BACKGROUND
- Empagliflozin’s effects on CKD progression are unclear
- The EMPA-KIDNEY trial aimed to evaluate empagliflozin in diverse CKD patients with varying kidney function
METHODS
- Patients with CKD were randomly assigned to:
- Treatment Arm: Empagliflozin 10mg OD
- Control Arm: Placebo
- Primary Outcome:
- Composite of kidney disease progression or cardiovascular death
- Statistics:
- Cox proportional hazards regression model analyzed time-to-event data
- Adjustmens for baseline variables were made
- Semi-parametric joint frailty model analyzed hospitalization outcomes
- Shared paremeter models assessed annual eGFR change rates
- Follow Up:
- Median duration of 2 years
RESULTS
- Primary Outcome:
- 432 of 3304 patients (13.1%) on empagliflozin
- 558 of 3305 (16.9%) on placebo
- Hazard Ratio:
- Empagliflozin vs Placebo: 0.72 (p < 0.001)
- Hospitalisation Rates
- Lower in Empagliflozin group (hazard ratio, 0.86; p = 0.003)
- Heart Failure:
- No significant differences in heart failure hospitalisations
- Mortality Rates:
- No significant differences in overall mortality rates
- Adverse Events
- Serious adverse events were similar between both groups
- CKD progression is often linked to decreased GFR and albuminuria
LIMITATIONS
- Lower than expected number of cardiovascular events reduced statistical power
- Some limitations in understanding empagliflozin’s effects on CKD
- Exclusion of patients with Polycystic Kidney Disease and Kidney Transplants
CONCLUSIONS