{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T09:07:27Z","timestamp":1782983247359,"version":"3.54.5"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2025,12,20]],"date-time":"2025-12-20T00:00:00Z","timestamp":1766188800000},"content-version":"vor","delay-in-days":1693,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2021,5,2]],"date-time":"2021-05-02T00:00:00Z","timestamp":1619913600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>The major cardiovascular (CV) adverse effects observed with sipuleucel-T from large multi-institutional clinical trials included thromboembolic events, myocardial infarction, and congestive heart failure in up to 0.3% of patients with CV risk factors. The incidence, outcomes, and mechanisms in real-world clinical settings of these CV adverse effects to date have not been fully elucidated. Our study identified a patient with sipuleucel-T-induced inflammatory cardiomyopathy, which led to the identification of CV adverse effects associated with sipuleucel-T from a large pharmacovigilance database and elucidation of its potential mechanisms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>Using the MedDRA term \u2018cardiac disorders\u2019 (System Organ Class level), CV adverse events associated with sipuleucel-T versus all other drugs were reviewed from VigiBase, a large pharmacovigilance database. Disproportionality analysis was calculated by the information component (IC), a Bayesian disproportionality indicator. A positive IC025 (IC 95% lower end credibility interval) value (&amp;gt;0) is the traditional threshold used in statistical signal detection at the Uppsala Monitoring Centre. From VigiBase, the total number of CV adverse drug reaction reported with sipuleucel-T was 306 out of a total of 22 980 104 adverse drug reactions in VigiBase on 10\/25\/2020. MedDRA preferred terms levels were grouped into major CV adverse drug reaction categories where we observed significant reports of myocardial ischaemia, supraventricular tachycardia (particularly atrial fibrillation\/atrial flutter), congestive heart failure, and valvular disorders. Myocardial ischemia included acute myocardial infarction (IC025 2.3) with n = 4\/26 (15%) of these individual case safety reports considered fatal. Among patients with \u2018cardiac failure congestive\u2019 (IC025 1.5), 11 of these 43 cases (26%) were fatal with 42 (98%) of these cases considered to be solely due to sipuleucel-T.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Patients with CV risk factors who are receiving sipuleucel-T may be at higher risk for congestive heart failure, myocardial ischemia, and supraventricular tachycardia. Electrocardiograms during weekly sipuleucel-T infusions and left ventricular function monitoring with echocardiogram should be considered in these patients. Our findings are suggestive of another rare presentation of T-cell-mediated CV toxicity with cancer immunotherapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ehf2.13400","type":"journal-article","created":{"date-parts":[[2021,5,2]],"date-time":"2021-05-02T21:27:38Z","timestamp":1619990858000},"page":"3360-3368","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Sipuleucel-T Associated Inflammatory Cardiomyopathy: A Case Report and Observations from a Large Pharmacovigilance Database"],"prefix":"10.1093","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8117-0487","authenticated-orcid":false,"given":"Melissa Y.Y.","family":"Moey","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Sciences, East Carolina Heart Institute, Vidant Medical Center\/East Carolina University , 115 Heart Drive, Greenville, NC, 27834 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1324-865X","authenticated-orcid":false,"given":"Rahim A.","family":"Jiwani","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Vidant Medical Center\/East Carolina University , Greenville, NC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kotaro","family":"Takeda","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Vidant Medical Center\/East Carolina University , Greenville, NC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karyn","family":"Prenshaw","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Vidant Medical Center\/East Carolina University , Greenville, NC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. Wayne","family":"Kreeger","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Sciences, East Carolina Heart Institute, Vidant Medical Center\/East Carolina University , 115 Heart Drive, Greenville, NC, 27834 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Inzerillo","sequence":"additional","affiliation":[{"name":"Marion L. Shepard Cancer Center , Washington, NC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1480-7887","authenticated-orcid":false,"given":"Darla K.","family":"Liles","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Vidant Medical Center\/East Carolina University , Greenville, NC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5444-9573","authenticated-orcid":false,"given":"C. Bogdan","family":"Marcu","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Sciences, East Carolina Heart Institute, Vidant Medical Center\/East Carolina University , 115 Heart Drive, Greenville, NC, 27834 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6676-5063","authenticated-orcid":false,"given":"B\u00e9n\u00e9dicte","family":"Lebrun-Vignes","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Regional Pharmacovigilance Centre, Piti\u00e9-Salp\u00eatri\u00e8re Hospital, Sorbonne Universit\u00e9, INSERM CIC-1901, AP-HP , Paris ,","place":["France"]},{"name":"EA Epiderme-Epidemiology in Dermatology and Evaluation of Therapeutics, Universit\u00e9 Paris-Est Cr\u00e9teil , Cr\u00e9teil ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. 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