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Dapagliflozin Labeling for Heart Failure With Reduced Ejection Fraction Applicable in US Clinical Practice

Initiation of dapagliflozin based on the Food and Drug Administration label is applicable to 4 of 5 patients with heart failure with reduced ejection fraction (HFrEF), according to a recent study published in JAMA Cardiology (2020;e205864. doi:10.1001/jamacardio.2020.5864).

Dapagliflozin was approved by the FDA in May 2020 for patients with HFrEF, but limited data are available for its applicability to US clinical practice.

In this cohort study, researchers aimed “to evaluate candidacy for initiation of dapagliflozin based on the FDA label among contemporary patients with HFrEF in the US,” said Muthiah Vaduganathan, MD, MPH, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School (Boston, MA).

The study included 154,714 patients with HFrEF hospitalized at 406 sites in the Get With the Guidelines-Heart Failure registry. Patients were admitted to the hospital between January 1, 2014 and September 30, 2019. The proportion of patients hospitalized with HFrEF who would be candidates for dapagliflozin under the FDA label was identified.

According to the FDA label, 81.1% of the patients hospitalized with HFrEF would be candidates for dapagliflozin. The proportion was similar across all study years and higher among those without type 2 diabetes than with type 2 diabetes.

“These data from a large, contemporary US registry of patients hospitalized with heart failure suggest that 4 of 5 patients with HFrEF (with or without type 2 diabetes) would be candidates for initiation of dapagliflozin, supporting its broad generalizability to US clinical practice,” concluded Dr Vaduganathan and colleagues.—Lisa Kuhns