Lacosamide monotherapy in clinical practice: A retrospective chart review

Abstract

ObjectiveTo assess effectiveness and tolerability of first‐line and conversion to lacosamide monotherapy for focal seizures.Materials and MethodsRetrospective, non‐interventional chart review of lacosamide monotherapy patients aged ≥16 years in Europe. Outcomes included retention rate at observational point (OP) 3 (12 ± 3 months), seizure freedom rates at OP2 (6 ± 3 months) and OP3 and adverse drug reactions (ADRs).ResultsA total of 439 patients were included (98 first‐line and 341 conversion to monotherapy; 128 aged ≥65 years [25 first‐line and 103 conversion to monotherapy]). First‐line and conversion to monotherapy retention rates were 60.2% (59/98; 95% confidence interval [CI] 49.8%‐70.0%) and 62.5% (213/341; 57.1%‐67.6%), respectively. Kaplan‐Meier estimates of 12‐month retention rates were 81.2% and 91.4% for first‐line and conversion to monotherapy, respectively. First‐line and conversion to monotherapy retention rates in patients aged ≥65 years were 60.0% (38.7%‐78.9%) and 68.9% (59.1%‐77.7%), respectively. At OP2, 66.3% of first‐line and 63.0% of conversion to monotherapy patients were seizure free. At OP3, 60.2% of first‐line and 52.5% of conversion to monotherapy patients were seizure free. In the ≥65 years subgroup, seizure freedom rates at OP2 were 72.0% and 68.0% for first‐line and converted to monotherapy, respectively, and at OP3, 68.0% and 56.3%, respectively. Overall, 52 of 439 (11.8%) patients reported ADRs (16.4% in ≥65 years subgroup), most commonly dizziness (5.0%), headache (2.1%) and somnolence (1.6%).ConclusionsLacosamide was effective and well tolerated as first‐line or conversion to monotherapy in a clinical setting in adult and elderly patients with focal seizures.

Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli

“…31 Even considering the limited comparability of these studies to the current data, ESL seems to be at least as effective as other sodium channel blockers. 31 Even considering the limited comparability of these studies to the current data, ESL seems to be at least as effective as other sodium channel blockers.…”

“…in those who converted to lacosamide monotherapy from another AED, and the corresponding 12-month seizure freedom rates were 60.2% and 52.5%, respectively. 31 Even considering the limited comparability of these studies to the current data, ESL seems to be at least as effective as other sodium channel blockers.…”

“…1,26 For example, in the phase III monotherapy trial conducted in patients with newly diagnosed epilepsy, the most frequently reported ESL-related AEs (≥5% of patients) were dizziness, headache, somnolence, and fatigue, and the AEs that most frequently led to ESL discontinuation (≥1% of patients) were fatigue, nausea, dizziness, somnolence, and rash. [31][32][33] In a retrospective, non-interventional chart review of 439 patients with focal seizures, aged ≥16 years, who were treated with lacosamide monotherapy according to standard clinical practice in Italy, Spain, and the Netherlands, 6-month seizure freedom rates were 66.3% in patients treated with lacosamide as initial monotherapy and 63.0% 26 Therefore, it is perhaps unsurprising that the incidence of AEs leading to discontinuation was higher when ESL was used as adjunctive therapy versus monotherapy, since sodium channel blocking is the most common mechanism of have reported outcomes for the use of monotherapy with another member of the dibenzazepine family of AEDs, oxcarbazepine, in the clinical practice setting.…”

“…29 Furthermore, several studies have assessed the effectiveness of monotherapy with another sodium channel blocker, lacosamide, in clinical practice. [31][32][33] In a retrospective, non-interventional chart review of 439 patients with focal seizures, aged ≥16 years, who were treated with lacosamide monotherapy according to standard clinical practice in Italy, Spain, and the Netherlands, 6-month seizure freedom rates were 66.3% in patients treated with lacosamide as initial monotherapy and 63.0%…”

Reply to ‘Computation of antiepileptic drug retention rates in the presence of a competing risk’

“…Secondly, one of the benefits of a KM analysis is that it allows easy comparison with the existing literature. KM analyses are widely used for estimates of retention rates of AEDs, also in the elderly [2][3][4].Furthermore, we are uncertain that a competing risk analysis would be the most informative model for our research question. The patient and the neurologist are typically interested in the likelihood of discontinuation under the assumption that no competing death will occur.…”