Acetylsalicylic Acid
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
- Acetylsalicylic Acid
- Acetylsalicylic Acid (Aspirin): From Established Antiplatelet and Analgesic Use to Migraine with Brainstem Aura
Acetylsalicylic Acid (Aspirin): From Established Antiplatelet and Analgesic Use to Migraine with Brainstem Aura
One-Sentence Summary
Aspirin is widely known as an antiplatelet and pain-relief drug, but the SAHPRA data supplied do not state its registered indication. The TxGNN model predicts it may be effective for migraine with brainstem aura. Support is thin: 0 clinical trials and 19 publications, and only one retrospective study looks at aspirin in migraine with aura.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Migraine with brainstem aura |
| TxGNN Prediction Score | 99.94% (model rank 587) |
| Evidence Level | L3 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 4 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Based on general aspirin pharmacology, it inhibits COX-1 and COX-2. This reduces prostaglandin-mediated neurogenic inflammation and platelet activation, both plausible contributors to migraine.
Aspirin is an established acute migraine option. A double-blind trial found that intravenous aspirin lysinate was compared with subcutaneous sumatriptan and placebo in acute migraine. A retrospective study also reviewed low-dose aspirin as prophylaxis in migraine with aura. The platelet-hypothesis literature, and the reports of migraine with aura improving on antiplatelet therapy (clopidogrel) after cardiac shunt closure, add indirect support.
However, none of the supplied evidence is specific to the brainstem aura subtype. The only aura-specific clinical data are that one retrospective study. The prediction is therefore an extrapolation from migraine with aura in general.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 10448545 | 1999 | RCT | Cephalalgia | Double-blind, double-dummy trial of IV aspirin lysinate vs SC sumatriptan vs placebo in 278 patients with acute migraine, with or without aura |
| 25729594 | 2014 | Retrospective cohort | Curr Health Sci J | 203 patients with migraine with aura: 95 on low-dose aspirin vs 108 on other prophylaxis, assessing efficacy and tolerability |
| 25600718 | 2015 | Evidence assessment/guideline | Headache | American Headache Society update on evidence for acute migraine drug therapies |
| 39989443 | 2025 | Systematic review | Headache | Reviews evidence for antithrombotic drugs in migraine prevention |
| 30291554 | 2018 | Review | Curr Pain Headache Rep | Compares pathophysiology, management and risks of migraine with vs without aura |
| 34384631 | 2021 | Review | Rev Neurol | Overview of migraine aura, cortical spreading depression and diagnosis |
| 26908949 | 2016 | RCT | Eur Heart J | PRIMA trial of PFO closure in medically refractory migraine with aura; not an aspirin study |
| 16103551 | 2005 | Clinical report | Heart | Clopidogrel (an antiplatelet) associated with less migraine with aura after transcatheter shunt closure |
| 33525313 | 2021 | Review | Neurol Int | Ubrogepant review; notes aspirin-containing analgesics among treatments for mild to moderate migraine |
| 2701286 | 1989 | Review | Biomed Pharmacother | Platelet hypothesis of migraine after 10 years |
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 53/8/0369.368 | Aspirin 100 Clicks | Tablet | Not stated in the data supplied |
| Reg. No. 31/8/0413 | Bayer aspirin cardio | Tablet | Not stated in the data supplied |
| Reg. No. 44/8.2/0657 | Clopiwin Plus 75/75 | Tablet | Not stated in the data supplied |
| Reg. No. B1127 (OM) | Tenston | Tablet | Not stated in the data supplied |
All registrations are oral tablets. Essential Medicines List status was not part of the data supplied.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: Aspirin has a plausible mechanism and a long history in migraine. However, the evidence for the brainstem aura subtype is model prediction plus one retrospective aura study. In addition, the SAHPRA safety information has not been retrieved, which blocks progression to safety screening.
Other predicted indications for this drug have stronger evidence, notably thrombotic disease, thrombophilia and Raynaud disease (all L2).
To proceed, the following is needed:
- Safety information (warnings and contraindications) from the SAHPRA package inserts, a blocking gap
- Mechanism of action data from DrugBank
- Full-text review of the retrospective aspirin study in migraine with aura, to confirm the direction and size of effect
- Any aura-subtype-specific data, ideally a prospective trial that includes brainstem aura
- Registered indication text for the four SAHPRA products
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.