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Review of levetiracetam, with a focus on the extended release formulation, as adjuvant therapy in controlling partial-onset seizures
Carol M Ulloa, Allen Towfigh, Joseph Safdieh
Neuropsychiatric Disease and Treatment , 2009, DOI: http://dx.doi.org/10.2147/NDT.S4844
Abstract: f levetiracetam, with a focus on the extended release formulation, as adjuvant therapy in controlling partial-onset seizures Review (5282) Total Article Views Authors: Carol M Ulloa, Allen Towfigh, Joseph Safdieh Published Date September 2009 Volume 2009:5 Pages 467 - 476 DOI: http://dx.doi.org/10.2147/NDT.S4844 Carol M Ulloa, Allen Towfigh, Joseph Safdieh Department of Neurology and Neuroscience, Weill Medical College of Cornell University, New York, NY, USA Abstract: Levetiracetam is a second-generation antiepileptic drug (AED) with a unique chemical structure and mechanism of action. The extended release formulation of levetiracetam (Keppra XR ; UCB Pharma) was recently approved by the Food and Drug Administration for adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. This approval is based on a double-blind, randomized, placebo-controlled, multicenter, multinational trial. Levetiracetam XR allows for once-daily dosing, which may increase compliance and, given the relatively constant plasma concentrations, may minimize concentration-related adverse effects. Levetiracetam’s mode of action is not fully elucidated, but it has been found to target high-voltage, N-type calcium channels as well as the synaptic vesicle protein 2A (SV2A). Levetiracetam has nearly ideal pharmacokinetics. It is rapidly and almost completely absorbed after oral ingestion, is 10% protein-bound, demonstrates linear kinetics, is minimally metabolized through a pathway independent of the cytochrome P450 system, has no significant drug–drug interactions, and has a wide therapeutic index. The most common reported adverse events with levetiracetam XR were somnolence, irritability, dizziness, nausea, influenza, and nasopharyngitis. Levetiracetam XR provides an efficacious and well-tolerated treatment option for adjunctive therapy in the treatment of partial-onset seizures.
Review of levetiracetam, with a focus on the extended release formulation, as adjuvant therapy in controlling partial-onset seizures  [cached]
Carol M Ulloa,Allen Towfigh,Joseph Safdieh
Neuropsychiatric Disease and Treatment , 2009,
Abstract: Carol M Ulloa, Allen Towfigh, Joseph SafdiehDepartment of Neurology and Neuroscience, Weill Medical College of Cornell University, New York, NY, USAAbstract: Levetiracetam is a second-generation antiepileptic drug (AED) with a unique chemical structure and mechanism of action. The extended release formulation of levetiracetam (Keppra XR ; UCB Pharma) was recently approved by the Food and Drug Administration for adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. This approval is based on a double-blind, randomized, placebo-controlled, multicenter, multinational trial. Levetiracetam XR allows for once-daily dosing, which may increase compliance and, given the relatively constant plasma concentrations, may minimize concentration-related adverse effects. Levetiracetam’s mode of action is not fully elucidated, but it has been found to target high-voltage, N-type calcium channels as well as the synaptic vesicle protein 2A (SV2A). Levetiracetam has nearly ideal pharmacokinetics. It is rapidly and almost completely absorbed after oral ingestion, is 10% protein-bound, demonstrates linear kinetics, is minimally metabolized through a pathway independent of the cytochrome P450 system, has no significant drug–drug interactions, and has a wide therapeutic index. The most common reported adverse events with levetiracetam XR were somnolence, irritability, dizziness, nausea, influenza, and nasopharyngitis. Levetiracetam XR provides an efficacious and well-tolerated treatment option for adjunctive therapy in the treatment of partial-onset seizures.Keywords: levetiracetam, partial-onset seizures, antiepileptic drugs
Safety and efficacy of levetiracetam for the treatment of partial onset seizures in children from one month of age
Cormier J, Chu CJ
Neuropsychiatric Disease and Treatment , 2013, DOI: http://dx.doi.org/10.2147/NDT.S30224
Abstract: fety and efficacy of levetiracetam for the treatment of partial onset seizures in children from one month of age Review (684) Total Article Views Authors: Cormier J, Chu CJ Published Date February 2013 Volume 2013:9 Pages 295 - 306 DOI: http://dx.doi.org/10.2147/NDT.S30224 Received: 22 December 2012 Accepted: 21 January 2013 Published: 21 February 2013 Justine Cormier, Catherine J Chu Massachusetts General Hospital, Department of Neurology, Programs in Child Neurology and Neurophysiology, Boston, MA, USA Abstract: Epilepsy is a common neurological disorder in the pediatric population, affecting up to one percent of children, and for which the mainstay of treatment is anticonvulsant medication. Despite the frequent use of anticonvulsant drugs, remarkably little is known about the safety and efficacy of most of these medications in the pediatric epilepsy population. Of 34 anticonvulsants currently approved for use by the US Food and Drug Administration (FDA), only 13 have been approved for use in children. Although infants and young children are disproportionately affected by epilepsy, there are currently only three anticonvulsant medications that have been specifically evaluated and approved for use in children younger than 2 years of age. In 2012, the FDA approved levetiracetam as an adjunctive treatment for partial onset seizures in infants and children from one month of age. Here we review the available data on levetiracetam in the pediatric epilepsy population. We first discuss the pharmacological profile of levetiracetam, including its mechanism of action, formulations and dosing, and pharmacokinetics in children. We then review the available efficacy, safety, and tolerability data in children from one month of age with partial onset seizures. We conclude that the current data leading to the approval of levetiracetam for use in infants and children with partial onset seizures is encouraging, although more work needs to be done before definitive conclusions can be drawn about the efficacy of levetiracetam across different pediatric age groups.
