A prospective, multicenter, noninterventional study in Taiwan to evaluate the safety and tolerability of lacosamide as adjunctive therapy for epilepsy in clinical practice

Abstract

Rationale: Lacosamide (LCM) was initially approved in Taiwan in March 2014 for use as adjunctive therapy for focal impaired awareness seizures and secondarily generalized seizures (SGS) in patients with epilepsy ! 16 years of age. The efficacy and tolerability of adjunctive LCM for the treatment of patients with focal seizures have been demonstrated in randomized, placebo-controlled trials. However, the trials do not reflect a flexible dose setting. This study (EP0063) was conducted to assess the safety and tolerability of LCM in real-world clinical practice in Taiwan. Effectiveness of LCM was also assessed as an exploratory objective. Methods: EP0063 was a multicenter, prospective, noninterventional study with an expected observation period of 12 months ± 60 days. Eligible patients were ! 16 years of age, had focal impaired awareness seizures and/or SGS (in line with approved indication in Taiwan at the time of the study), were taking at least one concomitant antiseizure medication (ASM), and had at least one seizure in the 3 months before baseline. Patients were prescribed LCM by their treating physician in the course of routine clinical practice. The primary safety variable was treatment-emergent adverse events (TEAEs) spontaneously reported to, or observed by, the treating physician. Based on safety data from previous studies of LCM and known side effects of other ASMs, certain TEAEs (including but not limited to cardiac and electrocardiogram, suicidality, and rash related terms) were analyzed separately. Effectiveness variables included Clinical Global Impression of Change (CGIC) and change in 28-day seizure frequency from baseline to 12 months (or final visit), and freedom from focal seizures. Results: A total of 171 patients were treated with LCM, of whom 139 (81.3%) completed the study. The Kaplan-Meier estimated 12-month retention was 82.9%. Patients had a mean (standard deviation [SD], range) age of 38.5 (14.0, 16-77) years, and 96 (56.1%) were male. Patients were taking a mean (SD, range) of 2.8 (1.1, 1-6) ASMs at baseline. Mean (SD, range) duration of LCM treatment was 288.7 (111.9, 2-414) days, and the mean (SD, range) daily dosage of LCM was 205.0 (82.7, 50.0-505.2) mg/day. Overall, 95

Third generation antiseizure medications exposure during pregnancy and neonatal adverse birth outcomes: A systematic review

“…The majority of publications included in this review were the 14 case reports for lacosamide. [18][19][20][21][22][23][24][25][26][27][28][29][30][31] The other publications on lacosamide included nine case series, [32][33][34][35][36][37][38][39][40] one retrospective cohort study, 41 and two pharmacovigilance safety reports. 42,43 Ben-Menachem et al reported in a multicenter open-label trial that two individuals became pregnant.…”

“…The majority of publications included in this review were the 14 case reports for lacosamide. 18–31 The other publications on lacosamide included nine case series, 32–40 one retrospective cohort study, 41 and two pharmacovigilance safety reports. 42,43…”

Plasma lacosamide monitoring in children with epilepsy: Focus on reference therapeutic range and influencing factors

“…In fact, the clinical use of a new ASM follows a stepwise vigorous approach to better understand its mechanism of action, efficacy, pharmacokinetics, and tolerability. LCM gained its approval from China government in 2018, but reports on its clinical experience with LCM as an add-on or first-line monotherapy in Chinese children, even in adults, with epilepsy are still rare ( 8 – 11 , 17 ). No or only sparse data on LCM concentration monitoring at this young age group are available.…”

Effective Modulation by Lacosamide on Cumulative Inhibition of INa during High-Frequency Stimulation and Recovery of INa Block during Conditioning Pulse Train

“…It is commonly administrated in patients with epilepsy and occasionally in patients with trigeminal neuralgia or other neuropathic pain [ 1 , 5 , 7 , 8 , 9 , 10 , 11 , 12 ]. A growing body of evidence demonstrated the effectiveness and tolerability of LCS in patients with epilepsy [ 13 , 14 , 15 , 16 , 17 , 18 , 19 ]. Earlier reports have shown that this compound can decrease the frequency of interictal spikes as well as high-frequency oscillations in mesial temporal lobe epilepsy or refractory focal epilepsy [ 13 , 20 ].…”