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 score significantly improved from 8.8 ± 2.3 at baseline to 6.6 ± 1.7 at 12 weeks ( P  = 0.003). A normal GerdQ score (<8) was achieved in 88.9% of the patients. One patient (5.6%) experienced a UGI clinical event and one had a recurrent transient ischemic attack. Conclusions This preliminary prospective single-arm study using a structured symptom-based assessment suggests that fexuprazan may be associated with symptom relief in patients with AIS and GERD receiving antithrombotic therapy. However, due to the small sample size and lack of a control group, these findings should be interpreted as hypothesis-generating and warrant further confirmation in larger, controlled trials.