Diltiazem
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Diltiazem: From Cardiovascular Use to Susceptibility to Ischemic Stroke (Obsolete Term)
One-Sentence Summary
Diltiazem is a non-dihydropyridine calcium channel blocker that is marketed in South Africa, but the registration records supplied do not state its approved indication. The TxGNN model predicts it may be relevant to “obsolete susceptibility to ischemic stroke”, a retired ontology label for stroke predisposition. There are 0 clinical trials and 0 publications supporting this prediction, so it rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA registration data supplied (diltiazem is a calcium channel blocker used in cardiovascular disease) |
| Predicted New Indication | Obsolete susceptibility to ischemic stroke |
| TxGNN Prediction Score | 99.08% (model rank 4,529) |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 3 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the record. Diltiazem is a non-dihydropyridine L-type calcium channel blocker. It is established cardiovascular therapy, and mechanistically it may be relevant to stroke risk.
A plausible link to ischemic stroke would run through three effects:
- Lowering blood pressure.
- Cerebral vasodilation.
- Heart rate and rhythm control, which could reduce cardioembolic risk.
This reasoning is a hypothesis. The mechanism cannot be checked against source data because no original indications or MOA were supplied.
The predicted disease label is also a problem. “Obsolete susceptibility to ischemic stroke” is a retired ontology term. It describes a risk factor or predisposition, not a treatable clinical indication. The prediction should be remapped to a current stroke or stroke-prevention term before any evidence review.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 28/7.1/0298 | Sandoz Diltiazem HCl 60 | Tablet (oral) | Not stated in data supplied |
| Reg. No. 28/7.1/0579 | Tilazem 180 CR | Slow-release capsule/tablet (SRC) | Not stated in data supplied |
| Reg. No. 30/7.1/0183 | Adco-Zildem SR | Slow-release capsule/tablet (SRC) | Not stated in data supplied |
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
The drug-drug interaction query returned no records. This is most likely a gap in the dataset and should not be read as evidence of safety.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support is a high TxGNN score, which is a computational prediction and not clinical evidence (L5). The predicted disease is an obsolete term for a risk state rather than a treatable indication, and no trials or publications were found.
To proceed, the following is needed:
- Remap the predicted disease to a current stroke or stroke-prevention term, then re-run the evidence search.
- Obtain the SAHPRA package inserts to confirm approved indications, warnings and contraindications. This is a blocking gap for safety screening.
- Retrieve mechanism of action data from DrugBank to support the mechanistic-link analysis.
- Run a proper drug-drug interaction query, since the current empty result is likely a data gap.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.