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In patients with status epilepticus refractory to benzodiazepines, what is the efficacy and safety of the second-line anti-convulsants in aborting the seizure?
In comparing levetiracetam, fosphenytoin, and valproate, they are all equally efficacious with a seizure cessation rate of approximately fifty percent and statistically similar rates of adverse events.
- Multicenter, blinded, parallel-group, randomized controlled trial
- Levetiracetam (n=145) vs Fosphenytoin (n=118) vs Valproate (n=121)
- Setting: 57 hospital emergency departments across the United States
- Mean follow-up:
- Analysis: Intention-to-treat
- Primary outcome: Abortion of status epilepticus and improvement of level of consciousness by 60 minutes
- Older than 2 years old
- Treated with accepted cumulative dose of benzodiazepines for status epilepticus and continued to have seizures
- No more than 30 minutes had passed after last dose of benzodiazepine
- If the acute precipitant of seizure was major trauma, hypoglycemia, hyperglycemia, cardiac arrest, or postanoxia
- If the patient was pregnant or incarcerated
- The patient preemptively opted out of this trial by wearing a medical alert tag marked “ESETT declined” (these tags were made available by the trial when requested)
- If they had already been treated for the current episode of status epilepticus with anticonvulsant agents other than benzodiazepines
- If the trachea was intubated
- Known allergy or contraindications to any of the trial drugs, including known inborn metabolic disorder, liver disease, or severe renal impairment
Comparisons are intensive therapy vs. standard therapy.
- Abortion of status epilepticus and improvement of level of consciousness by 60 minutes
- National Institutes of Health
- Federal Drug Administration