Real-world effectiveness and safety of tolvaptan in liver cirrhosis patients with hepatic edema: results from a post-marketing surveillance study (START study).

ABSTRACT:

Background

This large-scale post-marketing surveillance study (START study) evaluated the effectiveness and safety of tolvaptan in Japanese liver cirrhosis patients with hepatic edema in real-world clinical settings. Here, we present the final analysis outcomes.

Methods

A prospective, multicenter, non-interventional study involving patients who received tolvaptan for the treatment of liver cirrhosis with hepatic edema with an insufficient response to conventional diuretics. The observation period was up to 6 months. Effectiveness evaluation included changes in body weight and clinical symptoms. Safety analysis included evaluation of adverse drug reactions (ADRs).

Results

Case reports of 1111 patients were collected. Of these, 1109 were included in the safety analysis

SUBMITTER: Sakaida I 

PROVIDER: S-EPMC7376514 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature