Long-term results from the phase 3 trial of sucroferric oxyhydroxide versus sevelamer show that both phosphate binders lower serum phosphorus and both were generally well tolerated by dialysis patients after one year of use.
For this 28-week extension of the original trial, Jürgen Floege, MD, of RWTH University Hospital Aachen, Aachen, Germany, and collaborators examined outcomes in a subset of patients taking the medications for up to 1 year. More than 600 dialysis patients from 143 countries participated in the study: 384 patients received iron-based sucroferric oxyhydroxide (1-3 g/day) and 260 received sevelamer carbonate (2.4–14.4 g/day). Doses could be adjusted over time for efficacy and tolerability.
According to results published in Nephrology Dialysis Transplantation, serum phosphorus concentrations were maintained during the study period. The average change in serum phosphorus was 0.02 mmol/L with sucroferric oxyhydroxide and 0.09 mmol/L with sevelamer. For both medications, serum phosphorus stayed within the Kidney Disease Outcomes Quality Initiative (KDOQI) target range. Changes in serum phosphorus levels did not differ significantly between the treatment arms.
Hyperphosphatemia was the most common adverse effect for both medications in the latter 6 months (whereas GI disorders predominated in the first 6 months of the original trial).
Researchers found no evidence of iron accumulation with sucroferric oxyhydroxide. Average serum ferritin increased in both groups, but transferrin saturation, iron, and hemoglobin concentrations were relatively stable. Some U.S. patients received intravenous iron which may have affected the results.
Sucroferric oxyhydroxide users had a lower pill burden (4 vs. 10 tablets per day), which might help improve adherence to phosphate binder therapy, the researchers suggested.
The study was sponsored by Vifor Pharma, the manufacturers of sucroferric oxyhydroxide (Velphoro).