According to the Centers for Disease Control and Prevention, approximately 6 million U.S. adults have heart failure. The diabetes drug empagliflozin (Jardiance) is now approved to reduce the risk of cardiovascular death and hospitalization in adults with heart failure, even if they do not have diabetes. Previously, empagliflozin was approved as adjunct treatment to diet and exercise for type 2 diabetes, as well as to decrease the risk of hospitalization and cardiovascular death in patients with type 2 diabetes who have established cardiovascular disease. Empagliflozin should not be used in patients with type 1 diabetes or to decrease glucose levels in those with type 2 diabetes who have an estimated glomerular filtration rate of less than 30 mL/min/1.73 m2. Empagliflozin is contraindicated in patients receiving dialysis.
Empagliflozin inhibits sodium-glucose cotransporter-2, decreasing renal reabsorption of filtered glucose. This lowers the renal threshold for glucose and increases urinary glucose excretion. Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This second effect may be the mechanism that allows empagliflozin to treat heart failure, as both preload and afterload are decreased and there is downregulating of sympathetic activity.
Empagliflozin's effectiveness as an adjunct to standard of care was evaluated in a pair of randomized, double-blind, international trials comparing empagliflozin's effect on patients with various degrees of heart failure. The primary end point was death or hospitalization for heart failure. In one trial, 1,863 participants with a left ventricular ejection fraction of 40% or less were given empagliflozin 10 mg daily and 1,867 similar patients received placebo. In the other trial, 2,997 adults with a left ventricular ejection fraction of more than 40% received empagliflozin 10 mg daily and 2,991 similar adults received placebo. In both trials, those receiving empagliflozin had a significant reduction in the composite end point (death or hospitalization), although most of the effect was attributable to decreased hospitalization.
Adverse effects for this new indication are similar to those for other indications of the drug, the most common being urinary tract infections and female genital mycotic infections. Because of its mechanism of action, the drug may lead to a low circulating fluid volume. Nurses caring for patients receiving empagliflozin or NPs who prescribe the drug should carefully assess the patient's fluid status before beginning therapy and correct any deficits prior to treatment. Throughout treatment, patients should be assessed for evidence of dehydration. Other potential adverse effects that require continued assessment include ketoacidosis, urosepsis/pyelonephritis, hypoglycemia, necrotizing fasciitis of the perineum (Fournier gangrene), genital mycotic infections, and serious hypersensitivity reactions.
For complete prescribing information for empagliflozin, see https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/ja.