- Direct Comparison of the Two non-Calcium Phosphate Binders Gives new Insights Into Relative Efficacy
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announces the publication in Clinical Nephrology of findings from a head-to-head clinical study comparing the efficacy of two non-calcium based phosphate binders, FOSRENOL(R) (lanthanum carbonate) and sevelamer hydrochloride (Genzyme's Renagel(R)) in chronic kidney disease (CKD) patients on haemodialysis.
The study's primary endpoint, change in serum phosphorus from baseline to end of treatment, was evaluated using several statistical analyses; the primary analysis used last observation carried forward (LOCF) for the intention to treat (ITT) population treatment with both phosphate binders and had a serum phosphorus value at the end of treatment.
The analysis of LOCF for the ITT population showed a numerically greater reduction in serum phosphorus with FOSRENOL (1.7mg/dL) versus sevelamer (1.4mg/dL), although this did not reach statistical significance>
Study investigators concluded that the statistically larger reduction within the completer group suggested that FOSRENOL may offer greater serum phosphorus reduction in CKD patients on haemodialysis.
"This study is important, because up until now, there was no data comparing the relative efficacies of lanthanum carbonate and sevelamer," said lead investigator Professor Stuart Sprague of Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
"The findings suggest that over four weeks of treatment, FOSRENOL may be a more effective binder of phosphate. Further research is now required to evaluate whether the trends observed in this crossover study are continued in the long term," he added.