TREAT - Darbepoetin in DM2 & CKD

Background: Study of the outcome effect of increasing hemoglobin levels in patients with type 2 diabetes and CKD.

Methods: Multi-national, randomized, double-blind, placebo-controlled trial. Included patients with DM2, CKD (GFR 20-60 [MDRD]), anemia (Hb < 11.0), and transferrin saturation of 15%. Excluded uncontrolled HTN, kidney transplant, current use of IV ABx, chemo, XRT, cancer (x BCCA or SCCA of the skin), HIV, active bleeding, heme disorder, or pregnancy. n = 4038.

Treatment: darbepoetin alfa to achieve Hb of 13 g/dL v rescue darbepoetin when Hb < 9.0.

Results: darbepoetin v placebo

Death (any cause): 20.5 v 19.5%, p = 0.48

MI: 6.2 v 6.4%, p = 0.73

Stroke: 5.0 v 2.6, p = <0.001, NNH = 42

Heart failure: 10.2 v 11.3, p = 0.24

Myocardial ischemia: 2.0 v 2.4, p = 0.40

ESRD: 16.8 v 16.3, p = 0.83