TEMPO 3:4
Tolvaptan Efficacy and Safety in Management of ADPKD and its Outcomes
Patient / Population Intervention / Exposure Comparison Outcome
In 1,445 patients with autosomal dominant polycystic kidney disease, tolvaptan slowed total kidney-volume growth compared with placebo.
N
1,445
Design
Double-blind RCT over 3 years
Endpoint
Annual rate of total kidney-volume increase
Relevance
2
Result2.8% 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
Discussion & critique
First disease-modifying therapy for ADPKD; aquaretic side effects and idiosyncratic hepatotoxicity drove a 23% dropout.