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Review

Overcoming barriers to the management of seizure clusters: ease of use and time to administration of rescue medications

, , , , &
Pages 425-432 | Received 03 Feb 2023, Accepted 20 Apr 2023, Published online: 01 May 2023

References

  • Haut SR, Nabbout R. Recognizing seizure clusters in the community: the path to uniformity and individualization in nomenclature and definition. Epilepsia. 2022;63(suppl 1):S6–13.
  • Dreifuss FE, Rosman NP, Cloyd JC, et al. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med. 1998;338(26):1869–1875. DOI:10.1056/NEJM199806253382602
  • Penovich P, Glauser T, Becker D, et al. Recommendations for development of acute seizure action plans (ASAPs) from an expert panel. Epilepsy Behav. 2021;123:108264. DOI:10.1016/j.yebeh.2021.108264
  • Wheless JW, Miller I, Hogan RE, et al. Final results from a phase 3, long-term, open-label, repeat-dose safety study of diazepam nasal spray for seizure clusters in patients with epilepsy. Epilepsia. 2021;62(10):2485–2495. DOI:10.1111/epi.17041
  • Jafarpour S, Hirsch LJ, Gainza-Lein M, et al. Seizure cluster: definition, prevalence, consequences, and management. Seizure. 2019;68:9–15. DOI:10.1016/j.seizure.2018.05.013
  • Dingledine R, Varvel NH, Dudek FE. When and how do seizures kill neurons, and is cell death relevant to epileptogenesis? Adv Exp Med Biol. 2014;813:109–122.
  • Haut SR. Seizure clusters: characteristics and treatment. Curr Opin Neurol. 2015;28(2):143–150.
  • Cloyd J, Haut S, Carrazana E, et al. Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters. Epilepsia. 2021;62(4):846–856. DOI:10.1111/epi.16847
  • Shah MI, Macias CG, Dayan PS, et al. An evidence-based guideline for pediatric prehospital seizure management using GRADE methodology. Prehosp Emerg Care. 2014;18(suppl 1):15–24. DOI:10.3109/10903127.2013.844874
  • Pong AW, Ross J, Tyrlikova I, et al. Epilepsy: expert opinion on emerging drugs in phase 2/3 clinical trials. Expert Opin Emerg Drugs. 2022;27(1):75–90. DOI:10.1080/14728214.2022.2059464
  • Bausch Health US, LLC. Diastat® C-IV (diazepam rectal gel). Full prescribing information. Bridgewater NJ: Bausch Health US, LLC; 2023.
  • UCB, Inc. Nayzilam® (midazolam nasal spray). Full prescribing information. Smyrna GA: UCB, Inc.; 2023.
  • Neurelis, Inc. VALTOCO® (diazepam nasal spray). Full prescribing information. San Diego CA: Neurelis, Inc.; 2023.
  • Tatum WO. Adult patient perceptions of emergency rectal medications for refractory seizures. Epilepsy Behav. 2002;3(6):535–538.
  • Neurelis, Inc. VALTOCO. Instructions for use for 5 mg and 10 mg doses. San Diego CA: Neurelis, Inc; 2022.
  • Lepkowski AM. School nursing evidence-based practice clinical guideline: students with seizures and epilepsy. Silver Spring MD: National Association of School Nurses; 2018.
  • US Food and Drug Administration. Clinical Superiority Findings [Internet]. cited 2020 Jun 23]. Available from: https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings
  • Shire Services BVBA. Buccolam summary of product characteristics (midazolam hydrochloride oromucosal solution). Summary of product characteristics. Brussels Belgium: Shire Pharmaceuticals; 2020.
  • Electronic Medicines Compendium. Diazepam RecTubes 10mg rectal solution [Internet]. [cited 2021 Sep 7]. Available from: https://www.medicines.org.uk/emc/product/6799/smpc
  • Electronic Medicines Compendium. Stesolid rectal tubes 10mg [Internet]. [cited 2021 Sep 10]. Available from: https://www.medicines.org.uk/emc/product/104/smpc
  • Electronic Medicines Compendium. Diazepam desitin 5 mg rectal solution [Internet]. [cited 2021 Sep 8]. Available from: https://www.medicines.org.uk/emc/product/2997/smpc
  • Penovich PE, Buelow J, Steinberg K, et al. Burden of seizure clusters on patients with epilepsy and caregivers: survey of patient, caregiver, and clinician perspectives. Neurologist. 2017;22(6):207–214. DOI:10.1097/NRL.0000000000000140
  • Haut SR, Seinfeld S, Pellock J. Benzodiazepine use in seizure emergencies: a systematic review. Epilepsy Behav. 2016;63:109–117.
  • Chhabra R, Gupta R, Gupta LK. Intranasal midazolam versus intravenous/rectal benzodiazepines for acute seizure control in children: a systematic review and meta-analysis. Epilepsy Behav. 2021;125:108390.
  • Kapur J, Long L, Dixon-Salazar T. Consequences: bench to home. Epilepsia. 2022;63(suppl 1):S14–24.
  • Ertan D, Hubert-Jacquot C, Maillard L, et al. Anticipatory anxiety of epileptic seizures: an overlooked dimension linked to trauma history. Seizure. 2021;85:64–69.
  • Gopinath B, Radhakrishnan K, Sarma PS, et al. A questionnaire survey about doctor-patient communication, compliance and locus of control among south Indian people with epilepsy. Epilepsy Res. 2000;39(1):73–82. DOI:10.1016/S0920-1211(99)00112-6
  • Boddu VK, Rebello A, Chandrasekharan SV, et al. How does “locus of control” affect persons with epilepsy? Epilepsy Behav. 2021;123:108257.