Safety and efficacy of levetiracetam for the treatment of partial onset seizures in children from one month of age  [cached]
Cormier J,Chu CJ
Neuropsychiatric Disease and Treatment , 2013,
Abstract: Justine Cormier, Catherine J ChuMassachusetts General Hospital, Department of Neurology, Programs in Child Neurology and Neurophysiology, Boston, MA, USAAbstract: Epilepsy is a common neurological disorder in the pediatric population, affecting up to one percent of children, and for which the mainstay of treatment is anticonvulsant medication. Despite the frequent use of anticonvulsant drugs, remarkably little is known about the safety and efficacy of most of these medications in the pediatric epilepsy population. Of 34 anticonvulsants currently approved for use by the US Food and Drug Administration (FDA), only 13 have been approved for use in children. Although infants and young children are disproportionately affected by epilepsy, there are currently only three anticonvulsant medications that have been specifically evaluated and approved for use in children younger than 2 years of age. In 2012, the FDA approved levetiracetam as an adjunctive treatment for partial onset seizures in infants and children from one month of age. Here we review the available data on levetiracetam in the pediatric epilepsy population. We first discuss the pharmacological profile of levetiracetam, including its mechanism of action, formulations and dosing, and pharmacokinetics in children. We then review the available efficacy, safety, and tolerability data in children from one month of age with partial onset seizures. We conclude that the current data leading to the approval of levetiracetam for use in infants and children with partial onset seizures is encouraging, although more work needs to be done before definitive conclusions can be drawn about the efficacy of levetiracetam across different pediatric age groups.Keywords: levetiracetam, anticonvulsant drug, partial seizures, pediatric epilepsy
Levetiracetam in the treatment of epilepsy  [cached]
Bassel Abou-Khalil
Neuropsychiatric Disease and Treatment , 2008,
Abstract: Bassel Abou-KhalilDepartment of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee, USAAbstract: Epilepsy is a common chronic disorder that requires long-term antiepileptic drug therapy. Approximately one half of patients fail the initial antiepileptic drug and about 35% are refractory to medical therapy, highlighting the continued need for more effective and better tolerated drugs. Levetiracetam is an antiepileptic drug marketed since 2000. Its novel mechanism of action is modulation of synaptic neurotransmitter release through binding to the synaptic vesicle protein SV2A in the brain. Its pharmacokinetic advantages include rapid and almost complete absorption, minimal insignificant binding to plasma protein, absence of enzyme induction, absence of interactions with other drugs, and partial metabolism outside the liver. The availability of an intravenous preparation is yet another advantage. It has been demonstrated effective as adjunctive therapy for refractory partial-onset seizures, primary generalized tonic-clonic seizures, and myoclonic seizures of juvenile myoclonic epilepsy. In addition, it was found equivalent to controlled release carbamazepine as first-line therapy for partial-onset seizures, both in efficacy and tolerability. Its main adverse effects in randomized adjunctive trials in adults have been somnolence, asthenia, infection, and dizziness. In children, the behavioral adverse effects of hostility and nervousness were also noted. Levetiracetam is an important addition to the treatment of epilepsy.Keywords: epilepsy, seizures, antiepileptic drugs, long-term therapy, efficacy, safety, levetiracetam
Extended Antiepileptic Drug Prophylaxis and Late Onset Seizures in Aneurysmal Subarachnoid Hemorrhage  [PDF]
Wen Hao Low, Qing Yuan Goh, Miqi Mavis Teo
Open Journal of Modern Neurosurgery (OJMN) , 2019, DOI: 10.4236/ojmn.2019.94037
