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Lacosamide (Vimpat) is a newly licensed novel antiepileptic drug. We report a case of refractory convulsive status epilepticus (CSE) that was successfully controlled with lacosamide. The 38‐year‐old male patient was admitted for a series of complex partial seizures with secondary generalization leading to refractory CSE. During the transport to the hospital the patient was given 22.5 mg diazepam,...
Purpose: Lacosamide is a new antiepileptic drug effective for adjunctive treatment of partial‐onset seizures. We evaluated the safety and tolerability of an intravenous (i.v.) formulation of lacosamide (200–800 mg/day) infused over 10, 15, and 30 min as short‐term replacement for oral lacosamide in patients with partial‐onset seizures.
Methods: This multicenter, open‐label, inpatient trial enrolled...
Purpose: To evaluate the efficacy and safety of lacosamide (400 and 600 mg/day) as adjunctive treatment in patients with uncontrolled partial‐onset seizures taking one to three concomitant antiepileptic drugs (AEDs).
Methods: This multicenter, double‐blind, placebo‐controlled trial randomized patients 1:2:1 to placebo, lacosamide 400 mg, or lacosamide 600 mg/day. After an 8‐week baseline period,...
Current standard treatment of established status epilepticus after failure of benzodiazepines is intravenous phenytoin/fosphenytoin, phenobarbital, or valproate. Since 2006 two new antiseizure drugs have become available as intravenous formulation: levetiracetam (2006) and lacosamide (2008). Both drugs have been taken up very rapidly by the clinicians to treat acute seizures and status epilepticus,...
Purpose: Lacosamide is a new antiepileptic drug that has a novel mechanism of action, linear pharmacokinetics, and proven efficacy in the adjunctive treatment of partial‐onset seizures. We ascertained the relationship between serum and saliva lacosamide concentrations so as to determine whether saliva may be a useful alternative to serum for therapeutic drug monitoring.
Methods: Blood samples were...
Dose‐dependent PR interval prolongation has been reported in preclinical studies of lacosamide (LCM), a recently U.S. Food and Drug Administration (FDA)–approved antiepileptic drug (AED). Here we report a case of second‐degree atrioventricular block (AV) block caused by the addition of LCM to other AEDs known to prolong the PR interval, resulting in hypotension and bradycardia, with consequent seizure...
Purpose: To evaluate the long‐term (up to 5 years exposure) safety and efficacy of lacosamide as adjunctive therapy in patients with uncontrolled partial‐onset seizures taking one to three concomitant antiepileptic drugs (AEDs) in open‐label extension trial SP756 (NCT00522275).
Methods: Patients who completed the double‐blind trial SP754 (NCT00136019) were eligible to participate in this open‐label...
Purpose: In chronic epilepsy, a substantial proportion of up to 30% of patients remain refractory to antiepileptic drugs (AEDs). An understanding of the mechanisms of pharmacoresistance requires precise knowledge of how AEDs interact with their targets. Many commonly used AEDs act on the transient and/or the persistent components of the voltage‐gated Na+ current (INaT and INaP, respectively). Lacosamide...
Nonconvulsive seizures (NCS) and nonconvulsive status epilepticus (NCSE) are electrographic seizures (ESz) that are not associated with overt clinical seizure activity. NCS are distinct ESz, whereas NCSE has ongoing, continuous electrographic seizure activity. Both are common in critically ill patients admitted to hospital intensive care units (ICUs), and studies have shown that about 20% of ICU patients...
Purpose: To test for bioequivalence of 200 mg lacosamide oral tablet and syrup formulations. Additional objectives were to compare the pharmacokinetic profile of lacosamide in saliva and plasma, and to evaluate its tolerability.
Methods: This open‐label, randomized, two‐way crossover trial was conducted in 16 healthy Caucasian male participants in Germany. The bioequivalence of 200 mg lacosamide...
