TY - JOUR
T1 - Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease
T2 - a randomized clinical trial
AU - Kim, Su Il
AU - Lee, Young Chan
AU - Cha, Wonjae
AU - Jung, Ah Ra
AU - Jang, Jeon Yeob
AU - Choi, Jeong Seok
AU - Lee, Dong Kun
AU - Lee, Hwan Ho
AU - Kwon, Min Su
AU - Lee, Yoon Se
AU - Eun, Young Gyu
N1 - Publisher Copyright:
© The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024.
PY - 2024/11
Y1 - 2024/11
N2 - Purpose: Laryngopharyngeal reflux disease (LPRD) is mainly treated with proton pump inhibitors (PPI) such as esomeprazole, which have shortcomings like delayed absorption and increased osteoporosis. Fexuprazan is a novel potent potassium-competitive acid blocker that inhibits gastric acid secretion with rapid onset and long duration of action. To assess the efficacy and safety of fexuprazan compared to esomeprazole in patients with LPRD. Methods: This prospective, randomized, double-blinded, multicenter, active-controlled trial was conducted in nine otolaryngologic clinics. Patients with reflux symptom index (RSI) ≥ 13 and reflux finding score (RFS) ≥ 7 were randomly assigned to the fexuprazan or esomeprazole groups, and received fexuprazan 40-mg or esomeprazole 40-mg once daily for 8 weeks. The outcomes were (1) mean change, change rate, and valid rate in RSI, RFS, and LPR-related questionnaires; and (2) adverse events. Results: A total of 136 patients (fexuprazan n = 68, esomeprazole n = 68) were followed up for ≥ 1 month. Each parameter significantly improved after 4 and 8 weeks in each group, with no significant differences between the two groups. For those with severe symptoms (RSI ≥ 18), the fexuprazan group (n = 32) showed more improvement in the mean change and change rate in the RSI than esomeprazole group (n = 31) after 4 weeks (p =.036 and.045, respectively). This phenomenon was especially observed in hoarseness and troublesome cough. Conclusion: Fexuprazan improved symptoms and signs without no serious adverse events in patients with LPRD. In patients with severe symptoms, fexuprazan resulted in a faster symptom improvement than PPI. Trial registration: KCT0007251, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22100.
AB - Purpose: Laryngopharyngeal reflux disease (LPRD) is mainly treated with proton pump inhibitors (PPI) such as esomeprazole, which have shortcomings like delayed absorption and increased osteoporosis. Fexuprazan is a novel potent potassium-competitive acid blocker that inhibits gastric acid secretion with rapid onset and long duration of action. To assess the efficacy and safety of fexuprazan compared to esomeprazole in patients with LPRD. Methods: This prospective, randomized, double-blinded, multicenter, active-controlled trial was conducted in nine otolaryngologic clinics. Patients with reflux symptom index (RSI) ≥ 13 and reflux finding score (RFS) ≥ 7 were randomly assigned to the fexuprazan or esomeprazole groups, and received fexuprazan 40-mg or esomeprazole 40-mg once daily for 8 weeks. The outcomes were (1) mean change, change rate, and valid rate in RSI, RFS, and LPR-related questionnaires; and (2) adverse events. Results: A total of 136 patients (fexuprazan n = 68, esomeprazole n = 68) were followed up for ≥ 1 month. Each parameter significantly improved after 4 and 8 weeks in each group, with no significant differences between the two groups. For those with severe symptoms (RSI ≥ 18), the fexuprazan group (n = 32) showed more improvement in the mean change and change rate in the RSI than esomeprazole group (n = 31) after 4 weeks (p =.036 and.045, respectively). This phenomenon was especially observed in hoarseness and troublesome cough. Conclusion: Fexuprazan improved symptoms and signs without no serious adverse events in patients with LPRD. In patients with severe symptoms, fexuprazan resulted in a faster symptom improvement than PPI. Trial registration: KCT0007251, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22100.
KW - Fexuprazan
KW - Larynopharyngeal reflux diseases
KW - Potassium-competitive acid blocker
KW - Proton pump inhibitor
KW - Treatment efficacy
UR - http://www.scopus.com/inward/record.url?scp=85200856882&partnerID=8YFLogxK
U2 - 10.1007/s00405-024-08877-6
DO - 10.1007/s00405-024-08877-6
M3 - Article
C2 - 39115573
AN - SCOPUS:85200856882
SN - 0937-4477
VL - 281
SP - 5873
EP - 5883
JO - European Archives of Oto-Rhino-Laryngology
JF - European Archives of Oto-Rhino-Laryngology
IS - 11
ER -