Effectiveness and safety of empagliflozin: final results from the EMPRISE study
Authors' conclusion
Empagliflozin relative to DPP-4i was associated with risk reductions of MI or stroke, HHF, MACE and the composite of cardiovascular mortality or HHF. Absolute risk reductions were larger in older individuals and in those who had history of ASCVD or heart failure. Regarding the safety outcomes, empagliflozin was associated with an increased risk of DKA and lower risks of AKI, hypoglycaemia and progression to proliferative retinopathy, with no difference in the short-term risks of lower-extremity amputation, non-vertebral fractures, kidney and renal pelvis cancer, and bladder cancer.
Study context
- Population
- Individuals ≥18 years with T2D initiating empagliflozin or DPP-4i, 2014–2019, US Medicare and commercial claims databases115,116 matched pairs
- Exposure
- Empagliflozin vs DPP-4i
- Outcome
- Four a priori-defined effectiveness outcomes: MI or stroke; hospitalisation for HF (HHF); MACE; CV mortality or HHF
Methodological details1:1 propensity score matching using 143 baseline characteristics, US Medicare and commercial claims databases
- 1:1 propensity score matching using 143 baseline characteristics
- US Medicare and commercial claims databases
Main finding
As reported in the abstract
- Empagliflozin
- RD per 1000 person-years (myocardial infarction (MI)/stroke) −2.08 (95% CI −3.26 to −0.90)
- Empagliflozin
- RD per 1000 person-years (hospitalisation for heart failure (HHF)) −5.35 (95% CI −6.22 to −4.49)
- Empagliflozin
- RD per 1000 person-years (major adverse cardiovascular events (MACE)) −6.37 (95% CI −8.98 to −3.77)
- Empagliflozin
- RD per 1000 person-years (CV mortality/HHF) −10.36 (95% CI −12.63 to −8.12)
Observational data: associations, not effects.
Further findings
Subgroups by age and atherosclerotic cardiovascular disease (ASCVD)/HF
- Absolute benefits were larger in older individuals and in those with ASCVD/HF
Safety
| Outcome | Estimate | |
|---|---|---|
| Safety outcomesEmpagliflozinvs DPP-4i | HR (DKA) 1.78 (CI 1.44–2.19) | |
| Safety outcomesEmpagliflozinvs DPP-4i | HR (AKI) 0.62 (CI 0.54–0.72) | |
| Safety outcomesEmpagliflozinvs DPP-4i | HR (hypoglycaemia) 0.75 (CI 0.67–0.84) | |
| Safety outcomesEmpagliflozinvs DPP-4i | HR (retinopathy progression) 0.78 (CI 0.63–0.96) | |
| 0.512Ratio (log scale) |
| Outcome | Estimate |
|---|---|
| Safety outcomesEmpagliflozin vs DPP-4i | RD per 1000 person-years (DKA) 1.59 (CI 1.08–2.09) |
| Safety outcomesEmpagliflozin vs DPP-4i | RD per 1000 person-years (AKI) −2.39 (CI −3.08 to −1.71) |
| Safety outcomesEmpagliflozin vs DPP-4i | RD per 1000 person-years (hypoglycaemia) −2.46 (CI −3.32 to −1.60) |
| Safety outcomesEmpagliflozin vs DPP-4i | RD per 1000 person-years (retinopathy progression) −9.49 (CI −16.97 to −2.10) |
Safety outcomes
- Similar risks of other safety events
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →