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Meta-Analysis
. 2024 Nov 27;29(1):12.
doi: 10.1007/s11325-024-03163-5.

Efficacy and safety of sodium oxybate treatment in adults with narcolepsy and cataplexy: a systematic review and meta-analysis

Ahmed Mostafa Amin  1   2 , Ahmed Hassan  3   4 , Yehya Khlidj  5   4 , Ahmed Mansour  6   4 , Ahmed Esawy  7   4 , Rashad G Mohamed  7   4 , Anas Mansour  6   4 , Abdallah Abbas  8   4
Affiliations
Meta-Analysis

Efficacy and safety of sodium oxybate treatment in adults with narcolepsy and cataplexy: a systematic review and meta-analysis

Ahmed Mostafa Amin et al. Sleep Breath. .

Abstract

Background and purpose: Narcolepsy is a chronic illness characterized by excessive daytime sleepiness and cataplexy. Recently, sodium oxybate (SXB) has been the only effective drug in treating multiple symptoms of narcolepsy. Our study aims to assess the effectiveness and safety of SXB in treating narcolepsy.

Method: We searched four databases for eligible studies. Our primary outcome was to investigate the effectiveness of SXB through symptom improvement. For the secondary outcome, we assess its safety through the reported adverse events.

Result: Five RCTs were included. The SXB group had significantly improved weekly cataplexy attacks better than the placebo (MD = -5.04, 95% CI [-6.35, -3.72], P < 0.00001), also the improvement in the Maintenance of Wakefulness Test, and ESS was better in the SXB group with (MD = 4.66, 95% CI: [2.24, 7.07], p = 0.0002), (MD = -1.93, 95% CI: [-2.73, -1.13], p < 0.00001) respectively. CGI-I was observed to be significantly better in the SXB group with (RR = 2.15, 95% CI: [1.69, 2.73], p < 0.00001). The weekly cataplexy attack was significantly improved by the doses (4.5, 6, and 9 gm) in comparison with the placebo, with the 9-gm dose having the most beneficial effect. The improvements were significant only in SXB 9 gm in ESS and 6 and 9 gm in CGI-I.

Conclusion: SXB is an effective pharmacological treatment for the management of narcoleptic patients with cataplexy with an acceptable safety profile. Further studies with a large scale are needed to investigate and prove the efficacy and tolerability of SXB.

Keywords: Narcolepsy; SXB; Sodium oxybate.

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Conflict of interest statement

Declarations. Ethical approval and consent to participate: This study is a systematic review and meta-analysis that did not require ethical approval, as it did not involve the direct participation of individuals who would provide informed consent. Consent to publication: Consent to publication is not applicable in this case since this study is not a primary research study but rather a review and analysis of existing literature. Previous publication: We declare that this research paper has not been published elsewhere in any other academic journal or platform. Generative AI in scientific writing: We declare that we have not used AI in writing any part of this manuscript. Conflict of interest: No conflict of interest.

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