Empagliflozin was associated with reduced risk for cardiovascular death regardless of patient diabetes status, a newly published analysis suggests.
“Sodium–glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes,” the authors wrote in their rationale. “More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction.”
Researchers for EMPORER-Reduced double-blind trial randomly assigned 3,730 patients with NYHA class II-IV heart failure and ejection fraction <40% to either empagliflozin 10 mg once daily or to placebo. The primary study outcome of interest was a composite of cardiovascular death or heart failure hospitalization. Median follow-up was 16 months.
According to the study results, the primary study outcome occurred in 361 patients (19.4%) in the intervention group and 462 (24.7%) in the placebo group (HR=0.75; 95% CI, 0.65 to 0.86; P<0.001). The authors reported that the effects of empagliflozin were consistent regardless of the patients’ diabetes status or the absence of diabetes. The annual glomerular filtration rate was slower in the intervention arm compared with placebo (P<0.001). Patients treated with empagliflozin also had lower rates of serious renal outcomes, although uncomplicated genital tract infection was more frequently reported in patients takin empagliflozin.
“Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes,” the authors concluded.
The study was published in the New England Journal of Medicine.