Neurocognitive effects of adjunctive levetiracetam in children with partial‐onset seizures: A randomized, double‐blind, placebo‐controlled, noninferiority trial

Abstract

SUMMARYPurpose: Evaluate potential neurocognitive effects of adjunctive levetiracetam in children with inadequately controlled partial-onset seizures (POS). Methods: Randomized, double-blind, placebocontrolled, noninferiority safety study. Children (4-16 years; IQ ‡65) with ‡1 POS during 4 weeks before screening despite taking 1-2 antiepileptic drugs (AEDs) were randomized Levetiracetam was noninferior to placebo because the 90% % CI lower bound was greater than the defined noninferiority margin ()9.0). There were no statistically significant differences between groups in Wide Range Assessment of Memory and Learning-2 indexes and Leiter-R Examiner's Rating Scale scores. Median reductions from baseline in weekly POS frequency were 91.5% % versus 26.5% % for levetiracetam versus placebo; ‡50% % responder rates: 62.5% % versus 41.2% %; seizure freedom rates: 46.9% % versus 8.8% % (ITT). Adverse events were reported by 89.1% % levetiracetam-treated and 85.3% % placebo-treated patients; those reported by ‡10% % levetiracetam patients and more often with levetiracetam were headache, nasopharyngitis, fatigue, vomiting, somnolence, and aggression. Discussion: Neurocognitive effects were no different in pediatric patients with POS treated with adjunctive levetiracetam or placebo. Levetiracetam was effective and well tolerated.

Safety and Tolerability of Antiepileptic Drug Treatment in Children with Epilepsy

“…+ [52] Depression + [31] + [53] + [52,54] Suicidal ideation + [53] Behavioural problems + [39,55] + [30,56] + [51,57] + [40] + [32,58] + [59,60] + [45] + [46] + [41][42][43] + [35] + [36,37,49,52] + [38,50] Hallucinations/psychosis + [37] Blurred vision/visual field deficits + [51,63] + [53] Diplopia/eye movement abnormalities…”

“…Unauthorised copying and distribution is prohibited. + [33] + [34] + [35] + [36,37] + [38] Insomnia + [39] + [40] + [41][42][43] Somnolence + [39] + [30,31] + [40] + [32] + [33,44,45] + [46] + [34,47,48] + [41][42][43] + [35] + [36,49] + [50] Sedation + [51] Concentration problems + [36] Aphasia/dysarthria…”

Algorithms of mono- and polytherapy in clinical epileptology

“…Наличие раствора для приема внутрь -очень большой плюс, принципиально отличающий кеппру от других ПЭП и дженериков левети-рацетама [47,54,56,57]. Имеющиеся в настоящее время данные о применении леветирацетама позволяют реко-мендовать его также для стартовой монотерапии юноше-ской миоклонической эпилепсии у женщин [53,58].…”

Efficacy and Tolerability of Levetiracetam (Keppra®) in the Treatment of Epilepsy: Review of Literature

“…Целью исследования P. M. Levisohn et al (2009) бы-ло изучение потенциального влияния леветирацетама на когнитивные функции в дополнительной терапии у детей с фокальными плохо контролируемыми при-ступами [63]. Проведено рандомизированное двойное слепое плацебо-контролируемое исследование без-опасности терапии.…”

“…Побочные эффекты зарегистри-рованы у 89,1 % пациентов, получавших леветираце-там, и у 85,3 % пациентов, получавших плацебо. Побочные эффекты, встречающиеся с частотой ≥ 10 % в группе леветирацетама и чаще встречающиеся при приеме леветирацетама, чем плацебо, включали головную боль, назофарингит, усталость, рвоту, сонли-вость и агрессию [63].…”