Original Article

Tolvaptan in Patients with Autosomal Dominant

Polycystic Kidney Disease
Vicente E. Torres, M.D., Ph.D., Arlene B. Chapman, M.D., Olivier Devuyst, M.D.,
Ph.D., Ron T. Gansevoort, M.D., Ph.D., Jared J. Grantham, M.D., Eiji Higashihara,
M.D., Ph.D., Ronald D. Perrone, M.D., Holly B. Krasa, M.S., John Ouyang, Ph.D.,
Frank S. Czerwiec, M.D., Ph.D., for the TEMPO 3:4 Trial Investigators

N Engl J Med
Volume 367(25):2407-2418
December 20, 2012
 Study Overview
• In this trial, patients with autosomal dominant polycystic kidney disease
were randomly assigned to tolvaptan, a vasopressin V2-receptor
antagonist, or placebo.
• Over 3 years, the increase in total kidney volume in the tolvaptan group
was half that in the placebo group.
 Patient Enrollment and Outcomes.

Torres VE et al. N Engl J Med 2012;367:2407-2418

Effect of Tolvaptan on the Annual Slopes of Total Kidney Volume and Kidney Function.

Torres VE et al. N Engl J Med 2012;367:2407-2418

 Effect of Tolvaptan on the Time to Multiple Events Associated with Autosomal Dominant
Polycystic Kidney Disease (ADPKD).

Torres VE et al. N Engl J Med 2012;367:2407-2418

Demographic and Clinical Characteristics of the Patients at Baseline.

Torres VE et al. N Engl J Med 2012;367:2407-

2418
Most Common Adverse Events and Serious Adverse Events.

Torres VE et al. N Engl J Med

2012;367:2407-2418
 Conclusions
• Tolvaptan, as compared with placebo, slowed the increase in total
kidney volume and the decline in kidney function over a 3-year period in
patients with ADPKD but was associated with a higher discontinuation
rate, owing to adverse events.