Guan Xin, Yang Yusi, Li Xinru, Feng Yue, Li Jizhen, Li Xuewen
Department of Cardiology, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences Tongji Shanxi Hospital, Taiyuan, China.
Second School of Clinical Medicine, Shanxi Medical University, Taiyuan, China.
Front Pharmacol. 2024 Jul 17;15:1417951. doi: 10.3389/fphar.2024.1417951. eCollection 2024.
Eplerenone is approved for the treatment of hypertension as well as symptomatic heart failure with reduced ejection fraction (HFrEF) following an acute myocardial infarction. However, the adverse events (AEs) have not been systematically analyzed. The aim of this study was to identify adverse drug reactions (ADRs) related to eplerenone using the FDA Adverse Event Reporting System (FAERS) database. By identifying previously unreported AEs, the study could potentially contribute to updating the drug's label. In order to find significant AEs, four algorithms, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Empirical Bayesian Geometric Mean (EBGM), were used to analyze the signal strength of the ADRs connected to eplerenone that were gathered from the FAERS database over the previous 20 years. From 2004Q1 to 2023Q4, a total of 20, 629, 811 reported cases were gathered from the FAERS database for this study. After processing the data and filtering, 1,874 case reports were analyzed. Of these cases, 1,070 AEs were identified, 128 of which were eplerenone-related ADRs. We investigated the occurrence of ADRs induced by eplerenone in 27 organ systems. Our study showed that the AEs listed in the medication's package insert correspond with those listed in the literature, including hyperkalemia and increased creatinine. Additionally, the prescription label for eplerenone does not include all system organ class (SOC) terms, like Vascular disorders, hepatobiliary Disorders, etc. The study used multiple algorithms to quantify the signal strength and then identified any previously unrecognized ADRs, further studies are needed to confirm the association of ADRs with eplerenone. The findings of this study may provide important insights into the safety profile of eplerenone, ensure that healthcare providers have up-to-date information about their potential risks and help guide them in the correct use of the drug.
依普利酮被批准用于治疗高血压以及急性心肌梗死后射血分数降低的有症状心力衰竭（HFrEF）。然而，尚未对不良事件（AE）进行系统分析。本研究的目的是使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库识别与依普利酮相关的药物不良反应（ADR）。通过识别以前未报告的AE，该研究可能有助于更新药物标签。为了找到显著的AE，使用了四种算法，包括报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯置信传播神经网络（BCPNN）和经验贝叶斯几何均值（EBGM），来分析从FAERS数据库中收集的过去20年里与依普利酮相关的ADR的信号强度。从2004年第一季度到2023年第四季度，本研究从FAERS数据库中总共收集了20629811例报告病例。在对数据进行处理和筛选后，分析了1874份病例报告。在这些病例中，识别出1070例AE，其中128例为依普利酮相关的ADR。我们调查了依普利酮在27个器官系统中引起的ADR的发生情况。我们的研究表明，药品说明书中列出的AE与文献中列出的一致，包括高钾血症和肌酐升高。此外，依普利酮的处方标签并未包括所有系统器官分类（SOC）术语，如血管疾病、肝胆疾病等。该研究使用多种算法来量化信号强度，然后识别任何以前未被认识到的ADR，需要进一步研究来确认ADR与依普利酮之间的关联。本研究的结果可能为依普利酮的安全性概况提供重要见解，确保医疗保健提供者了解其潜在风险的最新信息，并帮助指导他们正确使用该药物。
