Rationale: Midazolam nasal spray (MDZ-NS) was the first approved nasal option for seizure clusters (SCs). The aim was to describe baseline characteristics and antiseizure medication (ASM) use of patients with epilepsy in the year prior to newly initiating rescue treatment with MDZ-NS, diazepam rectal gel (DZP-RG), or diazepam nasal spray (DZP-NS) for SCs.
Methods: Descriptive observational study used claims records (December 31, 2007–October 31, 2021) from IBM MarketScan.
Patients with ≥1 newly initiated pharmacy claim (at minimum approved age) for MDZ-NS (≥12 years), DZP-RG (≥2 years), or DZP-NS (≥6 years) (date of claim=index date), and an epilepsy diagnosis (ICD-9: 345.X, 780.39; ICD-10: G40.X, R56.9) prior or within the 12-month pre-index period (baseline) were included. Baseline characteristics (socio-demographics, epilepsy characteristics, comorbidities) and ASM use (prior ASM: claim during baseline; concomitant ASM: claim ±30 days relative to index) were captured.
Results: Of 8058 patients, 4283 (age [mean]: 20.9 years; 54.8% male) received MDZ-NS, 2005 (age: 10.7 years; 56.2% male) received DZP-RG, and 1770 (age: 14.9 years; 53.5% male) received DZP-NS. The most common age categories were 12–17 years for MDZ-NS (52.2%) and 6–11 years for DZP-RG (34.5%) and DZP-NS (44.4%). Patients aged < 6 years were only in the DZP-RG cohort (29.2%), whereas patients aged ≥18 years constituted 47.8%, 14.5%, and 24.0% of MDZ-NS, DZP-RG, and DZP-NS groups, respectively. The most common epilepsy types were partial/focal seizures in the MDZ-NS (26.7%) and DZP-NS (30.0%) cohorts, followed by unspecified and mixed seizures (17.3% each for MDZ-NS, 16.2% and 15.9% DZP-NS). The most common epilepsy types in the DZP-RG cohort were seizure/convulsion (28.4%), mixed (22.6%), and unspecified (18.5%).
Most patients had an epilepsy diagnosis >12 months before SC treatment initiation (82.7% MDZ-NS, 68.2% DZP-RG, 77.9% DZP-NS).
Most common comorbid condition was cardiac arrhythmia (16.1% MDZ-NS, 19.2% DZP-RG, 11.9% DZP-NS). Most common central nervous system condition was anxiety in MDZ-NS (23.0%) and DZP-NS (18.2%), and headache and encephalopathy in DZP-RG (11.0% each).
Prior ASMs were similar between nasal spray cohorts (for MDZ-NS, DZP-RG, DZP-NS, respectively: 0 ASM: 5.7%, 26.5%, 8.5%; 1 ASM: 26.8%, 30.9%, 27.1%; ≥2 ASMs: 67.5%, 42.6%, 64.4%). Similar trends were seen with concomitant ASMs (for MDZ-NS, DZP-RG, DZP-NS, respectively: 0 ASM: 5.6%, 20.6%, 10.1%; 1 ASM: 36.2%, 40.5%, 38.8%; ≥2 ASMs: 58.3%, 38.9%, 51.1%).
Levetiracetam was the most common prior and concomitant ASM. The most common prior benzodiazepine (BZP) was diazepam (23.7% MDZ-NS, 12.0% DZP-RG, 33.3% DZP-NS); the most common concomitant BZP was clonazepam (10.9% MDZ-NS, 9.1% DZP-RG, 10.3% DZP-NS).
Conclusions: New users of MDZ-NS and DZP-NS showed generally similar baseline characteristics, but were older with more prior/concomitant ASMs vs the DZP-RG cohort. Baseline characteristics and prior/concomitant ASM use were influenced by approved patient age and BZP prescribing information, with adults most commonly receiving MDZ-NS.
Funding: UCB Pharma