Exploring Proposed Recommendations for Acute Cluster Treatment and Rapid and Early Seizure Termination Using Data From a Long-Term Safety Study of Diazepam Nasal Spray
Micheal Chez1, Pavel Klein2, Danielle Becker3, Jurriaan Peters4, Enrique Carrazana5, Adrian Rabinowicz6
1Sutter Neuroscience Institute, 2Mid-atlantic Epilepsy and Sleep Center, 3Ohio State University Wexner Medical Center, 4Harvard Medical School and Boston Children’s Hospital, 5Neurelis, Inc; John A. Burns School of Medicine, University of Hawaii, 6Neurelis, Inc; Center for Molecular Biology and Biotechnology (CMBB) in the Charles E. Schmidt College of Science at Florida Atlantic University
Objective:
To examine whether a single immediate-use seizure medication for seizure clusters (SCs) in epilepsy could appropriately fit both medication categories recently recommended for preventing progression to a higher-level emergency.
Background:
Appropriate and prompt treatment of SCs is needed to reduce the risk of negative outcomes. Recent expert consensus recommendations focused on antiseizure medications for acute cluster treatment (ACT) to prevent further seizures in a cluster and rapid and early seizure termination (REST) of ongoing seizures.
Design/Methods:
We examined practical application of ACT and REST criteria using patient diary data from the long-term safety study (n=163 patients with epilepsy aged 6–65 years) of diazepam nasal spray. To explore ACT, use of second doses across 24 hours was a proxy for effectiveness. REST was investigated using time from administration to SC termination. Timing for termination of prolonged seizures (PSs) in clusters also was examined.
Results:
For ACT, a single dose of diazepam nasal spray was used across 24 hours for 87.4% (3368/3853) of SCs (second doses were used for 12.6% of SCs). For REST, median time to administration of diazepam nasal spray (n=3225 occurrences) was 2 minutes, and median time to seizure termination was 3 minutes. Of the SCs with treatment administered within 5 minutes (n=2169 occurrences [67.3%]), median time to seizure termination was 2 minutes. For PSs with treatment administered 5–15 minutes after the SC began (n=727 occurrences), median time to administration was 6 minutes, and median time to termination was 7 minutes. Safety data for diazepam nasal spray were similar to that for diazepam rectal gel.
Conclusions:
Data from the long-term safety study of diazepam nasal spray demonstrate its benefit in immediate use for both prevention of further seizures in SCs (ACT) and termination of an acute SC and PS in a cluster (REST).
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