Ranitidine
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
Ranitidine: Peptic ulcer perforation
One-Sentence Summary
Ranitidine is an H2-receptor antagonist that reduces stomach acid. The TxGNN model predicts it may be useful for peptic ulcer perforation, but no clinical trials and no study that tests ranitidine as a treatment for this condition were found. The evidence level is therefore L5.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Peptic ulcer perforation |
| TxGNN Prediction Score | 0.9988 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 5 of 5) |
| Number of DINs | 5 (marketed: 5) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Ranitidine is known as an H2-receptor blocker, a class that lowers gastric acid output.
Acid suppression is sometimes used as supportive care around a perforated ulcer, but the main treatment is surgical repair or non-operative management with antibiotics and gastric decompression. Ranitidine cannot close a perforation. The literature retrieved is indirect: reviews of long-term H2-blocker ulcer maintenance and NSAID-related stomach injury, plus a randomized trial of non-operative treatment (PMID 2927479) in which ranitidine was not the tested intervention. One placebo-controlled randomized trial (PMID 7861219) tested ranitidine to prevent postoperative gastroduodenal bleeding and perforation in high-risk neurosurgical patients, which is a different clinical question from treating an existing perforation. No study directly tests ranitidine for this condition.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 2927479 | 1989 | RCT | N Engl J Med | Non-operative vs emergency surgical treatment of perforated peptic ulcer; ranitidine was not the tested intervention |
| 7861219 | 1995 | RCT | J Neurosurg | Ranitidine vs placebo to prevent postoperative gastroduodenal bleeding or perforation in 101 high-risk neurosurgical patients (prevention, not treatment of perforation) |
| 11488789 | 2001 | Retrospective and randomized studies | Br J Surg | H. pylori eradication and ulcer recurrence after simple closure of perforated duodenal ulcer |
| 8364140 | 1993 | Review | Aliment Pharmacol Ther | Continuous H2-blocker therapy reduces ulcer recurrence in controlled trials |
| 8103373 | 1993 | Review | Aliment Pharmacol Ther | A decade of long-term H2-blocker treatment to prevent ulcer recurrence and complications |
| 3213266 | 1988 | Clinical study | Z Rheumatol | Ulcer healing with ranitidine and antacids despite continued NSAID therapy in 21 patients |
| 8346951 | 1993 | Clinical study | Arch Dis Child | Intravenous ranitidine and intragastric pH in preterm infants on dexamethasone, a group at risk of gastric perforation |
| 1679675 | 1991 | Review | Aliment Pharmacol Ther | Therapeutic recommendations for NSAID-induced gastroduodenal injury |
| 8165479 | 1994 | Case report | Surg Endosc | Giant marginal ulcer after gastroenterostomy |
| 8781800 | 1996 | Case report | Endoscopy | Gastric ulcer perforating into the heart |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02443716 | MAR-RANITIDINE | Not listed | Not listed |
| 02526379 | MINT-RANITIDINE | Not listed | Not listed |
| 02293471 | MAXIMUM STRENGTH ACID REDUCER WITHOUT PRESCRIPTION | Not listed | Not listed |
| 02443708 | MAR-RANITIDINE | Not listed | Not listed |
| 02526387 | MINT-RANITIDINE | Not listed | Not listed |
Safety Considerations
- Drug Interactions: 100 interactions are recorded in total. Examples include a major interaction with atazanavir, and moderate interactions with acalabrutinib, acetohexamide, aminophylline, bosutinib, brigatinib, cefuroxime, ceritinib and chlorpropamide.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high, but no study tests ranitidine as treatment of peptic ulcer perforation, and the main treatment for this condition is surgical or non-operative care that ranitidine cannot replace. The evidence level is L5.
To proceed, the following is needed:
- Direct clinical data on ranitidine as adjunctive therapy in perforated ulcer
- Mechanism-of-action data
- Package insert warnings and contraindications from Health Canada
- A review of the major drug interactions for the intended patient group
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.