The use of Darbepoetin alfa ( Aranesp ) in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes ( either death or a cardiovascular event or death or a renal event ) and was associated with an increased risk of stroke.

Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although Aranesp can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested.

A new study evaluated Aranesp in 4038 patients with diabetes, chronic kidney disease, and anemia, randomly assigned 2012 patients to Darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue Darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter.

The primary end points were the composite outcomes of death or a cardiovascular event ( nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia ) and of death or end-stage renal disease.

Death or a cardiovascular event occurred in 632 patients assigned to Aranesp and 602 patients assigned to placebo ( hazard ratio for Aranesp vs. placebo, 1.05; P=0.41 ). Death or end-stage renal disease occurred in 652 patients assigned to Aranesp and 618 patients assigned to placebo ( hazard ratio, 1.06; P=0.29 ).

Fatal or nonfatal stroke occurred in 101 patients assigned to Aranesp and 53 patients assigned to placebo ( hazard ratio, 1.92; P<0.001 ).

Red-cell transfusions were administered to 297 patients assigned to Aranesp and 496 patients assigned to placebo ( P<0.001 ).

There was only a modest improvement in patient-reported fatigue in the Aranesp group as compared with the placebo group.

Over the last two years, the FDA ( Food and Drug Administration ) has repeatedly strengthened warning labels on Aranesp, Epogen and Procrit as concerns rose that they may worsen survival in certain cancer patients, especially at higher doses.

Source: The New England Journal of Medicine, 2009

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