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Risk of ischemic stroke in benzbromarone versus allopurinol users: a real-world cohort study using TriNetX
Shih-Wei Lai1,2, Kuan-Fu Liao3
1School of Medicine, China Medical University, Taichung, Taiwan. wei@mail.cmuh.org.tw.
Clinical Rheumatology
|December 9, 2025
Summary
Benzbromarone use is linked to a higher risk of ischemic stroke compared to allopurinol in individuals with hyperuricemia or gout. This study highlights potential differences in long-term safety profiles for these urate-lowering therapies.
Area of Science:
- Cardiovascular epidemiology
- Pharmacovigilance
- Rheumatology
Background:
- Benzbromarone and allopurinol are urate-lowering therapies for hyperuricemia and gout.
- The comparative risk of ischemic stroke between these medications is not well-established.
Purpose of the Study:
- To compare the risk of ischemic stroke associated with benzbromarone versus allopurinol in patients aged 20-84 years.
- To evaluate the long-term safety of these urate-lowering drugs concerning ischemic stroke risk.
Main Methods:
- A retrospective cohort study using TriNetX network data (2006-2024).
- 1:1 matching of individuals using benzbromarone or allopurinol based on demographics and comorbidities.
- Unadjusted risk ratios and adjusted hazard ratios (Cox regression) were calculated.
Main Results:
- The study included 26,510 individuals in each matched group.
- Benzbromarone use was associated with a higher cumulative incidence of ischemic stroke (1.375%) compared to allopurinol (1.179%).
- An adjusted hazard ratio of 1.296 (95% CI: 1.129-1.488) indicated a statistically significant increased risk of ischemic stroke with benzbromarone.
Conclusions:
- Benzbromarone use is associated with a significantly higher long-term risk of ischemic stroke than allopurinol.
- These findings suggest benzbromarone may pose a greater ischemic stroke risk, informing clinical decisions.
- The study underscores the importance of considering stroke risk when selecting urate-lowering therapies.
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