Trial reportGut2018
Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study.
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 65 papers, 9 of them syntheses that pooled 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.
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.
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 Low-dose Aspirin
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 Low-dose Aspirin
Who cites it
65 citing papers in PubMed, 9 syntheses or guidelines pooled it, 115 citations in OpenAlex.
- Evidence-based clinical practice guidelines for peptic ulcer disease 2026.Journal of gastroenterology · 2026Guideline
- Proton pump inhibitors for prevention of upper and lower gastrointestinal bleeding in patients taking aspirin: a systematic review and meta-analysis.European journal of clinical pharmacology · 2026Pooled it
- Safety of Potassium-Competitive Acid Blockers Compared With Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease and Peptic Ulcer Disease: A Systematic Review and Meta-Analysis.Journal of gastroenterology and hepatology · 2026Pooled it
- Proton pump inhibitors are not associated with an increased risk ofGut microbes · 2025Pooled it
- Vonoprazan vs. Proton Pump Inhibitors for Treatment and Prevention of Gastric and/or Duodenal Ulcers: A Systematic Review with Meta-Analysis.Digestive diseases and sciences · 2024Pooled it
- Pantoprazole and Vonoprazan Performed Well in Preventing Peptic Ulcer Recurrence in Low-Dose Aspirin Users.Digestive diseases and sciences · 2024Pooled it
- Efficacy and safety of vonoprazan versus proton pump inhibitors in the treatment of peptic ulcer disease: a systematic review and network meta-analysis for randomized controlled trails.Frontiers in nutrition · 2024Pooled it
- Evidence-based clinical practice guidelines for peptic ulcer disease 2020.Journal of gastroenterology · 2021Guideline
- Comparison of the Use of Vonoprazan and Proton Pump Inhibitors for the Treatment of Peptic Ulcers Resulting from Endoscopic Submucosal Dissection: A Systematic Review and Meta-Analysis.Medical science monitor : international medical journal of experimental and clinical research · 2019Pooled it
- Trial
- Comparing the Efficacy and Safety of Fexuprazan and Lansoprazole for the Prevention of Nonsteroidal Anti-inflammatory Drug-Induced Peptic Ulcer.Gut and liver · 2025Trial
- 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.BMC gastroenterology · 2023Trial
- Influence of daily versus alternate-day dosing of vonoprazan on intragastric pH, serum gastrin, and the antiplatelet function of clopidogrel : Influence of alternate-day dosing of vonoprazan.European journal of clinical pharmacology · 2022Trial
- Effect of a proton-pump inhibitor on intestinal microbiota in patients taking low-dose aspirin.European journal of clinical pharmacology · 2021Trial
- Omeprazole vs famotidine for the prevention of gastroduodenal injury in high-risk users of low-dose aspirin: A randomized controlled trial.Journal of the Chinese Medical Association : JCMA · 2021Trial
- Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.Clinical and translational gastroenterology · 2019Trial
- Evolving landscape of potassium-competitive acid blockers: toward disease-specific use beyond acid suppression.Journal of gastroenterology · 2026Review
- P-CAB vs. PPI for Upper Gastrointestinal Bleeding Prevention in Patients With Atherothrombotic Disease on Antithrombotic Therapy: A CDM Cohort Study.Alimentary pharmacology & therapeutics · 2026Article
- Management of Peptic Ulcer Disease in Patients Taking Antithrombotic Agents.The Korean journal of helicobacter and upper gastrointestinal research · 2026Review
- Acid peptic disorder compass: An Indian expert consensus on comprehensive management.World journal of gastrointestinal pharmacology and therapeutics · 2026Review
5 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
8 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveCompare efficacy and safety of vonoprazan and lansoprazole for secondary prevention of low-dose aspirin (LDA)-associated peptic ulcers in a 24-week study and long-term extension therapy in separate study.
designDouble-blind, randomised, non-inferiority study; single-blind extension study at 104 Japanese sites, including 621 patients (439 in extension) with a history of peptic ulcers who required long-term LDA therapy. Randomised (1:1:1, computer generated) patients received lansoprazole 15 mg (n=217), vonoprazan 10 mg (n=202) or vonoprazan 20 mg (n=202) once daily for 24 weeks (double blind) and ≤2 years (extension). The following measurements were made: 24-week (primary outcome; double blind) and 12-week peptic ulcer recurrence rate, 24-week GI bleeding rate, cumulative incidences of peptic ulcer recurrence and GI bleeding, treatment-emergent adverse events, laboratory results, serum gastrin and pepsinogen I/II concentrations.
resultsThe 24-week peptic ulcer recurrence rate was 2.8%, 0.5% and 1.5% in the lansoprazole 15 mg, vonoprazan 10 mg and vonoprazan 20 mg groups, respectively. Vonoprazan was non-inferior (Farrington and Manning test: margin 8.7%, significance level 2.5%) to lansoprazole. In the post hoc analyses of the extension study, peptic ulcer recurrence rates were significantly lower with vonoprazan 10 mg (log-rank test, P=0.039), but not vonoprazan 20 mg (P=0.260), compared with lansoprazole 15 mg. GI bleeding rates were higher with lansoprazole compared with two doses of vonoprazan in both 24-week study and extension study.
conclusionVonoprazan (10 and 20 mg) was as effective as lansoprazole (15 mg) in preventing peptic ulcer recurrence during LDA therapy, had a similar long-term safety profile and was well tolerated. TRIAL REGISTRATION NUMBERS: NCT01452763; NCT01456247.
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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.