Effects of Citrate Mixture on Gout Flares During Urate-Lowering Therapy Initiation Among Chinese Male Underexcretion-Type Gout Patients: A Prospective Cohort Study.

PURPOSE: To evaluate the effect of urine alkalization with citrate mixture on reducing flare incidence during initial urate-lowering therapy period in male gout patients with renal underexcretion-type.

PATIENTS AND

METHODS

In this prospective cohort study, patients with renal underexcretion and urinary pH < 6.2 were enrolled. All participants received febuxostat 20 mg/day during weeks 0-4, later increased to 40 mg/day if serum urate (SU) levels > 360 μmol/L. According to group assignment, patients received either alkalization therapy (Alk group; citrate mixture, 3.5 g twice/day) or no alkalization (Control group). The primary outcome measure was gout flare incidence.

RESULTS

In total, 240 patients (Alk 114, Control 126) completed the 12-week follow-up. The Alk group had a significantly lower flare incidence (35.1%) than the Control group (59.5%, P < 0.001) and a lower recurrence of flares (14.0% vs. 31.0%, P = 0.002). At week 4, the proportion of participants with SU < 360 μmol/L was significantly higher in the Alk than in the Control group (P = 0.039). The Alk group had lower triglycerides and higher high-density lipoprotein cholesterol levels than the Control group at weeks 4, 8, and 12 (P < 0.05). The urinary albumin-to-creatinine ratio (UACR) decreased from 1.65 (0.36-7.01) to 1.08 (0.62-2.99) at week 12 in the Alk group, significantly lower than that in the Control group (P = 0.001). No significant difference was noted in the incidence of adverse events between groups.

CONCLUSION

In patients with renal underexcretion gout, urine alkalization with febuxostat therapy prevented gout flares, improved lipid metabolism, and lowered UACR.

STUDY REGISTRATION: ChiCTR, https://www.chictr.org.cn, ChiCTR2100043573.