Cohort study
Ibrutinib Is Associated With Increased Cardiovascular Events and Major Bleeding in Older Chronic Lymphocytic Leukemia (CLL) Patients
- Retrospective cohort study
- inverse probability weighted
- linked SEER-Medicare database
Authors' conclusion
In patients a decade older than those in the initial clinical trials, treatment with ibrutinib was associated with an increased risk of stroke, AF, and bleeding.
Study context
- Population
- Older patients with chronic lymphocytic leukemia (CLL), linked SEER-Medicare databasemedian age 77 years
- Participants
- 4,958 patients
- Exposure
- Ibrutinib vs treatment without ibrutinib
- Outcome
- Incidence of stroke, atrial fibrillation (AF), MI and bleeding
Main finding
As reported in the abstract
Ibrutinib vs Without ibrutinibHazard ratio (95% CI)
stroke
1.91(1.06–3.45)
AF
3.65(2.42–5.49)
bleeding
4.92(3.46–7.01)
major bleeding
7.49(4.32–12.99)
Observational data: associations, not effects.
Original publication
Ibrutinib Is Associated With Increased Cardiovascular Events and Major Bleeding in Older CLL Patients. JACC CardioOncol. Published 18 April 2023. doi:10.1016/j.jaccao.2023.02.001
Summarised from the published abstract; every number is checked against it