Levetiracetam in children with refractory epilepsy: A multicenter open label study in Germany
| Autor: | Gerd Kurlemann, Theodor W. May, Christoph Härtel, Joachim Opp, Adelheid Wiemer-Kruel, Dietz Rating, Elisabeth Korn-Merker, Ingrid Tuxhorn, Ulrich Bettendorf, Gunther Gross-Selbeck, Gerhard Kluger, U. Brandl |
|---|---|
| Rok vydání: | 2005 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Levetiracetam Efficacy Clinical Neurology Drug-resistant epilepsy Epilepsy Open label add-on study Germany medicine Humans Single-Blind Method Prospective Studies Child Adverse effect Prospective cohort study Children Demography Retrospective Studies business.industry Infant Newborn Infant Retrospective cohort study General Medicine Tolerability Drug Resistant Epilepsy medicine.disease Piracetam Discontinuation Treatment Outcome Neurology Child Preschool Anesthesia Drug Evaluation Anticonvulsants Drug Therapy Combination Female Neurology (clinical) business medicine.drug |
| Zdroj: | Seizure. 14:476-484 |
| ISSN: | 1059-1311 |
| DOI: | 10.1016/j.seizure.2005.08.002 |
| Popis: | Summary Purpose: To evaluate the efficacy and tolerability of Levetiracetam (LEV) in a large pediatric cohort with drug-resistant epilepsy from a prospective multicenter observational study. Methods: We report the results of a multicenter observational survey of a cohort of 285 pediatric patients (mean: 9.9 years, range: 0; 6–17; 11) with refractory generalized and focal epilepsy who received Levetiracetam as an add-on open label treatment trial. The average duration of epilepsy was 6.0 years and the patients were treated with a mean of 7.0 antiepileptic drugs (AED) before LEV was introduced. Results: No serious persistent adverse events were reported. Reversible colitis and an apnoea syndrome in a child with phosphorylase-A-kinase-deficiency were noted. Mild to moderate side effects were reported in 128 patients (44.9%), consisting most frequently of somnolence (23.9%), general behavioral changes (15.4%), aggression (10.5%) and sleep disturbances (3.2%). In 209 patients, efficacy was analyzed over a treatment period of at least 12 weeks compared to a baseline of 2 weeks. Thirteen patients (6.2%) became seizure free, 39 (18.7%) responded with a seizure reduction of more than 50% following introduction of LEV. No response to LEV was reported in 65.1% ( n =136). A decrease of initial treatment effect was seen in 37 patients (17.8%) while in 6.7% the seizure frequency doubled to the baseline ( n =14). In seven patients (3.3%), the effect of LEV on seizure frequency could not be evaluated. A positive psychotropic effect was observed in 18 patients (8.6%). Mental retardation was associated with poor response and associated with more side effects and earlier discontinuation of LEV therapy. Conclusion: LEV is a well-tolerated new AED that may effectively improve seizure control as an add-on drug in resistant epilepsy in childhood with good tolerability. However, neurologically handicapped children appear at increased risk for reversible neurocognitive side effects and have a poorer treatment response. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect