Lansoprazole
| Evidence Level: L4 | Predicted Indications: 2 |
Table of Contents
Lansoprazole: From Acid-Related Disorders to Duodenogastric Reflux
One-Sentence Summary
Lansoprazole is a proton pump inhibitor (PPI), a class of drug typically used to treat acid-related gastrointestinal conditions such as peptic ulcer disease and gastro-oesophageal reflux disease. The TxGNN model predicts it may be effective for Duodenogastric Reflux, but the current evidence base consists of 0 clinical trials and 2 publications, one of which is a preclinical study suggesting the opposite effect.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the evidence pack; Lansoprazole is a proton pump inhibitor generally indicated for peptic ulcer disease and gastro-oesophageal reflux disease |
| Predicted New Indication | Duodenogastric Reflux |
| TxGNN Prediction Score | 99.69% |
| Evidence Level | L4 |
| UK Market Status | Not marketed |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data was not available in this evidence pack. Based on general pharmacological knowledge, Lansoprazole belongs to the proton pump inhibitor (PPI) class and works by irreversibly inhibiting the H⁺/K⁺-ATPase enzyme in gastric parietal cells, thereby reducing gastric acid secretion.
Duodenogastric reflux involves the backflow of duodenal contents — primarily bile and pancreatic enzymes, not acid — into the stomach. Because Lansoprazole’s mechanism only addresses acid secretion, there is no direct pharmacological pathway by which it would resolve the underlying bile/alkaline reflux process. The link identified by TxGNN therefore appears to be based on shared anatomical/disease-area proximity (both are upper GI conditions) rather than a clear mechanistic rationale.
Importantly, the key supporting literature (PMID 15052437) is an animal model study, and its finding runs counter to a therapeutic hypothesis: it reports that Lansoprazole promoted gastric carcinogenesis in rats with induced duodenogastric reflux, rather than treating the condition. This represents a potential safety signal rather than efficacy evidence, and substantially weakens the case for this prediction.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 15052437 | 2004 | Animal/Preclinical | Gastric Cancer | Lansoprazole promoted gastric carcinogenesis in rats with induced duodenogastric reflux — a finding contrary to a treatment hypothesis and suggestive of a safety concern rather than benefit |
| 18679668 | 2008 | Review | European Journal of Clinical Pharmacology | General review of PPI clinical use and pharmacokinetics across peptic ulcer, H. pylori, GORD and NSAID-related indications; not specific to duodenogastric reflux |
UK Market Information
No UK marketing authorisations are currently recorded for Lansoprazole in this evidence pack (market status: Not marketed, 0 licences). Lansoprazole is a well-established generic PPI marketed internationally (e.g. as Zoton) and falls under BNF section 1.3.5 (Proton pump inhibitors); however, specific MHRA licence data was not available for this evaluation.
Safety Considerations
- Notable Safety Signal from Literature: A preclinical rat study (PMID 15052437) found that Lansoprazole promoted gastric carcinogenesis when combined with duodenogastric reflux, rather than showing a protective or therapeutic effect. This should be treated as a caution flag pending human data.
Please refer to the SmPC and BNF for full safety information. Report suspected adverse reactions via the Yellow Card Scheme.
Conclusion and Next Steps
Decision: Hold
Rationale: Despite a high TxGNN prediction score, there are no clinical trials supporting this indication, and the only mechanistically relevant literature (an animal model) shows Lansoprazole worsening rather than treating gastric pathology under duodenogastric reflux conditions. Combined with the complete absence of MOA, UK marketing authorisation, and safety/DDI data, the evidence does not currently support progression.
To proceed, the following is needed:
- Confirmed mechanism of action (MOA) data from DrugBank
- SmPC/label warnings and contraindications (currently a Blocking data gap per DG001)
- Human clinical or observational data specific to duodenogastric reflux (not bile reflux-adjacent acid indications)
- Clarification of the directionality and clinical relevance of the carcinogenesis signal seen in PMID 15052437
- Confirmed original indication and regulatory history for Lansoprazole
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.