Risk of bleeding complications and atrial fibrillation associated with ibrutinib treatment: A systematic review and meta-analysis.

Pellegrini, Luca; Novak, Urban; Andres, Martin; Suter, Thomas; Nagler, Michael (2021). Risk of bleeding complications and atrial fibrillation associated with ibrutinib treatment: A systematic review and meta-analysis. Critical reviews in oncology/hematology, 159, p. 103238. Elsevier 10.1016/j.critrevonc.2021.103238

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The use of ibrutinib is hampered by major bleeding events and atrial fibrillation. Speculating whether randomized controlled trials might underestimate the risk of adverse events in clinical practice, we conducted a systematic review and meta-analysis studying patients treated in any setting and indication. We systematically searched the literature using MEDLINE and EMBASE databases for case series, cohort studies, or randomized controlled trials and retrieved all data in parallel. Proportions of patients with adverse events were pooled in relevant subgroups using the binominal distribution and Freeman-Tukey double arcsine transformation. Among 2'537 records screened, 85 were finally included, comprising 7'317 patients. Methodological quality according to the Newcastle-Ottawa Scale was rated as moderate to poor with regard to bleeding events and atrial fibrillation; 106 studies were excluded because of missing data at all. Reported events varied substantially between 0 % and 78 % (any bleedings), 0 % and 25 % (major bleedings), and 0 % and 38 % (new-onset atrial fibrillation). Pooled estimates were 28 % (95 % confidence interval 22 %, 34 %), 3 % (2 %, 4 %), and 8 % respectively (7 %, 10 %). The risk of events was higher in studies with an older population, high ibrutinib dosage, thrombocytopenia, antithrombotic treatment, and retrospective studies. In conclusions, reporting of bleeding events and atrial fibrillation varied substantially among studies. These observations, in combination with the estimates obtained, suggest a relevant risk in clinical practice.

Item Type:

 Journal Article (Original Article)

Division/Institute:

 04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Haematology and Central Haematological Laboratory
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology

UniBE Contributor:

 Novak, Urban, Andres, Martin, Suter, Thomas, Nagler, Michael

Subjects:

 600 Technology > 610 Medicine & health

ISSN:

 1879-0461

Publisher:

 Elsevier

Language:

 English

Submitter:

 Pierrette Durand Lüthi

Date Deposited:

 15 Feb 2021 15:41

Last Modified:

 05 Dec 2022 15:47

Publisher DOI:

 10.1016/j.critrevonc.2021.103238

PubMed ID:

 33515702

Uncontrolled Keywords:

 B-cell BTK protein Bleeding Chronic Drug-related Side effects and adverse reactions Frequency Human [Supplementary Concept] Leukaemia Lymphocytic Lymphoma Lymphoproliferative disorders Mantle-cell PCI 32765 [Supplementary Concept] Predictors Waldenstrom macroglobulinaemia

BORIS DOI:

 10.48350/152167

URI:

 https://boris.unibe.ch/id/eprint/152167

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