December 2, 2019Neurology
Status epilepticus is characterized by individual seizures or multiple seizures close together lasting more than five minutes, with a loss of consciousness. If not treated, it can lead to severe brain damage or death. Benzodiazepines are the first line of treatment for status epilepticus and are effective in two- thirds of patients. Refractory status epilepticus are severe seizures that continue even after benzodiazepine medications, which are effective in controlling seizures in more than two-thirds of patients. Currently there are three treatment options commonly used in the emergency room to treat patients with refractory status epilepticus. New findings published in the New England Journal of Medicine (28 November 2019) reveal that the three drugs, levetiracetam, fosphenytoin, and valproate, are equally safe and effective in treating patients with this condition.
In the Established Status Epilepticus Treatment Trial (ESETT), more than 380 children and adults were randomized to receive levetiracetam, fosphenytoin, or valproate when they came to the emergency room experiencing a seizure. The ESETT researchers utilized a clinical trial design known as response adaptive randomization to improve the study's efficiency and maximize the chances of identifying the best treatment. The study used an algorithm to determine which drugs patients would receive based on accumulating trial data.
The authors were trying to determine which of the anticonvulsant drugs was most effective in stopping seizures and improving a patient's level of responsiveness within 60 minutes of administering treatment. Study results showed that the three drugs stopped seizures and improved responsiveness in approximately half of the study participants. Specifically, these benefits were seen in 47% of subjects in the levetiracetam group, in 45% of participants in the fosphenytoin group and in 46% of subjects in the valproate group. These differences were not statistically significant. There were also no differences in serious side effects among the drugs.
The study was stopped early when a planned interim analysis found that the drugs were equally safe and effective.