Sacubitril/valsartan use in a real-world population of patients with heart failure and reduced ejection fraction

2020 ◽  
Vol 21 (11) ◽  
pp. 882-888
Author(s):  
Massimo Mapelli ◽  
Elisabetta Salvioni ◽  
Fabiana de Martino ◽  
Irene Mattavelli ◽  
Alice Bonomi ◽  
...  
2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Ilaria Ferrari ◽  
Francesco Cicogna ◽  
Claudia Tota ◽  
Leonardo Calò ◽  
Luca Monzo

Abstract Aims The sodium–glucose co-transporter-2 (SGLT2) inhibitors dapagliflozin and empagliflozin have been demonstrated to reduce adverse cardiovascular outcomes in patients with heart failure with reduced ejection fraction (HFrEF). Limited data are available characterizing the generalizability of SGLT2 inhibitors treatment in the clinical practice. The aim of the study was to evaluate the proportion of outpatients with HFrEF that would be eligible for SGLT2 inhibitors in a contemporary real-world population. Methods and results We retrospectively evaluated patients with chronic stable HFrEF followed-up at the HF outpatient clinic of our institution. Patients’ eligibility was assessed according to the entry criteria of DAPA-HF (dapagliflozin) and EMPEROR-Reduced (empagliflozin) trials and to US Food and Drug Administration (FDA) label criteria (only dapagliflozin). A total of 441 HFrEF patients was enrolled. According to the major inclusion and exclusion criteria from DAPA-HF and EMPEROR-Reduced trials, 198 (45%) patients would be candidates for initiation of both dapagliflozin and empagliflozin, 61 (14%) would be eligible only to dapagliflozin and 23 (5%) only to empagliflozin, without significant differences between diabetic and non-diabetic patients (P = 0.23). Among patients not suitable for gliflozins treatment (159 patients; 36%), the major determinant of ineligibility was the failure to achieve the predefined NT-proBNP inclusion threshold. Excluding NTproBNP as per FDA label criteria, dapagliflozin eligibility increased to 86%. Conclusions In our real-world analysis a large proportion of HFrEF patients would be candidates for initiation of SGLT2 inhibitors, supporting its broad generalizability in clinical practice. This would be expected to reduce morbidity and mortality in eligible patients.


2018 ◽  
Vol 35 (6) ◽  
pp. 785-795 ◽  
Author(s):  
Dana Drzayich Antol ◽  
Adrianne Waldman Casebeer ◽  
Richard W. DeClue ◽  
Stephen Stemkowski ◽  
Patricia A. Russo

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S.F.C Maltes ◽  
B.L Rocha ◽  
G.L Cunha ◽  
J.P Presume ◽  
L Campos ◽  
...  

Abstract Background In patients with heart failure (HF) and reduced left ventricle ejection fraction (LVEF), the sodium-glucose cotransporter inhibitor (iSGLT2) dapagliflozin has recently been shown to reduce the risk of worsening heart failure or death from cardiovascular causes in the DAPA-HF trial. Results of iSGLT2 in HF with preserved LVEF are awaited. Our goal was to investigate how many patients in a real-world setting would be eligible for dapagliflozin according to the DAPA-HF criteria. Methods This is a single-center retrospective study enrolling consecutive patients followed in an HF Clinic from 2013 to 2019. The key DAPA-HF inclusion criteria [i.e., Left Ventricular Ejection Fraction (LVEF) <40% and NT-proBNP >600pg/mL (or >900pg/ml if AF)] and exclusion criteria [estimated glomerular filtration rate (eGFR) <30ml/kg/1.73m2, systolic blood pressure (SBP) <95mmHg] were considered. Results Overall, 479 patients (mean age 75.7±12.8 years; 50.4% male; 78.8% with hypertension; 45.0% with an eGFR <60ml/min/1.73m2; 36.5% with type 2 diabetes mellitus; 33.5% ischaemic HF) were assessed. Of these, 155 (33.2%) patients had LVEF <40%. Patients had a mean SBP of 131±28 mmHg, a median eGFR of 48 (IQR 33–65) ml/min/m2 and a NT-proBNP of 2183 (IQR 1010–5310) pg/mL Overall, according to the DAPA-HF trial key criteria, 88 patients (18.3%) would be eligible for dapagliflozin. The remainder would be excluded due to a LVEF>40% (67.5%), eGFR <30 ml/min/1.73m2 (19.4%), NT-proBNP <600 pg/mL (or <900 pg/mL if AF) (16.7%) and/or SBP <90mmHg (2.1%) (figure 1). If we limit the analysis to those with a LVEF <40%, 56.7% would be eligible for dapagliflozin. The remainder would be excluded due to a eGFR <30ml/kg/1.73m2 (20%), NT-proBNP <600 pg/mL (or <900 pg/mL if AF) (16.1%) and/or SBP <90mmHg (8.4%) (figure 1). Conclusion Roughly one in every five patients in our real-world HF cohort would be eligible to start dapagliflozin according to the key criteria of the DAPA-HF trial. The main reason for non-eligibility was a LVEF >40%. These findings highlight the urgent need for disease-modifying drugs in mid-range and preserved LVEF. The results of ongoing iSGLT2 trials in these LVEF subgroups are eagerly awaited. Funding Acknowledgement Type of funding source: None


