785 Sodium–glucose cotransporter 2 inhibitors in real-life patients at high cardiovascular risk

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Arturo Cesaro ◽  
Fabio Fimiani ◽  
Felice Gragnano ◽  
Elisabetta Moscarella ◽  
Giovanni Signore ◽  
...  
Keyword(s):  
Heart Failure ◽  
Adverse Event ◽  
Cardiovascular Risk ◽  
Ejection Fraction ◽  
Real World ◽  
High Cardiovascular Risk ◽  
Sodium Glucose Cotransporter ◽  
Risk Patients ◽  
Tract Infections

Abstract Sodium-glucose cotransporter 2 inhibitors (SGLT2i), were recently approved in the USA and the EU for the treatment of adults with symptomatic heart failure with reduced ejection fraction (HFrEF). These drugs currently play a prominent role in the treatment algorithm for HFrEF [ejection fraction ≤40%], and international guidelines considered they as first-line drugs. However, data on the use of SGLT2i in real-world practice lack. We aim at providing data on SGLT2i in high cardiovascular risk patients in the real-world setting. We have retrospectively evaluated high cardiovascular risk patients treated with SGLT2i according to Italian national regulation, and collected 1-year outcomes. The primary objective of the study is to generate real-world data about clinical characteristics, major adverse cardiovascular events (MACE), hospitalizations for heart failure, and adverse event in patients receiving canagliflozin, empagliflozin, dapagliflozin, ertugliflozin from our cohort. Ninety-three patients with diabetes treated with SGLT2i were retrospectively enrolled. At 1-year follow-up, the rate of hospitalization was 10.7%, the MACE events occurred in 6.4% of patients; of these, 4.3% had a myocardial infarction, and 2.1% had a stroke/TIA, the rate of urinary tract infections was 5.3% while no major adverse event occurred. In conclusion, in a real-world study including patients with high and very high cardiovascular risk, SGLT2i showed to be safe, with no major adverse events occurring at follow-up.

scholarly journals 112 Safety and biochemical efficacy of sodium–glucose cotransporter 2 inhibitors based on cardiovascular risk profile and volume status in a real-world diabetic population

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Mauro Gitto ◽  
Alexios Kotinas ◽  
Riccardo Terzi ◽  
Angelo Oliva ◽  
Jorgele Zagoreo ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cardiovascular Risk ◽  
Glycaemic Control ◽  
Real World ◽  
Glycated Haemoglobin ◽  
Diabetic Patients ◽  
World Population ◽  
High Cardiovascular Risk ◽  
Sodium Glucose Cotransporter ◽  
Tract Infections

Abstract Aims Sodium–glucose cotransporter 2 inhibitors (SGLT2i) have become a first-line cardiovascular medication. However, their potential side effects still limit a widespread use in real-world clinical practice. Further, there is uncertainty about the mechanisms mediating SGLT2i-associated cardiovascular benefit. Methods We performed a retrospective analysis on consecutive diabetic patients who were prescribed a SGLT2i in a tertiary referral centre. Patients who completed at least 1 year of treatment were included in the data analysis. Changes in glycated haemoglobin, weight and haematocrit were evaluated and compared across two cardiovascular risk categories, defined through the inclusion criteria of three large randomized clinical trials. Additionally, a modified clinical score (mH2FPEF) was applied to detect the probability of heart failure with preserved ejection fraction (HFpEF). Results Of the 459 patients screened from 2015 to 2020, 312 completed 1 year of treatment (68.0%), 92 interrupted the treatment prematurely (20.0%) and 55 were lost to follow-up (12.0%). The most common causes of drug discontinuation were genital or urinary tract infections (9.4%) and poor glycaemic control (5%). At 1 year, a significant reduction in glycated haemoglobin concentration (−0.6 ± 1.4%, P < 0.001) and body weight (2.4 ± 4.6 Kg, P < 0.001) was observed and was comparable between patients at high vs. low cardiovascular risk. Haematocrit increase at 1 year (2.3 ± 3.3%, P < 0.001) was more marked in patients with high cardiovascular risk and low baseline haematocrit. Among patients with no established heart failure (N = 295), 156 (52.9%) had >50% probability of HFpEF (mH2FPEF ≥3). Conclusions In a real-world population of diabetic patients, SGLT2i were well-tolerated at 1 year and led to improved glycaemic control and weight loss. Haematocrit increase was more consistent in patients with high cardiovascular risk and signs of fluid overload, indicating the potentially beneficial role of euvolemic restoration. More than half of these diabetic patients had a high likelihood of unrecognized HFpEF.

