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Original Investigation
November 13, 2020

Applicability of US Food and Drug Administration Labeling for Dapagliflozin to Patients With Heart Failure With Reduced Ejection Fraction in US Clinical Practice: The Get With the Guidelines–Heart Failure (GWTG-HF) Registry

Author Affiliations
  • 1Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 2Duke Clinical Research Institute and Division of Cardiology, Duke University School of Medicine, Durham, North Carolina
  • 3Department of Medicine, University of Mississippi Medical Center, Jackson
  • 4Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, California
  • 5AstraZeneca, Wilmington, Delaware
  • 6Department of Cardiology, Smidt Heart Institute, Cedars-Sinai, Los Angeles, California
  • 7Department of Medicine, Cardiovascular Division, Washington University School of Medicine, St Louis, Missouri
  • 8Heart and Vascular Center, Perelman Center for Advanced Medicine, University of Pennsylvania, Philadelphia
  • 9Department of Medicine, Denver Health Medical Center, Denver, Colorado
  • 10Center for Care Delivery and Outcomes Research, Minneapolis Veterans Affairs Health Care System and University of Minnesota, Minneapolis
  • 11Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois
  • 12Deputy Editor, JAMA Cardiology
  • 13Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles, Los Angeles
  • 14Associate Editor for Health Care Quality and Guidelines, JAMA Cardiology
JAMA Cardiol. Published online November 13, 2020. doi:10.1001/jamacardio.2020.5864
Key Points

Question  What proportion of the contemporary patients with heart failure with reduced ejection fraction (HFrEF) in the US would be potentially eligible for initiation of dapagliflozin based on the US Food and Drug Administration label?

Findings  This cohort study found that, among 154 714 patients hospitalized with HFrEF in the Get With The Guidelines–Heart Failure registry, 125 497 (81%) would be candidates for dapagliflozin, a proportion that was higher among those without type 2 diabetes than those with type 2 diabetes (86% vs 76%). Across 355 sites with patients with 10 or more hospitalizations, the median proportion of patients who were candidates for dapagliflozin was 81%.

Meaning  This study suggests 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.

Abstract

Importance  In May 2020, dapagliflozin was approved by the US Food and Drug Administration (FDA) as the first sodium-glucose cotransporter 2 inhibitor for heart failure with reduced ejection fraction (HFrEF), based on the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) trial. Limited data are available characterizing the generalizability of dapagliflozin to US clinical practice.

Objective  To evaluate candidacy for initiation of dapagliflozin based on the FDA label among contemporary patients with HFrEF in the US.

Design, Setting, and Participants  This cohort study included 154 714 patients with HFrEF (left ventricular ejection fraction ≤40%) hospitalized at 406 sites in the Get With the Guidelines–Heart Failure (GWTG-HF) registry admitted between January 1, 2014, and September 30, 2019. Patients who left against medical advice, transferred to an acute care facility or to hospice, or had missing data were excluded. The FDA label (which excluded patients with an estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2, those undergoing dialysis, and those with type 1 diabetes) was applied to the GWTG-HF registry sample. Data analyses were conducted from April 1 to June 30, 2020.

Main Outcomes and Measures  The proportion of patients hospitalized with HFrEF who would be candidates for dapagliflozin under the FDA label.

Results  Among 154 714 patients hospitalized with HFrEF, 125 497 (81.1%; 83 481 men [66.5%]; mean [SD] age, 68 [15] years) would be candidates for dapagliflozin according to the FDA label. Across 355 sites with patients with 10 or more hospitalizations, the median proportion of candidates for dapagliflozin according to the FDA label was 81.1% (interquartile range, 77.8%-84.6%) at each site. This proportion was similar across all study years (interquartile range, 80.4%-81.7%) and was higher among those without type 2 diabetes than with type 2 diabetes (85.5% vs 75.6%). Among GWTG-HF participants, the most frequent reason for not meeting the FDA label criteria was eGFR less than 30 mL/min/1.73 m2 at discharge (18.5%). Among 75 654 patients with available paired admission and discharge data, 14.2% had an eGFR less than 30 mL/min/1.73 m2 at both time points, while 3.8% developed an eGFR less than 30 mL/min/1.73 m2 by discharge. Although there were more older adults, women, and Black patients in the GWTG-HF registry than in the DAPA-HF trial, most clinical characteristics were qualitatively similar between the 2 groups. Compared with the DAPA-HF trial cohort, there was lower use of evidence-based HF therapies among patients in GWTG-HF.

Conclusions and Relevance  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.

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