Magnesium Sulfate
| Evidence Level: L3 | Predicted Indications: 8 |
Table of Contents
Magnesium Sulfate: Thrombotic disease
One-Sentence Summary
Magnesium sulfate is a magnesium salt that has long been marketed in Australia. The TxGNN model predicts it may be useful for thrombotic disease. Support is limited to 1 clinical trial (a Phase 3 study in thrombotic thrombocytopenic purpura, with status unknown and no results available) and a small body of mostly animal and early human literature.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Thrombotic disease |
| TxGNN Prediction Score | 0.9990 |
| Evidence Level | L3 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available for this drug. The following reasoning is drawn from the published studies compiled for this report.
Animal studies from 1980 to 2001 suggest that magnesium sulfate reduces platelet deposition and thrombus formation after vascular injury. In a rat carotid thrombosis model, intravenous magnesium prevented or delayed clot formation, and the authors also noted impaired coagulation. Magnesium acts as a physiological calcium antagonist, so it may modulate calcium-dependent coagulation, platelet activation and vascular tone.
Human data are sparse. They consist of one small non-randomised pilot study in patients receiving coronary stents, and one Phase 3 randomised trial in thrombotic thrombocytopenic purpura (TTP). No confirmatory human efficacy evidence is available, so the prediction remains hypothesis-generating.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT03237819 | Phase 3 | Unknown | 74 | Multicentre randomised controlled trial of magnesium sulfate in TTP in intensive care. TTP is a thrombotic microangiopathy with microthrombi caused by ADAMTS13 deficiency. Planned 2018–2021, and no results are available. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 14506544 | 2003 | Prospective pilot cohort (non-randomised) | J Cardiovasc Pharmacol Ther | Tested the feasibility of magnesium in patients undergoing non-acute PCI with stent implantation, following animal data showing inhibition of acute stent thrombosis |
| 11816720 | 2001 | Preclinical | Thromb Haemost | Intravenous magnesium sulfate prevented or delayed FeCl3-induced carotid thrombosis in rats, with in vivo impairment of coagulation |
| 3441141 | 1987 | Preclinical | Magnesium | Magnesium sulfate showed an antithrombogenic effect at sites of coronary and carotid constriction in dogs and rabbits |
| 7368083 | 1980 | Preclinical | Surgery | Magnesium sulfate reduced platelet deposition after temporary arterial occlusion in rabbits |
| 3724238 | 1986 | Clinical study | Magnesium | In 15 patients with Prinzmetal’s angina, magnesium terminated and prevented cold-induced vasoconstriction (indirect, vascular tone) |
| 8024163 | 1994 | Clinical study | Angiology | Magnesium infusion in 12 women with primary Raynaud’s phenomenon and 12 controls, with effects on noradrenaline and neuropeptide-Y levels (indirect) |
| 14168822 | 1964 | Clinical report | Practitioner | Early report of parenteral magnesium sulphate in arterial disease (no abstract available) |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 307E (licence number as recorded) | 1 (valid: 1) | Not specified | Not specified in the licence record |
The Australian register lists one valid single-ingredient licence for this drug.
Safety Considerations
Drug Interactions: The data compiled for this report list 92 interacting drugs. The main examples are:
- Major: dolutegravir, bictegravir and amikacin
- Moderate: doxycycline, tetracycline and ciprofloxacin, as well as bisphosphonates (alendronic acid, risedronic acid, ibandronate), nifedipine and amlodipine, cisatracurium, corticosteroids (hydrocortisone, dexamethasone, betamethasone, triamcinolone), and vitamin D analogues (cholecalciferol, calcifediol, calcitriol)
For warnings and contraindications, please refer to the TGA-approved Product Information (PI).
Conclusion and Next Steps
Decision: Hold
Rationale: The model score is very high, but the only clinical trial targets a single rare condition (TTP), has unknown status and has no results. The remaining support is mostly animal work from the 1980s and 1990s plus one small pilot study. This is not enough to justify progressing.
To proceed, the following is needed:
- Results or status confirmation for NCT03237819, and a decision on which thrombotic condition (for example TTP, stent thrombosis or venous thromboembolism) to pursue
- Controlled human studies with thrombotic endpoints and defined dosing
- Detailed mechanism of action data
- A review of the TGA Product Information for safety and interaction guidance, particularly for the major interactions listed above
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.