The efficacy and safety of fexuprazan in treating erosive esophagitis : a phase III, randomized, double-blind, multicenter study
© 2024 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd..
BACKGROUND AND AIM: Fexuprazan is a novel potassium-competitive acid blocker (P-CAB). This study aimed to explore the noninferior efficacy and safety of fexuprazan to esomeprazole in treating erosive esophagitis (EE).
METHODS: This was a phase III, randomized, double-blind multicenter study. Patients with endoscopically confirmed EE were randomized to receive fexuprazan 40 mg or esomeprazole 40 mg once a daily for 4-8 weeks. The healing rates of EE, symptom response, GERD-health-related quality life (GERD-HRQL), and treatment-emergent adverse events (TEAEs) were compared between fexuprazan group and esomeprazole group.
RESULTS: A total of 332 subjects were included in full analysis set (FAS) and 311 in per-protocol set (PPS). The healing rates of fexuprazan and esomeprazole groups at 8 weeks were 88.5% (146/165) and 89.0% (145/163), respectively, in FAS and 97.3% (145/149) and 97.9% (143/146), respectively, in PPS. Noninferiority of fexuprazan compared with esomeprazole according to EE healing rates at 8 weeks was demonstrated in both FAS and PPS analysis. No significant difference was found between groups in EE healing rates at 4 weeks, symptom responses, and changes of GERD-HRQL. The incidence of drug-related AEs was 19.4% (32/165) in fexuprazan arm and 19.6% (32/163) in esomeprazole arm.
CONCLUSION: This study demonstrated noninferior efficacy of fexuprazan to esomeprazole in treating EE. The incidence of TEAEs was similar between fexuprazan and esomeprazole. Trial registration number NCT05813561.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:39 |
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| Enthalten in: |
Journal of gastroenterology and hepatology - 39(2024), 4 vom: 20. Apr., Seite 658-666 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zhuang, Qianjun [VerfasserIn] |
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| Links: |
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| Themen: |
Amines |
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| Anmerkungen: |
Date Completed 04.04.2024 Date Revised 04.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT05813561 Citation Status MEDLINE |
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| doi: |
10.1111/jgh.16471 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367422921 |
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| 100 | 1 | |a Zhuang, Qianjun |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The efficacy and safety of fexuprazan in treating erosive esophagitis |b a phase III, randomized, double-blind, multicenter study |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 04.04.2024 | ||
| 500 | |a Date Revised 04.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05813561 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd. | ||
| 520 | |a BACKGROUND AND AIM: Fexuprazan is a novel potassium-competitive acid blocker (P-CAB). This study aimed to explore the noninferior efficacy and safety of fexuprazan to esomeprazole in treating erosive esophagitis (EE) | ||
| 520 | |a METHODS: This was a phase III, randomized, double-blind multicenter study. Patients with endoscopically confirmed EE were randomized to receive fexuprazan 40 mg or esomeprazole 40 mg once a daily for 4-8 weeks. The healing rates of EE, symptom response, GERD-health-related quality life (GERD-HRQL), and treatment-emergent adverse events (TEAEs) were compared between fexuprazan group and esomeprazole group | ||
| 520 | |a RESULTS: A total of 332 subjects were included in full analysis set (FAS) and 311 in per-protocol set (PPS). The healing rates of fexuprazan and esomeprazole groups at 8 weeks were 88.5% (146/165) and 89.0% (145/163), respectively, in FAS and 97.3% (145/149) and 97.9% (143/146), respectively, in PPS. Noninferiority of fexuprazan compared with esomeprazole according to EE healing rates at 8 weeks was demonstrated in both FAS and PPS analysis. No significant difference was found between groups in EE healing rates at 4 weeks, symptom responses, and changes of GERD-HRQL. The incidence of drug-related AEs was 19.4% (32/165) in fexuprazan arm and 19.6% (32/163) in esomeprazole arm | ||
| 520 | |a CONCLUSION: This study demonstrated noninferior efficacy of fexuprazan to esomeprazole in treating EE. The incidence of TEAEs was similar between fexuprazan and esomeprazole. Trial registration number NCT05813561 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
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| 650 | 7 | |a Amines |2 NLM | |
| 650 | 7 | |a Pyrroles |2 NLM | |
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