Cargando…
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...
Autores principales: | , , , , , , , |
---|---|
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 |
_version_ | 1784899434270687232 |
---|---|
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. |
format | Online Article Text |
id | pubmed-9978077 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT mengjiahao theefficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT yanzeya theefficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT taoxinyu theefficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT wangwei theefficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT wangfei theefficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT xuetao theefficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT liuyanfei theefficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT wangzhong theefficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT mengjiahao efficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT yanzeya efficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT taoxinyu efficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT wangwei efficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT wangfei efficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT xuetao efficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT liuyanfei efficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials AT wangzhong efficacyandsafetyofganaxoloneforthetreatmentofrefractoryepilepsyametaanalysisfromrandomizedcontrolledtrials |