Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial

Su Il Kim¹, Young Chan Lee¹, Wonjae Cha², Ah Ra Jung³, Jeon Yeob Jang⁴, Jeong-Seok Choi⁵, Dong Kun Lee⁶, Hwan Ho Lee⁷, Min Su Kwon⁸, Yoon Se Lee^#⁹, Young-Gyu Eun^#¹⁰

Affiliations

¹ Department of Otolaryngology-Head and Neck Surgery, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
² Department of Otorhinolaryngology-Head & Neck Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
³ Department of Otolaryngology-Head and Neck Surgery, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.
⁴ Department of Otolaryngology, Ajou University School of Medicine, Suwon, Korea.
⁵ Department of Otorhinolaryngology-Head and Neck Surgery, Inha University College of Medicine, Incheon, Korea.
⁶ Department of Otorhinolaryngology, Head and Neck Surgery, Dong-A University College of Medicine, Busan, Korea.
⁷ Department of Otolaryngology-Head and Neck Surgery, Kosin University College of Medicine, Busan, Korea.
⁸ Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, College of Medicine, University of Ulsan, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Korea.
⁹ Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, College of Medicine, University of Ulsan, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Korea. yselee@amc.seoul.kr.
¹⁰ Department of Otolaryngology-Head and Neck Surgery, Kyung Hee University School of Medicine, Kyung Hee University Medical Center, 23 Kyungheedae-Ro, Dongdaemun-Gu, Seoul, 02447, Korea. ygeun@khu.ac.kr.

^# Contributed equally.

PMID: 39115573
DOI: 10.1007/s00405-024-08877-6

Randomized Controlled Trial

Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial

Su Il Kim et al. Eur Arch Otorhinolaryngol. 2024 Nov.

. 2024 Nov;281(11):5873-5883.

doi: 10.1007/s00405-024-08877-6. Epub 2024 Aug 8.

Authors

Su Il Kim¹, Young Chan Lee¹, Wonjae Cha², Ah Ra Jung³, Jeon Yeob Jang⁴, Jeong-Seok Choi⁵, Dong Kun Lee⁶, Hwan Ho Lee⁷, Min Su Kwon⁸, Yoon Se Lee^#⁹, Young-Gyu Eun^#¹⁰

Affiliations

¹ Department of Otolaryngology-Head and Neck Surgery, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
² Department of Otorhinolaryngology-Head & Neck Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
³ Department of Otolaryngology-Head and Neck Surgery, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.
⁴ Department of Otolaryngology, Ajou University School of Medicine, Suwon, Korea.
⁵ Department of Otorhinolaryngology-Head and Neck Surgery, Inha University College of Medicine, Incheon, Korea.
⁶ Department of Otorhinolaryngology, Head and Neck Surgery, Dong-A University College of Medicine, Busan, Korea.
⁷ Department of Otolaryngology-Head and Neck Surgery, Kosin University College of Medicine, Busan, Korea.
⁸ Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, College of Medicine, University of Ulsan, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Korea.
⁹ Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, College of Medicine, University of Ulsan, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Korea. yselee@amc.seoul.kr.
¹⁰ Department of Otolaryngology-Head and Neck Surgery, Kyung Hee University School of Medicine, Kyung Hee University Medical Center, 23 Kyungheedae-Ro, Dongdaemun-Gu, Seoul, 02447, Korea. ygeun@khu.ac.kr.

^# Contributed equally.

PMID: 39115573
DOI: 10.1007/s00405-024-08877-6

Abstract

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 .

Keywords: Fexuprazan; Larynopharyngeal reflux diseases; Potassium-competitive acid blocker; Proton pump inhibitor; Treatment efficacy.

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References

1. Mosli M, Alkhathlan B, Abumohssin A et al (2018) Prevalence and clinical predictors of LPR among patients diagnosed with GERD according to the reflux symptom index questionnaire. Saudi J Gastroenterol 24(4):236–241 - DOI - PubMed - PMC
1. Lechien JR, Akst LM, Hamdan AL et al (2019) Evaluation and management of laryngopharyngeal reflux disease: state of the art review. Otolaryngol Head Neck Surg 160(5):762–782 - DOI - PubMed
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Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial

Affiliations

Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial

Authors

Affiliations

Abstract

References

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Full Text Sources