TREAT

Trial to Reduce Cardiovascular Events with Aranesp Therapy

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In 4,038 patients with type 2 diabetes, CKD and anaemia, darbepoetin alfa did not reduce death or cardiovascular events and doubled the risk of stroke compared with placebo.

4 038

Schéma

Double-blind RCT

Critère

Composite of death or cardiovascular event; death or ESRD

Pertinence

RésultatDeath/CV HR 1.05 (p=0.41); fatal or non-fatal stroke HR 1.92 (95% CI 1.38–2.68; p<0.001).

Pfeffer MA, et al. N Engl J Med. 2009;361(21):2019-2032. 10.1056/NEJMoa0907845

Discussion et critique

The stroke signal anchored conservative haemoglobin targets and an FDA black-box warning.