Long-term adjunctive lacosamide treatment in patients with partial-onset seizures

Rosenow, Felix; Kelemen, Anna; Ben‐Menachem, Elinor; McShea, Cindy; Isojärvi, Jouko; Doty, Pamela

doi:10.1111/ane.12451

Cited by 39 publications

(61 citation statements)

References 12 publications

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“…Moreover, these retention rates are also consistent with the 59.3% retention rate at 1 year described in a study of 59 adults receiving lacosamide in adjunctive use 18. When comparing to Kaplan‐Meier estimates the 1‐year retention rates in our study are higher than those described in another long‐term follow‐up study with lacosamide in adjunctive use (74.5% Kaplan‐Meier estimates) 19. However, this may be due to the less severe patient population included into our study.…”

Section: Discussionsupporting

confidence: 90%

Lacosamide monotherapy in clinical practice: A retrospective chart review

et al. 2018

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ObjectiveTo assess effectiveness and tolerability of first‐line and conversion to lacosamide monotherapy for focal seizures.Materials and MethodsRetrospective, non‐interventional chart review of lacosamide monotherapy patients aged ≥16 years in Europe. Outcomes included retention rate at observational point (OP) 3 (12 ± 3 months), seizure freedom rates at OP2 (6 ± 3 months) and OP3 and adverse drug reactions (ADRs).ResultsA total of 439 patients were included (98 first‐line and 341 conversion to monotherapy; 128 aged ≥65 years [25 first‐line and 103 conversion to monotherapy]). First‐line and conversion to monotherapy retention rates were 60.2% (59/98; 95% confidence interval [CI] 49.8%‐70.0%) and 62.5% (213/341; 57.1%‐67.6%), respectively. Kaplan‐Meier estimates of 12‐month retention rates were 81.2% and 91.4% for first‐line and conversion to monotherapy, respectively. First‐line and conversion to monotherapy retention rates in patients aged ≥65 years were 60.0% (38.7%‐78.9%) and 68.9% (59.1%‐77.7%), respectively. At OP2, 66.3% of first‐line and 63.0% of conversion to monotherapy patients were seizure free. At OP3, 60.2% of first‐line and 52.5% of conversion to monotherapy patients were seizure free. In the ≥65 years subgroup, seizure freedom rates at OP2 were 72.0% and 68.0% for first‐line and converted to monotherapy, respectively, and at OP3, 68.0% and 56.3%, respectively. Overall, 52 of 439 (11.8%) patients reported ADRs (16.4% in ≥65 years subgroup), most commonly dizziness (5.0%), headache (2.1%) and somnolence (1.6%).ConclusionsLacosamide was effective and well tolerated as first‐line or conversion to monotherapy in a clinical setting in adult and elderly patients with focal seizures.

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Section: Discussionsupporting

confidence: 90%

Lacosamide monotherapy in clinical practice: A retrospective chart review

et al. 2018

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“…2,3 Efficacy and safety of lacosamide as adjunctive therapy were established in three randomized, double-blind, placebo-controlled trials. [7][8][9] Monotherapy approval of lacosamide in the EU was based on the results of a large-scale, double-blind trial, which demonstrated that lacosamide was noninferior to controlledrelease carbamazepine (carbamazepine-CR) and was well tolerated as first-line monotherapy in patients with newly diagnosed epilepsy. [7][8][9] Monotherapy approval of lacosamide in the EU was based on the results of a large-scale, double-blind trial, which demonstrated that lacosamide was noninferior to controlledrelease carbamazepine (carbamazepine-CR) and was well tolerated as first-line monotherapy in patients with newly diagnosed epilepsy.…”

Section: Introductionmentioning

confidence: 99%

Long‐term safety and efficacy of lacosamide and controlled‐release carbamazepine monotherapy in patients with newly diagnosed epilepsy

et al. 2019

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Objective: A large-scale, double-blind trial (SP0993; NCT01243177) demonstrated that lacosamide was noninferior to controlled-release carbamazepine (carbamazepine-CR) in terms of efficacy, and well tolerated as first-line monotherapy in patients (≥16 years of age) with newly diagnosed epilepsy. We report primary safety outcomes from the double-blind extension of the noninferiority trial (SP0994; NCT01465997) and post hoc analyses of pooled long-term safety and efficacy data from both trials. Methods: Patients were randomized 1:1 to lacosamide or carbamazepine-CR. Doses were escalated (lacosamide: 200/400/600 mg/d; carbamazepine-CR: 400/800/1200 mg/d) based on seizure control. Eligible patients continued randomized treatment in the extension. Primary outcomes of the extension were treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuations due to TEAEs. Post hoc analyses of data from combined trials included 12-and 24-month seizure freedom and TEAEs by number of comorbid conditions. Results: A total of 886 patients were treated in the initial trial and 548 in the extension; 211 of 279 patients (75.6%) on lacosamide and 180/269 (66.9%) on carbamazepine-CR completed the extension. In the extension, 181 patients (64.9%) on lacosamide and 182 (67.7%) on carbamazepine-CR reported TEAEs; in both groups, nasopharyngitis, headache, and dizziness were most common. Serious TEAEs were reported by 32 patients (11.5%) on lacosamide and 22 (8.2%) on carbamazepine-CR; 12 (4.3%) and 21 (7.8%) discontinued due to TEAEs. In the combined trials (median exposure: lacosamide 630 days; carbamazepine-CR 589 days), Kaplan-Meier estimated proportions of patients with 12-and 24-month seizure freedom from first dose were 50.8% (95% confidence interval 46.2%-55.4%) and 47.0% (42.2%-51.7%) on lacosamide, and 54.9% (50.3%-59.6%) and 50.9% (46.0%-55.7%) on carbamazepine-CR. Incidences of drug-related TEAEs and discontinuations due to TEAEs increased by number of comorbid conditions and were lower in patients on lacosamide.This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmerc ial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

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“…In the 3 long‐term extension studies, efficacy was assessed within the “yearly completer cohort.” As expected, the responder rates increased over time because, according to this design, efficacy was assessed only in those individuals remaining on LCM for 1‐5 years, thus did not reflect the efficacy profile of LCM in the real world.…”

Section: Discussionmentioning

confidence: 99%

Long‐term efficacy of add‐on lacosamide treatment in children and adolescents with refractory epilepsies: A single‐center observational study

et al. 2018

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Long-term adjunctive lacosamide treatment in patients with partial-onset seizures

Abstract: In eligible patients who entered the open-label extension trial, lacosamide was generally well tolerated. For most patients within each yearly completer cohort, seizure reduction was maintained over time.

Cited by 39 publications

References 12 publications

Lacosamide monotherapy in clinical practice: A retrospective chart review

Lacosamide monotherapy in clinical practice: A retrospective chart review

Long‐term safety and efficacy of lacosamide and controlled‐release carbamazepine monotherapy in patients with newly diagnosed epilepsy

Long‐term efficacy of add‐on lacosamide treatment in children and adolescents with refractory epilepsies: A single‐center observational study

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