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Epilepsia. 2018 Sep;59(9):1740-1752. doi: 10.1111/epi.14522. Epub 2018 Jul 31.

Perampanel in routine clinical use in idiopathic generalized epilepsy: The 12-month GENERAL study.

Author information

1
University Hospital and Polytechnic La Fe, Valencia, Spain.
2
Lluis Alcanyis Hospital, Xátiva, Spain.
3
General University Hospital Valencia, Valencia, Spain.
4
University Hospital Clinic Lozano Blesa, Zaragoza, Spain.
5
University Hospital Dr Peset, Valencia, Spain.
6
University Hospital Complex Santiago, Santiago de Compostela, Spain.
7
University Hospital Clinic Valencia, Valencia, Spain.
8
University Hospital Bellvitge, Barcelona, Spain.
9
University Hospital Miguel Servet, Zaragoza, Spain.
10
IMED Levante Hospital, Benidorm, Spain.
11
Niño Jesus University Children's Hospital, Madrid, Spain.
12
University Hospital Cruces, Bilbao, Spain.
13
Verge de la Cinta Hospital, Tortosa, Spain.
14
Hospital Clinic Barcelona, Barcelona, Spain.
15
Advanced Neurology Center, Sevilla, Spain.
16
University Hospital Clinic, Valladolid, Spain.
17
Arnau de Vilanova Hospital, Valencia, Spain.
18
University Complex Infanta Cristina, Badajoz, Spain.
19
University Hospital Josep Trueta, Girona, Spain.
20
University Hospital Virgen Arraixaca, Murcia, Spain.
21
University Hospital Vall d'Hebrón, Barcelona, Spain.

Abstract

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.

KEYWORDS:

absence; idiopathic generalized epilepsy; myoclonic; pharmacotherapy; real-world evidence

PMID:
30062784
DOI:
10.1111/epi.14522
[Indexed for MEDLINE]
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