Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis
Abstract
BACKGROUNDFexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K + /H + -ATPase enzyme in proton pumps within gastric parietal cells.Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner. AIMTo compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE). METHODSKorean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks.The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8.The secondary endpoints included the healing rate of EE at week 4, symptom response, and quality of life assessment.Safety profiles and serum gastrin levels were compared between the groups. RESULTSOf the 263 randomized, 218 completed the study per protocol (fexuprazan 40 mg, n = 107; esomeprazole 40 mg, n = 111).Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) vs 99.1% (110/111)].There were no between-group differences in the EE healing rate at week 4 [90.3%(93/103) vs 88.5% (92/104)], symptom responses, and quality of life assessments.Additionally, serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups. CONCLUSIONFexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8.We suggest that fexuprazan…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 111 participants or records.
Read the paper
Related studies
- Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study
- Treatment and prognostic factors for long-term outcome in patients with anti-N-Methyl-D-Aspartate (NMDA) receptor encephalitis: a cohort study
- Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study
- Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study
- Ethnic and socioeconomic differences in SARS-CoV-2 infection: prospective cohort study using UK Biobank
- Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.