Amgen Reports Top-Line Results Of Phase3 Trail For Aranesp

Published: 25-Aug-2009

For treatment of anemia associated with CRF

Amgen has reported the top-line results of phase 3 study of Aranesp. Aranesp is for the treatment of anemia associated with CRF for patients on dialysis and patients not on dialysis.

The study was a large, randomized, double-blind, placebo-controlled, study of patients with chronic kidney disease, anemia and type-2 diabetes (TREAT), treatment of anemia with Aranesp to a hemoglobin target of 13g/dL had no statistically significant effect on either of two primary endpoints compared with placebo treatment.

Reportedly, the two primary endpoints were a composite of time to all-cause mortality or cardiovascular morbidity and a composite of time to all-cause mortality or chronic renal replacement therapy. Among the elements that formed these composite endpoints, an excess of stroke events occurred in the Aranesp-treated patients compared to those receiving placebo.

Roger Perlmutter, executive vice president of research and development at Amgen, said: TREAT was designed to answer important questions about the effects of erythropoiesis-stimulating agents (ESAs) on cardiovascular and renal outcomes in patients with renal insufficiency and type-2 diabetes. The trial will provide nephrologists with important information as they endeavor to improve renal care.

In contrast to a recent, smaller study of ESAs in a similar patient population, TREAT did not show a statistically significant adverse effect on all-cause mortality or cardiovascular morbidity when patients were treated to a hemoglobin target of 13 g/dL. We continue to believe that ESAs have a favorable benefit: risk profile when used according to the approved label.

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