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z Serious adverse events, cardiovascular adverse events and mortality in randomized controlled trials of febuxostat

From: Advances in gout: some answers, more questions

Study Duration Febuxostat
40 mg/day
Febuxostat
80 mg/day
Febuxostat
120 mg/day
Allopurinol
200/300 mg/day
Placebo
Cardiovascular adverse events
Schumacher et al. [7] 1 month - 5/267 (2%)a 5/269 (2%) 1/268 (0.4%) 1/134 (0.7%)
Current study [1] 6 months APTC: 0/757 (0%) APTC: 3/756 (0.4%) - APTC: 3/756 (0.4%) -
   Non-APTC: 10/757 (1.3%) Non-APTC: 9/756 (1.2%)   Non-APTC: 7/756 (0.9%)  
Death       
Schumacher et al. [7] 1 month - 0/267 (0%)a 0/269 (0%) 0/268 (0%) 0/134 (0%)
Becker et al. [6] 1 month 0/37 (0%) 0/40 (0%) 0/38 (0%) - 0/38 (0%)
Current study [1] 6 months 1/757 (0.1%) 1/756 (0.1%) - 3/756 (0.4%) -
Becker et al. [5] 1 year - 2/256 (1%) 2/251 (1%) 0/253 (0%) -
Serious adverse events as defined in each study b
Schumacher et al. [7] 1 month - 11/267 (4%)a 9/269 (3%) 7/268 (3%) 2/134 (1%)
Becker et al. [6] 1 month 0/37 (0%) 1/40 (2.5%) 2/38 (5.5%) - 0/38 (0%)
Current study [1] 6 months 19/757 (2.5%) 28/756 (3.7%) - 31/756 (4.1%) -
Becker et al. [5] 1 year - 11/256 (4.3%) 21/251 (8.4%) 19/253 (7.5%) -
  1. aOne out of 134 (1%) had cardiovascular adverse events, 5 out of 134 (4%) had serious adverse events and none of the patients died in the 240 mg febuxostat group in the study by Schumacher and colleagues [7]. Adjudicated Antiplatelet Trialists Collaboration (APTC) events were defined as one or more of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. Non-APTC cardiovascular events included unstable angina, coronary revascularization, cerebral revascularization, transient ischemic attack, venous and peripheral arterial vascular thrombotic event, congestive heart failure, and arrhythmia. aSerious adverse events were defined as follows in each study: no definitions were provided in the Schumacher and colleagues [7], Becker and colleagues [6] or the current study [1]; Becker and colleagues [5] defined a serious adverse event as '...an event that was life-threatening or that resulted in death, hospitalization or prolongation of hospitalization, persistent disability or incapacity, or a congenital anomaly or birth defect'.