Javed Butler, MD, MPH, discusses the results of a prespecified analysis of EMPEROR-Reduced examining the effect of empagliflozin on KCCQ-CSS and heart failure symptoms.
Not only can empagliflozin (Jardiance) provide clinical benefits in the way of reducing risk for worsening heart failure, data from a prespecified analysis of EMPEROR-Reduced demonstrates use of the SGLT2 inhibitor also improved quality of life and physical limitations of patients.
According to the new data, which were presented at the American Heart Association (AHA) Scientific Sessions 2020, use of empagliflozin was associated with significant improvements in heart failure symptoms and physical limitations among patients in the phase 3 trial.
Originally presented at ESC 2020, results of the EMPEROR-Reduced trial confirmed the suspicions of many clinicians—the benefits of SGLT2 inhibitors on heart failure are a class effect. Now, trial investigators are providing a deeper look into the specific effects of empagliflozin in heart failure patients with and without diabetes.
In the original trial, empagliflozin was associated with a 25% reduction in risk of the primary composite outcome of cardiovascular death or hospitalization for worsening heart failure (HR, 0.75; 95% CI, 0.65-0.86; P <.001). Results also suggested empagliflozin use was associated with a 30% reduction in total hospitalization for heart failure (HR, 0.70; 95% CI, 0.58-0.85; P <.001).
In the prespecified analysis from AHA 2020, investigators sought to evaluate the impact of empagliflozin on health status through Kansas City Cardiomyopathy Questionnaire (KCCQ) data. The primary outcomes of this analysis was change in KCCQ Clinical Summary Score us between baseline and week 52 using a mixed model repeated measures analysis.
Of the 3730 patients randomized in the trial, 65.9% (n=2458) had information related to KCCQ-CSS assessments at baseline and week 52—the mean KCCQ-CSS score was 70.7 at baseline. Among these patients, the mean KCCQ-CSS score at baseline was 70.7. Investigators pointed out the KCCQ-CSS tertiles at baseline were less than 62.50, 62.50-85.42, and at least 85.42. Upon analysis, the mean adjusted point change in KCCQ-CSS score from baseline to 52 weeks was 5.83 (standard error, 0.44) with empagliflozin and 4.09 (SE, 0.45) with placebo therapy.
Improvements in KCCQ-CSS were observed in 40% of the empagliflozin group and 35.9% of the placebo group (OR, 1.23; 95% CI, 1.05-1.45), but deteriorations were seen in 32.8% of patients with empagliflozin and 36.1% of patients in the placebo group (OR, 0.84; 95% CI, 0.72-0.99). Investigators pointed out there was no significant interaction observed between the effects of empagliflozin and baseline KCCQ-CSS tertile on the primary endpoint.
For more on the results of this recent analysis and what it tells clinicians about empagliflozin, Practical Cardiology reached out to study presenter Javed Butler, MD, MPH, professor and chairman in the Department of Medicine at University of Mississippi Medical Center, to take part in an AHA 2020 House Call.
This study, “Empagliflozin Improves Heart Failure Symptoms and Physical Limitation in Patients With Chronic Heart Failure With Reduced Ejection Fraction—A Pre-specified Analysis From EMPEROR-Reduced,” was presented at AHA 2020.