アブストラクト | Although rare, immune checkpoint inhibitor (ICI)-related myocarditis can be life-threatening, even fatal. In view of increased ICI prescription, identification of clinical risk factors for ICI-related myocarditis is of primary importance. This study aimed to assess whether pre-existing cardiovascular (CV) patient conditions are associated with the reporting of ICI-related myocarditis in VigiBase, the WHO global database of suspected adverse drug reactions (ADRs). In a (retrospective) matched case-control study, 108 cases of ICI-related myocarditis and 108 controls of ICI-related ADRs other than myocarditis were selected from VigiBase. Drugs labeled as treatment for CV conditions (used as a proxy for concomitant CV risk factors and/or CV diseases) were found to be associated more strongly with the reporting of ICI-related myocarditis than with other ICI-related ADRs (McNemar's chi-square test of marginal homogeneity: p = 0.026, Cramer's coefficient of effect size: Phi = 0.214). No significant association was found between pre-existing diabetes and ICI-related myocarditis reporting (McNemar's test of marginal homogeneity: p = 0.752). These findings offer an invitation for future prospective pharmacoepidemiological studies to assess the causal relationship between pre-existing CV conditions and myocarditis onset in a cohort of cancer patients followed during ICI treatment. |
組織名 | Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological;Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, 6900 Lugano,;Switzerland.;Team Data Science & Research, Area ICT, Ente Ospedaliero Cantonale, 6500;Bellinzona, Switzerland.;Dalle Molle Institute for Artificial Intelligence Research, 6928 Manno,;Faculty of Biomedical Sciences, University of Southern Switzerland, 6900 Lugano,;Department of Clinical Pharmacology and Toxicology, University Hospital Zurich,;8091 Zurich, Switzerland. |