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.
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
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
Parallel
Empagliflozin 10 mg
DrugFor the empagliflozin arm, participants will take 10 mg daily.
Placebo
DrugParticipants in the placebo arm will take a placebo daily.
Serum Urate Change
Change in serum urate \[SU\] levels as compared with controls at Week 12. SU levels will be obtained at screening and Week 4, 8, and 12.
Changes in highly selective C-reactive protein (hsCRP)
hs-CRP levels will be measured at screening and Week 12
Gout flares
Gout flares will be ascertained using the Gaffo criteria, which requires presence of three or more out of the four items included in the flare diary and asked at each study visit: 1) subject-defined gout-flare, 2) pain at rest \>3 on a 0-10 numeric scale, 3) presence of at least one swollen joint, and 4) presence of at least one warm joint.
Medication Adherence
Adherence to empagliflozin or placebo, defined by taking 80% or more of the dispensed doses and calculated by the number of pills taken (pills dispensed - pills counted).
Changes in Interleukin 6 [IL-6]
IL-6 levels will be measured at screening and 12 weeks.
Quality of Life Measures (36-Item Short Form Survey)
The 36-Item Short Form Survey \[SF-36\] will be administered at screening and eight weeks later to measure quality of life measures
Quality of Life Assessment [GAQ]
The Gout Assessment Questionnaire \[GAQ\] will be administered at screening and every monthly visit for the full three month period to assess quality of life in specific regards to gout outcomes.
Tophi Measurement
If tophi are present in participants at screening, tophi will be measured for the maximum diameter of the longest tophus using a Vernier caliper and the total number and sites of tophi.
Work Productivity and Activity Impairment Questionnaire [WPAI]
Participant absences from work and other work-related outcomes will be measured at every visit from screening to the final visit twelve weeks later
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Massachusetts General Hospital
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
