PRADA
PRevention of cArdiac Dysfunction during Adjuvant breast cancer therapy
Doente / População Intervenção / Exposição Comparação Desfecho
In 130 women with early breast cancer receiving adjuvant anthracycline-based chemotherapy, concomitant candesartan attenuated the early decline in left ventricular ejection fraction on cardiac MRI, whereas metoprolol did not, compared with placebo.
N
130
Desenho
2×2 factorial, double-blind, placebo-controlled RCT
Desfecho
Change in left ventricular ejection fraction on cardiac magnetic resonance imaging
Relevância
3
ResultadoLVEF decline 2.6 percentage points (95 % CI 1.5–3.8) with placebo vs 0.8 (95 % CI −0.4–1.9) with candesartan (p=0.026); no effect of metoprolol.
Gulati G, Heck SL, Ree AH, et al. Eur Heart J. 2016;37(21):1671-1680. 10.1093/eurheartj/ehw022
Discussão e crítica
Small and low-risk, with a surrogate imaging endpoint and an effect size below the 5-point threshold the investigators themselves called clinically important; the benefit did not persist in extended follow-up. It remains the reference trial for renin-angiotensin blockade during anthracycline therapy.