Is colchicine prophylaxis required with start-low go-slow allopurinol dose escalation in gout? A non-inferiority randomised double-blind placebo-controlled trial
Primary result · Gout flares/month, meanResult — go to the resultMean difference 0.25 gout flares/month 95% CI 0.07–0.44Authors' conclusion
Placebo is not non-inferior to colchicine in prevention of gout flares in the first 6 months of starting allopurinol using the 'start-low go-slow' strategy.
Study context
- Population
- Adults with ≥1 gout flare in the preceding 6 months, fulfilling American College of Rheumatology (ACR) recommendations for starting ULT, serum urate ≥0.36 mmol/Lrandomised 1:1
- Participants
- 200 adults
- Comparison
- Placebo vs colchicine 0.5 mg daily for the first 6 months of start-low go-slow allopurinol
- Primary endpoint
- Mean number of gout flares/month between 0 and 6 months (non-inferiority margin 0.12 gout flares/month)
- Follow-up
- 0–6 months
Methodological detailsdouble-blind, placebo-controlled, non-inferiority, 12-month
- Double-blind
- Placebo-controlled
- Non-inferiority
- 12-month
Primary result
Gout flares/month, mean · baseline to month 6
Mean difference
0.25 gout flares/month
95% CI 0.07–0.44
non-inferiority p=0.92
By group
Placebovs Colchicine
mean difference 0.25 gout flares/month (95% CI 0.07–0.44); non-inferiority p=0.92
As reported in the abstract
Further findings
| Outcome | P value |
|---|---|
| Gout flares/month, mean, over 12 months | P = 0.68 |
Gout flares/month, mean, over 12 months
- No difference between randomised groups
Safety
| Outcome | Placebo | Colchicine |
|---|---|---|
| Serious adverse events (events in participants) | ||
| Participants with SAE | 2 | 7 |
Original publication
Is colchicine prophylaxis required with start-low go-slow allopurinol dose escalation in gout? A non-inferiority randomised double-blind placebo-controlled trial. Ann Rheum Dis. Published 31 August 2023. doi:10.
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