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An analysis applying data from the DELIVER trial to the Get With The Guidelines-Heart Failure Registry suggests 81% of hospitalized Medicare beneficiaries with HFpEF could be considered candidates for dapagliflozin use under a potential FDA label expansion.
A recent analysis of data from the Get With The Guidelines-Heart Failure (GWTG-HF) Registry is providing clinicians with new insight into the potential benefit of dapagliflozin in Medicare beneficiaries with heart failure with preserved ejection fraction (HFpEF).
Using the eligibility criteria from the landmark DELIVER trial, results of the analysis, which were presented at the Heart Failure Society of America (HFSA) 2022 annual scientific meeting, indicate 76% of beneficiaries hospitalized for heart failure with an ejection fraction greater than 40% would have been eligible for the trial based on inclusion criteria, with investigators pointing out a potential label expansion could expand eligibility to up to 81% of beneficiaries included in the study.
“The main conclusions are that 3 out of 4 Medicare beneficiaries hospitalized for heart failure with mildly reduced or preserved ejection fraction in the US would be eligible for dapagliflozin even when applying the stringent DELIVER clinical trial“ said Muthiah Vaduganathan, MD, MPH, cardiologist and codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, during his presentation at HFSA 2022.
The analysis from HFSA 2022 was designed with the specific intent of assessing eligibility for dapagliflozin, post-discharge clinical risk, and projected benefits of optimal implementation among Medicare beneficiaries hospitalized with heart failure with an ejection fraction greater than 40% in the US. From the 146,616 individuals with data included within the GWTG-HF Registry, investigates identified 52,964 adults with 12 months follow-up or greater hospitalized with heart failure from January 2014-December 2018 who were aged 65 years or older and with an LVEF of 40% or less.
For the purpose of analysis, the potential expanded level exclusions for dapagliflozin were defined as an eGFR closest to discharge less than 25 mL/min/1.73m2, type 1 diabetes, in-hospital dialysis, or a history of chronic dialysis. The specific trial exclusions included a discharge systolic blood press less than 95 or exceeding 180 mmHg, having nonelevated natriuretic peptide levels, undergoing an in-hospital cardiac procedure, having a BMI exceeding 50 kg/m2, and ischemia or acute coronary syndrome precipitating heart failure event.
From the target population of 52,964, investigators determined 81% (n=45,147) could be considered candidates for initiation of Dapagliflozin under the potential label expansion used in the analysis. When using the DELIVER inclusion criteria, results indicated 76% of the target population from the GWTG-HF registry would have been considered candidates for inclusion. Further analysis suggested there would be a projected absolute risk reduction of 9% (4-13%) for heart failure readmission or death in the year proceeding hospitalization if effect sizes from DELIVER were translated to clinical practice. Vaduganathan also pointed out the number needed to treat to prevent 1 of these events was 11 (7-23).
At HFSA 2022, Practical Cardiology sat down with study investigator Stephen Greene, MD, assistant professor of medicine at Duke University School of Medicine, to learn more about the study and its implications for use of dapagliflozin.
This study, “Translating the Findings of the DELIVER Trial to Medicare Beneficiaries Hospitalized for HF in the United States,” was presented at HFSA 2022.