Use of Left Ventricular Strain to Predict Heart Failure and Mortality in High Cardiovascular Risk Patients

2018 ◽  
Vol 27 ◽  
pp. S285-S286
Author(s):  
K. Haji ◽  
T. Marwick ◽  
C. Neil ◽  
S. Stewart ◽  
M. Carington ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cardiovascular Risk ◽  
Left Ventricular ◽  
High Cardiovascular Risk ◽  
Left Ventricular Strain ◽  
Risk Patients

Real-World Characteristics And Risk Of Cardiovascular Events In High Cardiovascular Risk Patients In France

2019 ◽  
Vol 287 ◽  
pp. e180
Author(s):  
G. Désaméricq ◽  
F. Fagnani ◽  
C. Emery ◽  
J. Gourmelen ◽  
J.V. Chauny ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Real World ◽  
Cardiovascular Events ◽  
High Cardiovascular Risk ◽  
Risk Patients

scholarly journals Real‐World Analysis of Guideline‐Based Therapy After Hospitalization for Heart Failure

2020 ◽  
Vol 9 (16) ◽  
Author(s):  
Heidi S. Wirtz ◽  
Richard Sheer ◽  
Narimon Honarpour ◽  
Adrianne W. Casebeer ◽  
Jeff D. Simmons ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Triple Therapy ◽  
Real World ◽  
Dual Therapy ◽  
Treatment Intensity ◽  
Angiotensin Receptor ◽  
Post Discharge ◽  
Reduced Ejection Fraction

Background Patients hospitalized with heart failure (HF) with reduced ejection fraction have high risk of rehospitalization or death. Despite guideline recommendations based on high‐quality evidence, a substantial proportion of patients with HF with reduced ejection fraction receive suboptimal care and/or do not comply with optimal care following hospitalization. Methods and Results This retrospective observational study identified 17 106 patients with HF with reduced ejection fraction with an incident HF‐related hospitalization using the Humana Medicare Advantage database (2008–2016). HF medication classes (beta‐blockers, angiotensin‐converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor neprilysin inhibitors, or mineralocorticoid receptor antagonists) received in the year after hospitalization were recorded, and categorized by treatment intensity (ie, number of concomitant medication classes received: none [23% of patients; n=3987], monotherapy [22%; n=3777], dual therapy [41%; n=7056], or triple therapy [13%; n=2286]). Compared with no medication, risk of primary outcome (composite of death or rehospitalization) was significantly reduced (hazard ratio [95% CI]) with monotherapy (0.68 [0.64–0.71]), dual therapy (0.56 [0.53–0.59]), and triple therapy (0.45 [0.41–0.50]). Nearly half (46%) of patients who received post‐discharge medication had no dose escalation. Overall, 59% of patients had follow‐up with a primary care physician within 14 days of discharge, and 23% had follow‐up with a cardiologist. Conclusions In real‐world clinical practice, increasing treatment intensity reduced risk of death and rehospitalization among patients hospitalized for HF, though the use of guideline‐recommended dual and triple HF therapy remained low. There are opportunities to improve post‐discharge medical management for patients with HF with reduced ejection fraction such as optimizing dose titration and improving post‐discharge follow‐up with providers.

Dapagliflozin in a real-world population with chronic heart failure: how many would be eligible?

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S.F.C Maltes ◽  
B.L Rocha ◽  
G.L Cunha ◽  
J.P Presume ◽  
L Campos ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Real World ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
World Population ◽  
Ventricular Ejection Fraction ◽  
Disease Modifying Drugs ◽  
Sodium Glucose Cotransporter ◽  
Patients With Heart Failure

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

Dapagliflozin in a Real-World Chronic Heart Failure Population: How Many Are Actually Eligible?

