Abstract 17027: Generalizability of the US FDA Label for Dapagliflozin to Patients With Heart Failure With Reduced Ejection Fraction in the GWTG-HF Registry

Abstract

Background: In May 2020, dapagliflozin was approved by the US FDA as the first SGLT-2 inhibitor for HF with reduced ejection fraction (HFrEF) based on the pivotal DAPA-HF trial. Limited data are available characterizing its generalizability to US clinical practice. Methods: We studied patients with HFrEF (≤40%) hospitalized at 406 sites in the Get With The Guidelines (GWTG)-HF registry admitted between Jan 2014 - Sept 2019. We excluded patients who left against medical advice, transferred to an acute care facility or to hospice, or had missing critical data. We applied the FDA label (excluding eGFR<30 mL/min/1.73 m 2 , dialysis, or type 1 DM) and eligibility criteria of DAPA-HF to the GWTG-HF registry sample. Results: Among 154,714 patients hospitalized with HFrEF, 125,497 (81.1%) would be candidates for dapagliflozin under the FDA label. Across 355 sites with ≥10 hospitalizations, median proportion of FDA label candidates was 81.1% (77.8%-84.6%). This proportion was similar across all study years (80.4-81.7%) and higher among those without type 2 DM than with type 2 DM (85.5% vs. 75.6%). Among GWTG-HF participants, the most frequent reason for not meeting the FDA label was eGFR<30 mL/min/1.73 m 2 (n=28,605). Among patients with available paired admission and discharge data, 14.2% had eGFR<30 mL/min/1.73 m 2 at both time points, while 3.8% developed eGFR<30 mL/min/1.73 m 2 by discharge. While there were more women, more Black patients, and less Asian patients in GWTG-HF, clinical characteristics were qualitatively similar between DAPA-HF trial and GWTG-HF registry participants. Compared with the DAPA-HF trial cohort, there was lower use of evidence-based HF therapies among GWTG-HF patients ( Table ). Conclusions: These data from a large, contemporary US hospitalized HF registry suggest that 4 out of 5 patients with HFrEF (with or without type 2 DM) would be candidates for initiation of dapagliflozin, and support its broad generalizability to US clinical practice.