Abstract: Background: The indication and optimal duration of antiepileptic drug (AED) prophylaxis after aneurysmal subarachnoid hemorrhage (SAH) remains controversial. Our institution practices routine seizure prophylaxis for variable durations at the discretion of the neurosurgeon and neuro-intensivist. Given the propensity of late onset seizures to progress to chronic epilepsy, we sought to investigate the efficacy of extended AED prophylaxis in reducing the risk of late seizures. Methods: This retrospective study analyzed 36 patients who were admitted to our neurosurgical intensive care unit (NICU) over a 2-year period (1st November 2015 to 31st October 2017). All hospital admissions records, electronic medication records as well as outpatient visits up to 1 year were reviewed. Late onset seizures were defined as seizures occurring more than 7 days post-intervention (or presentation if no intervention was performed) up to 1 year of follow-up. Results: Majority of the patients received Levetiracetam (94%) as seizure prophylaxis and late onset seizures occurred in 6 (17%) of the patients. Those patients who received a greater proportion of in-patient stay with AED prophylaxis had a statistically significant lower risk of developing late seizures (OR = 0.964, 95%, p = 0.02). Although the value tended towards benefit (OR = 0.382) for AED > 21 days in-hospital, the result was not statistically significant (p = 0.307). Conclusion: An extended duration of AED prophylaxis, in particular Levetiracetam, may confer some benefit in reducing risk of developing late seizures. However, the optimal duration of therapy is yet to be determined and further large multi-centered randomized studies are necessary.
Cost-effectiveness analysis of intravenous levetiracetam versus intravenous phenytoin for early onset seizure prophylaxis after neurosurgery and traumatic brain injury
Rashid Kazerooni, Mark Bounthavong
ClinicoEconomics and Outcomes Research , 2010, DOI: http://dx.doi.org/10.2147/CEOR.S8965
Abstract: st-effectiveness analysis of intravenous levetiracetam versus intravenous phenytoin for early onset seizure prophylaxis after neurosurgery and traumatic brain injury Original Research (4306) Total Article Views Authors: Rashid Kazerooni, Mark Bounthavong Published Date March 2010 Volume 2010:2 Pages 15 - 23 DOI: http://dx.doi.org/10.2147/CEOR.S8965 Rashid Kazerooni1, Mark Bounthavong1,2 1Pharmacoeconomics/Formulary Management, Veterans Affairs San Diego Healthcare System, San Diego, CA, USA; 2UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences, San Diego, CA, USA Objective: There has been growing interest in newer anti-epileptic drugs (AEDs) for seizure prophylaxis in the intensive care setting because of safety and monitoring issues associated with conventional AEDs like phenytoin. This analysis assessed the cost-effectiveness of levetiracetam versus phenytoin for early onset seizure prophylaxis after neurosurgery and traumatic brain injury (TBI). Methods: A cost-effectiveness analysis was conducted from the US hospital perspective using a decision analysis model. Probabilities of the model were taken from three studies comparing levetiracetam and phenytoin in post neurosurgery or TBI patients. The outcome measure was successful seizure prophylaxis regimen (SSPR) within 7 days, which was defined as patients who did not seize or require discontinuation of the AED due to adverse drug reactions (ADRs). One-way sensitivity analyses and probabilistic sensitivity analysis were conducted to test robustness of the base-case results. Results: The total direct costs for seizure prophylaxis were $8,784.63 and $8,743.78 for levetiracetam and phenytoin, respectively. The cost-effectiveness ratio of levetiracetam was $10,044.91 per SSPR compared to $11,525.63 per SSPR with phenytoin. The effectiveness probability (patients with no seizures and no ADR requiring change in therapy) was higher in the levetiracetam group (87.5%) versus the phenytoin group (75.9%). The incremental cost effectiveness ratio for levetiracetam versus phenytoin was $360.82 per additional SSPR gained. Conclusions: Levetiracetam has the potential to be more cost-effective than phenytoin for early onset seizure prophylaxis after neurosurgery if the payer’s willingness-to-pay is greater than $360.82 per additional SSPR gained.
