Blockbuster!The FDA approved engliazin for the treatment of HFpEF
On February 24, 2022, the U.S. Food and Drug Administration (FDA) approved expanded indications for the sodium-glucose cotransporter 2 inhibitor (Jardiance, Boehringer Ingelheim) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with heart failure, including HFrEF and HFpEF.Data for the approval of Englijing from EMPEROR-Preserved study were supported by the approval of ENGlijing from EMPEROR-Preserved study.Dr. Norman Stockbridge, director of the Division of Cardiology and Nephrology, FDA’s Center for Drug Evaluation and Research, said, “The approval of engrezin is an important step toward the next phase of heart failure treatment by providing additional treatment options for patients with heart failure.”Results OF the EMPEROR-Preserved study 5988 patients with heart failure (NYHA ⅱ – ⅳ) and left ventricular ejection fraction > 40%, with a mean age of 72 years, were enrolled in the EMPEROR-Preserved study. 45% were women and 49% were diabetic.Patients were randomly assigned to engliazin (10 mg qd) (n=2997) or placebo (n=2991) in a 1:1 ratio.The primary end point was a composite of cardiovascular death and hospitalization for heart failure.During a median follow-up period of 26.2 months, the primary end point event occurred in 415 (13.8%) patients in the engliazin group and 511 (17.1%) patients in the placebo group (HR, 0.79;95% CI, 0.69-0.90;Pfor HFpEF patients, engliazin is the first drug to be shown to be effective in improving the outcome of major heart failure.In recent years, engliazin has been approved by FDA for the treatment of diabetes and HFrEF.Engliazin was first approved by the FDA in 2014 to control blood glucose levels in adults with type 2 diabetes.In 2016, the FDA approved engliazin to reduce the risk of cardiovascular death in adults with type 2 diabetes with cardiovascular disease.In August 2021, the FDA approved engliazin to reduce the risk of cardiovascular death and hospitalization for heart failure in adult HFrEF patients, with or without diabetes.References:1. FDA Approves Treatment for Wider Range of Patients with Heart Failure. Food and Drug Administration. February 24, 2022.2. FDA authorities in empagliflozin to reduce CV death, HF hospitalization in HFpef. Healio. February 24,Michael O’Riordan. FDA authorities in Empagliflozin for Treatment of HFpEF. TcdMD.2022.4. Stefan D. Anker, Javed Butler, Gerasimos Filippatos,et al. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. August 27, 2021. DOI: 10.1056 / NEJMoa2107038.