Evidence map›Paper›PMID 27891632›Full record

Trial reportAlimentary pharmacology & therapeutics2017

Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials.

H Miwa, N Uedo, J Watari, Y Mori, Y Sakurai, Y Takanami, A Nishimura, T Tatsumi, N Sakaki

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05005910 (Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis), which is not on this map. Cited by 56 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 8 pooled it
9.1field-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.

NCT05005910 early_phase1completednot on this mapstarted 2021, after this paper: background citation

Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

TypeinterventionalSponsorUayporn KaosombatwattanaRan2021 to 2022Enrolled194ConditionsPeptic Ulcer With HaemorrhageArmsVonoprazan, PPIs IV infusion
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 8 syntheses or guidelines pooled it, 124 citations in OpenAlex.

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  20. Acid peptic disorder compass: An Indian expert consensus on comprehensive management.World journal of gastrointestinal pharmacology and therapeutics · 2026
    Review
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

9 authors at 4 institutions in 1 country.

H MiwaHyogo College of Medicine, Hyogo, Japan.
N UedoOsaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
J WatariHyogo College of Medicine, Hyogo, Japan.
Y MoriTakeda Pharmaceutical Company Ltd, Osaka, Japan.
Y SakuraiTakeda Pharmaceutical Company Ltd, Osaka, Japan.
Y TakanamiTakeda Pharmaceutical Company Ltd, Osaka, Japan.
A NishimuraTakeda Pharmaceutical Company Ltd, Osaka, Japan.
T TatsumiOsaka University Graduate School of Medicine, Osaka, Japan.
N SakakiFoundation for Detection of Early Gastric Carcinoma, Tokyo, Japan.
Takeda (Japan) · JPHyogo Medical University · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPOsaka University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVonoprazan is a new potassium-competitive acid blocker for treatment of acid-related diseases.

aimTo conduct two randomised-controlled trials, to evaluate the non-inferiority of vonoprazan vs. lansoprazole, a proton pump inhibitor, for treatment of gastric ulcer (GU) or duodenal ulcer (DU).

methodsPatients aged ≥20 years with ≥1 endoscopically-confirmed GU or DU (≥5 mm white coating) were randomised 1:1 using double-dummy blinding to receive lansoprazole (30 mg) or vonoprazan (20 mg) for 8 (GU study) or 6 (DU study) weeks. The primary endpoint was the proportion of patients with endoscopically confirmed healed GU or DU.

resultsFor GU, 93.5% (216/231) of vonoprazan-treated patients and 93.8% (211/225) of lansoprazole-treated patients achieved healed GU; non-inferiority of vonoprazan to lansoprazole was confirmed [difference = -0.3% (95% CI -4.750, 4.208); P = 0.0011]. For DU, 95.5% (170/178) of vonoprazan-treated patients and 98.3% (177/180) of lansoprazole-treated patients achieved healed DU; non-inferiority to lansoprazole was not confirmed [difference = -2.8% (95% CI -6.400, 0.745); P = 0.0654]. The incidences of treatment-emergent adverse events were slightly lower for GU and slightly higher for DU with vonoprazan than with lansoprazole. There was one death (subarachnoid haemorrhage) in the vonoprazan group (DU). The possibility of a relationship between this unexpected patient death and the study drug could not be ruled out. In both studies, increases in serum gastrin levels were greater in vonoprazan-treated vs. lansoprazole-treated patients; levels returned to baseline after treatment in both groups.

conclusionsVonoprazan 20 mg has a similar tolerability profile to lansoprazole 30 mg and is non-inferior with respect to GU healing and has similar efficacy for DU healing.

Indexed as

AdultAgedAnti-Ulcer AgentsDouble-Blind MethodDuodenal UlcerEndoscopyFemaleHumansLansoprazoleMaleMiddle AgedProton Pump InhibitorsPyrrolesStomach UlcerSulfonamidesTreatment Outcome1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineAnti-Ulcer AgentsLansoprazoleProton Pump InhibitorsPyrrolesSulfonamides

Identifiers

PMID27891632
PMCPMC6680291
OpenAlexW2557411282

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.