Colchicine Is Safe and Effective Treating Gout

Atlanta—A pooled analysis of a phase 3, multicenter, randomized, placebo-controlled study found that patients taking low- and high-dose colchicine were not significantly more likely to have adverse events (AEs) compared with a placebo group. The results were presented at the ACR meeting in a poster session titled Chronologic Age, Renal Function, and Comorbid Conditions (Physiologic Age) of Patients with Gout Did Not Increase Likelihood of Adverse Events (AEs): AGREE Study Post Hoc Analyses. Currently, there are no guidelines to treat gout, which occurs in 1% to 2% of adults. Patients with gout commonly have comorbid conditions such as metabolic and cardiovascular disorders, hypertension, and kidney disease, which can complicate treatment. In this study, the authors examined the AGREE (Acute Gout Flare Receiving Colchicine Evaluation) study that compared the safety and tolerability of colchicine and placebo in 185 patients with acute gout flares. The patients took 1.8 mg of colchicine daily, 4.8 mg of colchicine daily, or placebo. The trial found that low-dose and high-dose colchicine had comparable maximum plasma concentration and gout pain relief, while they both had the same safety profile as the placebo. To determine how factors affected the incidence of AEs in patients taking colchicine, the authors performed a logistic regression analysis. The dependent variables were presence or absence of AEs, whereas the independent variables were creatinine clearance (≥60 mL/min); alanine aminotransferase and aspartate aminotransferase ([ALT, AST] above upper limit of normal [ULN]); albumin (≤3.5 g/L); alkaline phosphatase (>ULN); gout duration (>8 years); body mass index ([BMI] >30); age (years); and presence or absence of cardiovascular history, such as myocardial infarction or cerebrovascular illness. The post hoc analyses included 52 patients in the high-dose colchicine group, 74 patients in the low-dose colchicine group, and 59 patients in the placebo group. There were no significant differences among the groups in terms of age, sex, race, urate concentration, presence of ≥1 tophi, and BMI. Of the 185 patients, 83 (~45%) had an AE, with approximately 73% classified as mild-to- moderate gastrointestinal events. The high-dose colchicine group contained 40 patients (76.9%) with AEs compared with 27 patients (36.5%) in the low-dose colchicine group and 16 patients (27.1%) in the placebo group. In the high-dose colchicine group, 12 patients (23.1%) experienced a severe AE (10 diarrhea, 1 melena, and 1 nausea) compared with none in the low-dose colchicine group. One patient in the placebo group experienced severe-intensity gout. According to the post hoc analyses, none of the independent variables significantly affected the incidence of AEs in patients treated with colchicine. The results were consistent whether analyzing placebo versus either dose of colchicine or placebo and low-dose colchicine versus high-dose colchicine. The authors mentioned only 1 unusual result: in the placebo group, creatinine clearance ≥60 mL/minute was associated with reduced risk of developing AEs (P=.041), although it was only statistically significant when comparing placebo with the combined colchicine groups. There was no difference when the colchicine and placebo groups were combined and compared with the high-dose colchicine group (P=.618). The authors did not perform additional sensitivity analyses using cutoffs of 3 times ULN for AST, ALT, and alkaline phosphatase, and 3.0 g/L for albumin because the number of patients who fit the criteria was negligible.