Early add-on lacosamide in a real-life setting: results of the REALLY study.

Abstract

Many patients with epilepsy are treated with antiepileptic drug (AED) polytherapy. Several factors influence the choice of early add-on therapy, and deciding on the most appropriate drug can be difficult. This study aimed to assess the efficacy and tolerability of lacosamide as early add-on therapy in patients with partial-onset seizures. REALLY (REtrospective study of lAcosamide as earLy add-on aLong one Year) was a multicenter, retrospective, 1-year, real-life study. Patients included were aged older than 16years, had partial-onset seizures, and were treated with lacosamide as add-on therapy after one or two prior AEDs. Data were collected retrospectively from clinical records. The primary study objective was to assess the efficacy of lacosamide over 12months (seizure-free and responder rates), and the secondary objective was to assess the tolerability of lacosamide at 3, 6, and 12months [adverse events (AEs) and discontinuation]. One hundred and ninety-nine patients were enrolled in the study; 89 patients (44.7%) had tried one AED and 110 patients (55.3%) had tried two AEDs before lacosamide. At 12months, the proportion of patients who were seizure free was 44.9%, and 76% of patients were responders. The seizure-free rate at 12months for patients who had previously received one or two AEDs was 58 and 34.3%, and the responder rate at 12months was 83.0 and 70.4%, respectively. The AE rate was 21.5% at 3months, 27.1% at 6months, and 31.2% at 12months, with 7.0% of patients discontinuing treatment because of an AE. The most common AE reported was dizziness (11.6%). Cryptogenic epilepsy, a higher number of prior AEDs, and the use of a sodium channel blocker at onset were associated with a worse outcome. The number of concomitant AEDs decreased over 1year (Z=5.89; p<0.001). Twenty-two patients were converted to lacosamide monotherapy with at least one evaluation ≥6months from the beginning of monotherapy conversion. Lacosamide was effective and well tolerated as early add-on treatment in patients who had received one or two previous AEDs.