Purpose: This multicenter, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in pediatric and adult patients with uncontrolled epilepsy. 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. 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. Conclusion: Lacosamide may be a useful and safe pharmacological treatment option for both pediatric and adult patients with uncontrolled seizures. (C) 2012 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
Verrotti, A., Loiacono, G., Pizzolorusso, A., Parisi, P., Bruni, O., Luchetti, A., et al. (2013). Lacosamide in pediatric and adult patients: comparison of efficacy and safety. SEIZURE, 22(3), 210-216 [10.1016/j.seizure.2012.12.009].
Lacosamide in pediatric and adult patients: comparison of efficacy and safety
Grosso, S.;
2013-01-01
Abstract
Purpose: This multicenter, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in pediatric and adult patients with uncontrolled epilepsy. 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. 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. Conclusion: Lacosamide may be a useful and safe pharmacological treatment option for both pediatric and adult patients with uncontrolled seizures. (C) 2012 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.File | Dimensione | Formato | |
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https://hdl.handle.net/11365/1000366
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