1. Empaglifozin treatment was shown to have reduced rates of cardiovascular death or hospitalization in patients with heart failure and preserved ejection fraction.
2. Both treatment groups had a similar percentage of patients discontinuing the therapy.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a class of drugs shown to reduce the progression of heart failure in patients with reduced ejection fraction; however, this effect is unknown in heart failure patients with preserved ejection fraction. In this randomized control trial, patients with chronic heart failure and left ventricular ejection fraction of more than 40% were randomized to either receive 10mg of empagliflozin once daily or placebo treatment. The primary outcome was the incidence of cardiovascular death or hospitalization solely due to heart failure events. The study found that empagliflozin treatment was able to lower the risk of hospitalization compared to the placebo group, but the effect was not observed for cardiovascular deaths. This effect was found irrespective of patient diabetes status. Rates of serious adverse events were similar between the two groups. The study was limited by a high rate of discontinuation amongst both groups for reasons other than death. Together, this study establishes the basis of empagliflozin use in patients with heart failure and preserved ejection fraction to prevent adverse cardiovascular outcomes.
In-Depth [randomized controlled trial]: In this randomized controlled trial, 5988 patients were enrolled from 622 centers in 23 countries. Patients with a New York Heart Association functional class II-IV chronic heart failure and a left ventricular ejection fraction greater than 40% were included in the study. Patients were excluded if they had a disorder that would change their clinical course. The patients were randomized in a 1:1 ratio to either receive empagliflozin (10mg) or placebo treatment, respectively. Groups were also stratified by geographic region, diabetes status, estimated glomerular filtration rate (eGFR), and left ventricular ejection fraction greater than 50%. The primary outcome was the time between first treatment and incidence of cardiovascular-related hospitalization or death due to heart failure. In a median of 26.2 months to first event, 415 (13.8%) patients receiving empagliflozin experience the primary outcome compared to 511 (17.1%) patients in the placebo group 9hazard ratio [HR], 0.79; 95%confidence interval [CI], 0.69 to 0.90; P<0.001). When the primary outcomes were separated, patients receiving empagliflozin continued to demonstrate a lower rate of hospitalizations than the placebo group (HR, 0.71; 95%CI, 0.60 to 0.83). Conversely, the effect was not significant for the incidence of heart failure-related deaths (HR, 0.91; 95%CI, 0.76 to 1.09). These effects were also observed when patients were stratified for diabetes status. Altogether, the study supports the use of empagliflozin in heart failure patients with a preserved ejection fraction.
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