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Lacosamide in pediatric and adult patients: comparison of efficacy and safety.

Authors :: Verrotti A
Loiacono G
Pizzolorusso A
Parisi P
Bruni O
Luchetti A
Zamponi N
Cappanera S
Grosso S
Kluger G
Janello C
Franzoni E
Elia M
Spalice A
Coppola G
Striano P
Pavone P
Savasta S
Viri M
Romeo A
Aloisi P
Gobbi G
Ferretti A
Cusmai R
Curatolo P
Source :: Seizure [Seizure] 2013 Apr; Vol. 22 (3), pp. 210-6. Date of Electronic Publication: 2013 Jan 05.
Publication Year :: 2013
Abstract: Purpose: This multicenter, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in pediatric and adult patients with uncontrolled epilepsy.<br />Method: This study was carried out between September 2010 and December 2011 at 16 Italian and 1 German neurologic centers. Lacosamide was added to the baseline therapy at a starting dose of 1 mg/kg/day in patients aged <16 years (group A) and 100 mg daily in subjects aged 16 and older (group B), and titrated to the target dose, ranging from 3 to 12 mg/kg/day or from 100 to 600 mg daily, respectively. After completing the titration period, patients entered a 12-month maintenance period and they were followed up at 3, 6 and 12 months. The primary assessment of efficacy was based on the change from baseline in seizure frequency per 28 days and was evaluated at 3, 6 and 12 months as follows: number and proportion of 100% responders, 50% responders, non-responders and worsening patients. Safety evaluation was also performed at 3, 6 and 12 months.<br />Results: A total of 118 patients (59 group A, 59 group B) with uncontrolled generalized and focal epilepsy were enrolled. Patient mean±SD age was 15.9±6.80 years and the age range was 4-38 years. At 3-month evaluation, of 118 treated patients 56 subjects (47.4% group A; 47.4% group B; p=0.8537) experienced at least a 50% reduction in seizure frequency. At 6 and 12-month follow-up, the 50% responders were 57 (52.5% group A; 44.1% group B; p=0.4612) and 51 (47.4% group A; 39% group B; p=0.4573), respectively. Thirty-five subjects (30.5% group A; 28.8% group B; p=1) experienced side effects during the treatment period. The most common adverse events were dyspepsia for group A and dizziness for group B.<br />Conclusion: Lacosamide may be a useful and safe pharmacological treatment option for both pediatric and adult patients with uncontrolled seizures.<br /> (Copyright © 2012 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.)