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IMMUNE CHECKPOINT INHIBITORS AND THE RISK OF ATRIO-VENTRICULAR BLOCK - A PHARMACOVIGILANCE ANALYSIS by Mohan Chandra Vinay Bharadwaj Gudiwada; Ankit Sahni; Riya Mary Sam; Vinuthna Gaddam; Jaswanth Jasti; Harsha Sai Sreemantula is a Medicine article available to read on EtoBox.
What is IMMUNE CHECKPOINT INHIBITORS AND THE RISK OF ATRIO-VENTRICULAR BLOCK - A PHARMACOVIGILANCE ANALYSIS about?
Background: Immune checkpoint inhibitors (ICIs) have become standard of care for various cancers. Increased use revealed unexpected cardiovascular complications with few reports suggesting atrio-ventricular (AV) block as an adverse drug reaction. Methods: Adverse events spontaneously submitted to US Food and Drug Administration Adverse Event Reporting System (FAERS) database between Q1 2004 to Q1 2022 were included. The online tool OpenVigil 2.1-MedDRA-v24 was used to query the database. Research relied on definitions of preferred terms specified by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQs). Proportionality Reporting Ratios (PRR) with 95% confidence intervals (CIs) were used for disproportionality analysis as per Evans criteria. Results: After searching unique reports, pembrolizumab (PRR 7.91, 95% CI 5.99-10.46), nivolumab (PRR 3.59, 95% CI 2.66-4.86), atezolizumab (PRR 2.59, 95% CI 1.16-5.76) and ipilimumab (PRR 3.39, 95% CI 2.21 -5.21) are disproportionately associated with complete AV block, being strongest for pembrolizumab. Among the drugs of interest, 32.5% of patients with complete AV block have death as reported out
Who reads IMMUNE CHECKPOINT INHIBITORS AND THE RISK OF ATRIO-VENTRICULAR BLOCK - A PHARMACOVIGILANCE ANALYSIS?
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- Author
- Mohan Chandra Vinay Bharadwaj Gudiwada; Ankit Sahni; Riya Mary Sam; Vinuthna Gaddam; Jaswanth Jasti; Harsha Sai Sreemantula
- Publisher
- Elsevier BV
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)