Epilepsy
Conditions
Keywords
Epilepsy, Generic, Levetiracetam, Therapeutic equivalency
Brief summary
The retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in Thailand. Epilepsy patients who received generic substitution to original levetiracetam at the same dose and had stable conditions of seizure were only included. In the period of 6 months, the investigators assessed the change of seizure frequency, the incidence of hospitalization due to breakthrough seizure, the incidence of adverse events and the incidence of composite outcomes related to dosage adjustment of antiepileptic drugs.
Interventions
DRUGGeneric levetiracetam
Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date
Sponsors
Mahidol University
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of epilepsy for at least 6 months prior to generic levetiracetam substitution; * Same dosage form and strength of generic substitution to original levetiracetam; * Stable dose of original levetiracetam and stable seizure frequency prior to generic levetiracetam substitution; * Stable dose of generic levetiracetam after generic levetiracetam substitution
Exclusion criteria
* Absence seizure with levetiracetam monotherapy; * Original levetiracetam in dosage form of oral solution or intravenous solution prior to generic levetiracetam substitution; * Poor compliance; * Death or loss of follow up; * Unavailable data for evaluation of outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline seizure frequency | At baseline, 3 and 6 months after generic levetiracetam substitution | Change from baseline seizure frequency per month at 3 and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | During 6 months of generic levetiracetam substitution | Incidence of hospitalization due to breakthrough seizure |
| Adverse events | During 6 months of generic levetiracetam substitution | Incidence of adverse events after generic levetiracetam substitution |
| Composite outcomes | During 6 months of generic levetiracetam substitution | Incidence of composite outcomes related to dosage adjustment of antiepileptic drugs such as 1. Switching back to original levetiracetam due to experiencing an uncontrolled seizure or adverse drug reactions, 2. The incremental dose of generic levetiracetam due to experiencing an uncontrolled seizure, 3. The decremental dose of generic levetiracetam due to experiencing adverse events, 4. Add-on other antiepileptic drugs due to experiencing an uncontrolled seizure, 5. The incremental dose of concurrent antiepileptic drugs due to experiencing an uncontrolled seizure. |
Countries
Thailand
Outcome results
None listed