TEMPO 3:4
Tolvaptan Efficacy and Safety in Management of ADPKD and its Outcomes
Doente / População Intervenção / Exposição Comparação Desfecho
In 1,445 patients with autosomal dominant polycystic kidney disease, tolvaptan slowed total kidney-volume growth compared with placebo.
N
1445
Desenho
Double-blind RCT over 3 years
Desfecho
Annual rate of total kidney-volume increase
Relevância
2
Resultado2.8% vs 5.5% per year (p<0.001); slower reciprocal-creatinine decline.
Torres VE, et al. N Engl J Med. 2012;367(25):2407-2418. 10.1056/NEJMoa1205511
Discussão e crítica
First disease-modifying therapy for ADPKD; aquaretic side effects and idiosyncratic hepatotoxicity drove a 23% dropout.