Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis
Kang Nyeong Lee,Oh Young Lee,Hoon Jai Chun,Jin Il Kim,Sung Kook Kim,Sang Woo Lee,Kyung Sik Park,Kook Lae Lee,Suck Chei Choi,Jae Young Jang,Gwang Ha Kim,In Kyung Sung,Moo In Park,Joong Goo Kwon,Nayoung Kim,Jae J. Kim,Soo Teik Lee,Hyun Soo Kim,Ki Bae Kim,Yong Chan Lee,Myung-Gyu Choi,Joon Seong Lee,Hwoon-Yong Jung,Kwang Jae Lee,Jihyun Kim,Hyun Soo Chung +25 more
TL;DR: In this paper , the authors compared fexuprazan to esomeprazole and established its efficacy and safety in patients with erosive esophagitis (EE).
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Abstract: BACKGROUND Fexuprazan, 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. AIM To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE). METHODS Korean 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. RESULTS Of 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. CONCLUSION Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8. We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.
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Citations
AGA Clinical Practice Update on Integrating Potassium-Competitive Acid Blockers Into Clinical Practice: Expert Review
Amit Patel,Loren Laine,Paul Moayyedi,Justin S. Wu +3 more
TL;DR: This AGA Clinical Practice Update reviews the evidence and expert advice on integrating potassium-competitive acid blockers into clinical practice for foregut disorders, including gastroesophageal reflux disease, Helicobacter pylori infection, and peptic ulcer disease.
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Review of the clinical development of fexuprazan for gastroesophageal reflux–related disease
TL;DR: Fexuprazan is a newly developed potassium-competitive acid blocker (P-CAB), which inhibits acid generation and secretion in a competitive and reversible manner and is approved in South Korea for the treatment of EE and at the time of this writing is being considered for regulatory approval in several other countries.
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Comparison of Potassium-Competitive Acid Blockers and Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Demeke E Agago,Nazma Hanif,Anjali S. Kumar,Muhammad Arsalan,M. Dhanjal,Lubna Hanif,Calvin R. Wei +6 more
TL;DR: This meta-analysis of 11 randomized trials (4,108 patients) found potassium-competitive acid blockers (PCABs) more effective than proton pump inhibitors (PPIs) in healing erosive esophagitis and resolving heartburn symptoms in gastroesophageal reflux disease patients.
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Editorial: deja vu all over again – let the P‐CAB wars begin. Authors' reply
Inyoung Hwang,Seunghwan Lee +1 more
TL;DR: Hwang et al. as discussed by the authors showed that the maximum dosage of zastaprazan in multiple administration (40 mg once-daily) increased mean serum gastrin level to 211.4 pg/mL (SD 89.7) after 1 week, which was comparable to esomeprazole (253.1 ± 170.3 pg/mL) and fexuprazan (251.5 ± 171.3pg) after 8 weeks.
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Recurrent Non-Variceal Upper Gastrointestinal Bleeding among Patients Receiving Dual Antiplatelet Therapy
Ahyoung Yoo,Moon Kyung Joo,Jong-Jae Park,Beom Jae Lee,Seung Han Kim,Won Shik Kim,Hoon Jai Chun +6 more
TL;DR: Clinicians should be cautious about re-bleeding and mortality in elderly patients who experience NVUGIB while receiving DAPT, and the cumulative probabilities of re- bleeding, death, and bleeding-related death were significantly higher in patients aged 70 and older.
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