Oro-mucosal midazolam maleate: Use and effectiveness in adults with epilepsy in the UK

Abstract

BACKGROUND: Oro-mucosal midazolam maleate (OMM) with suitable training to family and carers is being increasingly recognized as the treatment of choice to mitigate the development of status epilepticus in non-hospital community settings. There are no studies to describe the use, effectiveness, and suitable dosing of OMM in adults with epilepsy in community settings. PURPOSE: To describe the use, effectiveness, and dosing of OMM in the emergency treatment of epileptic seizures in community settings. METHODS: A retrospective observational study (2016-17) design was used with participant recruitment from four UK NHS secondary care outpatient clinics providing epilepsy management. Study sample was of adult people with epilepsy (PWE) having had a recent seizure requiring OMM. Data on patient demographics, patient care plans, details of a recent seizure requiring emergency medication, and dose of OMM were collected from medical records. RESULTS: Study data from 146 PWE were included. The mean age of PWE was 41.0 years (SD 15.2) and mean weight was 64.8Kg (SD 18.2). Fifty-three percent of PWE were recorded as having intellectual disability. The most frequently used concomitant medications were lamotrigine (43%). The majority of seizures occurred at people's homes (n = 92, 63%). OMM was most often administered by family/professional care-givers (n = 75, 48.4%). Generalized (tonic/clonic) seizures were recorded in most people (n = 106, 72.6%). The most common initial dose of OMM was 10 mg (n = 124, 84.9%). The mean time to seizure cessation after administration of this initial dose was 5.5 minutes (SD = 4.5, Median 5.0, IQR 2.1-5.0). Only a minority of seizures led to ambulance callouts (n = 18, 12.3%) or hospital admissions (n = 13, 9%). CONCLUSION: This is the first observational study describing the use and effectiveness of OMM in adults in community settings. Minimal hospital admissions were reported in this cohort and the treatment was effective in ending seizures in adults in community settings.