Table 3.

Recent cardiovascular outcomes trials of drugs used in the management of gout

Drug name	Official title of the trial	Abbreviated name of the trial	Median duration for observed effect	Phase of the trial	NCT identifier	Primary outcomes	Key points
Colchicine (patients who had suffered from an MI in the last 30 days)	Colchicine Cardiovascular Outcomes Trial	COLCOT	22.6 months	III	NCT02551094	CV death, recurrent MI, stroke, resuscitated cardiac arrest and hospitalization for unstable angina requiring coronary revascularization	1. Absolute reduction of 1.6% in ischemic events in the colchicine group compared with placebo (primary endpoint was 5.5% vs. 7.1%, respectively; HR 0.77. 95% CI 0.61–0.96) 2. Pneumonia was higher with colchicine, but diarrhea rates did not significantly differ in either group
Colchicine	Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial	END-AF	Variable: range was 2–56 days	III	NCT03021343	Rate of AF lasting more than 5 min	1. There was no significant difference in rates of AF in the group administered colchicine prior to cardiac surgery compared with the no colchicine group (overall rates of AF were 14.5% vs. 20.5%, respectively; RRR 29.3%, p = 0.14). No net benefit in composite of primary endpoint 2. Diarrhea lead to colchicine discontinuation in about half of the patients with this adverse effect.
Allopurinol (patients undergoing cardiac surgery and no prior history of AF or supraventricular arrhythmias)	Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients	EXACT-HF	24 weeks	II	NCT00987415	Improvement, worsening, or unchanged clinical status of patients with heart failure	1. There was no significant difference in clinical status or left ventricular ejection fraction between the allopurinol- and placebo-treated patients 2. Rash was more common with allopurinol but there was no significant difference in serious adverse event rates compared with placebo
Febuxostat vs. allopurinol	A multicenter, randomized, active-control, phase 3B study to evaluate the cardiovascular safety of febuxostat and allopurinol in subjects with gout and cardiovascular comorbidities	CARES	7 years	III	NCT01101035	Percentage of patients with a composite of non-fatal MI, non-fatal stroke, CV death, and unstable angina requiring coronary revascularization	1. A primary endpoint event occurred in 10.8% in the febuxostat group compared with 10.4% in the allopurinol group 2. All-cause and CV mortality were higher in the febuxostat group than in the allopurinol group

AF atrial fibrillation, CI confidence interval, CV cardiovascular, HR hazard ratio, LDL low-density lipoprotein, MI myocardial infarction, RRR relative risk reduction