Shire says Fosrenol study shows long-term efficacy, safety for end-stage renal disease patients

By E. Janene Geiss

Philadelphia, Nov. 14 - Shire Pharmaceuticals Group plc said Monday that results from a study show that Fosrenol effectively maintains reductions in mean serum phosphorus levels while demonstrating safety and tolerability in end-stage renal disease patients for up to six years.

The open-label extension study enrolled 93 patients, of which 32 were treated with Fosrenol for up to six years. The study revealed that as patients continued on Fosrenol therapy, the number of drug-related adverse events did not increase in frequency as drug exposure increased, according to a company news release.

Fosrenol-treated patients also maintained reduced serum phosphorus and calcium-phosphorus product levels, which demonstrates the long-term effectiveness of the drug, officials said.

"These study results provide strong evidence of the safety and efficacy of Fosrenol," Alastair Hutchison, one of the trial's lead investigators from the Manchester Institute of Nephrology & Transplantation, Manchester, U.K., said in the release.

"With a robust long-term safety profile, end-stage renal disease patients and physicians can rely on Fosrenol to help manage hyperphosphatemia and meet [Kidney Disease Outcomes Quality Initiative] guidelines," Hutchison added.

The data was presented Saturday at the annual meeting of the American Society of Nephrology.

Basingstoke, England-based Shire is a specialty pharmaceutical company.

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