Empagliflozin reduced heart failure (HF) hospitalization and cardiovascular mortality in patients with type 2 diabetes without HF regardless of their HF risk, according to an analysis from the EMPA-REG OUTCOME Trial. The results were presented by Javed Butler, MD, MPH, FACC, on Aug. 28 at ESC Congress 2017 in Barcelona and simultaneously published in the European Heart Journal.

In the main EMPA-REG OUTCOME trial, empagliflozin reduced cardiovascular mortality, HF hospitalization, and the composite of cardiovascular mortality or HF hospitalization in 7,020 patients with type 2 diabetes and established cardiovascular disease. These benefits appeared to be the same for patients with and without a previous diagnosis of HF at baseline. The present analysis was conducted to determine whether the improved outcomes varied by baseline HF risk in patients meeting EMPA-REG OUTCOME criteria.

The five-year risk for incident HF was calculated for 6,314 patients without HF at baseline, using the nine-variable Health ABC HF Risk score. The five-year HF risk was classified as low-to-average (<10 percent), high (10-20 percent) and very high (≥ 20 percent). The outcomes analyzed were HF hospitalization or cardiovascular death and the individual components. Results of the analysis were compared in the pooled empagliflozin dose groups (10 and 25 mg) versus the placebo group using a time-to-first-event approach.

A total of 222 patients were excluded due to missing subgroup variables. The distribution of patients in the HF risk groups was balanced across the treatment arms. The median Health ABC score was 4 (–8 to 16) in the placebo group and 4 (–8 to 18) in the pooled empagliflozin group. The baseline five-year risk of HF was low-to-average in 67.2 percent, high in 24.2 percent and very high in 5.1 percent of patients. The patients with very high risk had a worse cardiometabolic profile, resembling the prevalent HF population, compared with the other risk groups.

In the low-to-average HF risk group, the incidence of HF hospitalization or cardiovascular death per 100-patient years was 1.20 (95 percent CI, 0.98-1.45) in the empagliflozin group and 1.68 (95 percent CI, 1.31-2.10) in the placebo group (hazard ratio [HR], 0.71; 95 percent CI, 0.52-0.96). In the high-risk group, the incidence of HF hospitalization or cardiovascular death per 100-patient years was 2.07 (95 percent CI, 1.58-2.62) in the empagliflozin group and 4.03 (95 percent CI, 3.06-5.13) in the placebo group (HR, 0.52; 95 percent CI, 0.36-0.75). In the very high risk group, the incidence of HF hospitalization or cardiovascular death per 100-patient years was 3.8 (95 percent CI, 2.38-5.54) in the empagliflozin group and 7.0 (95 percent CI, 4.33-10.29) in the placebo group (HR, 0.55; 95 percent CI, 0.30-1.00).

The benefits of empagliflozin were also consistent across risk groups for the individual outcomes of cardiovascular death and HF hospitalization.

The investigators stated their analysis revealed that a large percentage of patients with type 2 diabetes and established cardiovascular disease have a high or very high risk for HF outcomes. They concluded, “Empagliflozin reduced heart failure hospitalization and cardiovascular mortality in type 2 diabetes patients without HF at baseline across a spectrum of HF risk.”

Keywords: ESC Congress, ESC2017, Diabetes Mellitus, Type 2, Glucosides, Benzhydryl Compounds, Heart Failure, Hospitalization

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