No TREATment with Darbepoetin Dosed to Hemoglobin 13 Grams per Deciliter in Type 2 Diabetes with Pre-Dialysis Chronic Kidney Disease - Safety Warnings for Erythropoiesis-Stimulating Agents

1.92 (95% CI = 1.38-2.68, P < 0.001) for an increased risk of stroke (absolute rate = 5.0% for darbepoetin alfa vs. 2.6% for placebo). TREAT investigators also observed no significant reduction in the incidence of the 2 primary endpoint outcomes. Of the patients treated with darbepoetin alfa, 31.4% (n = 632) experienced the primary composite endpoint of death from any cause, stroke or cardiovascular events (myocardial infarction [MI], heart failure or myocardial ischemia) compared with 29.7% (n = 602) for placebo (HR = 1.05, 95% CI = 0.94-1.17, P = 0.41). There was also no significant difference between the darbepoetin and placebo groups in the other primary composite endpoint of death or end-stage renal disease (ESRD), 32.4% (n = 652) for darbepoetin alfa versus 30.5% (n = 618) with placebo (HR = 1.06, 95% CI = 0.95-1.19, P = 0.29).