Evidence map›Paper›PMID 39115573›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2024

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

Su Il Kim, Young Chan Lee, Wonjae Cha, Ah Ra Jung, Jeon Yeob Jang, Jeong-Seok Choi, Dong Kun Lee, Hwan Ho Lee, Min Su Kwon, Yoon Se Lee and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07326904 (A Multi-Center, Randomized, Open-Label Study to Evaluate Symptom Relief and Safety After Using Fexuprazan 40 Mg Compared to Esomeprazole 40 Mg in Patients With Gastroesophageal Reflux Disease), which is not on this map. Cited by 11 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07326904 phase3completednot on this map

A Multi-Center, Randomized, Open-Label Study to Evaluate Symptom Relief and Safety After Using Fexuprazan 40 Mg Compared to Esomeprazole 40 Mg in Patients With Gastroesophageal Reflux Disease (GERD)

TypeinterventionalSponsorIndonesia UniversityRan2024 to 2024Enrolled145ConditionsGastro Oesophageal Reflux DiseaseArmsFexuprazan, Esomeprazole
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Comparison of the efficacy of different pharmacological treatments for laryngopharyngeal reflux: a systematic review and network meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Treatment for Laryngopharyngeal Reflux Disease: A Systematic Review of Controlled Studies.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Su Il KimDepartment of Otolaryngology-Head and Neck Surgery, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
Young Chan LeeDepartment of Otolaryngology-Head and Neck Surgery, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
Wonjae ChaDepartment of Otorhinolaryngology-Head & Neck Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Ah Ra JungDepartment of Otolaryngology-Head and Neck Surgery, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.
Jeon Yeob JangDepartment of Otolaryngology, Ajou University School of Medicine, Suwon, Korea.
Jeong-Seok ChoiDepartment of Otorhinolaryngology-Head and Neck Surgery, Inha University College of Medicine, Incheon, Korea.
Dong Kun LeeDepartment of Otorhinolaryngology, Head and Neck Surgery, Dong-A University College of Medicine, Busan, Korea.
Hwan Ho LeeDepartment of Otolaryngology-Head and Neck Surgery, Kosin University College of Medicine, Busan, Korea.
Min Su KwonDepartment 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.
Yoon Se Lee *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.
Young-Gyu Eun *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.ORCID http://orcid.org/0000-0003-4081-5207

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeLaryngopharyngeal 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.

methodsThis 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.

resultsA 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.

conclusionFexuprazan 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 registrationKCT0007251, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22100 .

Indexed as

EsomeprazoleLaryngopharyngeal RefluxProton Pump InhibitorsAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeEsomeprazoleProton Pump InhibitorsFexuprazanLarynopharyngeal reflux diseasesPotassium-competitive acid blockerProton pump inhibitorTreatment efficacy

Identifiers

PMID39115573

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.