Effectiveness and safety of perampanel as early add-on treatment in patients with epilepsy and focal seizures in the routine clinical practice: Spain prospective study (PERADON).
Epilepsy Behav
; 102: 106655, 2020 01.
Article
em En
| MEDLINE
| ID: mdl-31812902
ABSTRACT
OBJECTIVE:
Perampanel (PER) has been shown to be effective as an adjunctive therapy for controlling refractory focal-onset seizures (FOS). However, the information as early add-on for the treatment of FOS in the clinical practice is still scarce and must be further assessed.METHODS:
An observational prospective study was conducted to evaluate the effectiveness of early add-on PER, assessed as 50% responders (seizure frequency reduced by at least 50% during the last 3â¯months as compared with baseline) rate at 6 and 12â¯months, in patients with FOS in the routine clinical practice of Spain.RESULTS:
One hundred and thirteen patients (mean age 40.3â¯years, 51.3% male) with FOS received PER as early add-on (1st add-on 37.2% and 2nd 62.8%) for a mean exposure of 11â¯months (mean PER dose 6.3â¯mg/day at month 12). At 6â¯months, 50.4% and 20.4% of the patients were responders and seizure-free (respectively) relative to baseline (3â¯months prior to PER initiation), and at 12â¯months, 68.1% and 26.5% of the patients were responders and seizure-free (respectively), relative to baseline (3â¯months prior to PER initiation). The retention rate at 6 and 12â¯months was 83.2% and 80.5%, respectively. The percentage of seizure-free patients at 12â¯months was significantly (pâ¯=â¯0.033) higher when PER was added as first vs. second add-on. The number of concomitant antiepileptic drugs (AEDs) was significantly reduced from baseline to 6 and 12â¯months (pâ¯=â¯0.001). Treatment was simplified in 23.9% of patients at the end of the observation period. Drug-related adverse events (AEs), most mild or moderate, were reported in 30.1% of patients, with irritability (8%) and dizziness (7.1%) as the most frequent ones.CONCLUSIONS:
This is the first observational, prospective study to evaluate efficacy and safety of early adjunctive treatment with PER in patients with focal epilepsy at 12â¯months. Perampanel demonstrated a good efficacy and safety profile when used at a median dose of 6â¯mg/day, regardless of the combination with other AEDs. Adverse events were mild or moderate, with dizziness being the most frequent one.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Piridonas
/
Convulsões
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Epilepsia
/
Anticonvulsivantes
Tipo de estudo:
Evaluation_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Adult
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Female
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Humans
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Male
/
Middle aged
País/Região como assunto:
Europa
Idioma:
En
Revista:
Epilepsy Behav
Assunto da revista:
CIENCIAS DO COMPORTAMENTO
/
NEUROLOGIA
Ano de publicação:
2020
Tipo de documento:
Article