Date of Award
Department of Pharmacy Practice
Dr.Anil K Bhat
Background: On February 21st 2019, FDA added a boxed warning for increased risk of death with febuxostat compared to allopurinol. Purpose: To compare the incidence of cardiovascular events and efficacy between febuxostat and allopurinol use. Methods: A retrospective cohort study was conducted in hyperuricemic/gout patients admitted between 2013 to 2017. Study cohort (febuxostat/allopurinol/both) and control cohort (drugs other than febuxostat/allopurinol) were selected based on inclusion and exclusion criteria. The primary outcomes were various cardiovascular events which were compared and analysed using IBM SPSS version 20 and p<0.05 was considered statistically significant. Results: Mean reduction in level of serum urate after febuxostat and allopurinol use was 2.754 mg/dl [p=0.000; CI (95%) 2.209-3.299] and 1.137 mg/dl [p=0.000; CI (95%) 0.792-1.482], respectively. However, there was no statistically significant difference between the groups. The mean survival time for febuxostat was 37 months [CI (95%) 24-51], whereas for allopurinol was 107 months [CI (95%) 52-162] and for both users was 38 months [CI (95%) 20-56]. However, there was no significant difference among the groups (p=0.762). Cardiovascular events occurred in 4 (5.63%) patients in febuxostat group (n=71), 6 (6.45%) patients in allopurinol group (n=93) and 3 (30%) patients in group with both drugs (n=10). The number needed to harm (NNH) for febuxostat, allopurinol and with both drugs were 22, 19 and 3, respectively. Conclusion: Both febuxostat and allopurinol are significantly efficacious in reducing serum urate levels. Lesser mean survival time in febuxostat group indicates faster occurrence of cardiovascular events. On the other hand, incidence of cardiovascular events was more with allopurinol than febuxostat without statistical significance. We observed these cardiovascular adverse events of allopurinol and febuxostat are duration depended.
Sekhar, Sonal M. Dr, "Cardiovascular Safety of Febuxostat and Allopurinol in Gout/Hyperuricemia Patients: A Retrospective Cohort Event Reporting in A Tertiary Healthcare Facility" (2019). Manipal College of Pharmaceutical Sciences, Manipal Theses and Dissertations. 23.