Cardiology ◽  
2021 ◽  
pp. 1-6
Author(s):  
Sérgio Maltês ◽  
Gonçalo J.L. Cunha ◽  
Bruno M.L. Rocha ◽  
João Presume ◽  
Renato Guerreiro ◽  
...  

<b><i>Background:</i></b> In patients with heart failure (HF) and reduced ejection fraction (HFrEF) with or without type 2 diabetes mellitus, the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin was recently shown to reduce the risk of worsening HF or death from cardiovascular causes in the dapagliflozin in patients with heart failure and reduced ejection fraction (DAPA-HF) trial. Our goal was to investigate how many patients in a real-world setting would be eligible for dapagliflozin according to the DAPA-HF enrolment criteria. <b><i>Methods:</i></b> This is a single-center retrospective study enrolling consecutive, unselected patients followed up in an HF clinic from 2013 to 2019. Key DAPA-HF inclusion criteria (i.e., left ventricular ejection fraction [LVEF] ≤40% and NT-proBNP ≥600 pg/mL [or ≥900 pg/mL if atrial fibrillation]) and exclusion criteria (estimated glomerular filtration rate [eGFR] &#x3c;30 mL/kg/1.73 m<sup>2</sup> and systolic blood pressure [SBP] &#x3c;95 mm Hg) were considered. <b><i>Results:</i></b> Overall, 479 patients (age 76 ± 13 years; 50.5% male; 78.9% hypertensive; 45.1% with an eGFR &#x3c;60 mL/min/1.73 m<sup>2</sup>; 36.5% with TD2M; and 33.5% with ischaemic HF) were assessed. The median SBP was 128.5 (112.0–146.0) mm Hg, mean eGFR was 50.8 ± 23.7 mL/min/1.73 m<sup>2</sup>, and median NT-proBNP was 2,183 (IQR 1,010–5,310) pg/mL. Overall, 155 (32.4%) patients had LVEF ≤40%. According to the DAPA-HF trial key criteria, 90 patients (18.8%) would be eligible for dapagliflozin. The remainder would be excluded due to LVEF &#x3e;40% (67.6%), eGFR &#x3c;30 mL/min/1.73 m<sup>2</sup> (19.4%), NT-proBNP below the cutoff (16.7%), and/or SBP &#x3c;95 mm Hg (6.5%). If we center the analysis to those with LVEF ≤40%, 58.1% would be eligible for dapagliflozin. The remainder would be excluded due to an eGFR &#x3c;30 mL/min/1.73 m<sup>2</sup> (20%), NT-proBNP below the cutoff (16.1%), and/or SBP &#x3c;95 mm Hg (8.4%). <b><i>Conclusion:</i></b> Roughly half of our real-world HFrEF cohort would be eligible for dapagliflozin according to the key criteria of the DAPA-HF trial. The main reason for non-eligibility was an eGFR &#x3c;30 mL/min/1.73 m<sup>2</sup>. However, two-thirds of patients had LVEF &#x3e;40%. These findings show that dapagliflozin is a promising complementary new drug in the therapeutic armamentarium of most patients with HFrEF, while highlighting the urgent need for disease-modifying drugs in mid-range and preserved LVEF and the need to assess the efficacy and safety of SLGT2i in advanced kidney disease patients. The results of ongoing SGLT2i trials in these LVEF subgroups are eagerly awaited.


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