Evidence map›Paper›PMID 28988197›Full record

Trial reportGut2018

Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study.

Yuji Mizokami, Kazunori Oda, Nobuo Funao, Akira Nishimura, Satoshi Soen, Takashi Kawai, Kiyoshi Ashida, Kentaro Sugano

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 57 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 4 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT01452750 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID).

TypeinterventionalSponsorTakedaRan2011 to 2013Enrolled642ConditionsGastric Ulcers, Duodenal UlcersArmsTAK-438, Placebo, Lansoprazole
NCT01456260 phase3completednot on this map

A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

TypeinterventionalSponsorTakedaRan2011 to 2013Enrolled406ConditionsGastric Ulcers, Duodenal UlcersArmsTAK-438, Placebo, Lansoprazole
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 4 syntheses or guidelines pooled it, 112 citations in OpenAlex.

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  18. Acid peptic disorder compass: An Indian expert consensus on comprehensive management.World journal of gastrointestinal pharmacology and therapeutics · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 4 countries.

Yuji MizokamiEndoscopic Center, University of Tsukuba Hospital, Tsukuba, Japan.
Kazunori OdaTakeda Development Center, Takeda Pharmaceutical Company Ltd, Osaka, Japan.
Nobuo FunaoTakeda Development Center, Takeda Pharmaceutical Company Ltd, Osaka, Japan.
Akira NishimuraTakeda Development Center, Takeda Pharmaceutical Company Ltd, Osaka, Japan.
Satoshi SoenDepartment of Orthopaedic Surgery and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan.
Takashi KawaiEndoscopy Center, Tokyo Medical University Hospital, Tokyo, Japan.
Kiyoshi AshidaDepartment of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.
Kentaro SuganoDepartment of Medicine, Jichi Medical University, Tochigi, Japan.
Takeda (Japan) · JPJichi Medical University · JPNara Medical University Hospital · JPOrthopaedic Center · USRakuwakai Otowa Hospital · JPTakeda (France) · FRUniversity of Tsukuba Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the non-inferiority of vonoprazan to lansoprazole for secondary prevention of non-steroidal anti-inflammatory drug (NSAID)-induced peptic ulcer (PU) and the safety of vonoprazan during extended use.

designA phase 3, 24-week, multicenter, randomised, double-blind (DB), active-controlled study, followed by a phase 3, ≥28 week, multicenter, single-blind, parallel-group extension study (EXT) in outpatients (n=642) receiving long-term NSAID therapy who are at risk of PU recurrence. The patients received vonoprazan (10 mg or 20 mg) or lansoprazole 15 mg once daily. For DB, non-inferiority of the proportion of patients with recurrent PU within 24 weeks was analysed by Farrington and Manning test (significance level 2.5%, non-inferiority margin 8.3%; primary endpoint), recurrent PU within 12 weeks, bleeding and time-to-event of PU (secondary endpoint) and treatment-emergent adverse events (TEAEs). For EXT, TEAEs (primary endpoint), recurrent PU and safety (secondary) were assessed up to 104 weeks for patients in the extension study.

resultsThe non-inferiority of vonoprazan 10 mg and 20 mg to lansoprazole 15 mg was verified (percentage difference -2.2%,95% CI -6.2% to 1.8%, p<0.001; -2.1%,95% CI -6.1% to 2.0%, p<0.001, respectively). The proportion of patients with endoscopically confirmed recurrent PU within 24 weeks was 3.3%, 3.4% and 5.5%, for vonoprazan 10 mg, 20 mg and lansoprazole 15 mg, respectively. No significant safety concerns were identified.

conclusionThe non-inferiority of vonoprazan (10 and 20 mg) was verified in patients receiving long-term NSAIDs in DB; it was effective and well tolerated in EXT for longer than 1 year, with a safety profile similar to lansoprazole (15 mg). TRIAL REGISTRATION NUMBERS: NCT01452750, NCT01456260; Results.

Indexed as

AgedAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsDouble-Blind MethodEquivalence Trials as TopicFemaleGastrointestinal HemorrhageHumansLansoprazoleMaleMiddle AgedPeptic UlcerPyrrolesRecurrenceSecondary PreventionSingle-Blind Method1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsLansoprazolePyrrolesSulfonamideslansoprazole osteoarthritisnon-inferiorityNSAIDspeptic ulcerpotassium-competitive acid blockersrheumatoid arthritisvonoprazan

Identifiers

PMID28988197
PMCPMC5969369
OpenAlexW2761524565

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.