Cardiometabolic & kidneySecondary analysis
Relationship between hypoglycaemia, cardiovascular outcomes, and empagliflozin treatment in the EMPA-REG OUTCOME® trial
- Secondary analysis of the EMPA-REG OUTCOME randomised trial
- post hoc exploratory analysis
Authors' conclusion
In this post hoc exploratory analysis, hypoglycaemia was associated with an increased risk of HHF and MI. Hypoglycaemia risk was not increased with empagliflozin and incident hypoglycaemia did not attenuate its cardio-protective effects.
Study context
- Population
- Patients with T2DM (HbA1c 7–10%) in EMPA-REG OUTCOME
- Participants
- 7,020 patients
- Comparison
- Empagliflozin vs placebo, by incident hypoglycaemia
- Primary endpoint
- Relationship between on-trial hypoglycaemia and CV outcomes, and effects of empagliflozin on outcomes by incident hypoglycaemia
- Follow-up
- Median 3.1 years
Primary result
As reported in the abstract
CV outcomes by on-trial hypoglycaemia (placebo group)
Each group vs placeboHazard ratio (95% CI)
HYPO-broadHHF, placebo group
1.91(1.25–2.93)
HYPO-strictHHF, placebo group
1.72(1.06–2.78)
HYPO-broadMI; not with HYPO-strict
1.56(1.06–2.29)
- Empagliflozin improved cardiovascular (CV) outcomes regardless of hypoglycaemia
- P-for interactions >0.05
Safety
Incident hypoglycaemia
- HYPO-broad in each group
- 28%
- HYPO-strict
- 19%
Original publication
Relationship between hypoglycaemia, cardiovascular outcomes, and empagliflozin treatment in the EMPA-REG OUTCOME® trial. Eur Heart J. Published 31 August 2019. doi:10.1093/eurheartj/ehz621
Summarised from the published abstract; every number is checked against it