FDA Approves Treatment for Wider Range of Patients With Heart Failure
The FDA approved empagliflozin (Jardiance) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The drug was originally approved in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Empagliflozin is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction. It is a product of Boehringer Ingelheim.
The approval provides a treatment option for a wider range of patients with heart failure, the FDA notes. Although empagliflozin might not be effective in all patients with heart failure, the approval is a significant step forward for patients and a better understanding of heart failure, the agency states.
A large clinical trial evaluating the safety and effectiveness of empagliflozin as an adjunct to standard-of-care therapy compared 2,997 participants who received empagliflozin 10 mg once daily to 2,991 participants who received placebo. The main efficacy measure was the time to death from cardiovascular causes or need to be hospitalized for heart failure. Of those who received empagliflozin for an average of 2 years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared with 17% of participants who received placebo. The difference was largely attributable to fewer patients being hospitalized for heart failure.
Adverse effects in clinical studies with empagliflozin for patients with heart failure were generally consistent with adverse effects for patients with diabetes (urinary tract infections and fungal infections in women). Empagliflozin must not be used in patients who previously have had a serious allergic reaction to the drug or in patients on dialysis. Consult labeling for full prescribing information.