Fexuprazan for upper gastrointestinal protection in patients with ischemic stroke and gastroesophageal reflux disease (GERD) receiving antithrombotic therapy: A preliminary prospective single-arm observational Study
Abstract
BACKGROUND: Proton pump inhibitors are standard for preventing upper gastrointestinal (UGI) complications in patients receiving antithrombotic therapy, but their limitations highlight the need for alternatives. Potassium-competitive acid blockers (P-CABs), such as fexuprazan, are emerging substitutes, yet evidence supporting their protective role in this setting remains limited. This study aimed to evaluate the effect of fexuprazan in patients with acute ischemic stroke (AIS) and gastroesophageal reflux disease (GERD) receiving antithrombotic therapy.
METHODS: This prospective, single-center, single-arm study included consecutive patients with AIS and GERD who were receiving antithrombotic therapy and treated with fexuprazan between June 2023 and March 2025. At the study hospital, all admitted AIS patients were systematically screened for GERD using the Gastroesophageal Reflux Disease Questionnaire (GerdQ), with a score ≥8 indicating GERD. The primary outcome was the change in GerdQ score from baseline to 12 weeks after the index AIS. Safety outcomes included recurrent stroke or serious adverse events within 12 weeks. The secondary efficacy outcome was the occurrence of a composite of UGI clinical events.
RESULTS: Among 623 patients with AIS screened during the study period, 18 patients with GERD receiving antithrombotic therapy and treated with fexuprazan were enrolled and followed for 12 weeks. The mean age was 65.6 years, and 9 patients (50.0%) were male. The mean GerdQ…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 623 participants or records.
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