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Cardiovascular toxicities associated with immune checkpoint inhibitors: An observational, retrospective, pharmacovigilance study

The Lancet Oncology Nov 20, 2018

Salem JE, et al. - In this observational, retrospective, pharmacovigilance study, researchers identified and characterized cardiovascular (CV) immune-related adverse events (irAEs) that are significantly associated with immune checkpoint inhibitors (ICIs). They used VigiBase, the World Health Organization’s global database of individual case safety reports, to compare CV event reporting in patients who received ICIs with this reporting in the full database. They identified 31,321 reported AEs among patients who received ICIs and 16,343,451 reported AEs among patients treated with any drugs in VigiBase. Overall, study findings indicated that treatment with ICIs can result in severe, disabling inflammatory CV irAEs soon after treatment initiation. These toxicities include pericardial diseases and temporal arteritis with a risk of blindness, along with the life-threatening myocarditis. The authors recommended considering these events in patient care and in combination clinical trial designs (ie, combinations of different immunotherapies as well as immunotherapies and chemotherapy).

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