1. In this analytical decision-making model study of 4.8 million adults with heart failure in the United States, the optimal implementation of sodium-glucose cotransporter-2 (SGLT-2) inhibitors over 3 years has been estimated to prevent or delay 630,000 events of worsening heart failure on the left ventricular ejection fraction (LVEF) spectrum, of which approximately 230,000 to 280,000 preventable events occurred in patients with LVEF greater than 40%.
2. An estimated 468,904 to 499,110 total heart failure hospitalizations could be avoided across the entire LVEF spectrum, of which 172,870 to 231,018 could be avoided in people with an LVEF greater than 40%.
Level of evidence assessment: 2 (good)
Summary of the study: THE EMPEROR-Preserved (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction) and DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure) trials have had major implications in the United States and have expanded the use of sodium-glucose-2 (SGLT-2) cotransport inhibitors in patients with heart failure (HF). The objective of this study was to estimate the potential US population-level implications of SGLT-2 inhibitor therapy in patients with HF by performing a decision analytic model study of all included participants. in the EMPEROR-Reduced, EMPEROR-Preserved, DAPA-HF, and DELIVER assays. A secondary objective was to assess the benefit of SGLT-2 inhibitor treatment in patients with HF and LVEF greater than 40%. The primary outcomes were worsening of IC events, including unplanned IC hospitalizations, urgent IC visits requiring intravenous therapy, or cardiovascular death. A total of 4,794,524 adults with HF were eligible for SGLT-2 inhibitors, of whom 2,619,248 were estimated to be newly eligible with an LVEF greater than 40%. Based on estimates from the EMPEROR-Reduced, EMPEROR-Preserved, DAPA-HF, and DELIVER trials, 624,247 worsening HF events were expected to be prevented across the entire LVEF spectrum with inhibitor therapy. SGLT-2 over 3 years, of which 232,589 to 282,879 events were deemed preventable in people with an LVEF greater than 40%. In addition, an estimated 468,904 to 499,110 total hospitalizations could be avoided across the entire LVEF spectrum, of which 172,870 to 231,018 could be avoided in people with an LVEF greater than 40%. One of the strengths of this study was its large sample size. A limitation, however, was that the projected estimates neglected to consider adherence patterns, drug costs, and potential perceived or actual adverse effects leading to drug discontinuation during SGLT-2 inhibitor therapy for the IC.
Click to read the study in JAMA Cardiology
Pertinent Reading: SGLT2 inhibitors reduce cardiovascular deaths and hospitalizations for heart failure in patients with heart failure: a systematic review and meta-analysis
In depth [retrospective cohort]: This study quantified the estimated US population-level implications of reducing the worsening of HF events with SGLT-2 inhibitor treatment in people with an LVEF greater than 40%. A projected total of 4,794,524 (95% CI, 3,997,363-5,591,684) adults (57% male; mean age, 66 years) with HF were eligible for SGLT-2 inhibitors, of which 2,619,248 (95% CI, 2,183.759-3,054,737) were estimated to be newly eligible with an LVEF greater than 40%. The National Health and Nutritional Examination Survey (NHANES) was used to estimate the weighted prevalence of patients with HF in the United States. The numbers needed to process estimates over a 3-year period were obtained for the following trial outcome measures: EMPEROR-Reduced, EMPEROR-Preserved, DAPA-HF, and DELIVER. Based on estimates from these trials, a projected worsening of 624,247 (95% CI, 520,457-728,037) to 627,124 (95% CI, 522,855-731,392) IC events could be prevented across the LVEF spectrum with SGLT-2 inhibitors over 3 years, including 232,589 (95% CI, 193,918-271,260) to 282,879 (95% CI, 235,846-329,912) events were judged to be preventable in people with an LVEF greater than 40%. Additionally, it is estimated that between 468,904 (95% CI, 390,942-546,867) and 499,110 (95% CI, 416,125-582,094) total hospitalizations could be averted across the spectrum of LVEF, of which 172,870 (95% CI, 144,128-201,613) to 231,018 (95% CI, 192,608-269,428) could be prevented in individuals with an LVEF greater than 40%. Numbers needed to treat (NNT) through 3 years of treatment for all efficacy endpoints were similar across the LVEF spectrum and ranged from 9 to 13 for the composite endpoint of total HF hospitalizations and deaths CV and 10 to 16 for total HF hospitalizations.
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