Balzano Nunzia, Mascolo Annamaria, Di Napoli Raffaella, Colapietra Federica, Di Domenico Marina, Capuano Annalisa, Gargano Francesca
Department of Experimental Medicine, University of Campania "L. Vanvitelli", 80138 Naples, Italy.
Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.
J Pers Med. 2024 Sep 10;14(9):961. doi: 10.3390/jpm14090961.
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.
右美托咪定是一种选择性α2肾上腺素能激动剂，因其对呼吸的抑制作用极小而在重症监护中备受青睐。本研究使用欧洲药物警戒数据库EudraVigilance，评估了右美托咪定与咪达唑仑和丙泊酚相比，横纹肌溶解症的报告频率。我们对2013年1月1日至2023年12月31日的个体病例安全报告（ICSR）进行了观察性回顾分析。主要和次要结局分别包括横纹肌溶解症及其指示性体征和症状的报告频率。我们检索到19268份ICSR，其中364份报告了与右美托咪定（3.8%）、咪达唑仑（10.2%）、丙泊酚（76.9%）或其组合（9.1%）相关的横纹肌溶解症。与丙泊酚相比，右美托咪定的横纹肌溶解症报告频率显著更低（相对危险度，0.32；95%可信区间，0.19 - 0.55），但与咪达唑仑相比无显著差异。亚组分析显示男性中的频率更高，尤其是丙泊酚。尽管存在报告不足等局限性，但我们的研究结果表明，右美托咪定导致横纹肌溶解症的风险低于丙泊酚，支持其在高危患者镇静中的安全使用。需要注意的是，由于本研究的回顾性设计，我们的研究结果表明的是相关性而非因果关系。建议持续监测并进行进一步研究以验证这些结果。
