PMID- 36780109 OWN - NLM STAT- MEDLINE DCOM- 20230315 LR - 20230315 IS - 1179-1918 (Electronic) IS - 1173-2563 (Linking) VI - 43 IP - 3 DP - 2023 Mar TI - Evaluation of Cardiac Adverse Events with Nivolumab Using a Japanese Real-World Database. PG - 177-184 LID - 10.1007/s40261-023-01246-x [doi] AB - BACKGROUND: Nivolumab has been used for the treatment of various types of cancers and has achieved improvements in overall survival. However, nivolumab can cause a variety of adverse events (AEs). Among these, cardiac-specific AEs have received little attention in clinical trials, despite their life-threatening potential. OBJECTIVE: The present study aimed to determine the risk of nivolumab-induced cardiac AEs, time to onset, incidence rates, and post hoc outcomes using the Japanese Adverse Drug Event Report database. METHODS: We analyzed data for the period between April 2004 and March 2021. Data on cardiac AEs were extracted and relative risk of AEs was estimated using the reporting odds ratio (ROR). RESULTS: We analyzed 1,772,494 reports and identified 18,721 reports of AEs caused by nivolumab. Of these, 409 reports involved cardiac AEs. Signals were detected for four cardiac AEs: myocarditis; pericardial effusion; pericarditis; and immune-mediated myocarditis. Among these, myocarditis was the most frequently reported (35.0%) and included fatal cases. A histogram of times to onset showed nivolumab-associated AEs occurring 41-127 days after starting administration, with outlier cases of myocarditis or pericardial effusion occurring after more than one year, both with catastrophic consequences. CONCLUSION: This study focused on cardiac AEs caused by nivolumab as post-marketing AEs. Myocarditis and pericardial effusion have been associated with some fatal cases after administration of nivolumab. Patients should be monitored for signs of onset for these AEs, not only at the start of administration, but also over an extended period after nivolumab administration. CI - (c) 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG. FAU - Kanbayashi, Yuko AU - Kanbayashi Y AUID- ORCID: 0000-0002-0095-2293 AD - Department of Education and Research Center for Clinical Pharmacy, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, 4-20-1 Nasahara, Takatsuki, Osaka, 569-1094, Japan. yuko.kambayashi@ompu.ac.jp. FAU - Shimizu, Tadashi AU - Shimizu T AD - School of Pharmacy, Hyogo Medical University, 1-3-6 Minatojima, Kobe, Hyogo, 650-8530, Japan. FAU - Anzai, Miku AU - Anzai M AD - Department of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1 Kodominamihokotate, Kyotanabe, Kyoto, 610-0395, Japan. FAU - Kawai, Rika AU - Kawai R AD - Department of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1 Kodominamihokotate, Kyotanabe, Kyoto, 610-0395, Japan. FAU - Uchida, Mayako AU - Uchida M AD - Department of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1 Kodominamihokotate, Kyotanabe, Kyoto, 610-0395, Japan. LA - eng PT - Journal Article DEP - 20230213 PL - New Zealand TA - Clin Drug Investig JT - Clinical drug investigation JID - 9504817 RN - 31YO63LBSN (Nivolumab) SB - IM MH - Humans MH - East Asian People MH - *Myocarditis/chemically induced MH - *Neoplasms/drug therapy MH - *Nivolumab/adverse effects MH - *Pericardial Effusion/chemically induced EDAT- 2023/02/14 06:00 MHDA- 2023/03/16 06:00 CRDT- 2023/02/13 11:18 PHST- 2023/01/19 00:00 [accepted] PHST- 2023/02/14 06:00 [pubmed] PHST- 2023/03/16 06:00 [medline] PHST- 2023/02/13 11:18 [entrez] AID - 10.1007/s40261-023-01246-x [pii] AID - 10.1007/s40261-023-01246-x [doi] PST - ppublish SO - Clin Drug Investig. 2023 Mar;43(3):177-184. doi: 10.1007/s40261-023-01246-x. Epub 2023 Feb 13.