Low-Dose Febuxostat vs Colchicine for Gout Flare Prevention

The efficacy of a low initial dose of febuxostat in preventing gout flares was found to be comparable to colchicine prophylaxis. Additionally, administering a high initial dose of febuxostat alone correlated with an increased susceptibility to gout flares, according to study results published in Rheumatology (Oxford).

Researchers conducted a single-center cohort study to examine the association between initial doses of urate-lowering medications and gout flares during the introduction of urate-lowering therapy (ULT) in adult men diagnosed with gout. Consecutive data was collected from patients with gout who visited the rheumatology department at Xingtai People’s Hospital between August 1st, 2017, and October 30th, 2020.

Patients with serum uric acid levels of at least 7.0 mg/dL, at least 1 gout attack within the year preceding enrollment, and a period of at least 1 month without the use of ULT prior to enrollment were included in the study. 

Patients were categorized into 3 groups based on their initial febuxostat dosage and whether it was combined with colchicine. Patients in group 1 started with an initial daily dose of 40 mg of febuxostat combined with 0.5 mg of colchicine daily for the first 3 weeks. Patients in group 2 commenced treatment with an initial daily dose of 20 mg of febuxostat alone for the first 3 weeks. Patients in group 3 initiated treatment with an initial daily dose of 40 mg of febuxostat alone for the first 3 weeks. Patients in all 3 groups either maintained this dosage or underwent a stepwise increase or decrease in febuxostat dosage over the following 3 weeks.

The primary study endpoint was the association between the initial doses of urate-lowering medications and the occurrence of the first gout flare within 6 weeks following ULT initiation. The secondary study endpoint was the assessment of adverse reactions.

A total of 582 adult male patients with gout were included in the study.

Throughout the 6-week follow-up period, gout flares occurred among 71 patients, constituting 12.2% of the total cohort. Among these cases, 20 out of 217 patients (9.2%) were from group 1. Among groups 2 and 3, 20 out of 196 patients (10.2%) and 31 out of 169 patients (18.34%) experienced gout flares, respectively (P =.021)

There was a statistically significant difference in gout flare occurrence between group 1 and group 3 (P =.009), while the difference between group 1 and group 2 was not significant (P =.50).

When compared with the colchicine prophylaxis group (group 1), it was observed that the initial low-dose febuxostat alone cohort (group 2) did not exhibit a statistically significant elevated risk for gout flares (hazard ratio [HR], 1.26; 95% CI, 0.58-2.72). Conversely, the initial high-dose febuxostat alone cohort (group 3) was associated with an increased risk for gout flares (HR, 3.08; 95% CI, 1.34-7.07).

No differences in the incidence of adverse events were found among the 3 groups.

Limitations of this study included its single-center design, inclusion of only male patients, potential residual confounding, missing data for some variables, and a short observation period.

The study authors concluded, “In patients with safety concerns or contraindications regarding colchicine, an initial low dose of febuxostat may be used as an alternative to reduce or prevent gout attacks.”