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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

Roddy, Edward; Bajpai, Ram; Forrester, Harry; James Partington, Richard; D Mallen, Christian; Clarson, Lorna Elise; Padmanabhan, Nishita; Whittle, Rebecca; Muller, Sara

Authors

Harry Forrester

Nishita Padmanabhan

Rebecca Whittle



Abstract

Objectives:
To determine the risk of adverse events associated with colchicine or non-steroidal anti-inflammatory drug (NSAID) prophylaxis when initiating allopurinol for gout.

Methods:
We conducted two matched retrospective cohort studies in linked UK Clinical Practice Research Datalink and Hospital Episode Statistics datasets. Adults initiating allopurinol for gout with (1) colchicine or (2) NSAID prophylaxis were compared with those initiating without prophylaxis, individually matched by age, sex and propensity to receive the relevant prophylaxis. Weighted Cox proportional hazards models investigated associations between colchicine/NSAID and specified adverse events.

Results:
13 945 individuals prescribed colchicine were matched to 13 945 with no prophylaxis and 25 980 prescribed NSAID to 25 980 with no prophylaxis. Adverse event incidence rates were <200/10 000 patient-years except diarrhoea (784.4; 95% CI 694.0 to 886.5) and nausea (208.1; 95% CI 165.4 to 261.7) for colchicine and angina for NSAID (466.6; 95% CI 417.2 to 521.8). Diarrhoea (HR 2.22; 95% CI 1.83 to 2.69), myocardial infarction (MI) (1.55; 95% CI 1.10, 2.17), neuropathy (4.75; 95% CI 1.20 to 18.76), myalgia (2.64; 95% CI 1.45 to 4.81), bone marrow suppression (3.29; 95% CI 1.43 to 7.58) and any adverse event (1.91, 95% CI 1.65 to 2.20) were more common with colchicine than no prophylaxis, but not nausea/vomiting (1.34; 95% CI 0.97 to 1.85). Angina (1.60; 95% CI 1.37 to 1.86), acute kidney injury (1.56; 95% CI 1.20 to 2.03), MI (1.89; 95% CI 1.44 to 2.48), peptic ulcer disease (1.67; 95% CI 1.14 to 2.44) and any adverse event (1.63; 95% CI 1.44 to 1.85) were more common with NSAID than without.

Conclusions:
Adverse events were more common when allopurinol was initiated with prophylaxis, particularly diarrhoea with colchicine. Other events were uncommon, providing reassurance for patients and clinicians to enable shared decision-making.

Journal Article Type Article
Acceptance Date Aug 10, 2023
Online Publication Date Oct 3, 2023
Publication Date Oct 1, 2023
Deposit Date Oct 9, 2023
Journal Annals of the Rheumatic Diseases
Print ISSN 0003-4967
Electronic ISSN 1468-2060
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Pages ard-2023-224154
DOI https://doi.org/10.1136/ard-2023-224154
Keywords Anti-Inflammatory Agents, Non-Steroidal, Epidemiology, Gout