| アブストラクト | INTRODUCTION: Epilepsy is one of the most common neurological disorders and requires long-term treatment with anti-seizure medication (ASM) which may cause adverse drug reactions (ADRs). Our aims were to investigate potential sex differences in reporting suspected ADR (sADRs) of ASMs through studying their seriousness, outcomes and Sudden Unexpected Death in Epilepsy (SUDEP). METHODS: Using EudraVigilance database, reported sADRs with different ASMs over a ten year period were extracted. List of ASMs was compiled according to Anatomical Therapeutic Chemical Classification System. Reporting Odds Ratio (ROR), 95 % confidence interval (95 % CI), p-value were calculated. RESULTS: In general, more sADRs were reported from females (603,936, 57.46 %). Males showed positive association with the following seriousness criteria: 'life threatening' (ROR=1.02, 95 %CI: 1.01-1.04; p < 0.001), 'caused/prolonged hospitalisation' (ROR=1.06, 95 %CI: 1.05-1.07; p < 0.001), 'results in death' (ROR=1.44, 95 %CI: 1.43-1.46; p < 0.001), and 'congenital anomaly' (ROR=2.43, 95 %CI: 2.41-2.45; p < 0.001). Only with 'not recovered / not resolved' outcome criteria showed negative association in males (ROR=0.72, 95 %CI: 0.70-0.73; p < 0.001), the other outcome criteria demonstrated positive association in the followings: 'fatal' (ROR=1.43, 95 %CI: 1.41-1.45; p < 0.001), 'recovered / resolved' (ROR=1.08, 95 %CI: 1.07-1.09; p < 0.001), 'recovered / resolved with sequelae' (ROR=1.06, 95 %CI: 1.01-1.12; p < 0.001), and 'recovering / resolving' (ROR=1.14, 95 %CI: 1.12-1.15; p < 0.001). CONCLUSION: Differences were observed between males and females, particularly in terms of seriousness criteria, worse outcomes but prone to recover, and associations with SUDEP to the detriment of males. When choosing an ASM for a patient or especially if the patient has previously experienced an adverse drug reaction. these aspects can also be taken into account and may be important. |
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| ジャーナル名 | European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences |
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| Pubmed追加日 | 2025/5/9 |
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| 投稿者 | Girgis, Michael Magdy Fahmy; Farkasinszky, Gergely; Fekete, Klara; Fekete, Istvan; Vecsernyes, Miklos; Bacskay, Ildiko; Horvath, Laszlo |
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| 組織名 | Department of Pharmaceutical Surveillance and Economics, Faculty of Pharmacy,;University of Debrecen, Debrecen, Hungary. Electronic address:;michael.girgis@pharm.unideb.hu.;Division of Nuclear Medicine and Translational Imaging, Department of Medical;Imaging, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.;Electronic address: farkasinszky.gergely@med.unideb.hu.;Department of Neurology, Faculty of Medicine, University of Debrecen, Debrecen,;Hungary. Electronic address: feketek@med.unideb.hu.;Hungary. Electronic address: fekete@med.unideb.hu.;vecsernyes.miklos@pharm.unideb.hu.;Healthcare Industry Institute, University of Debrecen, Debrecen, Hungary;;Department of Pharmaceutical Technology, Faculty of Pharmacy, University of;Debrecen, Debrecen, Hungary. Electronic address: bacskay.ildiko@pharm.unideb.hu.;lhorvath@med.unideb.hu. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40339760/ |
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