Adverse Events Compared for Gout Flare Prophylactic Drugs


Matched cohort studies revealed infrequent adverse events (AEs) with either treatment, but the number needed to harm for any AE was more than three times higher with colchicine vs NSAIDs.


  • The researchers conducted two matched retrospective cohort studies using the UK Clinical Practice Research Datalink and the Hospital Episode Statistics primary care datasets to compare AEs in adults initiating allopurinol for gout with and without colchicine or NSAID prophylaxis.

  • For the study, 13,945 patients with gout who received colchicine were matched to 13,945 patients who received no prophylaxis. In addition, 25,980 patients with gout who received NSAIDs were matched to 25,980 who received no prophylaxis.

  • The researchers used proportional hazard models to explore the associations between prophylaxis with either colchicine or NSAIDs and AEs.


  • The incidence of most AEs was less than 200 per 10,000 patient-years, but the most common AE among patients given colchicine was diarrhea, with an incidence of 784.4 per 10,000 person-years, whereas the most common AE in those given NSAIDs was angina, with an incidence of 466.6 per 10,000 person-years.

  • The number needed to harm in relation to any AE was 14.7 for colchicine, driven mainly by diarrhea, and 48.1 for NSAID.

  • In comparison with patients who started allopurinol without prophylaxis, those treated with colchicine were more likely to experience diarrhea, myocardial infarction, neuropathy, myalgia, and bone marrow suppression, whereas those treated with NSAIDs were more likely to experience angina, acute kidney injury, myocardial infarction, and peptic ulcer disease.

  • Diarrhea, the most common AE, occurred in 17.9% of individuals who received colchicine.


“Our findings will provide much-needed information about the safety of flare prophylaxis that can inform treatment decisions and the choice between colchicine or NSAID for prophylaxis when initiating allopurinol, directly benefiting people with gout and their clinicians,” the authors write.


First author Edward Roddy, MD, of Keele University, Keele, United Kingdom, and colleagues published their report online October 3 in BMJ’s Annals of the Rheumatic Diseases.


The study identified gout based on clinical diagnosis in primary care and only considered AEs serious enough to merit consultation or hospitalization; other limitations included the observational design and lack of data on the use of over-the-counter NSAIDs.


The study was supported by the National Institute for Health and Care Research (NIHR) Research for Patient Benefit programme. The researchers had no financial conflicts to disclose.

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