About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form.
Fulfilling American College of Rheumatology [ACR]/European Alliance of Associations for Rheumatology [EULAR] gout criteria
1+ gout flares in last 12 months
Serum urate level ≥ 6mg/dl
Disqualifiers
Estimated Glomerular Filtration Rate [eGFR] <20ml/min
Colchicine or nonsteroidal anti-inflammatory drug [NSAID] prophylaxis
active cardiovascular disease [CVD], type-1 diabetes
pregnant and lactating women
Trial design
Treatments tested in this trial
- Empagliflozin 10 mg
- Placebo