Outcomes of out‐of‐hospital treatment of impending tonic–clonic status epilepticus with diazepam nasal spray: A retrospective combined cohort analysis

Résumé fourni par la source

Abstract Objective We assessed the timing, dosing, and effectiveness of diazepam nasal spray in a large dataset of seizures treated in the out‐of‐hospital setting, using as reference the International League Against Epilepsy criteria for tonic–clonic status epilepticus (SE) and its treatment. Methods We analyzed pooled data from two studies evaluating the use of diazepam nasal spray as acute treatment for seizures in the out‐of‐hospital setting, a phase 1/2a pharmacokinetics and safety study (patients aged 2–5 years) and a phase 3 long‐term safety study (patients aged 6–65 years). For this analysis, tonic–clonic SE episodes were defined as seizures lasting beyond time point t 1 (5 min). Responder analyses examined SE termination by time point t 2 (30 min after seizure start) and SE termination ≤20 min after dose administration. SE recurrence at ≤1, 12, and 24 h after SE termination was also assessed. Rate of SE episodes for which ≥2 doses of diazepam nasal spray were administered was a proxy for effectiveness. We also reported safety data. Results Of episodes with sufficient data for classification, a total of 402 episodes were categorized as tonic–clonic SE. The majority of tonic–clonic SE episodes terminated by t 2 (248 [61.7%]) and nearly half terminated within 20 min after dose administration (200 [49.8%]). SE recurrence after SE termination was low, with <5% of tonic–clonic SE episodes followed by a recurrence in ≤24 h. Rate of usage of ≥2 doses for tonic–clonic SE episodes was low (5% [20 seizure episodes]). Serious treatment‐emergent events of SE occurred in 6.6% of patients with tonic–clonic SE episodes. Significance These findings support the safety and effectiveness of diazepam nasal spray for treating episodes of tonic–clonic SE and strengthen the evidence of the benefits of immediate‐use antiseizure medication for seizure emergencies, including early SE.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.