Impact of Empagliflozin on the Risk of Cardiovascular Death and Need for Hospitalization Due to Heart Failure
In the EMPA-REG OUTCOME study, empagliflozin reduced the risk of cardiovascular death and the number of hospitalizations due to heart failure in patients with type 2 diabetes (T2DM) who had confirmed cardiovascular disease at study entry. In the following analysis, the authors focused on the benefit of empagliflozin in patients with different levels of risk for heart failure development.
Analyzed Population
The study examined 7,020 patients with T2DM (HbA1c 53−86 mmol/mol and eGFR > 0.5 ml/s/1.73 m2), who took empagliflozin 10 or 25 mg once daily or placebo and were followed for a median of 3.1 years. Patients without heart failure at study entry (89.9%) were divided into groups based on the risk of developing heart failure over the next 5 years according to the Health ABC Heart Failure Risk score: risk < 10% was considered low to average (67.2% of enrolled patients), risk 10−20% was high (24.2% of patients in the study), and risk ≥ 20% was very high (5.1% of enrolled patients).
Results
The effect of empagliflozin on the occurrence of cardiovascular death and the need for hospitalization for heart failure was consistent across groups: in patients with low to average risk, the hazard ratio (HR) was 0.71 (95% confidence interval [CI] 0.52–0.96), for participants at high risk HR was 0.52 (95% CI 0.36–0.75), and among patients at very high risk HR was 0.55 (95% CI 0.30–1.00). The impact on the risk of cardiovascular death and hospitalization due to heart failure was positive (HR 0.67 [95% CI 0.47–0.97]) even in the highest risk group, i.e., patients who had been diagnosed with heart failure at study entry and/or developed it during the study. This group accounted for 37.9% of all cardiovascular deaths.
Conclusion
Among patients with T2DM and confirmed cardiovascular disease, a significant portion is at high or very high risk for developing heart failure, indicating that these patients need to be actively identified in this population. Empagliflozin consistently improved heart failure treatment outcomes in both low and high-risk heart failure development patients.
(epa)
Source: Fitchett D., Butler J., van de Borne P. et al.; EMPA-REG OUTCOME® trial investigators. Effects of empagliflozin on risk for cardiovascular death and heart failure hospitalization across the spectrum of heart failure risk in the EMPA-REG OUTCOME® trial. Eur Heart J 2017 Aug 28, doi: 10.1093/eurheartj/ehx511 [Epub ahead of print].
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