Ongoing Research
A retrospective cohort study examining levetiracetam prescribing patterns, outcomes, and the prevalence of Iatrogenic Refractory Epilepsy.
Study Progress
Background
Levetiracetam has become one of the most prescribed antiepileptic drugs in Australasia and globally. Despite its widespread use, the SANAD II trial (2021) demonstrated that lamotrigine is superior for focal epilepsy, and 20–35% of patients experience significant neuropsychiatric adverse effects. This study aims to quantify the real-world prescribing patterns of levetiracetam and assess whether inappropriate first-line prescribing is contributing to apparent drug resistance — the phenomenon described as Iatrogenic Refractory Epilepsy (IRE).
Study Aims
- 1
To describe the prescribing patterns of levetiracetam as first-line therapy across epilepsy types in Australasia.
- 2
To compare seizure outcomes between patients prescribed levetiracetam versus lamotrigine as first-line therapy for focal epilepsy.
- 3
To estimate the proportion of apparent drug-resistant epilepsy cases that may represent Iatrogenic Refractory Epilepsy.
- 4
To identify patient and prescriber factors associated with inappropriate first-line levetiracetam prescribing.
- 5
To assess the prevalence and severity of neuropsychiatric adverse events in real-world levetiracetam use.
Study Design
Retrospective population-based cohort study using linked administrative health data. The study will include all patients with a new diagnosis of epilepsy who received a first prescription for an antiepileptic drug within a defined study period. The primary outcome is time to treatment failure (seizure recurrence or drug discontinuation). Secondary outcomes include neuropsychiatric adverse events, emergency department presentations, and all-cause mortality.
Data Sources
| Data Source | Type | Coverage |
|---|---|---|
| Hospital Discharge Data | Administrative | All public hospital admissions |
| Pharmaceutical Benefits Scheme (PBS) | Prescribing | All subsidised AED prescriptions |
| Emergency Department Presentations | Clinical | ED visits for seizure-related conditions |
| Death Registry | Outcome | All-cause and cause-specific mortality |
Ethical Framework
This study will be conducted in accordance with the National Statement on Ethical Conduct in Human Research (NHMRC, 2023). Ethics approval will be sought from the relevant Human Research Ethics Committee (HREC) prior to data access. All data will be de-identified prior to analysis. The study is framed as a medication safety and prescribing improvement initiative.
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