| アブストラクト | Daridorexant (dari), as the first dual orexin receptor antagonist (DORA) marketed in Europe, offers a novel therapeutic approach to insomnia. However, data regarding its real-world safety are scarce. Thus, this study was aimed at assessing its safety profile using a large-scale pharmacovigilance database. Dari-related adverse drug reaction (ADR) reports from the Food and Drug Administration Adverse Event Reporting System were scrutinized, and ADRs were selected using reporting odds ratio (ROR) as a measure of disproportionality. Frequencies of events related to dari were compared to all other drugs (reference group, RG1) and only to other DORAs (RG2). Only significant disproportionalities to both RGs were evaluated in-depth. A total of 845 dari-related reports were selected; nightmares (n = 146; dari vs. RG1: ROR = 113.74; 95%CI [95.13, 136]; dari vs. RG2: ROR = 2.35; 95 CI% [1.93, 2.85]), depression (n = 22; dari vs. RG1: 2.13; [1.39, 3.25]; dari vs. RG2: ROR = 2.31; 95 CI% [1.45, 3.67]), and hangover (n = 20; dari vs. RG1: ROR = 127.92; 95 CI% [81.98, 199.62]; and dari vs. RG2: 3.38; [2.04, 5.61]) were considered as safety signals. These data provide valuable insights into the real-world safety profile of daridorexant, supporting the existence of safety signals related to nightmares, depression, and hangovers. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| 投稿日 | 2024/3/28 |
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| 投稿者 | Cicala, Giuseppe; Barbieri, Maria Antonietta; Russo, Giulia; Salvo, Francesco; Spina, Edoardo |
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| 組織名 | Department of Clinical and Experimental Medicine, University of Messina, 98125;Messina, Italy.;Regional Pharmacovigilance Centre of Bordeaux, Department of Medical;Pharmacology, Centre Hospitalier Universitaire de Bordeaux, F-33000 Bordeaux,;France.;AHeaD Team, U1219, Bordeaux Population Health, National Institute for Health and;Medical Research (Institut National de la Sante et de la Recherche Medicale,;INSERM), Universite de Bordeaux, F-33000 Bordeaux, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38543128/ |
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