TREAT
Trial to Reduce Cardiovascular Events with Aranesp Therapy
Patient / Population Intervention / Exposure Comparison Outcome
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.
N
4,038
Design
Double-blind RCT
Endpoint
Composite of death or cardiovascular event; death or ESRD
Relevance
1
ResultDeath/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 & critique
The stroke signal anchored conservative haemoglobin targets and an FDA black-box warning.