Table 2. Effects of empagliflozin versus placebo on gout.
Empagliflozin | Placebo | Hazard Ratio (95% CI) | |||
---|---|---|---|---|---|
n/N | Rate per 1000 patient-years |
n/N | Rate per 1000 patient-years |
||
First occurrence of gout* | 278/3304 | 45.7 | 317/3305 | 52.3 | 0.87 (0.74-1.02) |
All occurrences of gout† | 404/3304 | 62.2 | 465/3305 | 71.7 | 0.86 (0.72-1.03) |
All analyses use a time-to-first-event approach. Cox proportional hazards models include adjustment for the covariates used in the minimisation algorithm (categories of age, sex, diabetes, estimated glomerular filtration rate, urinary albumin-to-creatinine ratio and region).
Self-reported episode of gout recorded as adverse event (serious or non-serious); previously reported (The EMPA-KIDNEY Collaborative Group. 2023. NEJM).
First and recurrent events analysed using the Andersen-Gill extension of Cox regression. In a post-hoc analysis, excluding participants not already taking uric acid lowering therapy or colchicine at randomisation, empagliflozin resulted in a 19% reduction in the hazards of the composite of a first gout event or initiation of uric acid lowering or colchicine therapy (HR 0.81, 95%CI 0.69-0.96; 261 events in the empagliflozin group versus 314 in the placebo group).