The EMPEROR-Preserved trial showed empagliflozin 10 mg reduced cardiovascular hospitalization due to heart failure by 29% in patients with an ejection fraction of more than 40% compared to a placebo over a median follow-up time of 26.2 months. Researchers from the Clinical Research Center at Marshfield Clinic Research Institute enrolled participants for the trial in 2018 and followed them until the study ended recently.
Heart failure is a serious condition where more than half of those diagnosed die within five years. Empaglifozin is a member of a relatively new class of medicines called sodium-glucose transporter-2 (SGLT2) inhibitors originally developed for the treatment of diabetes mellitus. In large trials required by the FDA to establish the safety of this medication in patients with diabetes, it was unexpectedly discovered that empagliflozin reduced cardiovascular mortality and heart failure hospitalizations.
Empaglifozin and other SLGT2-inhibitors are now standard of care in patients with heart failure with reduced ejection fraction based on the EMPEROR-Reduced trial published last year and approved by the FDA for this indication. Empagliflozin and other SGLT2-inhibitors are also standard of care for most patients with type 2 diabetes and established heart disease.
“The EMPEROR-Preserved trial shows that empagliflozin is the first drug to unequivocally improve outcomes in patients with heart failure and preserved ejection fraction based on the EMPEROR-Preserved trial results. Although not yet approved by the FDA for this new indication as the results were just presented and published, it seems likely that empaglifozin will become the standard of care for heart failure with preserved ejection fraction," said Kelley Anderson, M.D., FACC, cardiologist for Marshfield Clinic Health System and principal investigator for the EMPEROR trials at the Research Institute. “EMPEROR-Preserved is the second part of the EMPEROR-Program, with the results of the EMPEROR-Reduced trial coming out last year. We have been waiting for a treatment option like this for many years, so it is very rewarding to finally take this step."
The Clinical Research Center had also previously participated in the EMPEROR-Reduced trial that showed empagliflozin 10 mg reduced cardiovascular death or hospitalization due to heart failure with low ejection fraction by 25% compared to a placebo over a media n follow-up time of 16 months, with or without diabetes.
The results of the EMPEROR-Preserved trial were recently reported at the European Society of Cardiology Congress and simultaneously published in the New England Journal of Medicine Aug. 27, 2021. Patients and investigators from more than 20 countries participated in the trial, which included 619 centers, according to clinicaltrials.gov.
“Heart failure patients can be difficult to enroll in research studies because they are hesitant in making changes in how their heart failure is being treated. This is especially true if they are stable on their current treatment regimen," said Angela Varsho, regulatory affairs specialist and former research coordinator on the EMPEROR study. “From the heart failure patients we screened at the Health System, four patients were enrolled in the study."
Heart failure has a relentless downhill course. Patients and providers often want to avoid add-on therapy if the patient seems to be doing well. Unfortunately, most will continue to deteriorate over time. Therefore, optimizing medical treatment is vital for all patients however stable they appear to be. The Heart Failure Improvement Clinic at the Health System provides state-of-the-art care and has been shown to improve outcomes compared to usual care.
Empagliflozin was approved by the FDA for treatment of patients with heart failure and reduced ejection fraction who do not have diabetes in August 2021. Empagliflozin is also currently approved by the FDA for treatment of patients with diabetes mellitus type 2, and is recommended by the American Diabetes Association and by Cardiology societies in North America and Europe for glycemic control in patients with type 2 diabetes and for reducing the risk of cardiovascular mortality in diabetes patients with established cardiovascular disease. In addition to their beneficial effects in heart failure, empaglifozin and other SGLT2-inhibitors reduce the progression of renal disease in patients with type 2 diabetes.