Long-term safety, efficacy, and quality of life during adjunctive brivaracetam treatment in patients with uncontrolled epilepsy: An open-label follow-up trial.
Epilepsy Behav
; 118: 107897, 2021 05.
Article
en En
| MEDLINE
| ID: mdl-33780735
ABSTRACT
OBJECTIVES:
The primary objective of this long-term follow-up (LTFU) trial was to evaluate the long-term safety and tolerability of brivaracetam (BRV). The secondary objective was to evaluate the maintenance of efficacy of BRV (including quality of life) over time.METHODS:
This open-label, multicenter, flexible-dose trial (N01379 [NCT01339559]) was conducted in adults (≥16â¯years) with focal or generalized-onset seizures, who had participated in a placebo (PBO)-controlled trial of adjunctive BRV (N01258 NCT01405508 or N01358 NCT01261325).RESULTS:
Seven hundred and sixty-six patients received BRV in this LTFU trial (753 had focal seizures and 13 had generalized-onset seizures). Kaplan-Meier-estimated retention was 71.9% at 12â¯months, and 53.7% at 36â¯months. Treatment-emergent adverse events (TEAEs) were reported by 643 (83.9%) patients, most commonly headache (104 [13.6%] patients) and dizziness (100 [13.1%] patients). Two hundred and fifty-seven (33.6%) patients had drug-related TEAEs, most commonly somnolence (49 [6.4%] patients) and dizziness (41 [5.4%] patients). Permanent discontinuation of BRV due to TEAEs occurred in 91 (11.9%) patients. Patients with focal seizures had a median percentage reduction in focal seizure frequency of 52.0% and 51.7% were 50% responders (sustained over time); 26.0% were seizurefree for 6â¯months, and 17.9% were seizurefree for 12â¯months. 42.4% of patients at 12â¯months and 46.8% at 24â¯months had clinically meaningful improvements in Patient Weighted Quality of Life in Epilepsy Questionnaire 31 total score.CONCLUSIONS:
In this select group of patients who entered the LTFU trial, BRV was generally safe and well tolerated. Results indicate the long-term efficacy of BRV in patients with focal seizures.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Calidad de Vida
/
Epilepsia
Tipo de estudio:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Aspecto:
Patient_preference
Límite:
Adult
/
Humans
Idioma:
En
Revista:
Epilepsy Behav
Asunto de la revista:
CIENCIAS DO COMPORTAMENTO
/
NEUROLOGIA
Año:
2021
Tipo del documento:
Article
País de afiliación:
España