Initial post marketing experience with lacosamide in adult patients with epilepsy

Harden, Cynthia L.; Cohn, Aaron; Lowe, Merredith R.; Serrano, Enrique

doi:10.1016/j.eplepsyres.2011.09.010

Cited by 23 publications

(29 citation statements)

References 7 publications

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“…Of these trials, some, including the abovementioned studies by Flores et al and Novy et al, did not notice an interaction between LCM and concomitant AED use. The primary focus of such trials was to evaluate the efficacy of LCM . Other trials, which focused primarily on the tolerability of LCM, reported more neurotoxic AEs among patients taking LCM with concomitant SCBs .…”

Section: Discussionmentioning

confidence: 99%

“…The primary focus of such trials was to evaluate the efficacy of LCM. 6,7,26 Other trials, which focused primarily on the tolerability of LCM, reported more neurotoxic AEs among patients taking LCM with concomitant SCBs. 8,27 The design and methodology of our study is in concordance with the study by McGinnis et al, 9 which reported a significant difference between LCM retention rates in the presence and absence of concomitant SCB use.…”

Section: Discussionmentioning

confidence: 99%

“…According to Cawello “this [sodium channel activation] mechanism of action results in stabilization of hyperexcitable neuronal membranes, inhibition of neuronal firing and reduction in long‐term channel availability without affecting physiological function.” Following the licensure of LCM, several clinical trials, which included mostly adult patients without intellectual disabilities (IDs), were conducted to evaluate the efficacy and safety of the drug . According to a pooled analysis of phase II/III studies, LCM provides additional efficacy when combined with a broad range of AEDs and is generally well tolerated . Adverse events are mostly dose dependent; restricted to the central nervous system and gastrointestinal system; and include dizziness, diplopia, somnolence, headache, nausea, and/or vomiting .…”

mentioning

confidence: 99%

“…[3][4][5] According to a pooled analysis of phase II/III studies, LCM provides additional efficacy when combined with a broad range of AEDs 6 and is generally well tolerated. 3,7 Adverse events are mostly dose dependent; restricted to the central nervous system and gastrointestinal system; and include dizziness, diplopia, somnolence, headache, nausea, and/or vomiting. 6 Other trials have demonstrated a significant decrease in LCM efficacy in the presence of other SCBs.…”

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confidence: 99%

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Lacosamide in the treatment of patients with epilepsy and intellectual disabilities: A long‐term study of 136 patients

2017

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One of the major challenges in medically caring for patients with epilepsy and IDs is the high rate of drug resistance. However, there is a lack of evidence-based information about the efficacy and tolerability of AEDs in this population. It has been shown that concomitant SCB use is a key factor in increasing the risk of LCM failure in children with epilepsy. This finding has not been replicated in our predominantly adult sample of patients with IDs.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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confidence: 99%

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Lacosamide in the treatment of patients with epilepsy and intellectual disabilities: A long‐term study of 136 patients

2017

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“…However, potential pharmacodynamic interactions of LCM with traditional SCB, and whether the mechanisms are sufficiently similar to increase treatment emergent adverse effect risk, is still unclear. Some studies have suggested that combined use with SCB increases the adverse effect rate with LCM, whereas others have not found any association . Lowering the dose with or without eventual discontinuation of concomitant SCB may improve the side effect profile of LCM …”

Section: Discussionmentioning

confidence: 99%

Lacosamide use in children with epilepsy: Retention rate and effect of concomitant sodium channel blockers in a large cohort

McGinnis

Kessler

2016

Epilepsia

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SUMMARYObjectives: To evaluate the effectiveness of lacosamide (LCM) in pediatric patients, using time to treatment failure as the outcome measure, and to assess the impact of concomitant sodium channel blocker (SCB) use on LCM retention. Methods: This is a retrospective cohort study of patients <21 years old receiving LCM from 2010 to 2015. Kaplan-Meier survival curves were generated for time to LCM failure, defined as discontinuation of LCM or addition of another antiepileptic therapy. The impact of concomitant use of traditional SCB agents (phenytoin, carbamazepine, oxcarbazepine, and/or lamotrigine) and other factors including age, seizure types, fast drug titration, and prior antiepileptic drug history were evaluated using Cox regression. Results: The analysis cohort included 223 patients, of whom 116 were taking one or more SCBs, with median follow-up of 7.4 months (1-53 months). For all patients, the probability of remaining on LCM without addition of another therapy was 44.7% at 12 months and 25.6% at 24 months. Concomitant SCB use was an independent predictor of time to LCM failure (hazard ratio [HR] 1.91, 95% confidence interval [CI] 1.38-2.65, p < 0.001).Although treatment emergent adverse effects were reported more often in patients taking SCB (65% vs. 39%, p < 0.001), intolerability was rarely the sole reason cited for LCM discontinuation, and SCB use was strongly associated with LCM failure, even when controlling for presence of treatment emergent adverse effects (adjusted HR 1.99, 95% CI 1.36-2.90, p < 0.001). Significance: This study provides observational evidence for treatment persistence of LCM in children, in a large cohort with long-term follow-up, using time to treatment failure as the outcome measure. Concomitant SCB use was a key factor increasing risk of LCM failure, but not due to treatment-emergent adverse effects alone.

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Epilepsie – was tun, wenn das erste Medikament nicht anfallsfrei macht?

Steinhoff

2012

InFo Neurologie

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Initial post marketing experience with lacosamide in adult patients with epilepsy

Cited by 23 publications

References 7 publications

Lacosamide in the treatment of patients with epilepsy and intellectual disabilities: A long‐term study of 136 patients

Lacosamide in the treatment of patients with epilepsy and intellectual disabilities: A long‐term study of 136 patients

Lacosamide use in children with epilepsy: Retention rate and effect of concomitant sodium channel blockers in a large cohort

Epilepsie – was tun, wenn das erste Medikament nicht anfallsfrei macht?

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