Cardiovascular Outcomes and Risks After Initiation of a Sodium Glucose Cotransporter 2 Inhibitor: Results From the EASEL Population-Based Cohort Study (Evidence for Cardiovascular Outcomes With Sodium Glucose Cotransporter 2 Inhibitors in the Real World)
Authors' conclusion
In this high-risk cohort, initiation of SGLT2i was associated with lower risk of all-cause mortality, hospitalization for heart failure, and major adverse cardiovascular events and higher risk of below-knee lower extremity amputation.
Study context
- Population
- Patients with T2DM and established CVD newly initiated on antihyperglycemic agents, US Department of Defense Military Health System, April 2013–December 2016after propensity matching
- Participants
- 25,258 patients
- Exposure
- SGLT2i vs other antihyperglycemic agents
- Outcome
- Composite of:
- All-cause mortality and hospitalization for HF
- MACE (all-cause mortality, nonfatal MI, nonfatal stroke)
- Follow-up
- Median 1.6 years
Methodological detailspopulation-based, propensity-score matched
- Population-based
- Propensity-score matched
Main finding
As reported in the abstract
SGLT2i
- All-cause mortality and HF hospitalization
- 1.73 events per 100 person-years
- MACE
- 2.31 events per 100 person-years
non-SGLT2i
- All-cause mortality and HF hospitalization
- 3.01 events per 100 person-years
- MACE
- 3.45 events per 100 person-years
All-cause mortality and HF hospitalization
SGLT2i1.73 events per 100 person-years
non-SGLT2i3.01 events per 100 person-years
MACE
SGLT2i2.31 events per 100 person-years
non-SGLT2i3.45 events per 100 person-years
SGLT2i vs non-SGLT2iHazard ratio (95% CI)
All-cause mortality and HF hospitalization
0.57(0.50–0.65)
MACE
0.67(0.60–0.75)
Observational data: associations, not effects.
Safety
Events per 100 person-years
| Outcome | SGLT2i | Non-SGLT2i | HR (95% CI) | |
|---|---|---|---|---|
| Below-knee lower extremity amputation (exploratory safety end point)Majority of amputations observed on canagliflozin | 0.17 | 0.09 | 1.99 (1.12–3.51) | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
Cardiovascular Outcomes and Risks After Initiation of a Sodium Glucose Cotransporter 2 Inhibitor: Results From the EASEL Population-Based Cohort Study (Evidence for Cardiovascular Outcomes With Sodium Glucose Cotransporter 2 Inhibitors in the Real World). Circulation. Published 13 November 2017. doi:10.
Summarised from the published abstract; every number is checked against it