■质子泵抑制剂(PPI)与痴呆之间的关联存在争议。本研究的目的是在减少竞争偏差后,对痴呆事件与PPI治疗之间的关联进行更新的药物警戒分析。
■我们根据2004年至2023年美国食品和药品管理局不良事件报告系统数据库收集了PPI治疗报告的病例。我们采用了不成比例的算法,包括报告优势比(ROR)和信息成分(IC),检测痴呆事件与PPI之间的关联。我们调查了事件竞争偏差对当前不成比例信号检测的影响。
■我们最终纳入了776,191例PPI病例,痴呆组1813例。分析主要可疑PPI,我们检测到痴呆与PPI之间存在显著关联(ROR=1.38,95CI1.22~1.56;IC=0.46,95CI0.04~0.86).排除PPI后,有肾损伤事件,痴呆症信号的强度增加。奥美拉唑(589例),泮托拉唑(514例)和埃索美拉唑(386例)是PPI报告中痴呆事件的前三位.
■当前的药物警戒研究确定了痴呆和PPI之间的显著关联,除了vonoprazan和tegoprazan,尤其是考虑到竞争偏见。仍需进一步高质量的前瞻性研究。
UNASSIGNED: The association between proton pump inhibitor (PPI) and dementia was controversial. The aim of the current study was to perform an updated pharmacovigilance analysis of the association between dementia event and PPI treatment after minimizing competition bias.
UNASSIGNED: We gathered cases reported with PPI treatment based on the United States Food and Drug Administration Adverse Event Reporting System database from 2004 to 2023. We employed disproportionality algorithms, including reporting odds ratio (ROR) and the information component (IC), to detect the association between dementia event and PPI. We investigated the affection of event competition bias on the current disproportionality signal detection.
UNASSIGNED: We finally included a total of 776,191 PPI cases, and 1813 cases in the dementia group. Analyzing primary suspect PPIs, we detected a significant association between dementia and PPI (ROR = 1.38, 95%CI 1.22 to 1.56; IC = 0.46, 95%CI 0.04 to 0.86). After excluding the PPI case with renal injury events, the strength of the dementia signal increased. Omeprazole (589 cases), pantoprazole (514 cases), and esomeprazole (386 cases) were the top three PPI reported with dementia events.
UNASSIGNED: The current pharmacovigilance study identified a significant association between dementia and PPIs, except vonoprazan and tegoprazan, especially taking competition bias into account. Further high-quality prospective study still needed.