Advances in gout: some answers, more questions

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

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%)	-

^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'.

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