Cognitive Effects of Lacosamide in Patients with Drug Refractory Focal Epilepsy: A Prospective Observational Study (original) (raw)
Related papers
Cognitive effects of lacosamide as adjunctive therapy in refractory epilepsy
Background -Lacosamide (LCM) is a novel antiepileptic drug (AED) with potential benefit as adjunctive treatment in patients with partialonset seizures. As yet, limited information on cognitive effects of LCM is available, especially in real-life settings. Aims -In this open clinical prospective study, the cognitive effects of LCM were evaluated when used as adjunctive antiepileptic therapy in patients with refractory epilepsy. Methods -We included 33 patients aged between 16 and 74 years (mean: 37 years). All patients had a localizationrelated epilepsy. Patients were assessed at baseline before starting LCM treatment and during follow-up when the optimal clinical dose was achieved. Materials -Subjective complaints were evaluated using the SIDAED; effects on cognition were evaluated using the computerized visual searching task (CVST). Results -The CVST showed significant faster information processing reaction times at the second evaluation (P = 0.013), which was not correlated with seizure control, type of epilepsy, age, gender, drug load, number of concomitant drugs, dose or duration of LCM treatment. On the SIDAED, patients complained more about their cognitive function at the second evaluation (P = 0.005). For the SIDAED, a positive correlation at follow-up was found between the total severity score and higher age (r = 0.375, P = 0.031), but not with epilepsy factors or treatment characteristics. Discussion/Conlusion -Screening of the cognitive effects of LCM showed that LCM does not have negative effects on information processing speed. As this is the most sensitive function for cognitive side effects of AEDs, LCM does not seem to induce the common negative cognitive effects. Remarkably, patients complained more, especially about their cognitive function, which is possible the 'doing better, feeling worse phenomenon'.
Epilepsy & Behavior, 2016
The objective of this study was to examine cognitive and quality-of-life measures/quality of life outcomes with adjunctive lacosamide therapy in patients with treatment-resistant partial epilepsy. Methods: This was a prospective, open-label, nonblinded, adjunctive therapy test-retest (within subjects) study of patients with treatment-resistant partial epilepsy in which outcome (cognitive functioning and mood/quality of life) was measured in the same subject before and after adjunctive lacosamide administration for 24 weeks. The cognitive assessment included the following: Controlled Oral Word Association Test, Buschke Selective Reminding Test, Brief Visuospatial Memory Test-Revised, Stroop Color Word Test, Symbol Digit Modalities Test, Digit Span, Digit Cancellation, and Trails A and B. The quality-of-life measures/quality-of-life assessment included the following: Beck Depression Inventory-II, Profile of Mood States, and Quality of Life Inventory-89. Lacosamide was started at 100 mg (50 mg twice daily) and could be titrated as needed up to 400 mg/day (200 mg twice daily). Baseline concomitant AEDs were kept constant. Composite scores were calculated for a pre-post difference score for the cognitive and mood/quality-of-life measures separately and used in regression analyses to correct for the effects of age, education, seizure frequency, seizure severity, dose of lacosamide, and number of AEDs at baseline. Results: Thirty-four patients were enrolled (13 males, 21 females). Mean age was 38.8 ± 2.43 years. Mean seizure frequency decreased significantly from 2.0 ± 2.55 seizures per week at baseline to 1.02 ± 1.72 seizures per week at posttreatment (t = 4.59, p b .0001) with a 50% responder rate seen in 18 patients (52.9%). No significant differences were found on the composite scores of the cognitive or the mood/quality-of-life measures after 6 months of lacosamide. Significance: Lacosamide appeared to have low risks of significant changes in cognition or mood/quality of life. In addition, the present study supports prior studies that have proven lacosamide as an effective adjunctive therapy for the treatment of resistant partial epilepsy.
