Amiodarone
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Amiodarone: Catecholaminergic polymorphic ventricular tachycardia
One-Sentence Summary
Amiodarone is an oral antiarrhythmic that is marketed in Australia. The TxGNN model predicts it may be useful for catecholaminergic polymorphic ventricular tachycardia (TxGNN score 0.9978). However, the data compiled for this report contain no clinical trials and no publication that tests amiodarone in this disease, so the prediction rests on the model alone (evidence level L5).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Catecholaminergic polymorphic ventricular tachycardia |
| TxGNN Prediction Score | 0.9978 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data are not available in the data compiled for this report. Amiodarone is generally described as a multi-channel blocker (potassium, sodium and calcium channels) with beta-adrenergic antagonist activity, which suppresses ventricular arrhythmias.
Catecholaminergic polymorphic ventricular tachycardia (CPVT) is a rare inherited arrhythmia caused by mutations such as RYR2 or CASQ2, in which adrenaline-triggered calcium leak provokes ventricular arrhythmias. Amiodarone’s anti-adrenergic and calcium-channel effects are plausibly relevant. However, amiodarone is not a first-line option in this condition; beta-blockers and flecainide are the standard approaches. The link is therefore theoretical and is not backed by direct evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
The retrieved publications describe CPVT itself or other treatments. None demonstrates amiodarone efficacy in CPVT.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 35892906 | 2022 | Systematic review | Life (Basel) | Clinical features, genetics and arrhythmic outcomes of CPVT patients from China |
| 39076628 | 2022 | Cohort | Reviews in Cardiovascular Medicine | Clinical characteristics, genetics, healthcare use and costs of CPVT patients in a Chinese city |
| 26513538 | 2015 | Review | Expert Opinion on Pharmacotherapy | Overview of antiarrhythmic drug therapy for ventricular arrhythmias |
| 22553997 | 2012 | Case report | Pacing and Clinical Electrophysiology | Flecainide suppressed defibrillator-induced storming in a boy with CPVT |
| 39735866 | 2024 | Case report | Frontiers in Cardiovascular Medicine | CPVT resolved with right cardiac sympathetic denervation after left-sided denervation |
| 30116135 | 2018 | Case report | Turk Pediatri Arsivi | CPVT presenting as sudden cardiac arrest in a two-year-old |
| 29668588 | 2018 | Case report | Medicine | Six-year delayed diagnosis of CPVT with an RYR2 mutation in a child |
| 37852665 | 2023 | Case report | BMJ Case Reports | Young child surviving cardiac arrest with recurrent ventricular arrhythmia, where deviation from standard resuscitation was needed |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 2343H | Amdarone | Tablet containing amiodarone hydrochloride 200 mg | Not available |
Market status: marketed, with one valid licence for a single-ingredient oral product.
Safety Considerations
No warnings or contraindications from approved label text are available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for full safety information.
Drug interactions: The interaction screen returned 100 entries. Examples classed as Major include:
- Agalsidase beta
- Hydrocortisone and dexamethasone
- Amphotericin B (including cholesteryl sulfate, lipid complex and liposomal forms)
- Cisapride
- Clarithromycin
- Clotrimazole
- Dolasetron
- Eliglustat
Moderate examples include famotidine, aprepitant, bisacodyl, budesonide, castor oil and cimetidine.
Conditions flagged as contraindicated in the data compiled for this report (not label text): long QT syndrome, torsades de pointes, atrioventricular block, sick sinus syndrome, liver disease, hypothyroidism, hyperthyroidism, interstitial lung disease, hypersensitivity pneumonitis, optic neuritis, peripheral neuropathy and potassium deficiency. These should be checked against the PI.
Conclusion and Next Steps
Decision: Hold
Rationale:
- The prediction is supported by the model score alone. No clinical trial or publication tests amiodarone in CPVT, and established treatments (beta-blockers, flecainide) already exist. Amiodarone also carries substantial toxicity and interaction risks.
To proceed, the following is needed:
- Direct clinical evidence of amiodarone in CPVT, such as controlled studies or well-documented cohorts compared with standard therapy
- Detailed mechanism of action data
- Review of the TGA-approved Product Information for warnings and contraindications
- A safety monitoring plan covering thyroid, lung, liver and cardiac conduction effects
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.