Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients with Erosive Esophagitis.

Autor:	Lee SP; Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea., Sung IK; Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea., Lee OY; Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea., Choi MG; Department of Internal Medicine, The Catholic University of Korea, Seoul ST. Mary's Hospital, Seoul, Korea., Huh KC; Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea., Jang JY; Department of Internal Medicine, KyungHee University Medical Center, Seoul, Korea., Chun HJ; Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea., Kwon JG; Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea., Kim GH; Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea., Kim N; Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea., Rhee PL; Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Kim SG; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea., Jung HY; Department of Internal Medicine, Asan Medical Center, Seoul, Korea., Lee JS; Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, Korea., Lee YC; Department of Internal Medicine, Severance Hospital, Seoul, Korea., Jung HK; Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea., Kim JG; Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea., Kim SK; Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea., Sohn CI; Department of Internal Medicine, Kangbuk Samsung Hospital, Seoul, Korea.
Jazyk:	angličtina
Zdroj:	Journal of neurogastroenterology and motility [J Neurogastroenterol Motil] 2024 Dec 13. Date of Electronic Publication: 2024 Dec 13.
DOI:	10.5056/jnm24032
Abstrakt:	Background/aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acidrelated disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatmentemergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, -0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, -0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions: Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
Databáze:	MEDLINE
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