Amgen announced that in a large, randomized, double-blind, placebo-controlled, phase-3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anaemia and type-2 diabetes (the Trial to Reduce Cardiovascular Endpoints with Aranesp Therapy, or TREAT), treatment of anaemia with Aranesp (darbepoetin alfa) to a haemoglobin target of 13 g/dL had no statistically significant effect on either of two primary endpoints compared with placebo treatment.

The two primary endpoints were a composite of time to all-cause mortality or cardiovascular morbidity (including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia) 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 (a labelled risk of Aranesp therapy) occurred in the Aranesp-treated patients compared to those receiving placebo.

These summary results will be followed by full efficacy and safety analyses, which will be shared with global regulatory authorities and presented at an upcoming medical meeting later this year.

"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. It is by any measure the most comprehensive analysis that has ever been performed to examine the impact of anaemia therapy in patients who do not yet require dialysis. The trial will provide nephrologists with important information as they endeavour to improve renal care," said Roger M Perlmutter, executive vice president of Research and Development at Amgen. "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 haemoglobin target of 13 g/dL. We continue to believe that ESAs have a favourable benefit:risk profile when used according to the approved label."

Currently, Aranesp is indicated for the treatment of anaemia in patients with chronic renal failure (CRF), including patients on dialysis and patients not on dialysis. The approved label for Aranesp recommends individualizing dosing to achieve and maintain haemoglobin levels within the range of 10 to 12 g/dL. TREAT studied uses for Aranesp in which it is not approved.

Aranesp was approved by the US Food and Drug Administration in 2001 for the treatment of anaemia associated with CRF for patients on dialysis and patients not on dialysis.