Nunzia Balzano, Annamaria Mascolo, Raffaella Di Napoli, Federica Colapietra, Marina Di Domenico, Annalisa Capuano, Francesca Gargano
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引用次数: 0
Abstract
Dexmedetomidine, a selective α2-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.
期刊介绍:
Journal of Personalized Medicine (JPM; ISSN 2075-4426) is an international, open access journal aimed at bringing all aspects of personalized medicine to one platform. JPM publishes cutting edge, innovative preclinical and translational scientific research and technologies related to personalized medicine (e.g., pharmacogenomics/proteomics, systems biology). JPM recognizes that personalized medicine—the assessment of genetic, environmental and host factors that cause variability of individuals—is a challenging, transdisciplinary topic that requires discussions from a range of experts. For a comprehensive perspective of personalized medicine, JPM aims to integrate expertise from the molecular and translational sciences, therapeutics and diagnostics, as well as discussions of regulatory, social, ethical and policy aspects. We provide a forum to bring together academic and clinical researchers, biotechnology, diagnostic and pharmaceutical companies, health professionals, regulatory and ethical experts, and government and regulatory authorities.