Integrated Analysis of Vonoprazan Safety for Symptomatic Gastro-Oesophageal Reflux Disease or Erosive Oesophagitis.

ABSTRACT:

Background

Patients with erosive oesophagitis, and those with persistent symptomatic non-erosive gastro-oesophageal reflux disease, require long-term maintenance treatment with acid-suppressing agents.

Aim

To evaluate the safety of vonoprazan, a potassium-competitive acid blocker, in an integrated analysis of data from clinical trials in adults.

Methods

We included 14 clinical trials of vonoprazan conducted in multiple countries. Mean duration of exposure in person-years to vonoprazan (n = 5318) was 2068, to comparators lansoprazole (n = 1925) or esomeprazole (n = 86) was 751, and to placebo (n = 779) was 59. We report adverse events, serum gastrin, and liver enzyme levels as the main outcomes. Post-marketing safety data from December 26, 2014 (date of commercialisati

SUBMITTER: Howden CW 

PROVIDER: S-EPMC11825931 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature