Gout and Hyperuricemia

SAVE-Care (Sodium Glucose Cotransporter-2 inhibitors \[SGLT2i\] As Novel Gout Care) Trial is a double-blind randomized placebo-controlled trial (RCT) designed to assess the effect of empagliflozin on serum urate \[SU\] levels of gout patients, as well as levels of highly-sensitivity C-reactive protein \[hsCRP\] and interleukin 6 \[IL-6\], and estimate gout flares over 3 months, in order to develop a full-scale RCT of clinical endpoints to directly inform gout care guidelines.

This study is a randomized, double-blind, non-befloxacin-controlled, multicenter, phase II clinical trial, evaluating the efficacy, safety, and pharmacokinetic characteristics of BR2251 tablets when administered multiple times in subjects with primary gout and hyperuricemia. This study is a dose exploration study, including a screening period (up to 2 weeks), a double-blind treatment period (12 weeks), and a follow-up period (2 weeks). The screened subjects were stratified based on whether their serum uric acid (sUA) was less than 480 μmol/L or greater than or equal to 480 μmol/L. They were randomly assigned to 4 treatment groups in a 1:1:1:1 ratio: the test drug group 1 (low-dose group), the test drug group 2 (medium-dose group), the test drug group 3 (high-dose group), and the control group (non-befloxacin tablets 40 mg), with 40 subjects in each group. Each group will use titration dosing.

Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), are rare but life-threatening complications that can occur after starting allopurinol for gout. The HLA-B58:01 allele is a strong genetic risk factor for allopurinol-associated SCARs in Asian populations. This study evaluates the feasibility and clinical value of HLA-B58:01 screening before first-time allopurinol use in Vietnamese adults with gout. Adults (≥18 years) diagnosed with gout (ACR/EULAR 2020 criteria) and initiating urate-lowering therapy will be enrolled at Hai Phong International General Hospital (January 2025-June 2027). Participants who undergo HLA-B58:01 genotyping (PCR-based assay) will be treated according to test results: HLA-B58:01 negative participants receive allopurinol; HLA-B58:01 positive participants receive febuxostat. A comparison group consists of patients treated with febuxostat without HLA testing. Participants will be followed for 12 months with assessments at baseline, 1, 3, 6, and 12 months to monitor serum uric acid, gout flares, and safety outcomes (SCARs and other adverse events, including liver and kidney function). The study also includes an economic evaluation to estimate the cost-effectiveness of HLA-B58:01 screening for preventing SCARs and optimizing gout treatment.