EMPA-REG OUTCOME trial
The EMPA-REG OUTCOME® trial assessed the CV safety of empagliflozin versus placebo
EMPA-REG OUTCOME trial
EMPA-REG OUTCOME
EMPA-REG OUTCOME trial design
Key inclusion and exclusion criteria
Hierarchical testing plan and prespecified endpoints
Hypothesis testing outcomes and subsequent analysis
Baseline characteristics
Baseline characteristics: glucose-lowering medications
Baseline characteristics: CV disease
Baseline characteristics: other CV risk factors
Baseline characteristics: CV medication (1/2)
Baseline characteristics: CV medication (2/2)
EMPA-REG OUTCOME
Primary outcome 3P-MACE: time to first occurrence of CV death, non-fatal MI or non-fatal stroke
3P-MACE and 4P-MACE
EMPA-REG OUTCOME
CV death
The effect of empagliflozin on CV death was generally consistent across various subgroup analyses*
EMPA-REG OUTCOME
Hospitalisation for heart failure (HHF)
The effect of empagliflozin on HHF was generally consistent across various subgroup analyses*
EMPA-REG OUTCOME
All-cause mortality
The effect of empagliflozin on all-cause mortality was generally consistent across various subgroup analyses*
EMPA-REG OUTCOME
Kidney outcomes*
Kidney outcomes*
Kidney outcomes* according to baseline eGFR and UACR categories
Mean adjusted eGFR over time
The effect of empagliflozin on kidney outcomes* was generally consistent across various subgroup analyses†
EMPA-REG OUTCOME: summary
EMPA-REG OUTCOME
Mean adjusted HbA1c
Mean adjusted weight
Mean adjusted BP parameters
Mean adjusted LDL-/HDL-cholesterol
EMPA-REG OUTCOME
EMPA-REG OUTCOME: AEs
Predefined AEs of special interest
Lower limb amputation
EMPA-REG OUTCOME
EMPA-REG OUTCOME: summary
Back-up
Patient disposition and exposure
Categories of CV death
Number needed to treat with empagliflozin added to standard of care to prevent one death in patients with T2D at high CV risk
3P-MACE
3P-MACE: subgroup analysis
CV death: subgroup analysis (1/2)
CV death: subgroup analysis (2/2)
CV death
CV death across types of CV disease present at baseline (1/2)
CV death across types of CV disease present at baseline (2/2)
CV death according to history of atherothrombotic events (prior MI or stroke) at baseline
CV death according to baseline HbA1c
CV death change from baseline in HbA1c at Week 12
CV death according to baseline CV medications
CV death according to baseline glucose-lowering medications
CV death in patients with HF at baseline
The effect of empagliflozin on CV death was consistent across the spectrum of HF risk
CV death in patients with prevalent kidney disease
Time to CV death in patients with prevalent kidney disease
All-cause mortality
All-cause mortality according to history of atherothrombotic events at baseline (MI or stroke)
All-cause mortality according to spectrum of CV risk
All-cause mortality in patients with HF at baseline
All-cause mortality according to kidney function at baseline
Estimated long-term survival
3P-MACE: subgroup analysis in the Asian patient population
CV death: subgroup analysis in the Asian patient population
HHF: subgroup analysis in the Asian patient population
All-cause mortality: subgroup analysis in the Asian patient population
Kidney outcomes: subgroup analysis in the Asian patient population