MONOZEB: Long-term observational study of eslicarbazepine acetate monotherapy

Abstract

AIM\nThe aim of the study was to evaluate the effectiveness and tolerability of eslicarbazepine acetate (ESL) when used as monotherapy for 1\u202fyear or more in routine clinical use in patients with focal seizures in epilepsy clinics in Spain.\n\n\nMETHODS\nThis is a retrospective, observational, noninterventional study. Eligible patients were aged ≥18\u202fyears, had focal seizures, and started on ESL ≥1\u202fyear before database closure. Primary endpoint was the following: proportion seizure-free for ≥6\u202fmonths at 1 and 2\u202fyears. Secondary endpoints included retention on ESL monotherapy at 1 and 2\u202fyears, seizure frequency change, seizure worsening, and side effects. Other analyses included seizure freedom from baseline to 1 and 2\u202fyears and outcomes in special populations.\n\n\nRESULTS\nFour hundred thirty-five patients were included (127 on first-line monotherapy and 308 converting to ESL monotherapy): median daily dose was 800\u202fmg at all time points; 63.2% were seizure-free at 1\u202fyear, 65.1% at 2\u202fyears, and 50.3% for the entire follow-up. Mean duration of ESL monotherapy was 66.7\u202fmonths; retention was 88.0% at 1\u202fyear and 81.9% at 2\u202fyears. Mean reduction in seizure frequency was 75.5% at last visit. Over the entire follow-up, seizure worsening was seen in 22 patients (5.1%), side effects in 28.0%, considered severe in 1.8%, and leading to discontinuation in 5.7%. Dizziness, hyponatremia (sodium <135\u202fmEq/l), and somnolence were the most frequent side effects. Outcomes in special populations (patients aged ≥65\u202fyears and those with psychiatric history or learning difficulty) were consistent with the overall population.\n\n\nCONCLUSIONS\nPatients with focal seizures taking ESL monotherapy had excellent retention, high seizure-free rates, and good tolerability up to 2\u202fyears.