| アブストラクト | Dexmedetomidine, a selective alpha2-adrenergic agonist, is favoured in intensive care for its minimal respiratory depression. This study evaluated the reporting frequency of rhabdomyolysis with dexmedetomidine compared to midazolam and propofol using the European pharmacovigilance database Eudravigilance. We conducted an observational, retrospective analysis of Individual Case Safety Reports (ICSRs) from 1 January 2013, to 31 December 2023. Primary and secondary outcomes included the reporting frequencies of rhabdomyolysis and its indicative signs and symptoms, respectively. We retrieved 19,268 ICSRs, of which 364 reported rhabdomyolysis associated with dexmedetomidine (3.8%), midazolam (10.2%), propofol (76.9%), or combinations thereof (9.1%). Dexmedetomidine showed a significantly lower reporting frequency of rhabdomyolysis compared to propofol (ROR, 0.32; 95% CI, 0.19-0.55) but no significant difference compared to midazolam. Subgroup analyses revealed higher frequencies in males, especially with propofol. Despite limitations such as underreporting, our findings suggest dexmedetomidine poses a lower rhabdomyolysis risk than propofol, supporting its safe use for sedation in high-risk patients. It is important to note that due to the retrospective design of this study our findings are indicative of correlations rather than causation. Continuous monitoring and further studies are recommended to validate these results. |
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| ジャーナル名 | Journal of personalized medicine |
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| 投稿日 | 2024/9/28 |
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| 投稿者 | Balzano, Nunzia; Mascolo, Annamaria; Di Napoli, Raffaella; Colapietra, Federica; Di Domenico, Marina; Capuano, Annalisa; Gargano, Francesca |
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| 組織名 | Department of Experimental Medicine, University of Campania "L. Vanvitelli",;80138 Naples, Italy.;Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138;Naples, Italy.;Department of Life Science, Health, and Health Professions, Link Campus;University, 00165 Rome, Italy.;Department of Precision Medicine, University of Campania "L. Vanvitelli", 80138;Unit of Anesthesia and Intensive Care, Fondazione Policlinico Universitario;Campus Bio-Medico, 00128 Rome, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39338215/ |
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