Evidence map›Paper›PMID 26559637›Full record

Trial reportAlimentary pharmacology & therapeutics2016

Randomised clinical trial: vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the healing of erosive oesophagitis.

K Ashida, Y Sakurai, T Hori, K Kudou, A Nishimura, N Hiramatsu, E Umegaki, K Iwakiri

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04028466 (Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease), which is not on this map. Cited by 156 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
156citing papers in PubMed, 11 pooled it
16.0field-weighted citation impact, top 1% of its field
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.

NCT04028466 phase4terminatednot on this mapstarted 2019, after this paper: background citation

Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features in a Primary Care Setting: A Pragmatic, Randomized, Single Blind Study

TypeinterventionalSponsorSt. Luke's Medical Center, PhilippinesRan2019 to 2020Enrolled82ConditionsGERD, Gastro Esophageal RefluxArmsVonoprazan, Omeprazole
3 · Its place in the literature

Who cites it

156 citing papers in PubMed, 11 syntheses or guidelines pooled it, 294 citations in OpenAlex.

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  6. Vonoprazan versus lansoprazole in erosive esophagitis - A systematic review and meta-analysis of randomized controlled trials.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2023
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  14. [The efficacy of vonoprazan fumarate in the treatment of laryngopharyngeal reflux disease evaluated by the Chinese version of the RSS-12 scale].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2025
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96 more citing papers are in PubMed but not listed here.

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

8 authors at 5 institutions in 1 country.

K AshidaRakuwakai Otowa Hospital, Kyoto, Japan.
Y SakuraiTakeda Pharmaceutical Company Ltd., Osaka, Japan.
T HoriTakeda Pharmaceutical Company Ltd., Osaka, Japan.
K KudouTakeda Pharmaceutical Company Ltd., Osaka, Japan.
A NishimuraTakeda Pharmaceutical Company Ltd., Osaka, Japan.
N HiramatsuOsaka University Graduate School of Medicine, Osaka, Japan.
E UmegakiKobe University Graduate School of Medicine, Kobe, Japan.
K IwakiriNippon Medical School Graduate School of Medicine, Tokyo, Japan.
Takeda (Japan) · JPKobe University · JPNippon Medical School · JPOsaka University · JPRakuwakai Otowa Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVonoprazan is a novel potassium-competitive acid blocker which may provide clinical benefit in acid-related disorders.

aimTo verify the non-inferiority of vonoprazan vs. lansoprazole in patients with erosive oesophagitis (EE), and to establish its long-term safety and efficacy as maintenance therapy.

methodsIn this multicentre, randomised, double-blind, parallel-group comparison study, patients with endoscopically confirmed EE (LA Classification Grades A-D) were randomly allocated to receive vonoprazan 20 mg or lansoprazole 30 mg once daily after breakfast. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 8. In addition, subjects who achieved healed EE in the comparison study were re-randomised into a long-term study to investigate the safety and efficacy of vonoprazan 10 or 20 mg as maintenance therapy for 52 weeks.

resultsOf the 409 eligible subjects randomised, 401 completed the comparison study, and 305 entered the long-term maintenance study. The proportion of patients with healed EE up to week 8 was 99.0% for vonoprazan (203/205) and 95.5% for lansoprazole (190/199), thus verifying the non-inferiority of vonoprazan (P < 0.0001). Vonoprazan was also effective in patients with more severe EE (LA Classification Grades C/D) and CYP2C19 extensive metabolisers. In the long-term maintenance study, there were few recurrences (<10%) of EE in patients treated with vonoprazan 10 or 20 mg. Overall, vonoprazan was well-tolerated.

conclusionsThe non-inferiority of vonoprazan to lansoprazole in EE was verified in the comparison study, and vonoprazan was well-tolerated and effective during the long-term maintenance study.

Indexed as

AdultAgedCytochrome P-450 CYP2C19Double-Blind MethodEsophagitisFemaleHumansLansoprazoleMaleMiddle AgedProton Pump InhibitorsPyrrolesRecurrenceSulfonamidesWound Healing1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineCytochrome P-450 CYP2C19LansoprazoleProton Pump InhibitorsPyrrolesSulfonamides

Identifiers

PMID26559637
PMCPMC4738414
OpenAlexW2115870674

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.