6/29/23, 11:57 PM STOP GOUT Pathway Feedback Search Clinical Topics Home Studies STOP GOUT STOP GOUT Disease Gout Trial question Is allopurinol noninferior to febuxostat in patients with gout? Study design Multi-center Double blinded RCT Population Characteristics of study participants 2.0% female N = 940 98.0% male 940 patients (15 female, 925 male) Inclusion criteria: patients with gout and hyperuricemia Key exclusion criteria: stage 4 or 5 CKD; women aged < 50 years; previous solid organ transplantation; previous hematopoietic transplantation; intolerance to study drugs Interventions N=468 allopurinol (oral dose of 100-800 mg daily) N=472 febuxostat (oral dose of 40-120 mg daily) Primary outcome Percentage of patients experiencing 1 gout flare at week 49 to 72 43.5 % 43.5 https://web.pathway.md/studies/rec2OxYAeD8Pc5PwS 1/2 6/29/23, 11:57 PM STOP GOUT Pathway 3 5 36.5 32.6 % 21.8 % Difference not exceeding nonferiority margin 10.9 % 0.0 % Allopurinol Febuxostat Difference not exceeding nonferiority margin in the percentage of patients experiencing 1 gout flare at week 49 to 72 (36.5% vs. 43.5%; RR 0.84, 95% CI 0.34 to 1.34) Secondary outcomes No significant difference in the percentage of patients with serum urate levels below 6 mg/dL at week 25 to 48 (81.1% vs. 78.4%; RR 1.04, 95% CI 0.96 to 1.11) Significant decrease in the percentage of patients with CKD experiencing 1 gout flare at week 49 to 72 (31.9% vs. 45.3%; ARD -13.4, 95% CI -Infinity to -3.9) Safety outcomes No significant differences in death, serious adverse events, or cardiovascular events. Conclusion In patients with gout and hyperuricemia, allopurinol was noninferior to febuxostat with respect to the percentage of patients experiencing 1 gout flare at week 49 to 72. Reference James R O'Dell, Mary T Brophy, Michael H Pillinger et al. Comparative Effectiveness of Allopurinol and Febuxostat in Gout Management. NEJM Evid. 2022 Mar;1(3):10.1056/evidoa2100028. Open reference URL https://web.pathway.md/studies/rec2OxYAeD8Pc5PwS 2/2