Ramakrishnan K, Braunhofer P, Newsome BA. Serum phosphorus levels and pill burden are inversely associated with adherence in patients on hemodialysis. Nephrol Dial Transplant. 2014;29(11):2092-2099.
Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
For additional important safety information, please see the full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at
1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This information is intended for use by US healthcare professionals only.