SONAR
Study of Diabetic Nephropathy with Atrasentan
Doente / População Intervenção / Exposição Comparação Desfecho
In 2,648 patients with type 2 diabetes and CKD selected for response, atrasentan reduced the composite of creatinine doubling or ESKD compared with placebo.
N
2648
Desenho
Double-blind RCT, enrichment (responder) design
Desfecho
Doubling of serum creatinine or ESKD
Relevância
3
ResultadoHR 0.65 (95% CI 0.49–0.88; p=0.0047); more fluid retention and oedema with atrasentan.
Heerspink HJL, et al. Lancet. 2019;393(10184):1937-1947. 10.1016/S0140-6736(19)30772-X
Discussão e crítica
Proof of concept for selective endothelin-A antagonism; the enrichment design limits generalisability.