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The Evaluation of the Efficacy and Safety of Midazolam Nasal Spray in Patients With Seizure Clusters: A Systematic Review and Meta-Analysis - PubMed

  • ️Sun Jan 01 2023

Review

. 2023 Jan 22;15(1):e34064.

doi: 10.7759/cureus.34064. eCollection 2023 Jan.

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Review

The Evaluation of the Efficacy and Safety of Midazolam Nasal Spray in Patients With Seizure Clusters: A Systematic Review and Meta-Analysis

Niraj Niraj et al. Cureus. 2023.

Abstract

Midazolam nasal spray (MDZ-NS) is a new emerging rescue medication that suppresses epileptic seizures. Until now, few studies, pharmacokinetic (PK) and pharmacodynamic (PD) profiles, and clinical trials have shown that midazolam nasal spray could become an effective and promising alternative to conventional routes (intravenous {IV}/rectal). Therefore, we thought of conducting a systematic review and meta-analysis of midazolam (MDZ) to assess its potential outcomes. The analysis was also evaluated based on the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of midazolam nasal spray. A systematic literature search was carried out through various databases to identify studies of accounted outcomes of midazolam nasal spray (MDZ-NS). Randomized and other studies of patients (12 years or older) with seizure clusters (SCs) were included. A total of three full-text articles were considered for systematic review and meta-analysis as per the inclusion and exclusion criteria. The 5 mg MDZ-NS was observed to be equally safe as a placebo, and the risk ratio (RR) was 1.01 (95% confidence interval (CI): 0.67-1.53). After the administration of MDZ-NS, either the patients remained seizure-free for six hours or more or the seizure was terminated within 10 minutes and had no recurrence between 10 minutes and six hours. The risk ratio (RR) obtained was 1.54 (95% CI: 1.25-1.91). The result was statistically significant as a higher success rate was observed with the use of 5 mg midazolam nasal spray compared to placebo (p < 0.0001). Heterogeneity was not observed in the results of the included studies (inconsistency index {I2}: 0%). The present systematic review and meta-analysis demonstrated that 5 mg midazolam nasal spray was efficacious in treating patients with seizure clusters and is well-tolerated. Also, its use is relatively safe.

Keywords: epilepsy; meta-analysis; midazolam nasal spray; seizure clusters; systematic review.

Copyright © 2023, Niraj et al.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. PRISMA flow chart

PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses

Figure 2
Figure 2. Risk of bias graph
Figure 3
Figure 3. Risk ratios for treatment success with 5 mg midazolam nasal spray versus placebo

MDZ-NS, midazolam nasal spray; CI, confidence interval; I2, inconsistency index; df, degrees of freedom

Figure 4
Figure 4. Risk ratios for treatment-emergent adverse events with 5 mg midazolam nasal spray versus placebo

MDZ-NS, midazolam nasal spray; CI, confidence interval; I2, inconsistency index; df, degrees of freedom

Figure 5
Figure 5. Risk ratios for nasal discomfort with 5 mg midazolam nasal spray versus placebo

MDZ-NS, midazolam nasal spray; CI, confidence interval; I2, inconsistency index; df, degrees of freedom

Figure 6
Figure 6. Risk ratios for somnolence with 5 mg midazolam nasal spray versus placebo

MDZ-NS, midazolam nasal spray; CI, confidence interval; I2, inconsistency index; df, degrees of freedom

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References

    1. ILAE classification of the epilepsies: position paper of the ILAE Commission for Classification and Terminology. Scheffer IE, Berkovic S, Capovilla G, et al. Epilepsia. 2017;58:512–521. - PMC - PubMed
    1. The impact of epilepsy on patients' lives. Kerr MP. Acta Neurol Scand Suppl. 2012:1–9. - PubMed
    1. Instruction manual for the ILAE 2017 operational classification of seizure types. Fisher RS, Cross JH, D'Souza C, et al. Epilepsia. 2017;58:531–542. - PubMed
    1. Cognition and dementia in older patients with epilepsy. Sen A, Capelli V, Husain M. Brain. 2018;141:1592–1608. - PMC - PubMed
    1. Seizure clusters: characteristics and treatment. Haut SR. Curr Opin Neurol. 2015;28:143–150. - PubMed

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