Cost-effectiveness analysis of intravenous levetiracetam versus intravenous phenytoin for early onset seizure prophylaxis after neurosurgery and traumatic brain injury  [cached]
Rashid Kazerooni,Mark Bounthavong
ClinicoEconomics and Outcomes Research , 2010,
Abstract: Rashid Kazerooni1, Mark Bounthavong1,21Pharmacoeconomics/Formulary Management, Veterans Affairs San Diego Healthcare System, San Diego, CA, USA; 2UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences, San Diego, CA, USAObjective: There has been growing interest in newer anti-epileptic drugs (AEDs) for seizure prophylaxis in the intensive care setting because of safety and monitoring issues associated with conventional AEDs like phenytoin. This analysis assessed the cost-effectiveness of levetiracetam versus phenytoin for early onset seizure prophylaxis after neurosurgery and traumatic brain injury (TBI).Methods: A cost-effectiveness analysis was conducted from the US hospital perspective using a decision analysis model. Probabilities of the model were taken from three studies comparing levetiracetam and phenytoin in post neurosurgery or TBI patients. The outcome measure was successful seizure prophylaxis regimen (SSPR) within 7 days, which was defined as patients who did not seize or require discontinuation of the AED due to adverse drug reactions (ADRs). One-way sensitivity analyses and probabilistic sensitivity analysis were conducted to test robustness of the base-case results.Results: The total direct costs for seizure prophylaxis were $8,784.63 and $8,743.78 for levetiracetam and phenytoin, respectively. The cost-effectiveness ratio of levetiracetam was $10,044.91 per SSPR compared to $11,525.63 per SSPR with phenytoin. The effectiveness probability (patients with no seizures and no ADR requiring change in therapy) was higher in the levetiracetam group (87.5%) versus the phenytoin group (75.9%). The incremental cost effectiveness ratio for levetiracetam versus phenytoin was $360.82 per additional SSPR gained.Conclusions: Levetiracetam has the potential to be more cost-effective than phenytoin for early onset seizure prophylaxis after neurosurgery if the payer’s willingness-to-pay is greater than $360.82 per additional SSPR gained.Keywords: phenytoin, levetiracetam, seizure prophylaxis, cost-effectiveness, traumatic brain injury (TBI), and neurosurgery
Late Onset Poststroke Seizures  [cached]
Ba?ak Karakurum G?KSEL,Mehmet KARATA?,Meliha TAN,,Tülin YILDIRIM
Journal of Neurological Sciences , 2005,
Abstract: The most common cause of seizures is cerebrovascular disease in elderly population. Late onset seizures are not investigated as well as early onset seizures in patients with stroke. There is no common consensus about clinical, electrophysiological and radiological features of these seizures. In this study, 55 patients with late onset seizure who had stroke history were investigated. The 49 % of patients were women, the mean ages of patients were 63.9±9.2 years. The mean of duration between stroke and the first seizure was 30.4±36.8 months and the mean of following time was 14±13 months. The 89% of patients ischemic stroke and 11% of patients had hemorrhagic stroke. The lesion localizations were cortical in 17 (30.9%) patients, subcortical in 8 (14.5%) and cortico-subcortical in 29 (52.7%). As a result 84 % patients’ lesions were cortical localization. There were partial seizure in 39 (%70.9) patients, generalized tonic-clonic seizure in 16 (29.1%) patients. 43 (78%) patients had no seizure during antiepileptic therapy. 7 (12.7%) patients had seizure after beginning antiepileptic drug due to stopping drug, low blood level of drug and ineffectiveness of drug. 5 (9%) patients had not been given drug because of first seizure and no seizure during follow-up. In conclusion, the late onset poststroke seizures seem frequently in ischemic stroke, the reccurence rate was high and partial type seizures were more common than generalized and cortical localization was seen frequently. On the other hand, this condition has good prognosis.
Levetiracetam Use in the Critical Care Setting  [PDF]
Jennifer L. DeWolfe,Jerzy P. Szaflarski
Frontiers in Neurology , 2013, DOI: 10.3389/fneur.2013.00121
Abstract: Intravenous (IV) levetiracetam (LEV) is currently approved as an alternative or replacement therapy for patients unable to take the oral form of this antiepileptic drug (AED). The oral form has Food and Drug Administration (FDA) indications for adjunctive therapy in the treatment of partial onset epilepsy ages 1 month or more, myoclonic seizures associated with juvenile myoclonic epilepsy starting with the age of 12 and primary generalized tonic-clonic seizures in people 6 years and older. Since the initial introduction, oral and IV LEV has been evaluated in various studies conducted in the critical care setting for the treatment of status epilepticus, stroke-related seizures, seizures following subarachnoid or intracerebral hemorrhage, post-traumatic seizures, tumor-related seizures, and seizures in critically ill patients. Additionally, studies evaluating rapid infusion of IV LEV and therapeutic monitoring of serum LEV levels in different patient populations have been performed. In this review we present the current state of knowledge on LEV use in the critical care setting focusing on the IV uses and discuss future research needs.
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