Evidence map›Paper›PMID 37127558›Full record

Trial reportBMC gastroenterology2023

Randomised clinical trial: 3-year interim analysis results of the VISION trial to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive oesophagitis.

Ken Haruma, Yoshikazu Kinoshita, Takashi Yao, Ryoji Kushima, Junichi Akiyama, Nobuo Aoyama, Tatsuhiro Kanoo, Kouji Miyata, Naomi Kusumoto, Naomi Uemura

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMC gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02679508 (Vonoprazan Study In Patients With Erosive Esophagitis to Evaluate Long-term Safety), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
8.9field-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.

NCT02679508 phase4completednot on this map

Vonoprazan Study In Patients With Erosive Esophagitis to Evaluate Long-term Safety: A Study to Evaluate the Safety of Long-term Administration of Vonoprazan in Maintenance Treatment in Patients With Erosive Esophagitis (EE)

TypeinterventionalSponsorTakedaRan2016 to 2022Enrolled208ConditionsErosive EsophagitisArmsVonoprazan, Lansoprazole
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  11. Vonoprazan and proton pump inhibitors: Which is superior forWorld journal of gastroenterology · 2025
    Article
  12. Multiple metachronous foveolar-type gastric adenomas in a Helicobacter pylori-naïve patient with long-term use of a proton pump inhibitor: a case report.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    Article
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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

10 authors at 7 institutions in 1 country.

Ken HarumaDepartment of General Internal Medicine 2, Kawasaki Medical School, General Medical Center, Okayama, Japan.
Yoshikazu KinoshitaGeneral Internal Medicine, Hyogo Prefectural Harima-Himeji General Medical Center, Himeji, Hyogo, Japan.
Takashi YaoDepartment of Human Pathology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Ryoji KushimaDepartment of Clinical Laboratory Medicine, Shiga University of Medical Science Hospital, Otsu, Shiga, Japan.
Junichi AkiyamaDepartment of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Tokyo, Japan.
Nobuo AoyamaGI Endoscopy and IBD Center, Aoyama Medical Clinic, Kobe, Hyogo, Japan.
Tatsuhiro KanooTakeda Pharmaceutical Company Ltd, Tokyo, Japan.
Kouji MiyataTakeda Pharmaceutical Company Ltd, Tokyo, Japan.
Naomi KusumotoTakeda Pharmaceutical Company Ltd, Tokyo, Japan. naomi.kusumoto@takeda.com.
Naomi UemuraDepartment of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Kohnodai Hospital, Ichikawa, Chiba, Japan.
Takeda (Japan) · JPNational Center for Global Health and Medicine · JPHimeji Medical Center · JPJuntendo University · JPKawasaki Medical School · JPShiga Medical Center for Adults · JPShiga University of Medical Science Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVISION is a randomised, phase 4, open-label, parallel-group, multicentre study conducted in 33 centres in Japan. The aim of this study was to assess the long-term safety of vonoprazan for maintenance treatment of healed erosive oesophagitis versus lansoprazole.

methodsPatients with endoscopically diagnosed erosive oesophagitis were randomised 2:1 to once-daily vonoprazan 20 mg or lansoprazole 30 mg, for a 4- to 8-week healing phase. Patients with endoscopically confirmed healing entered a 260-week maintenance phase with a once-daily starting dose of vonoprazan 10 mg or lansoprazole 15 mg. Primary endpoint was change in gastric mucosal histopathology.

resultsOf 208 patients (vonoprazan, n = 139; lansoprazole, n = 69) entering the healing phase, 202 entered the maintenance phase (vonoprazan, n = 135; lansoprazole, n = 67). At 3 years, 109 vonoprazan-treated and 58 lansoprazole-treated patients remained on treatment. Histopathological evaluation of gastric mucosa showed that hyperplasia of parietal, foveolar and G cells was more common with vonoprazan than lansoprazole at week 156 of the maintenance phase. There was no marked increase in the occurrence of parietal, foveolar and G cell hyperplasia among patients in the vonoprazan group from week 48 to week 156. Histopathological evaluation of the gastric mucosa also showed no neoplastic changes in either group. No new safety issues were identified.

conclusionsIn this interim analysis of VISION, no new safety concerns were identified in Japanese patients with healed erosive oesophagitis receiving vonoprazan or lansoprazole as maintenance treatment for 3 years. (CT.gov identifier: NCT02679508; JapicCTI-163153; Japan Registry of Clinical Trials: jRCTs031180040).

Indexed as

Anti-Ulcer AgentsEsophagitisPeptic Ulcer2-PyridinylmethylsulfinylbenzimidazolesDouble-Blind MethodHumansHyperplasiaLansoprazoleProton Pump InhibitorsPyrrolesSulfonamidesTreatment Outcome1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine2-PyridinylmethylsulfinylbenzimidazolesAnti-Ulcer AgentsLansoprazoleProton Pump InhibitorsPyrrolesSulfonamidesAcidity (oesophageal)CarcinoidEndoscopyGastric cancerGastritisGERD or GORDOesophagus

Identifiers

PMID37127558
PMCPMC10152792
OpenAlexW4367598794

What OpenQuestion holds

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LicenceCC BY
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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.