Esomeprazole
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Esomeprazole: Duodenal obstruction
One-Sentence Summary
Esomeprazole is a proton pump inhibitor (PPI) originally used for peptic ulcer disease, gastro-oesophageal reflux disease (GORD), reflux oesophagitis and Zollinger-Ellison syndrome. The TxGNN model predicts it may be effective for Duodenal Obstruction, but the supporting evidence is thin: no clinical trials and 1 publication (a general PPI review) are currently available for this indication.
Note: the strongest evidence in the data compiled for this report relates to duodenal ulcer (rank 3) and active peptic ulcer disease (rank 4). These fall within or very close to the existing labelled use. They are discussed in the conclusion as the better-supported findings.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Duodenal obstruction |
| TxGNN Prediction Score | 0.9945 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (2 of 2 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 2 (valid: 2) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data are not available in the data compiled for this report. Esomeprazole is the S-isomer of omeprazole and, as a class, PPIs irreversibly block the gastric H+/K+ ATPase (the “proton pump”), suppressing gastric acid secretion.
Duodenogastric (bile) reflux is only partly acid-driven. Esomeprazole may ease acid-related symptoms or mucosal injury in these patients, but it does not stop bile reflux itself. The only supporting publication is a general review of PPI use, so the support is indirect. The high TxGNN score therefore reflects a plausible acid-related overlap rather than demonstrated benefit.
Clinical Trial Evidence
Currently no related clinical trials registered for duodenogastric reflux.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 18679668 | 2008 | Review | Eur J Clin Pharmacol | General update on PPI clinical use and pharmacokinetics; PPIs are first-choice drugs for peptic ulcer, H. pylori infection, GORD, NSAID-related lesions and Zollinger-Ellison syndrome. Does not address bile reflux directly. |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 10295W | Noxicid Caps | Enteric capsule 20 mg (as magnesium) | Not listed in the data compiled |
| ARTG 10759G | ESOMEPRAZOLE SANDOZ Hp7 | Co-pack: 14 enteric-coated esomeprazole 20 mg tablets, 14 clarithromycin 500 mg tablets and 28 amoxicillin 500 mg capsules (H. pylori eradication pack) | Not listed in the data compiled |
Safety Considerations
- Contraindication signals from a knowledge graph (not label text): liver failure, osteoporosis, postmenopausal osteoporosis, bone fracture, chronic atrophic gastritis. These should be verified against the Product Information.
- Drug Interactions: 100 interactions were identified in total. Examples from the first 20 reviewed:
- Major: acalabrutinib, atazanavir
- Moderate: hydrochlorothiazide, amphotericin B, amikacin, amphetamine, fenofibrate, apalutamide, armodafinil, atorvastatin, bendamustine, bosutinib, bumetanide
- Minor: acetylsalicylic acid, axitinib, bortezomib, brivaracetam, cyanocobalamin
- CYP2C19-related interactions are of particular relevance for this class.
Please refer to the TGA-approved Product Information (PI) for full warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: For duodenal obstruction, there are no trials and only one indirect review. Esomeprazole does not treat bile reflux itself, so the prediction rests on a model score and a plausible acid-related symptom benefit.
Better-supported findings from the same analysis (for context):
- Duodenal ulcer (L1, Proceed with Guardrails): multiple completed Phase 3 RCTs (for example NCT00633932, NCT00633672, NCT00542789, NCT01069939, NCT01142245) and RCTs of esomeprazole-based triple therapy (PMIDs 11742194, 11121908). This is effectively on-label or a close extension of the labelled use.
- Active peptic ulcer disease (L2, Proceed with Guardrails): a completed Phase 2 active-controlled trial and a Phase 4 triple-therapy study. This is already within the labelled indication, so it supports continued use rather than a new repurposing claim.
- Gastrojejunal ulcer is a reasonable research question (L4), while the remaining top-10 predictions (duodenal obstruction, abnormality of glucagon secretion, peptic ulcer perforation, smouldering systemic mastocytosis, multiple endocrine neoplasia and acne) have no supporting evidence or only indirect evidence and should be held.
To proceed, the following is needed:
- Mechanism of action data (currently missing) and the TGA Product Information warnings and contraindications (a blocking data gap for safety screening)
- Targeted studies of esomeprazole in duodenogastric reflux with defined bile-reflux endpoints
- For the ulcer indications: confirmation of the labelled indication scope, H. pylori testing and eradication where relevant, and a DDI management plan, including CYP2C19-related interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.