TRANSLATE-HF: More than 80% of Heart Failure Patients Eligible for Dapagliflozin

New research from the American Heart Association (AHA) Scientific Sessions 2020 suggests the majority of heart failure patients treated from 2014-2019 would have been eligible to receive dapagliflozin according to the US FDA label and DAPA-HF criteria.

Results from an analysis of the AHA’s Get With The Guidelines–Heart Failure Registry (GWTG-HF) indicates 81% of HFrEF patients from within the registry met eligibility criteria for dapagliflozin—leading investigators to call for greater use of SGLT2 inhibitors in clinical practice.

“Despite accelerating scientific discoveries, few patients with heart failure are being treated with the best available treatment options in 2020,” said study presenter Muthiah Vaduganathan, MD, MPH, a cardiologist at Brigham and Women’s Hospital and faculty at Harvard Medical School, in a statement from the AHA. “While SGLT2 inhibitors were first developed for treatment of diabetes, these therapies have now been recognized to reduce mortality, prevent worsening heart failure events, and improve health-related quality of life in patients with HFrEF, including among those without diabetes.”

With an interest in describing the generalizability of the FDA label for dapagliflozin, which received approval for treatment of HFrEF in May 2020, investigators designed their analysis using information from patients hospitalized at 406 sites in the GWTG-HF registry between January 2014 and September 2019. For the purpose of the analysis, investigators excluded patients who left against medical advice, were transferred to an acute care facility or hospice, or had missing clinical data.

Of note, this study is the first in a series of 6 included in the TRANSLATE-HF research platform. The platform was commissioned by the AHA in a collaborative effort with AstraZeneca to identify knowledge gaps and treatment barriers in heart failure care. The platform is designed to combine data from Centers for Medicare and Medicaid Services to track patients during their longitudinal journey during and after hospitalization for heart failure.

In the current study, investigators hoped to quantify the proportion of patients who were eligible for dapagliflozin using the FDA label and eligibility criteria of DAPA-HF. In total, 154,714 patients hospitalized with HFrEF were identified from the GWTG-HF registry. Using the aforementioned criteria, investigators determined 81.1% (n=125,497) would be candidates under the FDA label.

When assessing 355 sites with 10 or more hospitalizations in the study period, the median proportion of FDA label candidates was 81.1% (77.8-84.6%). Additionally, the results of the analysis suggested this proportion was similar across all study years (80.4-81.7%) and higher among those without type 2 diabetes than those with type 2 diabetes (85.5% vs 75.6%).

Further analysis of GWTG-HF registry participants indicated an eGFR below the minimum 30 mL/min/1.73 m2 was the most common reason for not meeting the prescribing criteria (n=28,605). In patients with both paired admission and discharge data, 14.2% had an eGFR below 30 mL/min/1.73 m2 at both times points while 3.8% developed an eGFR below the minimum threshold by discharge. Investigators pointed out that while there were more women, more black patients, and less Asian patients in GWTG-HF, characteristics between the GWTG-HF cohort and DAPA-HF cohort were qualitatively similar.

“These data support the broad generalizability of recent trial findings evaluating the SGLT2 inhibitors to U.S. clinical practice,” said lead investigator Gregg C. Fonarow, MD, co-director of the Preventative Cardiology Program and the Eliot Corday Chair in Cardiovascular Medicine and Science at the University of California. “The SGLT2 inhibitors are now established as a new pillar of care for patients with heart failure. We must now rapidly translate this knowledge to practice to improve patient outcomes.”

This study, “Generalizability of the US FDA Label for Dapagliflozin to Patients With Heart Failure With Reduced Ejection Fraction in the GWTG-HF Registry,” was presented at AHA 2020.

For more on the subject of SGLT2 inhibitor prescribing, check out this interview from October 2020 with Vaduganathan examining real-world barriers to optimal prescription of SGLT2 inhibitors.