Why the study?
Gemcitabine is widely used to treat multiple cancers, but it may also be associated with cardiovascular adverse-drug-reactions.
Is gemcitabine associated with increased reporting of cardiovascular adverse drug reactions compared to the full pharmacovigilance database?
Population
46,898 gemcitabine reports among 18,908,940 total reports in VigiBase
Comparison
Gemcitabine vs the full VigiBase database
Design
Literature review and pharmacovigilance disproportionality study
Authors
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Gemcitabine CV signals warrant monitoring in practice; leaves open causal confirmation in prospective oncology trials.
Is gemcitabine associated with increased reporting of cardiovascular adverse drug reactions compared to the full pharmacovigilance database?
Gemcitabine treatment is associated with potentially lethal cardiovascular adverse drug reactions, including myocardial ischemia, pericardial diseases, supraventricular arrhythmias, and heart failure, which should be considered in patient care.
Hilmi et al. (2020) studied this question.
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