CREATE results support NeoRecormon label

Swiss drug major Roche says that a study in the November 16 issue of the New England Journal of Medicine shows that no additional cardiac benefit is obtained by increasing hemoglobin beyond current recommendations.

The long-awaited landmark CREATE trial set out to see if there was additional cardiovascular benefit in treating anemia in patients with chronic kidney disease to the hemoglobin level seen in healthy individuals. According to Roche, the CREATE results clearly show that there is no additional CV benefit from treating to higher hemoglobin levels, confirming the current anemia therapy recommendations of treating to a sub-normal level of haemoglobin and supports the use of Roche's NeoRecormon (epoetin beta) within its current label, the firm noted.

These recommendations are in line with the consensus of the European Best Practice Guidelines for all erythropoiesis-stimulating agents like epoetins and darbepoetin alfa, Roche added.