Safety of colchicine and non-steroidal anti-inflammatory drug (NSAID) prophylaxis when initiating urate-lowering therapy for gout: propensity score-matched cohort studies in the UK Clinical Practice Research Datalink
Authors' conclusion
Adverse events were more common when allopurinol was initiated with prophylaxis, particularly diarrhoea with colchicine.
Study context
- Population
- Adults initiating allopurinol for gout, linked UK Clinical Practice Research Datalink and Hospital Episode Statisticstwo matched cohorts
- Participants
- 13,945 / 13,945 / 25,980 / 25,980
- Exposure
- Colchicine or NSAID prophylaxis vs no prophylaxis when initiating allopurinol for gout
- Colchicinen = 13,945
- No prophylaxis (colchicine cohort)n = 13,945reference
- NSAIDn = 25,980
- No prophylaxis (NSAID cohort)n = 25,980reference
- Outcome
- Specified adverse events
Methodological detailstwo matched cohort studies, propensity-score matched (age, sex, propensity to receive prophylaxis), weighted Cox proportional hazards models
- Two matched cohort studies
- Propensity-score matched (age, sex, propensity to receive prophylaxis)
- Weighted Cox proportional hazards models
Main finding
As reported in the abstract
Any adverse event
Hazard ratio (95% CI)
Colchicinevs No prophylaxis (colchicine cohort)
1.91(1.65–2.20)
NSAIDvs No prophylaxis (NSAID cohort)
1.63(1.44–1.85)
Observational data: associations, not effects.
Safety
| Outcome | Estimate | |
|---|---|---|
| Specific adverse events, colchicinevs no prophylaxis | HR (diarrhoea) 2.22 (95% CI 1.83–2.69) | |
| Specific adverse events, colchicinevs no prophylaxis | HR (MI) 1.55 (95% CI 1.10–2.17) | |
| Specific adverse events, colchicinevs no prophylaxis | HR (neuropathy) 4.75 (95% CI 1.20–18.76) | |
| Specific adverse events, colchicinevs no prophylaxis | HR (myalgia) 2.64 (95% CI 1.45–4.81) | |
| Specific adverse events, colchicinevs no prophylaxis | HR (bone marrow suppression) 3.29 (95% CI 1.43–7.58) | |
| Specific adverse events, colchicinevs no prophylaxisNot more common | HR (nausea/vomiting) 1.34 (95% CI 0.97–1.85) | |
| Specific adverse events, NSAIDvs no prophylaxis | HR (angina) 1.60 (95% CI 1.37–1.86) | |
| Specific adverse events, NSAIDvs no prophylaxis | HR (acute kidney injury) 1.56 (95% CI 1.20–2.03) | |
| Specific adverse events, NSAIDvs no prophylaxis | HR (MI) 1.89 (95% CI 1.44–2.48) | |
| Specific adverse events, NSAIDvs no prophylaxis | HR (peptic ulcer disease) 1.67 (95% CI 1.14–2.44) | |
| 0.050.21520Ratio (log scale) |
| Outcome | Colchicine | NSAID |
|---|---|---|
| Incidence rate per 10 000 patient-years | 784.4 (95% CI 694.0–886.5) per 10 000 patient-years (diarrhoea) | 466.6 (95% CI 417.2–521.8) per 10 000 patient-years (angina) |
| Nausea incidence rate (95% CI 165.4 to 261.7) | 208.1 | — not stated in the abstract |
— not stated in the abstract
Original publication
Safety of colchicine and NSAID prophylaxis when initiating urate-lowering therapy for gout: propensity score-matched cohort studies in the UK Clinical Practice Research Datalink. Ann Rheum Dis. Published 3 October 2023. doi:10.
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