Tuesday, May 23, 2017

Lacosamide and status epilepticus

Strzelczyk A, Zöllner JP, Willems LM, Jost J, Paule E, Schubert-Bast S, Rosenow F, Bauer S. Lacosamide in status epilepticus: Systematic review of current evidence. Epilepsia. 2017 Mar 11. doi: 10.1111/epi.13716. [Epub ahead of print]

Abstract
OBJECTIVE:
The intravenous formulation of lacosamide (LCM) and its good overall tolerability and safety favor the use in status epilepticus (SE). The aim of this systematic review was to identify and evaluate studies reporting on the use of LCM in SE.
METHODS:
We performed a systematic literature search of electronic databases using a combined search strategy from 2008 until October 2016. Using a standardized assessment form, information on the study design, methodologic framework, data sources, efficacy, and adverse events attributed to LCM were extracted from each publication and systematically reported.
RESULTS:
In total, 522 SE episodes (51.7% female) in 486 adults and 36 children and adolescents were evaluated with an overall LCM efficacy of 57%. Efficacy was comparable between use in nonconvulsive (57%; 82/145) and generalized-convulsive (61%; 30/49; p = 0.68) SE, whereas overall success rate was better in focal motor SE (92%; 34/39, p = 0.013; p < 0.001). The efficacy with later positioning of LCM decreased from 100% to 20%. The main adverse events during treatment of SE are dizziness, abnormal vision, diplopia, and ataxia. Overall, lacosamide is well tolerated and has no clinically relevant drug-drug interactions.
SIGNIFICANCE:
The available data regarding the use of LCM in SE are promising, with a success rate of 57%. The strength of LCM is the lack of interaction potential and the option for intravenous use in emergency situations requiring rapid uptitration.

Misra UK, Dubey D, Kalita J. A randomized controlled trial of lacosamide versus sodium valproate in status epilepticus. Epilepsia. 2017 Feb 18. doi:10.1111/epi.13706. [Epub ahead of print]

Abstract
OBJECTIVE:
To compare the efficacy and safety of lacosamide (LCM) and sodium valproate (SVA) in lorazepam (LOR)-resistant status epilepticus (SE).
METHODS:
Patients with LOR-resistant SE were randomized to intravenous LCM 400 mg at a rate of 60 mg/kg/min or SVA 30 mg/kg at a rate of 100 mg/min. The SE severity score (STESS), duration of SE and its etiology, and magnetic resonance imaging (MRI) findings were noted. Primary outcome was seizure cessation for 1 h, and secondary outcomes were 24 h seizure remission, in hospital death and severe adverse events (SAEs).
RESULTS:
Sixty-six patients were included, and their median age was 40 (range 18-90) years. Thirty-three patients each received LCM and SVA. Their demographic, clinical, STESS, etiology, and MRI findings were not significantly different. One hour seizure remission was not significantly different between LCM and SVA groups (66.7% vs. 69.7%; p = 0.79). Twenty-four hour seizure freedom was higher in SVA (20, 66.6%) compared with LCM group (15, 45.5%), but this difference was not statistically significant. Death (10 vs. 12) and composite side effects (4 vs. 6) were also not significantly different in LCM and SVA groups. LCM was associated with hypotension and bradycardia (one patient), and SVA with liver dysfunction (six patients).
SIGNIFICANCE:
In LOR-resistant SE patients, both LCM and SVA have comparable efficacy and safety. SVA resulted in slightly better 24 h seizure remission.

Verrotti A, Ambrosi M, Pavone P, Striano P. Pediatric status epilepticus: improved management with new drug therapies? Expert Opin Pharmacother. 2017 May 19:1-10. doi:10.1080/14656566.2017.1323873. [Epub ahead of print]

Abstract
INTRODUCTION:
Status Epilepticus (SE) is the most common neurological emergency of childhood. It requires prompt administration of appropriately selected anti-seizure medications. Areas covered: Following a distinction between estabilished and emergent drugs, we present pharmacological treatment options and their clinical utility in children, with a short mention on alternatives to drug treatment. We also propose an algorithm for the management of pediatric SE. For this review a Pubmed, Medline and Embase search was performed. Expert opinion: In early SE in children, in the prehospital setting, rectal diazepam or buccal midazolam are efficacious drugs; whereas in the hospital setting, intravenous lorazepam or diazepam are indicated. As regard estabilished stage of SE, in addition to the 'classic' compounds, such as phenytoin and phenobarbital, other drugs such as valproic acid, levetiracetam and lacosamide have been demonstrated efficacious. Treatment recommendations of refractory SE depend on retrospective case series and uncontrolled studies. We reported experiences about the use of midazolam, propofol, ketamine and lidocaine. They could be a valid option, but further prospective studies are necessary. Over the last few decades, important advances in basic mechanisms underlying refractory SE have been achieved, but few data are available regarding management of these stages.

Bauer S, Willems LM, Paule E, Petschow C, Zöllner JP, Rosenow F, Strzelczyk A.The efficacy of lacosamide as monotherapy and adjunctive therapy in focal epilepsy and its use in status epilepticus: clinical trial evidence and experience. Ther Adv Neurol Disord. 2017 Feb;10(2):103-126.

Abstract
Lacosamide (LCM) is approved for anticonvulsive treatment in focal epilepsy and exhibits its function through the slow inactivation of voltage-gated sodium channels (VGSCs). LCM shows comparable efficacy with other antiepileptic drugs (AEDs) licensed in the last decade: in three randomized placebo-controlled trials, significant median seizure reduction rates of 35.2% for 200 mg/day, 36.4-39% for 400 mg/day and 37.8-40% for 600 mg/day were reported. Likewise, 50% responder rates were 38.3-41.1% for 400 mg/day and 38.1-41.2% for 600 mg/day. Similar rates were reported in post-marketing studies. The main adverse events (AEs) are dizziness, abnormal vision, diplopia and ataxia. Overall, LCM is well tolerated and has no clinically-relevant drug-drug interactions. Due to the drug's intravenous availability, its use in status epilepticus (SE) is increasing, and the available data are promising.

Matthieu Perrenoud, Pascal André, Vincent Alvarez, Christine Stähli, Laurent A. Decosterd, Andrea O. Rossetti, Jan Novy.  Intravenous lacosamide in status epilepticus: Correlation between loading dose, serum levels, and clinical response.  Epilepsy research. [Epub ahead of print]

Abstract
Introduction
Intravenous lacosamide (LCM) is increasingly used in the treatment of status epilepticus (SE), but optimal loading dose and target serum levels are unclear. We analysed the correlation between LCM serum levels after intravenous loading dose and clinical response.

Materials and methods
Retrospective study in two centres from December 2014 to May 2016 including consecutive SE patients treated with LCM, in which trough serum levels after intravenous loading dose were available. Trough levels were correlated with the loading dose and the clinical response, defined as LCM introduction terminating SE without the need of further treatment. Correlations were adjusted for other SE characteristics.

Results
Among 40 patients, 16 (40%) responded to LCM. LCM serum concentrations within the reference interval (10–20 mg/l) were associated with loading doses of >9 mg/kg (p = 0.003; χ2). However, we observed no difference between LCM serum levels in responders (median 10.4 mg/l) versus non-responders (median 9.5 mg/l; p = 0.36; U-test), even after adjusting for other predictors of clinical outcome (SE severity, aetiology, and number of previous treatment).

Discussion

High intravenous LCM loading doses ( > 9 mg/kg) were associated with serum levels within the reference interval, there was however no correlation with the clinical response. Prospective studies are needed to evaluate the benefit of increasing the LCM loading dose in SE.

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