2021
Newer antiepileptic drugs (AEDs) offer favourable safety profiles than the previously used AEDs. Despite the introduction of many AEDs, a large number of patients continue to suffer from uncontrolled partial-onset seizures which have considerable impact on a patient’s quality of life. Lacosamide (LCM) is a third generation AED approved for adjunctive use in partial-onset seizures. Patients with epilepsy frequently experience cognitive dysfunctions due to a variety of factors. Because AEDs are the major therapeutic modality for epilepsy, the adverse effects of AEDs on cognition are important. Objectives To assess the adverse effects of lacosamide on cognition among patients with localization related epilepsy to whom lacosamide is given as adjuvant therapy. METHODOLOGY An open labelled prospective observational study in 22 patients who suffered from localization related epilepsy. Results Average Initial seizure frequency per month was 3.56 (SD 2.58) and median frequency 2.5 seizures p...
Epilepsy & Behavior, 2009
We report our 6 months of experience with adjunctive lacosamide in 25 patients with pharmacoresistant focal epilepsy. Baseline characteristics of our patients were similar to those of the populations in the three clinical trials that evaluated lacosamide for refractory focal epilepsy. One patient experienced sustained seizure freedom for 5 months; two more patients had nonsustained periods of seizure freedom of 1 and 4 months. A total of eight patients (32%) reported a greater than 50% reduction in seizure frequency. Thirteen patients (52%) reported side effects during the titration, mostly dizziness, fatigue, nausea, and gait instability. In five patients (20%), these disappeared during the maintenance phase and/or with dose reduction. Two patients lost more than 10% of their body weight. Otherwise, in terms of efficacy and adverse effects, our data mirror the profile of lacosamide described in the three clinical trials. Substantial weight loss may occur in individual patients.
Seizure, 2012
Lacosamide (LCS) is a new adjunctive drug licensed for the treatment of focal seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. Lacosamide was approved in the member states of the European Union in September 2008 and in the United States in October 2008. Lacosamide has a novel mechanism of action producing selective enhancement of sodium channel slow inactivation. 1 In addition to the treatment of epilepsy, LCS has also been found to be useful in the treatment of pain in diabetic neuropathy. 2 Three randomised, multicentre, double blind, placebo-controlled trials of LCS have shown a major reduction in seizure frequency at three different doses with responder rates ranging from 32.7% to 35% for 200 mg/day, 38.3% to 41.1% for 400 mg/day and 38.1% to 41.2% for 600 mg/day. With placebo the responder rates in those studies ranged from 18.3% to 25.8%. 3-5 Four postmarketing studies have been published, including one from the United Kingdom (UK), showing a high response rate and good tolerability. 6-9 We present the clinical experience with lacosamide
The Role Of Add-On Lacosamide Therapy In The Treatment Of Focal Onset Epilepsy
Epilepsi (İstanbul), 2017
Objectives: The aim of this study was to retrospectively evaluate the efficacy and safety of lacosamide (200-300-400 mg/day) as adjunct treatment in patients with uncontrolled focal-onset seizures taking 2 or more antiepileptic drugs (AED). Methods: The medical records of patients with uncontrolled focal epilepsy who received lacosamide as add-on therapy for at least 6 months was reviewed retrospectively. The demographic data, the doses of lacosamide, concomitant AED therapy, and seizure activity in first and sixth months were analysed. Results: A total of 83 patients were evaluated. The mean percent reduction in seizure frequency per month was 38.98% in the first month and 33.22% in the sixth month. In all, 53% of the patients had a decrease in seizures of 50% or more in the first month, and 47% saw a similar decrease in the sixth month. The percentage of those taking a sodium channel blocking AED in addition to lacosamide was 97.6%. Dose-related adverse events reported included dizziness, nausea, diplopia, gastroenterological side effects, headache, itchy skin, and blurred vision. It was determined that all of the patients with drug-related side effects were taking a sodium channel blocking AED concomitantly with lacosamide. Conclusion: Adjuvant treatment with lacosamide reduced seizure frequency for patients with uncontrolled focal-onset seizures.
