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Perampanel in routine clinical use in idiopathic generalized epilepsy: The 12-month GENERAL study
Vicente Villanueva1, Javier Montoya2,3, Ascension Castillo3
1University Hospital and Polytechnic La Fe, Valencia, Spain.
Insights
Perampanel effectively reduced seizures in idiopathic generalized epilepsy (IGE) patients, including generalized tonic-clonic, myoclonic, and absence seizures. This real-world study shows good tolerability and retention rates, supporting its use in routine care.
Area of Science:
- Neurology
- Epileptology
- Clinical Pharmacology
Background:
- Idiopathic generalized epilepsy (IGE) encompasses various seizure types, necessitating diverse treatment strategies.
- Perampanel is an antiepileptic drug (AED) approved for specific epilepsy types, but its real-world effectiveness across IGE seizure types requires further investigation.
Purpose of the Study:
- To evaluate the effectiveness and tolerability of perampanel in a real-world setting for patients diagnosed with idiopathic generalized epilepsy (IGE).
- To analyze perampanel's efficacy across different seizure types within the IGE spectrum, including generalized tonic-clonic seizures (GTCS), myoclonic seizures, and absence seizures.
Main Methods:
- A multicenter, retrospective, 1-year observational study involving 149 patients (aged ≥12 years) with confirmed IGE diagnoses across 21 specialist epilepsy centers in Spain.
- Data were collected from patient records for individuals prescribed perampanel before December 2016, analyzing retention rates, seizure freedom, and seizure frequency changes.
Main Results:
- The 12-month retention rate for perampanel was 83%. Seizure-free rates at 12 months were 59% overall, with specific rates for GTCS (63%), myoclonic seizures (65%), and absence seizures (51%).
- Significant reductions in seizure frequency were observed for GTCS (78%), myoclonic seizures (65%), and absence seizures (48%). Perampanel demonstrated effectiveness irrespective of epilepsy syndrome or concomitant AEDs, with better outcomes when initiated earlier in the treatment history.
- Adverse events occurred in 50% of patients, primarily mild to moderate, with irritability, somnolence, and dizziness being the most frequent.
Conclusions:
- Perampanel demonstrates significant effectiveness in improving seizure control for various seizure types in patients with IGE within a routine clinical care setting.
- The drug exhibits good tolerability and a high retention rate, suggesting it is a viable treatment option for IGE, particularly when used as an early add-on therapy.
- This study provides the first real-world evidence on perampanel's efficacy across diverse seizure types in IGE, supporting its broader clinical application.
Objective:
To analyze the effectiveness and tolerability of perampanel across different seizure types in routine clinical care of patients with idiopathic generalized epilepsy (IGE).
Methods:
This multicenter, retrospective, 1-year observational study collected data from patient records at 21 specialist epilepsy units in Spain. All patients who were aged ≥12 years, prescribed perampanel before December 2016, and had a confirmed diagnosis of IGE were included.
Results:
The population comprised 149 patients with IGE (60 with juvenile myoclonic epilepsy, 51 generalized tonic-clonic seizures [GTCS] only, 21 juvenile absence epilepsy, 10 childhood absence epilepsy, 6 adulthood absence epilepsy, and one Jeavons syndrome). Mean age was 36 years. The retention rate at 12 months was 83% (124/149), and 4 mg was the most common dose. At 12 months, the seizure-free rate was 59% for all seizures (88/149); 63% for GTCS (72/115), 65% for myoclonic seizures (31/48), and 51% for absence seizures (24/47). Seizure frequency was reduced significantly at 12 months relative to baseline for GTCS (78%), myoclonic (65%), and absence seizures (48%). Increase from baseline seizure frequency was seen in 5.2% of patients with GTCS seizures, 6.3% with myoclonic, and 4.3% with absence seizures. Perampanel was effective regardless of epilepsy syndrome, concomitant antiepileptic drugs (AEDs), and prior AEDs, but retention and seizure freedom were significantly higher when used as early add-on (after ≤2 prior AEDs) than late (≥3 prior AEDs). Adverse events were reported in 50% of patients over 12 months, mostly mild or moderate, and irritability (23%), somnolence (15%), and dizziness (14%) were most frequent.
Significance:
In routine clinical care of patients with IGE, perampanel improved seizure outcomes for GTCS, myoclonic seizures, and absence seizures, with few discontinuations due to adverse events. This is the first real-world evidence with perampanel across different seizure types in IGE.
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