Real-World Data on the Efficacy and Safety of Fexuprazan in Patients with Gastroesophageal Reflux Disease: Interim Analysis of Post-Marketing Surveillance
Abstract
Background/Aims
Fexuprazan, a novel potassium-competitive acid blocker, has emerged as a promising alternative to proton pump inhibitors for the treatment of gastroesophageal reflux disease (GERD). Although its efficacy has been confirmed in clinical trials, real-world evidence on fexuprazan safety and effectiveness, particularly in older populations, remains limited. This interim analysis of a post-marketing surveillance study was conducted to evaluate the safety and clinical effectiveness of fexuprazan in patients with GERD under routine clinical conditions.
Methods
A total of 671 case report forms were collected from multiple centers in Korea. After excluding ineligible cases, 630 patients were included in the safety analysis set, and 588 patients who completed at least 4 weeks of treatment were analyzed for the efficacy of fexuprazan. Symptom improvement and changes in GERD health-related quality of life (GERD-HRQL) scores were assessed. Adverse events and adverse drug reactions (ADRs) were monitored and compared across age groups.
Results
Among the 630 patients, 294 (46.7%) were aged ≥65 years, and 88 (14.0%) were aged ≥75 years. Symptom improvement was observed in 95.75% of the patients, with no significant differences among age groups. The GERD-HRQL scores improved from 13.3±9.5 at baseline to 3.0±4.4 after treatment. The overall incidence of ADRs was 2.38%, and no serious ADRs were reported, with no notable age-related differences.
Conclusions
Fexuprazan demonstrated…
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