Cardiology ◽  
2021 ◽  
pp. 1-6
Author(s):  
Sérgio Maltês ◽  
Gonçalo J.L. Cunha ◽  
Bruno M.L. Rocha ◽  
João Presume ◽  
Renato Guerreiro ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Real World ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Disease Modifying Drugs ◽  
Reduced Ejection Fraction ◽  
Sodium Glucose Cotransporter ◽  
Patients With Heart Failure

<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.

47One year of mediterranean diet decreases microvesicle release from activated platelets and leukocytes in asymptomatic high cardiovascular risk patients

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Chiva-Blanch ◽  
J Crespo ◽  
R Estruch ◽  
L Badimon
Keyword(s):  
Cardiovascular Risk ◽  
Mediterranean Diet ◽  
Cell Activation ◽  
Control Diet ◽  
Virgin Olive Oil ◽  
Long Term Effects ◽  
High Cardiovascular Risk ◽  
Risk Patients ◽  
One Year

Abstract Background/Introduction Microvesicles (MV) are small phospholipid-rich vesicles released into blood by cells that are either damaged, activated or apoptotic. MV participate in diverse functions and also can serve as biomarkers of ongoing cardiovascular cell instability and disease (CVD). Diet is one of cornerstones for CVD prevention, and the effects of diet on MV shedding are poorly characterized. Purpose We aimed at investigating the long term effects of a mediterranean diet compared to a low fat diet (LFD) in MV shedding by cells of the vascular compartment in asymptomatic but high cardiovascular risk patients treated as per guidelines. Methods A total of 155 patients with diabetes or >3 cardiovascular risk factors but free of cardiovascular event were included in the study, consisting in a 3-arm randomized clinical trial. The interventions were as follows: a mediterranean diet supplemented with extra-virgin olive oil -EVOO- (n=53); a mediterranean diet supplemented with mixed nuts -NUTS- (n=49); and a control diet -LFD- (n=53) for one year. Subjects were matched by age, sex, diabetes and dyslipidaemia. At baseline and after one year follow-up, the number of MV and their phenotypic characteristics were assessed by flow cytometry. Phosphatidylserine exposure by annexin V (AV) binding was assessed and different monoclonal antibodies against characteristic cell epitopes were used to identify parental cell origin. Results The mean patient age was 66 years (50% males). Patients were hypertensive (>75%), diabetics (>50%) and dyslipidemics (>30%). No significant changes were observed after one year follow-up in body weight, body mass index, blood pressure, glucose, triglycerides, total, LDL and HDL cholesterol, medication or physical activity within or among groups of intervention. Total MV (AV+/−) were present in higher concentration than AV+ MV for all analyzed phenotypes and cell origins (P<0.0001, all). After one year follow-up, in the EVOO group there was a significant decrease in the concentration of monocyte-derived (CD14+/AV+, CD14+/CD11a+/AV+) and smooth muscle cell-derived (SMA-α+/AV+) circulating MV. In the NUTS group there was a significant decrease in platelet-derived (PAC-1+/AV+, CD62P+/AV+, and CD61+/AV+) MV, and activated cells-derived (CD142+/AV+, CD11a+/AV+ and CD63+/AV+) MV concentrations. On the other hand, one year of LFD decreased platelet PAC-1+/CD62P+/AV+ and CD61+/AV+ MV release. Interestingly, after one year follow-up PAC-1+/AV+ and CD14+/CD11a+/AV+ MV were significantly different between both mediterranean diets compared to the LFD. Conclusions MV are liquid biopsy biomarkers of vascular- and blood-cell activation and injury, that appear sensitive to modification by diet. Therefore, our results indicate that following a mediterranean diet rich in nuts and EVOO clearly prevent cell activation towards a pro-atherosclerotic phenotype and therefore can delay the development of CV complications. Acknowledgement/Funding IJCI-2015-26358 (GC-B), SAF2016-76819-R (LB) (MINECO); RD16/0011/0018 (LB), CB16/11/0041 (LB) (ISCIII)

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