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Abstract：
BACKGROUND: Myopathy is one of the most common adverse reactions of daptomycin and statins. We aimed to evaluate the muscular toxicity of the combination therapy of daptomycin and statins in a large pharmacovigilance database.
METHODS: This was a retrospective disproportionality analysis based on real-world data. All cases reported between the first quarter of 2004 and the fourth quarter of 2022 where daptomycin and statins were reported were gathered from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analyses were conducted by estimating the proportional reporting ratios (PRRs), reporting odds ratio (ROR), and information component (IC).
RESULTS: A total of 971,861 eligible cases were collected from the FAERS database. Data analysis showed that rosuvastatin (ROR: 124.39, 95% CI: 87.35-178.47), atorvastatin (ROR: 68.53, 95% CI: 51.93-90.43), and simvastatin (ROR: 94.83, 95% CI: 71.12-126.46) combined with daptomycin increased the reporting frequency of myopathy. Moreover, myopathy was reported more frequently with the 3-drug combination (ROR: 598.01, 95% CI: 231.81-1542.71). For rhabdomyolysis, the frequency of reports also increased when daptomycin was combined with rosuvastatin (ROR: 156.34, 95% CI: 96.21-254.05), simvastatin (ROR: 72.65, 95% CI: 47.36-111.44), and atorvastatin (ROR: 66.31, 95% CI: 44.06-99.81).
CONCLUSIONS: The combination of daptomycin and statins increased the association of myopathy and rhabdomyolysis, especially with rosuvastatin, simvastatin, and atorvastatin.
METHODS: This was a retrospective disproportionality analysis based on real-world data. All cases reported between the first quarter of 2004 and the fourth quarter of 2022 where daptomycin and statins were reported were gathered from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analyses were conducted by estimating the proportional reporting ratios (PRRs), reporting odds ratio (ROR), and information component (IC).
RESULTS: A total of 971,861 eligible cases were collected from the FAERS database. Data analysis showed that rosuvastatin (ROR: 124.39, 95% CI: 87.35-178.47), atorvastatin (ROR: 68.53, 95% CI: 51.93-90.43), and simvastatin (ROR: 94.83, 95% CI: 71.12-126.46) combined with daptomycin increased the reporting frequency of myopathy. Moreover, myopathy was reported more frequently with the 3-drug combination (ROR: 598.01, 95% CI: 231.81-1542.71). For rhabdomyolysis, the frequency of reports also increased when daptomycin was combined with rosuvastatin (ROR: 156.34, 95% CI: 96.21-254.05), simvastatin (ROR: 72.65, 95% CI: 47.36-111.44), and atorvastatin (ROR: 66.31, 95% CI: 44.06-99.81).
CONCLUSIONS: The combination of daptomycin and statins increased the association of myopathy and rhabdomyolysis, especially with rosuvastatin, simvastatin, and atorvastatin.
摘要：
背景：肌病是达托霉素和他汀类药物最常见的不良反应之一。我们旨在在大型药物警戒数据库中评估达托霉素和他汀类药物联合治疗的肌肉毒性。
方法：这是一项基于真实世界数据的回顾性不相称性分析。2004年第一季度至2022年第四季度报告的达托霉素和他汀类药物报告的所有病例均来自美国食品和药物管理局不良事件报告系统（FAERS）数据库。不相称性分析是通过估计比例报告比率(PRR)进行的，报告赔率比(ROR)，和信息组件(IC)。
结果：从FAERS数据库中收集了971,861例合格病例。数据分析显示,瑞舒伐他汀(ROR:124.39,95%CI:87.35-178.47),阿托伐他汀（ROR：68.53，95%CI：51.93-90.43），辛伐他汀（ROR：94.83，95％CI：71.12-126.46）联合达托霉素增加了肌病的报告频率。此外，3-药物联合治疗组肌病的发生率更高(ROR:598.01,95%CI:231.81-1542.71).对于横纹肌溶解症,达托霉素与瑞舒伐他汀联合使用时，报告频率也增加（ROR：156.34，95％CI：96.21-254.05），辛伐他汀（ROR：72.65，95%CI：47.36-111.44），阿托伐他汀（ROR：66.31，95%CI：44.06-99.81）。
结论：达托霉素和他汀类药物的联合使用增加了肌病和横纹肌溶解的相关性，尤其是瑞舒伐他汀,辛伐他汀,和阿托伐他汀.
方法：这是一项基于真实世界数据的回顾性不相称性分析。2004年第一季度至2022年第四季度报告的达托霉素和他汀类药物报告的所有病例均来自美国食品和药物管理局不良事件报告系统（FAERS）数据库。不相称性分析是通过估计比例报告比率(PRR)进行的，报告赔率比(ROR)，和信息组件(IC)。
结果：从FAERS数据库中收集了971,861例合格病例。数据分析显示,瑞舒伐他汀(ROR:124.39,95%CI:87.35-178.47),阿托伐他汀（ROR：68.53，95%CI：51.93-90.43），辛伐他汀（ROR：94.83，95％CI：71.12-126.46）联合达托霉素增加了肌病的报告频率。此外，3-药物联合治疗组肌病的发生率更高(ROR:598.01,95%CI:231.81-1542.71).对于横纹肌溶解症,达托霉素与瑞舒伐他汀联合使用时，报告频率也增加（ROR：156.34，95％CI：96.21-254.05），辛伐他汀（ROR：72.65，95%CI：47.36-111.44），阿托伐他汀（ROR：66.31，95%CI：44.06-99.81）。
结论：达托霉素和他汀类药物的联合使用增加了肌病和横纹肌溶解的相关性，尤其是瑞舒伐他汀,辛伐他汀,和阿托伐他汀.
