Safety and efficacy of tolvaptan in real‑world Japanese patients with autosomal dominant polycystic kidney disease: final results of SLOW‑PKD surveillance.

ABSTRACT:

Background

Tolvaptan, a vasopressin type 2 receptor antagonist, has been used to treat autosomal dominant polycystic kidney disease in Japan since 2014.

Methods

This long-term, real-world, post-marketing surveillance (PMS) was conducted in Japan from March 2014 to March 2022. Safety was assessed based on adverse drug reactions (ADRs). For efficacy, changes in the slope of total kidney volume (TKV) and estimated glomerular filtration rate (eGFR) were assessed before and during the administration of tolvaptan.

Results

A total of 1676 patients were enrolled, with mean TKV (n = 1000) of 2149 ± 1339 mL and eGFR (n = 1641) of 44.4 ± 21.7 mL/min/1.73 m². Frequent ADRs were hepatic function abnormal (9.6%), hyperuricaemia (8.3%), and thirst (8.1%). Most of the incr

SUBMITTER: Mochizuki T 

PROVIDER: S-EPMC12125073 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature