The DOI matches its Crossref record; 52 of the 52 references it cites were found in a registry or an index.
Cardiovascular Toxicities Associated With Ibrutinib
Open accessAbstract
BACKGROUND Ibrutinib has revolutionized treatment for several B-cell malignancies. However, a recent clinical trial where ibrutinib was used in a front-line setting showed increased mortality during treatment compared with conventional chemotherapy. Cardiovascular toxicities were suspected as the culprit but not directly assessed in the study. OBJECTIVES The purpose of this study was to identify and characterize cardiovascular adverse drug reactions (CV-ADR) associated with ibrutinib. METHODS This study utilized VigiBase (International pharmacovigilance database) and performed a disproportionality analysis using reporting odds ratios (ROR) and information component (IC) to determine whether CV-ADR and CV-ADR deaths were associated with ibrutinib. IC compares observed and expected values to find associations between drugs and adverse drug reactions using disproportionate Bayesian-reporting; IC025 (lower end of the IC 95% credibility interval) >0 is significant. RESULTS This study identified 303 ibrutinib-associated cardiovascular deaths. Ibrutinib was associated with higher reporting of supraventricular arrhythmias (SVAs) (ROR: 23.1; 95% confidence interval: 21.6 to 24.7; p < 0.0001; IC025: 3.97), central nervous system (CNS) hemorrhagic events (ROR: 3.7; 95% confidence interval: 3.4 to 4.1; p < 0.0001; IC025: 1.63), heart failure (ROR: 3.5; 95% confidence interval: 3.1 to 3.8; p < 0.0001; IC025: 1.46), ventricular arrhythmias (ROR: 4.7; 95% confidence interval: 3.7 to 5.9; p < 0.0001; IC025: 0.96), conduction disorders (ROR: 3.5; 95% confidence interval: 2.7 to 4.6; p < 0.0001; IC025: 0.76), CNS ischemic events (ROR: 2.2; 95% confidence interval: 2.0 to 2.5; p < 0.0001; IC025: 0.73), and hypertension (ROR: 1.7; 95% confidence interval: 1.5 to 1.9; p < 0.0001; IC025: 0.4). CV-ADR often occurred early after ibrutinib administration. Importantly, CV-ADR were associated with fatalities that ranged from ∼10% (SVAs and ventricular arrhythmias) to ∼20% (CNS events, heart failure, and conduction disorders). Ibrutinib-associated SVA portends poor prognosis when CNS events occur concomitantly, with 28.8% deaths (15 of 52 cases). CONCLUSIONS Severe and occasionally fatal cardiac events occur in patients exposed to ibrutinib. These events should be considered in patient care and in clinical trial designs. (Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents [EROCA]; NCT03530215).
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Zamorano, J. L., Lancellotti, P., Rodriguez Muñoz, D., Aboyans, V., Asteggiano, R., Galderisi, M., Habib, G., Lenihan, D. J., Lip, G. Y. H., Lyon, A. R., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw211 · Cited by 2,544
Targeting BTK with Ibrutinib in Relapsed Chronic Lymphocytic Leukemia
Byrd, J. C., Furman, R. R., Coutre, S. E., Flinn, I. W., Burger, J. A., Blum, K. A., Grant, B., Sharman, J. P., Coleman, M., Wierda, W. G., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1215637 · Cited by 2,270
Zamorano, J. L., Lancellotti, P., Rodriguez Muñoz, D., Aboyans, V., Asteggiano, R., Galderisi, M., Habib, G., Lenihan, D. J., Lip, G. Y. H., Lyon, A. R., et al. (2017) · European Journal of Heart Failure · doi:10.1002/ejhf.654 · Cited by 1,795
Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia
Burger, J. A., Tedeschi, A., Barr, P. M., Robak, T., Owen, C., Ghia, P., Bairey, O., Hillmen, P., Bartlett, N. L., Li, J., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1509388 · Cited by 1,583
A Bayesian neural network method for adverse drug reaction signal generation
Bate, A., Lindquist, M., Edwards, I. R., Olsson, S., Orre, R., Lansner, A., & De Freitas, R. M. (1998) · European Journal of Clinical Pharmacology · doi:10.1007/s002280050466 · Cited by 1,476
Salem, J.-E., Manouchehri, A., Moey, M., Lebrun-Vignes, B., Bastarache, L., Pariente, A., Gobert, A., Spano, J.-P., Balko, J. M., Bonaca, M. P., et al. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30608-9 · Cited by 1,271
Self-citationThe reporting odds ratio and its advantages over the proportional reporting ratio
Rothman, K. J., Lanes, S., & Sacks, S. T. (2004) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.1001 · Cited by 1,111
Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL
Woyach, J. A., Ruppert, A. S., Heerema, N. A., Zhao, W., Booth, A. M., Ding, W., Bartlett, N. L., Brander, D. M., Barr, P. M., Rogers, K. A., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1812836 · Cited by 962
Self-citationIbrutinib in Previously Treated Waldenström’s Macroglobulinemia
Treon, S. P., Tripsas, C. K., Meid, K., Warren, D., Varma, G., Green, R., Argyropoulos, K. V., Yang, G., Cao, Y., Xu, L., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1501548 · Cited by 942
Cardiovascular Toxic Effects of Targeted Cancer Therapies
Moslehi, J. J. (2016) · New England Journal of Medicine · doi:10.1056/nejmra1100265 · Cited by 635
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Lyon, A. R., López-Fernández, T., Couch, L. S., Asteggiano, R., Aznar, M. C., Bergler-Klein, J., Boriani, G., Cardinale, D., Cordoba, R., Cosyns, B., et al. (2022) · European Heart Journal - Cardiovascular Imaging · doi:10.1093/ehjci/jeac106 · Cited by 507
Self-citationHeart Failure With Recovered Left Ventricular Ejection Fraction
Wilcox, J. E., Fang, J. C., Margulies, K. B., & Mann, D. L. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.05.075 · Cited by 322
Comparative Analysis of BTK Inhibitors and Mechanisms Underlying Adverse Effects
Estupiñán, H. Y., Berglöf, A., Zain, R., & Smith, C. I. E. (2021) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2021.630942 · Cited by 267
Metadata
- Authors
- Salem, J.-E., Manouchehri, A., Bretagne, M., Lebrun-Vignes, B., Groarke, J. D., Johnson, D. B., Yang, T., Reddy, N. M., Funck-Brentano, C., Brown, J. R., Roden, D. M., & Moslehi, J. J.
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2019-10
- Volume
- 74
- Issue
- 13
- Pages
- 1667-1678
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W2976280418
- Cited by
- 266
- References
- 52
- FWCI
- 14.82
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Salem, J.-E., Manouchehri, A., Bretagne, M., Lebrun-Vignes, B., Groarke, J. D., Johnson, D. B., Yang, T., Reddy, N. M., Funck-Brentano, C., Brown, J. R., Roden, D. M., & Moslehi, J. J. (2019). Cardiovascular Toxicities Associated With Ibrutinib. Journal of the American College of Cardiology. https://doi.org/10.1016/j.jacc.2019.07.056
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