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The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: A meta‐analysis from randomized controlled trials

OBJECTIVE: Epilepsy is one of the most common and refractory neurological disorders globally. Ganaxolone, a neuroactive steroid that enhances GABAergic inhibition, has been tested in many trials for the resolution of refractory epilepsy. Based on these, our study implemented a meta‐analysis to evalu...

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Autores principales: Meng, Jiahao, Yan, Zeya, Tao, Xinyu, Wang, Wei, Wang, Fei, Xue, Tao, Liu, Yanfei, Wang, Zhong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9978077/
https://www.ncbi.nlm.nih.gov/pubmed/36333279
http://dx.doi.org/10.1002/epi4.12669
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author Meng, Jiahao
Yan, Zeya
Tao, Xinyu
Wang, Wei
Wang, Fei
Xue, Tao
Liu, Yanfei
Wang, Zhong
author_facet Meng, Jiahao
Yan, Zeya
Tao, Xinyu
Wang, Wei
Wang, Fei
Xue, Tao
Liu, Yanfei
Wang, Zhong
author_sort Meng, Jiahao
collection PubMed
description OBJECTIVE: Epilepsy is one of the most common and refractory neurological disorders globally. Ganaxolone, a neuroactive steroid that enhances GABAergic inhibition, has been tested in many trials for the resolution of refractory epilepsy. Based on these, our study implemented a meta‐analysis to evaluate the general benefit of ganaxolone for refractory epilepsy. METHODS: EMBASE, Medline, Scopus, Cochrane Library, and Clinicaltrials.gov were searched for relevant randomized controlled trials (RCTs) up to June 20, 2022. The risk ratio (RR) and standard mean difference (SMD) were analyzed using dichotomous and continuous outcomes, respectively with a random effect model. Trial sequential analysis (TSA) was also performed to judge the reliability of results. RESULTS: We totally collected 659 patients from four RCTs to evaluate the efficacy and safety of ganaxolone. As results showed, ≥50% reduction in mean seizure frequency has improved significantly compared with placebo (RR = 1.60, 95%CI: 1.02–2.49, p = 0.04, I ( 2 ) = 30%), which is supported by TSA. However, the percentage of seizure‐free days shows no statistical significance (p = 0.36). For safety outcomes, adverse events (AEs), serious adverse events, and AE leading to study drug discontinuation all revealed no obvious difference between ganaxolone and placebo (p > 0.05). SIGNIFICANCE: Based on our research, we have observed that ganaxolone is safe and has potential efficacy in the treatment of refractory epilepsy, waiting for further studies.
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spelling pubmed-99780772023-03-03 The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: A meta‐analysis from randomized controlled trials Meng, Jiahao Yan, Zeya Tao, Xinyu Wang, Wei Wang, Fei Xue, Tao Liu, Yanfei Wang, Zhong Epilepsia Open Original Articles OBJECTIVE: Epilepsy is one of the most common and refractory neurological disorders globally. Ganaxolone, a neuroactive steroid that enhances GABAergic inhibition, has been tested in many trials for the resolution of refractory epilepsy. Based on these, our study implemented a meta‐analysis to evaluate the general benefit of ganaxolone for refractory epilepsy. METHODS: EMBASE, Medline, Scopus, Cochrane Library, and Clinicaltrials.gov were searched for relevant randomized controlled trials (RCTs) up to June 20, 2022. The risk ratio (RR) and standard mean difference (SMD) were analyzed using dichotomous and continuous outcomes, respectively with a random effect model. Trial sequential analysis (TSA) was also performed to judge the reliability of results. RESULTS: We totally collected 659 patients from four RCTs to evaluate the efficacy and safety of ganaxolone. As results showed, ≥50% reduction in mean seizure frequency has improved significantly compared with placebo (RR = 1.60, 95%CI: 1.02–2.49, p = 0.04, I ( 2 ) = 30%), which is supported by TSA. However, the percentage of seizure‐free days shows no statistical significance (p = 0.36). For safety outcomes, adverse events (AEs), serious adverse events, and AE leading to study drug discontinuation all revealed no obvious difference between ganaxolone and placebo (p > 0.05). SIGNIFICANCE: Based on our research, we have observed that ganaxolone is safe and has potential efficacy in the treatment of refractory epilepsy, waiting for further studies. John Wiley and Sons Inc. 2022-11-15 /pmc/articles/PMC9978077/ /pubmed/36333279 http://dx.doi.org/10.1002/epi4.12669 Text en © 2022 The Authors. Epilepsia Open published by Wiley Periodicals LLC on behalf of International League Against Epilepsy. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Meng, Jiahao
Yan, Zeya
Tao, Xinyu
Wang, Wei
Wang, Fei
Xue, Tao
Liu, Yanfei
Wang, Zhong
The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: A meta‐analysis from randomized controlled trials
title The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: A meta‐analysis from randomized controlled trials
title_full The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: A meta‐analysis from randomized controlled trials
title_fullStr The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: A meta‐analysis from randomized controlled trials
title_full_unstemmed The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: A meta‐analysis from randomized controlled trials
title_short The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: A meta‐analysis from randomized controlled trials
title_sort efficacy and safety of ganaxolone for the treatment of refractory epilepsy: a meta‐analysis from randomized controlled trials
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9978077/
https://www.ncbi.nlm.nih.gov/pubmed/36333279
http://dx.doi.org/10.1002/epi4.12669
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