Fitchett D, et al. – Empagliflozin attenuated the risk of cardiovascular (CV) death and heart failure (HF) hospitalizations in patients with type 2 diabetes (T2D) and established CV disease (CVD) in the EMPA–REG OUTCOME trial. This study investigated if the benefit of empagliflozin was observed across the spectrum of HF risk. Findings revealed that in patients with T2D and established CVD, high or very high risk for HF outcomes was reported for a sizeable proportion without HF at baseline, suggesting the need for active case finding in this patient population. HF outcomes were consistently improved with empagliflozin, both in patients at low or high HF risk.

Methods

• This study included 7020 patients with T2D (HbA1c 7–10% and eGFR > 30 mL/min/1.73 m²) who were treated with empagliflozin 10 or 25 mg, or placebo once daily and followed for median 3.1 years.
• In patients without HF at baseline (89.9%), researchers derived the 5-year risk for incident HF using the 9-variable Health ABC HF Risk score [classified as low-to-average (<10%), high (10–20%), and very high (≥20%)].

Results

• Findings reported that 67.2% of the population had low-to-average, 24.2% high, and 5.1% very high 5-year HF risk.
• Researchers observed that, across these groups, the impact on CV death and HF hospitalization with empagliflozin was consistent [hazard ratio 0.71 (95% confidence interval: 0.52, 0.96), 0.52 (0.36, 0.75), and 0.55 (0.30, 1.00), respectively].
• Results demonstrated that effects on CV death in the ostensibly highest HF risk group (HF at baseline and/or incident HF during the trial) in whom 37.9% of the overall CV deaths occurred, was also beneficial [0.67 (0.47, 0.97)], yet, similar benefits were seen in the lower risk patients.