Trial reportThe American journal of gastroenterology2012
Double-blind randomized trials of single-tablet ibuprofen/high-dose famotidine vs. ibuprofen alone for reduction of gastric and duodenal ulcers.
Trial report in The American journal of gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 102 citations in OpenAlex.
- [Clinical Guidelines for Drug-induced Peptic Ulcer, 2020 Revised Edition].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2020Guideline
- Nonsteroidal anti-inflammatory drugs, gastroprotection, and benefit-risk.Pain practice : the official journal of World Institute of Pain · 2014Pooled it
- Long-Term Safety of a Coordinated Delivery Tablet of Enteric-Coated Aspirin 325 mg and Immediate-Release Omeprazole 40 mg for Secondary Cardiovascular Disease Prevention in Patients at GI Risk.Cardiovascular therapeutics · 2016Trial
- From Fragment Hit to Clinical Candidate: Discovery of Dual H1R/H4R Ligands with Superior Efficacy in Allergic Conjunctivitis.Journal of medicinal chemistry · 2026Article
- Evaluating adverse events reported for non-steroidal anti-inflammatory drugs in osteoarthritis: a real-world pharmacovigilance study.Inflammopharmacology · 2026Article
- Article
- Ibuprofen in a Lipid Bilayer: Nanoscale Spatial Arrangement.Membranes · 2022Article
- Design, synthesis and in vivo evaluation of 1,4-dioxo-2-butenyl aryl amine derivatives as a promising anti-inflammatory drug prototype.Bioorganic chemistry · 2022Article
- Synthesis of Spin-Labeled Ibuprofen and Its Interaction with Lipid Membranes.Molecules (Basel, Switzerland) · 2022Article
- Herb-drug interaction in the protective effect ofJournal of pharmaceutical analysis · 2021Article
- Synthesis of New Binary Thiazole-Based Heterocycles and Their Molecular Docking Study as COVID-19 Main Protease (MRussian journal of general chemistry · 2021Article
- Clinical Guidelines for Drug-Related Peptic Ulcer, 2020 Revised Edition.Gut and liver · 2020Review
- Design, Synthesis and DFT/DNP Modeling Study of New 2-Amino-5-arylazothiazole Derivatives as Potential Antibacterial Agents.Molecules (Basel, Switzerland) · 2018Article
- Contextually Aided Recovery (CARe): a scientific theory for innate healing.Chiropractic & manual therapies · 2017Article
- Does Helicobacter pylori Exacerbate Gastric Mucosal Injury in Users of Nonsteroidal Anti-Inflammatory Drugs? A Multicenter, Retrospective, Case-Control Study.Gut and liver · 2016Article
- Esophageal ulcer induced by ibuprofen tablets.Chronic diseases and translational medicine · 2015Article
- Physiological implications of biased signaling at histamine H2 receptors.Frontiers in pharmacology · 2015Article
- Gastrointestinal injury associated with NSAID use: a case study and review of risk factors and preventative strategies.Drug, healthcare and patient safety · 2015Review
- Pharmacodynamic evaluation of intragastric pH and implications for famotidine dosing in the prophylaxis of non-steroidal anti-inflammatory drug induced gastropathy-a proof of concept analysis.Journal of drug assessment · 2014Article
- Fixed-dose ibuprofen/famotidine: a review of its use to reduce the risk of gastric and duodenal ulcers in patients requiring NSAID therapy.Clinical drug investigation · 2013Review
Corrections and comments
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Authors and funding
6 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe performed two 24-week double-blind trials (REDUCE-1 and -2 (Registration Endoscopic Studies to Determine Ulcer Formation of HZT-501 Compared with Ibuprofen: Efficacy and Safety Studies)) to assess whether double-dose famotidine given in a single-tablet combination with ibuprofen (HZT-501) significantly reduces gastric and duodenal ulcers as compared with ibuprofen.
methodsPatients (40-80 years) requiring daily non-steroidal anti-inflammatory drugs (NSAIDs) for ≥6 months with no prior ulcer complications, negative H. pylori stool test, and baseline endoscopy showing no ulcers and <5 erosions were randomly assigned in a 2:1 ratio to HZT-501 or identical-appearing ibuprofen 800 mg tablets thrice daily. Study endoscopies were done at 8, 16, and 24 weeks. After unblinding and initial analyses, 12 patients were found to be misclassified as having gastric ulcers based on the adjudication of endoscopy reports, and analyses were re-run.
resultsIn REDUCE-1, the primary end point analysis of gastric ulcers at 24 weeks with HZT-501 vs. ibuprofen was 12.7% vs. 22.9% (P=0.0044) in the post-adjudication analysis. In REDUCE-2, the primary end point analysis of upper gastrointestinal (GI) ulcers was 13.0% vs. 20.5% (P=0.0587) in the post-adjudication analysis. Prespecified pooled analyses showed significantly fewer gastric (12.5% vs. 20.7%) and duodenal ulcers (1.1% vs. 5.1%) with HZT-501 vs. ibuprofen. Proportional hazards analysis of multiple potential risk factors showed the risk ratio of upper GI ulcers with HZT-501 vs. ibuprofen was 0.46, 95% confidence interval was 0.34-0.61.
conclusionsCombined results of the REDUCE studies indicate that double-dose famotidine plus ibuprofen, given as a combination tablet, decreases endoscopic upper GI ulcers as compared with ibuprofen alone.
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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.