  • Mitchell WG, Conry JA, Crumrine PK, et al. An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. North American Diastat Group. Epilepsia. 1999;40(11):1610–1617. DOI:10.1111/j.1528-1157.1999.tb02047.x
  • Naylor DE. Treating acute seizures with benzodiazepines: does seizure duration matter? Epileptic Disord. 2014;16(Spec No 1):S69–83.
  • Cereghino JJ, Mitchell WG, Murphy J, et al. Treating repetitive seizures with a rectal diazepam formulation: a randomized study. The North American Diastat Study Group. Neurology. 1998;51(5):1274–1282. DOI:10.1212/WNL.51.5.1274
  • Detyniecki K, Van Ess PJ, Sequeira DJ, et al. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters—a randomized, double-blind, placebo-controlled trial. Epilepsia. 2019;60(9):1797–1808. DOI:10.1111/epi.15159
  • Glauser T, Shinnar S, Gloss D, et al. Evidence-based guideline: treatment of convulsive status epilepticus in children and adults: report of the guideline committee of the American Epilepsy Society. Epilepsy Curr. 2016;16(1):48–61. DOI:10.5698/1535-7597-16.1.48
  • Dean P, O’Hara K, Brooks L, et al. Managing acute seizures: new rescue delivery option and resources to assist school nurses. NASN Sch Nurse. 2021;36(6):346–354. DOI:10.1177/1942602X211026333
  • Fitzgerald BJ, Okos AJ, Miller JW. Treatment of out-of-hospital status epilepticus with diazepam rectal gel. Seizure. 2003;12(1):52–55.
  • Wheless JW, Meng TC, Van Ess PJ, et al. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters: an open-label extension trial. Epilepsia. 2019;60(9):1809–1819. DOI:10.1111/epi.16300
  • Wheless JW, Brunnert M, Floricel F, et al. Early intervention with midazolam nasal spray and efficacy in patients with seizure clusters: post-hoc analysis of an open-label extension trial (P13-8.007). Neurology. 2022;98(18 suppl):707. https://n.neurology.org/content/98/18_Supplement/707
  • Nunley S, Glynn P, Rust S, et al. A hospital-based study on caregiver preferences on acute seizure rescue medications in pediatric patients with epilepsy: intranasal midazolam versus rectal diazepam. Epilepsy Behav. 2019;92:53–56.
  • Holsti M, Dudley N, Schunk J, et al. Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. Arch Pediatr Adolesc Med. 2010;164(8):747–753. DOI:10.1001/archpediatrics.2010.130
  • Nunley S, Glynn P, Rust S, et al. Healthcare utilization characteristics for intranasal midazolam versus rectal diazepam. J Child Neurol. 2018;33(2):158–163. DOI:10.1177/0883073817744696
  • Bhattacharyya M, Kalra V, Gulati S. Intranasal midazolam vs rectal diazepam in acute childhood seizures. Pediatr Neurol. 2006;34(5):355–359.
  • Penovich P, Wheless JW, Hogan RE, et al. Examining the patient and caregiver experience with diazepam nasal spray for seizure clusters: results from an exit survey of a phase 3, open-label, repeat-dose safety study. Epilepsy Behav. 2021;121(Pt A):108013. DOI:10.1016/j.yebeh.2021.108013
  • Wheless J, Peters J, Misra SN, et al. Comment on “Intranasal midazolam versus intravenous/rectal benzodiazepines for acute seizure control in children: a systematic review and meta-analysis”. Epilepsy Behav. 2022;128:108550.
  • Aptar Pharma. Aptar brochure: nasal spray device with uni-dose and bi-dose systems. Crystal Lake, IL: The corporate headquarters; 2016. https://www.aptar.com/wp-content/uploads/2020/07/Brochure-Nasal-spray-device-with-Uni-dose-and-Bi-dose-systems.pdf
  • Gidal B, Klein P, Hirsch LJ. Seizure clusters, rescue treatments, seizure action plans: unmet needs and emerging formulations. Epilepsy Behav. 2020;112:107391.
  • Neville KL, McCaffery H, Baxter Z, et al. Implementation of a standardized seizure action plan to improve communication and parental education. Pediatr Neurol. 2020;112:56–63.
  • Dewar SR, Ranit L, Pieters HC. Reciprocal burden: adults with drug-resistant epilepsy reflect upon informal caregiver support. Seizure. 2021;89:85–92.
  • Terry D, Patel AD, Cohen DM, et al. Barriers to seizure management in schools: perceptions of school nurses. J Child Neurol. 2016;31(14):1602–1606. DOI:10.1177/0883073816666738
  • Hogan RE, Gidal BE, Koplowitz B, et al. Bioavailability and safety of diazepam intranasal solution compared to oral and rectal diazepam in healthy volunteers. Epilepsia. 2020;61(3):455–464. DOI:10.1111/epi.16449
  • Almohaish S, Sandler M, Brophy GM. Time is brain: acute control of repetitive seizures and status epilepticus using alternative routes of administration of benzodiazepines. J Clin Med. 2021;10(8):1754.
  • Barrecheguren M, Bourbeau J. Self-management strategies in chronic obstructive pulmonary disease: a first step toward personalized medicine. Curr Opin Pulm Med. 2018;24(2):191–198.
  • Lopez-Toledano MA, Guerra C, Misra SN, et al. Study design of an open-label pharmacokinetic and safety trial of diazepam nasal spray (Valtoco®) in children 2–5 years old with seizure clusters [poster #1.287]. Presented at: American Epilepsy Society; 2021 December 3-7; Chicago IL
  • ClinicalTrials.gov. Pharmacokinetics study of VALTOCO® in pediatric subjects with epilepsy (NCT05076838) [Internet]. [cited 2022 Aug 16]. Available from: https://clinicaltrials.gov/ct2/show/NCT05076838