WASHINGTON — The FDA approved dapagliflozin (Farxiga), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, to reduce the risk of cardiovascular death and heart failure hospitalizations in adult patients with functional class II-IV heart failure with reduced ejection fraction (HFrEF).
Dapagliflozin oral tablets, which were previously approved to improve glycemic control and reduce heart failure risk in patients with type 2 diabetes and established cardiovascular disease, made waves in the cardiology community during the European Society of Cardiology-World Health Congress meeting in Paris in Sept. 2019, where results from the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) showed that the drug reduced premature death and hospitalizations for patients with HFrEF, even among patients who did not have diabetes.
The FDA based its approval on these results.
DAPA-HF was a randomized, double-blind, placebo-controlled study that enrolled 4,744 patients with HFrEF (average age 66 years; 77% male). “To determine the drug’s effectiveness, investigators examined the occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits,” the FDA explained. “Participants were randomly assigned to receive a once-daily dose of either 10 milligrams of [dapagliflozin] or a placebo [in addition to optimal medical care].”
After a median follow-up of 18.2 months, patients on dapagliflozin saw a 26% reduction in relative risk for heart failure hospitalizations compared to patients taking placebo, as well as significant reduction in risk of worsening heart failure and cardiovascular death.
The FDA had designated dapagliflozin for Priority Review.
“Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in a statement. “This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization.”
The FDA noted several side effects in patients taking dapagliflozin, including dehydration, serious urinary tract infections, and genital yeast infections. “Elderly patients, patients with kidney problems, those with low blood pressure, and patients on diuretics should be assessed for their volume status and kidney function,” the agency added. “Patients with signs and symptoms of metabolic acidosis or ketoacidosis should also be assessed. [Dapagliflozin] can cause serious cases of necrotizing fasciitis of the perineum (Fournier’s Gangrene) in people with diabetes and low blood sugar when combined with insulin.”
The FDA granted the dapagliflozin approval related to HFrEF to AstraZeneca Pharmaceuticals LP Wilmington, DE.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 3
Topic ID: 74,3,730,3,914,192,725