Lorazepam and diazepam equivalent in head-to-head study of paediatric status epilepticus
Lorazepam and diazepam have equivalent efficacy and safety for the treatment of paediatric status epilepticus, results of a randomised controlled trial suggest.
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The research, which appears in a neurology themed issue of JAMA (2014;311:1652), found that intravenous formulations of the drugs were associated with similar rates of seizure control and severe respiratory depression in children presenting to emergency departments with convulsive status epilepticus.
In the UK, lorazepam or midazolam are recommended for use in children experiencing seizures whereas the US Food and Drug Administration has approved diazepam but not lorazepam. This study, by James Chamberlain, from the Children’s National Medical Centre in Washington, US, and colleagues, was undertaken in view of recent reports that lorazepam may have safety or efficacy advantages over diazepam.
The study included 273 children aged between three months and 18 years presenting to 11 paediatric hospitals in the US with generalised tonic-clonic status epilepticus. They were randomly assigned to receive either diazepam 0.2mg/kg or lorazepam 0.1 mg/kg; if convulsions continued, half this dose was given at five minutes followed by fosphenytoin at 12 minutes.
The primary efficacy outcome was cessation of status epilepticus within 10 minutes of treatment without recurrence for at least 30 minutes. This was achieved by 72.1 per cent of children in the diazepam group and 72.9 per cent of those in the lorazepam group.
The major safety outcome was the need for assisted ventilation; this was met by 16.0 per cent and 17.6 per cent of patients given diazepam and lorazapam, respectively.
The primary outcomes and all but one of the secondary outcomes did not differ significantly between the two groups. The only treatment-related difference was the likelihood of sedation, which was greater with lorazepam than with diazepam (66.9 versus 50.0 per cent).
Dr Chamberlain and co-authors conclude that “diazepam, lorazepam, or midazolam could be chosen as a reasonable first-line therapy” and add: “Future trials should consider newer medications and novel interventions targeting those at highest risk for medication failure or respiratory depression.”
Citation: The Pharmaceutical JournalURI: 11137731
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