Pooled Data Analysis of the Long-Term Treatment Effects of Tolvaptan in ADPKD.

ABSTRACT:

Introduction

In 1- and 3-year randomized trials, tolvaptan slowed kidney function decline in subjects with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression. The 3-year trial also evaluated effects on total kidney volume (TKV); slowing of TKV growth was demonstrated. Subjects were followed in open-label extension trials. To characterize longer-term effects of treatment, an analysis was conducted comparing tolvaptan-treated subjects with subjects from standard of care (SOC) ADPKD studies without tolvaptan.

Methods

This was a pooled, longitudinal analysis of data from 8 tolvaptan clinical trials and 5 studies without tolvaptan (natural history or SOC) in ADPKD. Data from subjects who participated in multiple studies were linked for longer follow

SUBMITTER: Zhou X 

PROVIDER: S-EPMC9091612 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature