Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial
There are no US Food and Drug Administration-approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profil...
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| Vydáno v: | Pediatrics (Evanston) Ročník 145; číslo 6 |
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| Médium: | Journal Article |
| Jazyk: | angličtina |
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United States
01.06.2020
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| ISSN: | 1098-4275, 1098-4275 |
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| Abstract | There are no US Food and Drug Administration-approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates. However, randomized studies have not been performed. Our objectives were to study the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment of neonatal seizures.
The study was a multicenter, randomized, blinded, controlled, phase IIb trial investigating the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment for neonatal seizures of any cause. The primary outcome measure was complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists.
Eighty percent of patients (24 of 30) randomly assigned to phenobarbital remained seizure free for 24 hours, compared with 28% of patients (15 of 53) randomly assigned to levetiracetam (
< .001; relative risk 0.35 [95% confidence interval: 0.22-0.56]; modified intention-to-treat population). A 7.5% improvement in efficacy was achieved with a dose escalation of levetiracetam from 40 to 60 mg/kg. More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
In this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed. |
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| AbstractList | There are no US Food and Drug Administration-approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates. However, randomized studies have not been performed. Our objectives were to study the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment of neonatal seizures.
The study was a multicenter, randomized, blinded, controlled, phase IIb trial investigating the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment for neonatal seizures of any cause. The primary outcome measure was complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists.
Eighty percent of patients (24 of 30) randomly assigned to phenobarbital remained seizure free for 24 hours, compared with 28% of patients (15 of 53) randomly assigned to levetiracetam (
< .001; relative risk 0.35 [95% confidence interval: 0.22-0.56]; modified intention-to-treat population). A 7.5% improvement in efficacy was achieved with a dose escalation of levetiracetam from 40 to 60 mg/kg. More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
In this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed. There are no US Food and Drug Administration-approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates. However, randomized studies have not been performed. Our objectives were to study the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment of neonatal seizures.BACKGROUND AND OBJECTIVESThere are no US Food and Drug Administration-approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates. However, randomized studies have not been performed. Our objectives were to study the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment of neonatal seizures.The study was a multicenter, randomized, blinded, controlled, phase IIb trial investigating the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment for neonatal seizures of any cause. The primary outcome measure was complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists.METHODSThe study was a multicenter, randomized, blinded, controlled, phase IIb trial investigating the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment for neonatal seizures of any cause. The primary outcome measure was complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists.Eighty percent of patients (24 of 30) randomly assigned to phenobarbital remained seizure free for 24 hours, compared with 28% of patients (15 of 53) randomly assigned to levetiracetam (P < .001; relative risk 0.35 [95% confidence interval: 0.22-0.56]; modified intention-to-treat population). A 7.5% improvement in efficacy was achieved with a dose escalation of levetiracetam from 40 to 60 mg/kg. More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).RESULTSEighty percent of patients (24 of 30) randomly assigned to phenobarbital remained seizure free for 24 hours, compared with 28% of patients (15 of 53) randomly assigned to levetiracetam (P < .001; relative risk 0.35 [95% confidence interval: 0.22-0.56]; modified intention-to-treat population). A 7.5% improvement in efficacy was achieved with a dose escalation of levetiracetam from 40 to 60 mg/kg. More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).In this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed.CONCLUSIONSIn this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed. |
| Author | Wang, Sonya Rasmussen, Maynard Rismanchi, Neggy Kim, Jae Le, Ngoc Minh Battin, Malcolm R Harbert, Mary Jo Honold, Jose Kuperman, Rachel Sharpe, Cynthia Lane, Brian Nespeca, Mark Ernstrom, Karin Michelson, David Haas, Richard H Reiner, Gail E Knodel, Ellen Gold, Jeffrey J Arnell, Kathy Joe, Priscilla Lee, Lilly Davis, Suzanne L Raman, Rema Mower, Andrew Bridge, Renee |
| Author_xml | – sequence: 1 givenname: Cynthia surname: Sharpe fullname: Sharpe, Cynthia organization: Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California – sequence: 2 givenname: Gail E surname: Reiner fullname: Reiner, Gail E organization: Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California – sequence: 3 givenname: Suzanne L surname: Davis fullname: Davis, Suzanne L organization: Department of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand – sequence: 4 givenname: Mark surname: Nespeca fullname: Nespeca, Mark organization: Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California – sequence: 5 givenname: Jeffrey J surname: Gold fullname: Gold, Jeffrey J organization: Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California – sequence: 6 givenname: Maynard surname: Rasmussen fullname: Rasmussen, Maynard organization: San Diego Neonatology Inc and – sequence: 7 givenname: Rachel surname: Kuperman fullname: Kuperman, Rachel organization: Pediatric Neurology, University of California, San Francisco Benioff Children's Hospital Oakland, Oakland, California – sequence: 8 givenname: Mary Jo surname: Harbert fullname: Harbert, Mary Jo organization: Department of Neurosciences, School of Medicine, University of California, San Diego and Sharp Mary Birch Hospital for Women & Newborns, San Diego, California – sequence: 9 givenname: David surname: Michelson fullname: Michelson, David organization: Division of Pediatric Neurology, Department of Pediatrics, Loma Linda University Children's Hospital, Loma Linda, California – sequence: 10 givenname: Priscilla surname: Joe fullname: Joe, Priscilla organization: Division of Neonatology, Departments of Pediatrics and – sequence: 11 givenname: Sonya surname: Wang fullname: Wang, Sonya organization: Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California – sequence: 12 givenname: Neggy surname: Rismanchi fullname: Rismanchi, Neggy organization: Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California – sequence: 13 givenname: Ngoc Minh surname: Le fullname: Le, Ngoc Minh organization: Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California – sequence: 14 givenname: Andrew surname: Mower fullname: Mower, Andrew organization: Department of Neurology, Children's Hospital of Orange County, Orange, California – sequence: 15 givenname: Jae surname: Kim fullname: Kim, Jae organization: Division of NeoNatology, Departments of Pediatrics and – sequence: 16 givenname: Malcolm R surname: Battin fullname: Battin, Malcolm R organization: Department of Neonatology, Auckland District Health Board, Auckland, New Zealand; and – sequence: 17 givenname: Brian surname: Lane fullname: Lane, Brian organization: Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California – sequence: 18 givenname: Jose surname: Honold fullname: Honold, Jose organization: Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California – sequence: 19 givenname: Ellen surname: Knodel fullname: Knodel, Ellen organization: Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California – sequence: 20 givenname: Kathy surname: Arnell fullname: Arnell, Kathy organization: Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California – sequence: 21 givenname: Renee surname: Bridge fullname: Bridge, Renee organization: Division of NeoNatology, Departments of Pediatrics and – sequence: 22 givenname: Lilly surname: Lee fullname: Lee, Lilly organization: Neurosciences, School of Medicine, University of California, San Diego, San Diego, California – sequence: 23 givenname: Karin surname: Ernstrom fullname: Ernstrom, Karin organization: Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California – sequence: 24 givenname: Rema surname: Raman fullname: Raman, Rema organization: Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California – sequence: 25 givenname: Richard H surname: Haas fullname: Haas, Richard H email: rhaas@health.ucsd.edu organization: Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California; rhaas@health.ucsd.edu |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32385134$$D View this record in MEDLINE/PubMed |
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| Title | Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial |
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