Projected Clinical Benefits of Implementation of SGLT-2 Inhibitors Among Medicare Beneficiaries Hospitalized for Heart Failure.
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2022-04
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Abstract
Background
The sodium-glucose cotransporter-2 (SGLT-2) inhibitors form the latest pillar in the management of heart failure with reduced ejection fraction (HFrEF) and appear to be effective across a range of patient profiles. There is increasing interest in initiating SGLT-2 inhibitors during hospitalization, yet little is known about the putative benefits of this implementation strategy.Methods
We evaluated Medicare beneficiaries with HFrEF (≤ 40%) hospitalized at 228 sites in the Get With The Guidelines-Heart Failure (GWTG-HF) registry in 2016 who had linked claims data for ≥ 1 year postdischarge. We identified those eligible for dapagliflozin under the latest U.S. Food and Drug Administration label (excluding estimated glomerular filtration rates < 25 mL/min per 1.73 m2, dialysis and type 1 diabetes). We evaluated 1-year outcomes overall and among key subgroups (age ≥ 75 years, gender, race, hospital region, kidney function, diabetes status, triple therapy). We then projected the potential benefits of implementation of dapagliflozin based on the risk reductions observed in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) trial.Results
Among 7523 patients hospitalized for HFrEF, 6576 (87%) would be candidates for dapagliflozin (mean age 79 ± 8 years, 39% women, 11% Black). Among eligible candidates, discharge use of β-blockers, ACEi/ARB, MRA, ARNI, and triple therapy (ACEi/ARB/ARNI+β-blocker+MRA) was recorded in 88%, 64%, 29%, 3%, and 20%, respectively. Among treatment-eligible patients, the 1-year incidence (95% CI) of mortality was 37% (36-38%) and of HF readmission was 33% (32-34%), and each exceeded 25% across all key subgroups. Among 1333 beneficiaries eligible for dapagliflozin who were already on triple therapy, the 1-year incidence of mortality was 26% (24%-29%) and the 1-year readmission due to HF was 30% (27%-32%). Applying the relative risk reductions observed in DAPA-HF, absolute risk reductions with complete implementation of dapagliflozin among treatment-eligible Medicare beneficiaries are projected to be 5% (1%-9%) for mortality and 9% (5%-12%) for HF readmission by 1 year. The projected number of Medicare beneficiaries who would need to be treated for 1 year to prevent 1 death is 19 (11-114), and 12 (8-21) would need to be treated to prevent 1 readmission due to HF.Conclusions
Medicare beneficiaries with HFrEF who are eligible for dapagliflozin after hospitalization due to HF, including those well-treated with other disease-modifying therapies, face high risks of mortality and HF readmission by 1 year. If the benefits of reductions in death and hospitalizations due to HF observed in clinical trials can be fully realized, the absolute benefits of implementation of SGLT-2 inhibitors among treatment-eligible candidates are anticipated to be substantial in this high-risk postdischarge setting.Type
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Vaduganathan, Muthiah, Stephen J Greene, Shuaiqi Zhang, Nicole Solomon, Karen Chiswell, Adam D Devore, Javed Butler, Paul A Heidenreich, et al. (2022). Projected Clinical Benefits of Implementation of SGLT-2 Inhibitors Among Medicare Beneficiaries Hospitalized for Heart Failure. Journal of cardiac failure, 28(4). pp. 554–563. 10.1016/j.cardfail.2021.11.010 Retrieved from https://hdl.handle.net/10161/31136.
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Scholars@Duke
Stephen Greene
I am a cardiologist with a clinical and research interest in heart failure. I take care of patients with various types of heart failure, including patients who are best treated with medications and patients who receive advanced therapies like heart transplantation and mechanical assist devices. I became a heart failure cardiologist to help patients manage their heart conditions and best achieve their goals for their health. I am strongly committed to helping patients thoroughly understand their medical conditions and helping them make informed medical decisions aligned with their preferences.
My research interests are focused on strategies and therapies to improve outcomes and quality of life for patients with heart failure. This involves research through clinical trials and through examining data from real-world clinical practice. Below, you will find my specific research interests:
- Use and dosing of evidence-based heart failure medications
- Management of worsening heart failure outside the hospital
- Novel pharmacological and non-pharmacological approaches to heart failure
- Improving outcomes following a hospitalization for heart failure
- Surrogate and nonfatal endpoints in heart failure clinical trials
- Clinical trial design and operations
- Improving site-based heart failure research
Nicole Solomon
Karen Chiswell
Ph.D., North Carolina State University - 2007
I work closely with clinical and quantitative colleagues to provide statistical leadership, guidance and mentoring on the design, execution, and analysis of clinical research studies. My work includes design and analysis of observational studies (including large cardiovascular registries, and clinical care databases linked with electronic health record data) and early-phase trials in pediatric populations. My statistical interests include study design, linear and non-linear mixed effects models, survival analysis, biology- and mechanism-based models, and statistical thinking and learning.
Adam David DeVore
Adam D. DeVore, MD, MHS
Dr. DeVore is a cardiologist and Associate Professor of Medicine in the Department of Medicine, Division of Cardiology, at Duke University School of Medicine. His clinical interests include caring for patients and families with heart failure, including those with left ventricular assist devices and heart transplants. He is involved in and leads multiple large studies of patients with heart failure at both Duke University Medical Center and the Duke Clinical Research Institute. He currently serves as the medical director of the Duke Heart Transplant program.
He attended medical school at the University of Chicago Pritzker School of Medicine and completed internal medicine residency at Brigham and Women’s Hospital. He then pursued cardiology training at Duke University and solidified his interests in clinical research and heart failure. He completed a research fellowship at the Duke Clinical Research Institute and a Masters of Health Sciences in Clinical Research before completing an advanced heart failure fellowship at Duke University.
The overarching goals of his research are to advance the current understanding of heart failure through clinical trials as well as develop an evidence base for implementation strategies that addresses the gap between heart failure trial results and clinical practice. For example, he has served on the Steering Committees for large clinical trials, including PIONEER-HF and SPIRRIT-HFpEF. Dr. DeVore also published the first clinical trial conducted within the American Heart Association’s Get With The Guidelines-Heart Failure program, a registry-based cluster randomized trial of quality improvement interventions. He was also the principal investigator for CONNECT-HF, a large-scale, pragmatic, cluster-randomized trial at 161 sites in the US evaluating heart failure quality improvement initiatives. Outside of his work on heart failure, Dr. DeVore is married with 4 children and spends his time corralling them all and coaching youth baseball.
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