Projected Clinical Benefits of Implementation of SGLT-2 Inhibitors Among Medicare Beneficiaries Hospitalized for Heart Failure.

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.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1016/j.cardfail.2021.11.010

Publication Info

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.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Greene

Stephen Greene

Associate Professor of Medicine

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
Solomon

Nicole Solomon

Biostatistician, Senior
Chiswell

Karen Chiswell

Statistical Scientist

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. 


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