Cho Jaehyeong, Jo Hyesu, Park Jaeyu, Oh Jeongseon, Kim Hyunjee, Kim Soeun, Lee Hayeon, Jo Yeona, Jeong Jinyoung, Lee Sooji, Woo Ho Geol, Smith Lee, López Sánchez Guillermo F, Rhee Sang Youl, Yang Jee Myung, Yon Dong Keon
Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea.
Department of Medicine, CHA University School of Medicine, Seongnam, South Korea.
Sci Rep. 2025 Aug 7;15(1):28849. doi: 10.1038/s41598-025-13234-6.
Myocarditis and pericarditis are managed with various treatments, yet prior studies and case reports indicate that certain drug classes may elevate the risk for these inflammatory cardiac conditions. This research aimed to systematically identify the leading drugs most frequently associated with myocarditis and pericarditis cases. Analyses were carried out using the global database of individual case safety reports from 1968 to 2024. We identified the drugs most frequently reported in signal detection with myocarditis and pericarditis, selecting the top 10 drugs based on record count, excluding those used in the treatment of inflammatory cardiac conditions to avoid potential confounding. Two statistical indicators, the information component (IC) with IC and reporting odds ratio (ROR) with 95% confidence interval (CI) were used to conduct the disproportionality analysis in this study. The following five drugs were consistently observed with both myocarditis and pericarditis: clozapine, mesalazine, smallpox vaccine, influenza vaccine, and COVID-19 mRNA vaccine. The other leading drugs differed by condition, with nivolumab, pembrolizumab, ipilimumab, valproate, and metronidazole appearing more frequently for myocarditis, and ribavirin, sulfasalazine, methotrexate, omalizumab, and heparin for pericarditis. Each of these drugs showed a significant signal detection with myocarditis (ROR, 83.22 [95% CI, 81.17-85.33]; IC, 3.96 [IC, 3.94]) and pericarditis (42.16 [41.19-43.16]; 3.66 [3.64]). Although our findings did not allow for causal inference, these findings highlight the importance of monitoring for possible adverse carditis cases when prescribing these drugs. Further studies are encouraged to investigate underlying mechanisms, assess individual patient risk factors, and explore the long-term impacts associated with myocarditis and pericarditis in relation to drug.
心肌炎和心包炎采用多种治疗方法,但先前的研究和病例报告表明,某些药物类别可能会增加这些炎症性心脏疾病的风险。本研究旨在系统地确定与心肌炎和心包炎病例最常相关的主要药物。分析使用了1968年至2024年的全球个体病例安全报告数据库。我们确定了在心肌炎和心包炎信号检测中报告频率最高的药物,根据记录数量选择前10种药物,排除用于治疗炎症性心脏疾病的药物以避免潜在的混杂因素。本研究使用两个统计指标,即信息成分(IC)以及带有95%置信区间(CI)的报告比值比(ROR)进行不成比例分析。在心肌炎和心包炎中均持续观察到以下五种药物:氯氮平、美沙拉嗪、天花疫苗、流感疫苗和新冠病毒mRNA疫苗。其他主要药物因疾病而异,纳武单抗、帕博利珠单抗、伊匹木单抗、丙戊酸盐和甲硝唑在心肌炎中出现的频率更高,而利巴韦林、柳氮磺吡啶、甲氨蝶呤、奥马珠单抗和肝素在心包炎中出现的频率更高。这些药物中的每一种在心肌炎(ROR,83.22 [95% CI,81.17 - 85.33];IC,3.96 [IC,3.94])和心包炎(42.16 [41.19 - 43.16];3.66 [3.64])中均显示出显著的信号检测。尽管我们的研究结果无法进行因果推断,但这些结果凸显了在开具这些药物时监测可能的不良心脏炎病例的重要性。鼓励进一步研究调查潜在机制、评估个体患者风险因素,并探索与药物相关的心肌炎和心包炎的长期影响。