Febuxostat-Charcoal Combo Fails to Improve Urate Control but Reduces Gout Flares in RCT

BACKGROUND: Activated charcoal (AC), a known adsorbent in the gastrointestinal tract, has been reported to reduce serum urate (SU) levels. This study aimed to assess the efficacy and safety of AC in managing primary gout. METHODS: This double-blind, double-dummy, randomized controlled trial involved 348 patients, who were randomly assigned to one of four groups: febuxostat 40 mg, febuxostat 20 mg + AC 4.5 g, febuxostat 20 mg + AC 7.2 g, and febuxostat 20 mg. Patients were followed-up every 4 weeks until week 24. The primary endpoint was the proportion of patients achieving SU level < 360 μmol/L. RESULTS: All 348 enrolled patients were included in analysis. The febuxostat-AC combination regimen didn't demonstrate superior efficacy in controlling SU levels. However, the combination regimen significantly reduced flare rates compared to the febuxostat 20 mg group (≥ 1 and ≥ 3 flares, P < 0.05) and the febuxostat 40 mg group (≥ 1 flare, P < 0.05; ≥ 3 flares, P < 0.01), and it also significantly prolonged the time to first flare. Additionally, the combination regimen resulted in significantly lower low-density lipoprotein cholesterol (LDL-C) levels at week 24. The incidence of adverse events was similar across the groups. CONCLUSIONS: The febuxostat-AC combination regimen didn't enhance urate-lowering effects but significantly reduced gout flare frequency, delayed the onset of first flare, and improved LDL-C levels. These findings underscore the role of AC in comprehensive gout management. TRIAL REGISTRATION: ChiCTR, http://www.chictr.org.cn, ChiCTR2000034138.