FDA approves empagliflozin to reduce CV death, HF hospitalization in HFpEF
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The FDA approved an expanded indication for the SGLT2 inhibitor empagliflozin to reduce the risk for CV death and HF hospitalization in adults with HF with reduced or preserved ejection fraction, according to an agency press release.
Empagliflozin (Jardiance, Boehringer Ingelheim) was originally approved 2014 to improve glucose response for adults with type 2 diabetes. In August, the FDA approved empagliflozin to reduce risk for CV death and HF hospitalization in adults with HFrEF, regardless of whether they have diabetes.
“Today’s approval will provide a treatment option for a wider range of patients with heart failure,” Norman Stockbridge, MD, PhD, director of the division of cardiology and nephrology in the FDA’s Center for Drug Evaluation and Research, said in the release. “While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure. Coinciding with February’s annual observance of American Heart Month — a reminder for individuals to focus on cardiovascular health — this action will provide physicians another tool to address heart disease.”
The approval was based on data from the EMPEROR-Preserved study, presented in August at the European Society of Cardiology Congress and reported by Healio. For that study, researchers randomly assigned 5,988 patients (mean age, 72 years; 45% women; 49% with diabetes) with NYHA class II to IV HF and an EF above 40% to receive empagliflozin 10 mg daily or placebo. The primary outcome was CV death or hospitalization for HF.
During a median follow-up of 26.2 months, the primary outcome occurred in 13.8% of the empagliflozin group compared with 17.1% of the placebo group (HR = 0.79; 95% CI, 0.69-0.9; P < .0003; number needed to treat to prevent one event = 31), driven by HF hospitalization (HR = 0.71; 95% CI, 0.6-0.83). The results were consistent in patients with and without diabetes and results did not differ according to EF.
The findings represented the first trial to show unequivocal benefit of any drug on major HF outcomes in patients with HFpEF.
Adverse events were consistent with the adverse event profile for adults with type 2 diabetes; the most common adverse events were urinary tract infections and female fungal infections.
The FDA previously granted priority review designation for this indication.
Perspective
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Carlos G. Santos-Gallego, MD
This is amazing news for patients. Empagliflozin is the first drug to demonstrate benefit for all clinically relevant endpoints in the HFpEF population and the results have been consistent.
SGLT2 inhibitors as a class have many positive benefits. Not only do they reduce HF hospitalization, but also improve all the comorbidities key for HFpEF — glucose response in type 2 diabetes, visceral adiposity related to insulin resistance, body weight, a slight reduction in BP and preservation of renal function. SGLT2s have also been shown to improve fatty liver and fibrosis in general.
Initially, there was fear of diabetic ketoacidosis risk with SGLT2 inhibitors; this risk has not borne out, even for people with type 2 diabetes. The data show SGLT2 inhibitors are also safe and even improve tolerance to other drugs.
Two key issues going forward are cost and implementation. We know these drugs work. SGLT2 inhibitors are safe, effective, well tolerated and can be started right in the hospital. Now, what we need to do is prescribe them to our patients.
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