Adjunctive therapy for the treatment of primary generalized tonic-clonic seizures: focus on oncedaily lamotrigine

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Adjunctive therapy for the treatment of primary generalized tonic-clonic seizures: focus on oncedaily lamotrigine

Author(s): Linda Steinbaugh, Jerzy Szaflarski

Publication date: 2010-11-18

Journal: Drug Design, Development and Therapy

Publisher: Dove Medical Press

Keywords: lamotrigine, gtc, treatment, generalized seizures, ige

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Abstract

Idiopathic generalized epilepsies are frequently encountered by neurologists, and providing an accurate diagnosis and effective treatment(s) are the necessary components of successful patient care. With the introduction of new antiepileptic medications, physicians are better equipped for this goal. The immediate-release formulation of lamotrigine (LTG-IR) has been approved for primary generalized tonic-clonic seizures since 2006. The extended-release formulation of lamotrigine (LTG-XR) was approved for adjunctive therapy in patients with primary generalized tonic-clonic seizures in 2010. Although its exact mechanism of action is not yet fully elucidated, studies have demonstrated multiple possible pathways. Although both the LTG-IR and LTG-XR formulations have similar side effects and are generally well tolerated, LTG-XR may be preferable for its ease of use, which may increase patient compliance and decrease fluctuations in serum drug levels. The ease of conversion between the formulations also makes lamotrigine an attractive treatment option for patients with primary generalized tonic-clonic seizures. LTG-IR has demonstrated efficacy in treatment-resistant idiopathic generalized epilepsies in both adults and children. Although there are still some questions regarding all possible applications of LTG-XR, as further research is being done, it is clear that LTG-XR may hold some advantages when compared with other anticonvulsants.

Most cited references 30

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A Core Group of the Task Force on Classification and Terminology has evaluated the lists of epileptic seizure types and epilepsy syndromes approved by the General Assembly in Buenos Aires in 2001, and considered possible alternative systems of classification. No new classification has as yet been proposed. Because the 1981 classification of epileptic seizure types, and the 1989 classification of epilepsy syndromes and epilepsies are generally accepted and workable, they will not be discarded unless, and until, clearly better classifications have been devised, although periodic modifications to the current classifications may be suggested. At this time, however, the Core Group has focused on establishing scientifically rigorous criteria for identification of specific epileptic seizure types and specific epilepsy syndromes as unique diagnostic entities, and is considering an evidence-based approach. The short-term goal is to present a list of seizure types and syndromes to the ILAE Executive Committee for approval as testable working hypotheses, subject to verification, falsification, and revision. This report represents completion of this work. If sufficient evidence subsequently becomes available to disprove any hypothesis, the seizure type or syndrome will be reevaluated and revised or discarded, with Executive Committee approval. The recognition of specific seizure types and syndromes, as well as any change in classification of seizure types and syndromes, therefore, will continue to be an ongoing dynamic process. A major purpose of this approach is to identify research necessary to clarify remaining issues of uncertainty, and to pave the way for new classifications.

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Dynamic time course of typical childhood absence seizures: EEG, behavior, and functional magnetic resonance imaging.

R Berman-Bieler, Matthew Vestal, Bryan M. Spann … (2010)

Absence seizures are 5-10 s episodes of impaired consciousness accompanied by 3-4 Hz generalized spike-and-wave discharge on electroencephalography (EEG). The time course of functional magnetic resonance imaging (fMRI) changes in absence seizures in relation to EEG and behavior is not known. We acquired simultaneous EEG-fMRI in 88 typical childhood absence seizures from nine pediatric patients. We investigated behavior concurrently using a continuous performance task or simpler repetitive tapping task. EEG time-frequency analysis revealed abrupt onset and end of 3-4 Hz spike-wave discharges with a mean duration of 6.6 s. Behavioral analysis also showed rapid onset and end of deficits associated with electrographic seizure start and end. In contrast, we observed small early fMRI increases in the orbital/medial frontal and medial/lateral parietal cortex >5 s before seizure onset, followed by profound fMRI decreases continuing >20 s after seizure end. This time course differed markedly from the hemodynamic response function (HRF) model used in conventional fMRI analysis, consisting of large increases beginning after electrical event onset, followed by small fMRI decreases. Other regions, such as the lateral frontal cortex, showed more balanced fMRI increases followed by approximately equal decreases. The thalamus showed delayed increases after seizure onset followed by small decreases, most closely resembling the HRF model. These findings reveal a complex and long-lasting sequence of fMRI changes in absence seizures, which are not detectable by conventional HRF modeling in many regions. These results may be important mechanistically for seizure initiation and termination and may also contribute to changes in EEG and behavior.

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Placebo-controlled study of levetiracetam in idiopathic generalized epilepsy.

Amy R. Knowlton, U Falter, Barbara Schiemann … (2007)

To assess the efficacy and tolerability of adjunctive levetiracetam in patients with uncontrolled generalized tonic-clonic (GTC) seizures associated with idiopathic generalized epilepsies (IGE). This multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled adults and children (4 to 65 years) with IGE experiencing >or=3 GTC seizures during the 8-week baseline period (4-week retrospective and 4-week prospective), despite receiving stable doses of one or two antiepileptic drugs (AEDs). Patients were randomized to levetiracetam (target dose 3,000 mg/day for adults; 60 mg/kg/day for children) or placebo and a 4-week titration period was followed by a 20-week evaluation period. Of 229 patients screened, 164 were randomized (levetiracetam, n = 80; placebo, n = 84). Levetiracetam produced a greater mean reduction in GTC seizure frequency per week over the treatment period (56.5%) than placebo (28.2%; p = 0.004). The percentage of patients who had >or=50% reduction of GTC seizure frequency per week (responders) during the treatment period was 72.2% for levetiracetam and 45.2% for placebo (p < 0.001; OR 3.28; 95% CI 1.68 to 6.38). During the first 2-week treatment 64.6% of patients on levetiracetam and 45.2% on placebo (p = 0.018) were classified as responders. During the evaluation period the percent of patients free of GTC seizures (34.2% vs 10.7%; p < 0.001) and all seizure types (24.1% vs 8.3%; p = 0.009) was greater for levetiracetam than placebo. Levetiracetam was well tolerated with 1.3% of patients discontinuing therapy due to adverse events vs 4.8% on placebo. Adjunctive levetiracetam is an effective and well-tolerated antiepileptic drug for treating generalized tonic-clonic seizures in patients with idiopathic generalized epilepsies.