STOP 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
98.0% male
N = 940
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
Patients experiencing ≥ 1 gout flare at week 49 to 72
36.5%
43.5%
43.5 %
32.6 %
21.8 %
10.9 %
0.0 %
Allopurinol
Febuxostat
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in 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 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 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 CV events.
Conclusion
In patients with gout and hyperuricemia, allopurinol was noninferior to febuxostat with respect to 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.
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