Purpose: To examine the safety and tolerability of rapidly initiating adjunctive lacosamide via a single intravenous loading dose followed by twice‐daily oral lacosamide in lacosamide‐naive adults with partial‐onset seizures.
Methods: This open‐label, multicenter trial, enrolled patients with epilepsy who were taking 1–2 antiepileptic drugs (AEDs) in one of four sequential cohorts containing 25...
Purpose: Defining the tolerability and safety profile of recently marketed antiepileptic drugs, such as lacosamide (LCM), is a prerequisite for their optimal utilization in clinical practice. We aimed to identify any adverse event (AE) associated with LCM treatment by conducting a systematic review and meta‐analysis of all available randomized controlled trials (RCTs). We also evaluated the association...
PurposeTo determine whether the antiepileptic drug lacosamide affects the pharmacokinetics or pharmacodynamics of a combined oral contraceptive (OC; ethinylestradiol 0.03 mg plus levonorgestrel 0.15 mg).
MethodsThis was an open‐label trial in healthy female volunteers. Eligible women entered cycle 1 of the trial on the first day of menstruation. Cycle 1 was a medication‐free, run‐in phase of approximately...
Status epilepticus is among the most common neurologic emergencies, with a mortality rate of up to 20%. The most important therapeutic goal is fast, effective, and well‐tolerated cessation of status epilepticus. Intravenous phenytoin/fosphenytoin, phenobarbital, or valproate is the current standard treatment after failure of benzodiazepines. Lacosamide as a new antiepileptic drug has been available...
Lacosamide, a recently introduced antiepileptic drug, acts by enhancing the slow inactivation of voltage‐dependent sodium channels. Cardiac conduction disturbances, namely atrial fibrillation and atrioventricular block, have been reported in patients with epilepsy. We report a patient with drug‐resistant focal epilepsy who developed asymptomatic sinus node dysfunction following lacosamide use, which...
PurposeThe antiepileptic drug, lacosamide, exerts its therapeutic activity by enhancing slow inactivation of voltage‐gated sodium channels. Because putative preventive or disease‐modifying effects of drugs may affect epileptogenesis, intrinsic severity, and comorbidities, it is of particular interest to assess the effect of lacosamide on the development of epilepsy and associated cellular alterations...
PurposeThe aim of this study was to evaluate the effect of the antiepileptic drug lacosamide on the pharmacokinetics and pharmacodynamics of the anticoagulant warfarin.
MethodsIn this open‐label, two‐treatment crossover study, 16 healthy adult male volunteers were randomized to receive a single 25‐mg dose of warfarin alone in one period and lacosamide 200 mg twice daily on days 1–9 with a single...
PurposeAntiepileptic drugs (AEDs) do not effectively treat 30–40% of patients with epilepsy. Export of AEDs by P‐glycoprotein (Pgp, ABCB1, or MDR1), which is overexpressed in the blood–brain barrier in drug‐resistant patients, may be a mechanism for resistance to AEDs. For most recently approved AEDs, whether they are transported by Pgp is unknown. We investigated whether a new AED, lacosamide (LCM),...
ObjectiveTo evaluate the efficacy and safety of conversion to lacosamide 400 mg/day monotherapy in adults with focal epilepsy.
MethodsThis historical‐controlled, double‐blind study (NCT00520741) enrolled patients aged 16–70 years on stable doses of 1–2 antiepileptic drugs (AEDs) and experiencing 2–40 partial‐onset seizures per 28 days during the 8‐week prospective Baseline. Patients were randomized...
ObjectiveTo assess long‐term use and safety of lacosamide (LCM) ≤800 mg/day monotherapy in patients with partial‐onset seizures (POS) enrolled previously in a historical‐controlled, conversion‐to‐monotherapy study (SP902; NCT00520741).
MethodsPatients completing or exiting SP902 with LCM as monotherapy or as adjunctive therapy were eligible to enter this 2‐year open‐label extension (OLE) trial (SP904;...
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