Epilepsia Open, 2021
The primary objective of this trial (SP1042; NCT02582866) was to assess long‐term safety and tolerability of lacosamide monotherapy (200‐600 mg/day) in adults with focal (partial‐onset) seizures or generalized tonic‐clonic seizures (without clear focal origin). This Phase III, long‐term, open‐label, multicenter, follow‐up trial enrolled patients with epilepsy who were taking lacosamide in, and completed, the previous double‐blind trial (SP0994; NCT01465997). Primary safety outcomes were treatment‐emergent adverse events (TEAEs), discontinuations due to TEAEs, and serious TEAEs. One hundred and six patients were enrolled and received lacosamide: 84 (79.2%) completed the trial and 22 (20.8%) discontinued. The median duration of exposure was 854.0 days, with a median modal dose of 200 mg/day. Ninety‐six (90.6%), 64 (60.4%), and 44 (41.5%) patients had ≥12, ≥24, and ≥36 months of lacosamide exposure, respectively. At least one TEAE was reported by 61 (57.5%) patients. The most common (≥...
Therapeutics and clinical risk management, 2018
Data regarding lacosamide treatment as an adjunctive therapy in patients representative of a focal-onset epilepsy population including those with and without intellectual/developmental disorders (IDDs) are limited. To evaluate the retention rates of lacosamide in focal-onset epilepsy patients with and without IDD. We retrospectively reviewed all consecutive electronic and paper medical records of patients diagnosed with focal-onset epilepsy who were treated with lacosamide in two tertiary epilepsy centers. One hundred and thirty-six patients who met the inclusion criteria were studied. Number of patients with IDD was 46 (33.8%). Median lacosamide dose was 300 mg/day. A total of 39 patients (28.7%) experienced side effects, and 22 of them (16.2%) discontinued lacosamide. The 1-, 2-, and 3-year retention rates of lacosamide in patients with IDD were 68%, 62%, and 53%, respectively. Kaplan-Meier survival analysis showed that the retention rates were significantly lower in patients with...
Lacosamide as monotherapy in focal seizure: Literature review
International Journal of Epilepsy, 2017
Lacosamide is a newer approved antiepileptic drug (AED) characterized by its novel pharmacodynamic profile. It is now approved by United States Food and Drug Administration for use as monotherapy in adults (aged>17 years) with focal seizures based on historical controlled trial by Wechsler RT et al in 2014. Randomized controlled trials on lacosamide monotherapy have demonstrated significant reduction in median seizure frequency. In addition, 50% responder rates for lacosamide was noted in half of the patients, with retention rate in two third of patients in 1 year follow up period. Adverse events reported in clinical trials were mostly mild to moderate in intensity. The most common adverse events were dizziness, headache, convulsion, nausea and fatigue while convulsion and dizziness were commonly responsible for drug discontinuation. Overall, lacosamide monotherapy can be a good treatment option in patients with focal seizure.
Preliminary Evaluation of the Antiepileptic Activity of Lacosamide in Libyan Epileptic Center
2018
Lacosamidewas recently approved as an antiepileptic drug by the United Statesand European Union. Lacosamideis used as an adjunctive therapy in the treatment of intractable partial-onset seizures in patients 16-17 years of age and older. Lacosamide introduced to Ali Askar Hospital, Tripoli-Libya, in tablet (50-100mg)and syrup dosage forms (10mg/ml).This study was performedon 61 patients (between the years of 2013 to 2015).The purpose of this study was to evaluate the safety and efficacy of oral lacosamideadministration as a concomitant therapy with multiple antiepileptic drugs (AEDs) with intractable epilepsy.Seizure frequency for patients with intractable partial epilepsy were recorded and compared to the seizure frequency after adding lacosamide to their prior treatment regimen. 74 % had reduction in seizure frequency with lacosamide and (5%) of seizure freedom. The non-responders to lacosamide were13%. While another 13% get worse with this drug. Complex partial seizures recorded t...