Abstract：
OBJECTIVE: The association between proton-pump inhibitors (PPIs) and rhabdomyolysis were unclear. The aim of this study was to explore and systematically analyze the potential link between five PPIs and the rhabdomyolysis events using the FDA Adverse Event Reporting System (FAERS) database.
METHODS: Suspected rhabdomyolysis events associated with PPIs were identified by data mining with the reporting odds ratio (ROR), proportional reporting ratio (PRR), the information component (IC), and Empirical Bayes Geometric Mean (EBGM). Demographic information, drug administration, and outcomes of PPI-induced rhabdomyolysis events were also analyzed.
RESULTS: There were 3311 reports associated with PPI-induced rhabdomyolysis that were identified. After removing duplicates, 1899 cases were determined to contain complete patient demographic data. The average age was 65 ± 18 year and 57% were male. Omeprazole and pantoprazole had the same largest percentage of reports. Lansoprazole had the highest ROR index of 12.67, followed by esomeprazole (11.18), omeprazole (10.27), rabeprazole (10.06), and pantoprazole (9.24). PRR, IC, and EBGM showed similar patterns. This suggested that lansoprazole exhibited the strongest correlation with rhabdomyolysis. In rhabdomyolysis events, PPIs were mainly \"concomitant\" (>60%), and only a few cases were \"primary suspects\" (<15%). Rabeprazole showed the lowest death rate while lansoprazole showed the highest.
CONCLUSIONS: The study suggested that significant rhabdomyolysis signals were associated with PPIs. Further research should be performed in drug safety evaluation for a more comprehensive association.
METHODS: Suspected rhabdomyolysis events associated with PPIs were identified by data mining with the reporting odds ratio (ROR), proportional reporting ratio (PRR), the information component (IC), and Empirical Bayes Geometric Mean (EBGM). Demographic information, drug administration, and outcomes of PPI-induced rhabdomyolysis events were also analyzed.
RESULTS: There were 3311 reports associated with PPI-induced rhabdomyolysis that were identified. After removing duplicates, 1899 cases were determined to contain complete patient demographic data. The average age was 65 ± 18 year and 57% were male. Omeprazole and pantoprazole had the same largest percentage of reports. Lansoprazole had the highest ROR index of 12.67, followed by esomeprazole (11.18), omeprazole (10.27), rabeprazole (10.06), and pantoprazole (9.24). PRR, IC, and EBGM showed similar patterns. This suggested that lansoprazole exhibited the strongest correlation with rhabdomyolysis. In rhabdomyolysis events, PPIs were mainly \"concomitant\" (>60%), and only a few cases were \"primary suspects\" (<15%). Rabeprazole showed the lowest death rate while lansoprazole showed the highest.
CONCLUSIONS: The study suggested that significant rhabdomyolysis signals were associated with PPIs. Further research should be performed in drug safety evaluation for a more comprehensive association.
摘要：
目的：质子泵抑制剂（PPI）与横纹肌溶解症之间的关系尚不清楚。本研究的目的是使用FDA不良事件报告系统（FAERS）数据库探索和系统分析五种PPI与横纹肌溶解事件之间的潜在联系。
方法：通过使用报告比值比（ROR）进行数据挖掘，确定与PPI相关的可疑横纹肌溶解事件，比例报告比率(PRR)，信息组件(IC)，和经验贝叶斯几何均值(EBGM)。人口统计信息,药物管理,并对PPI诱导的横纹肌溶解事件的结局进行了分析.
结果：有3311例与PPI诱导的横纹肌溶解相关的报告被确认。删除重复项后，1899例病例被确定为包含完整的患者人口统计学数据。平均年龄为65±18岁，男性占57％。奥美拉唑和泮托拉唑的报告百分比相同。兰索拉唑的ROR指数最高，为12.67，其次是埃索美拉唑(11.18)。奥美拉唑（10.27），雷贝拉唑（10.06），和泮托拉唑（9.24）。PRR,IC,和EBGM显示类似的模式。这表明兰索拉唑与横纹肌溶解症表现出最强的相关性。在横纹肌溶解事件中，PPI主要是“伴随”(>60%)，只有少数案件是“主要嫌疑人”(<15%)。雷贝拉唑的死亡率最低，而兰索拉唑的死亡率最高。
结论：该研究提示显著的横纹肌溶解信号与PPI相关。应在药物安全性评估中进行进一步的研究，以建立更全面的关联。
方法：通过使用报告比值比（ROR）进行数据挖掘，确定与PPI相关的可疑横纹肌溶解事件，比例报告比率(PRR)，信息组件(IC)，和经验贝叶斯几何均值(EBGM)。人口统计信息,药物管理,并对PPI诱导的横纹肌溶解事件的结局进行了分析.
结果：有3311例与PPI诱导的横纹肌溶解相关的报告被确认。删除重复项后，1899例病例被确定为包含完整的患者人口统计学数据。平均年龄为65±18岁，男性占57％。奥美拉唑和泮托拉唑的报告百分比相同。兰索拉唑的ROR指数最高，为12.67，其次是埃索美拉唑(11.18)。奥美拉唑（10.27），雷贝拉唑（10.06），和泮托拉唑（9.24）。PRR,IC,和EBGM显示类似的模式。这表明兰索拉唑与横纹肌溶解症表现出最强的相关性。在横纹肌溶解事件中，PPI主要是“伴随”(>60%)，只有少数案件是“主要嫌疑人”(<15%)。雷贝拉唑的死亡率最低，而兰索拉唑的死亡率最高。
结论：该研究提示显著的横纹肌溶解信号与PPI相关。应在药物安全性评估中进行进一步的研究，以建立更全面的关联。
