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

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.

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

European Heart Journal Supplements ◽

10.1093/eurheartj/suab131.002 ◽

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.

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Diabetes Management – Lowering Cardiovascular Risk

European Cardiology Review ◽

10.15420/ecr.2014.9.1.7 ◽

2014 ◽

Vol 9 (1) ◽

pp. 7

Author(s):

Dan Gaiţă ◽

Svetlana Moşteoru ◽

Laurence Sperling ◽

◽

...

Keyword(s):

Cardiovascular Risk ◽

Glycaemic Control ◽

Multidisciplinary Approach ◽

Diabetes Management ◽

Microvascular Complications ◽

Diabetic Patients ◽

High Cardiovascular Risk ◽

Hypoglycaemic Agents ◽

Artery Disease ◽

Shed Light

Diabetes mellitus is one of the most common diseases to plague the present day. Sixty percent of mortality in diabetic patients is caused by coronary artery disease. Numerous studies have shown that improving glycaemic control helps manage microvascular complications. On the other hand, some studies have shed light on the fact that a too tight glycaemic control can have adverse effects, especially on patients with high cardiovascular risk. Thus ‘the lower the better’ attitude should be exchanged for ‘the earliest the best’ attitude. A multidisciplinary approach should therefore be undertaken in order to achieve a proper management of the cardiovascular risk for diabetic patients. This includes using hypoglycaemic agents, antihypertensive medication and statins to balance the myriad of cardiovascular risk factors.

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

European Heart Journal ◽

10.1093/ehjci/ehaa946.1047 ◽

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

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Hypertension Management in the High Cardiovascular Risk Population

International Journal of Hypertension ◽

10.1155/2013/382802 ◽

2013 ◽

Vol 2013 ◽

pp. 1-7 ◽

Cited By ~ 6

Author(s):

Ilir Maraj ◽

John N. Makaryus ◽

Anthony Ashkar ◽

Samy I. McFarlane ◽

Amgad N. Makaryus

Keyword(s):

Myocardial Infarction ◽

Heart Failure ◽

Blood Pressure ◽

Cardiovascular Risk ◽

Diabetic Patients ◽

Hypertension Management ◽

High Cardiovascular Risk ◽

Risk Population ◽

Real Challenge ◽

Prevention Of Cardiovascular Disease

The incidence of hypertension is increasing every year. Blood pressure (BP) control is an important therapeutic goal for the slowing of progression as well as for the prevention of Cardiovascular disease. The management of hypertension in the high cardiovascular risk population remains a real challenge as the population continues to age, the incidence of diabetes increases, and more and more people survive acute myocardial infarction. We will review hypertension management in the high cardiovascular risk population: patients with coronary heart disease (CHD) and heart failure (HF) as well as in diabetic patients.

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257 Sodium-glucose CO-transporter-2 inhibitors eligibility in patients with heart failure with reduced ejection fraction

European Heart Journal Supplements ◽

10.1093/eurheartj/suab139.015 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Ilaria Ferrari ◽

Francesco Cicogna ◽

Claudia Tota ◽

Leonardo Calò ◽

Luca Monzo

Keyword(s):

Heart Failure ◽

Clinical Practice ◽

Ejection Fraction ◽

Real World ◽

Sglt2 Inhibitors ◽

Diabetic Patients ◽

World Population ◽

Limited Data ◽

Reduced Ejection Fraction ◽

Patients With Heart Failure

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.

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Patterns of Statin Use in a Real-World Population of Patients at High Cardiovascular Risk

Journal of Managed Care & Specialty Pharmacy ◽

10.18553/jmcp.2016.22.6.685 ◽

2016 ◽

Vol 22 (6) ◽

pp. 685-698 ◽

Cited By ~ 17

Author(s):

Iris Lin ◽

Jennifer Sung ◽

Robert J. Sanchez ◽

Usha G. Mallya ◽

Mark Friedman ◽

...

Keyword(s):

Cardiovascular Risk ◽

Real World ◽

World Population ◽

High Cardiovascular Risk ◽

Statin Use

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LOW DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) VALUES AMONG HIGH CARDIOVASCULAR RISK PATIENTS IN A REAL WORLD POPULATION

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(16)32035-6 ◽

2016 ◽

Vol 67 (13) ◽

pp. 2034

Author(s):

Rajeshwari S. Punekar ◽

Kathleen Fox ◽

Akshara Richhariya ◽

Shravanthi Gandra ◽

Mark Cziraky ◽

...

Keyword(s):

Cardiovascular Risk ◽

Real World ◽

Low Density Lipoprotein ◽

Density Lipoprotein ◽

Lipoprotein Cholesterol ◽

World Population ◽

Low Density ◽

Low Density Lipoprotein Cholesterol ◽

High Cardiovascular Risk ◽

Risk Patients

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Characteristics of monitored diabetic patients by glycated haemoglobin (HbA1c)

International Journal of Bioassays ◽

10.21746/ijbio.2016.05.006 ◽

2016 ◽

Vol 5 (05) ◽

pp. 4563

Author(s):

Tariq A. Zafar

Keyword(s):

Blood Glucose ◽

Glycemic Control ◽

Glycated Haemoglobin ◽

Poor Glycemic Control ◽

Diabetic Patients ◽

Age Group ◽

Hba1c Test ◽

Significant Difference ◽

Tract Infections ◽

The Impact

Glycated haemoglobin (HbA1c) test indicates the blood glucose levels for the previous two to three months. Using HbA1c test may overcome many of the practical issues and prevent infections such as urinary tract infections (UTIs). The study aimed to evaluate the impact of glycemic control using HbA1c test to understand patient characteristics and UTIs prevalence. Glycemic control was evaluated by measuring HbA1c for a total of 208 diabetes patients who were regularly attending diabetes center in Al-Noor specialist hospital in Makkah. The results showed that good and moderate glycemic controlled patients were 14.9% and 16.9% respectively while the poor glycemic patients were 68.3%. Among the good improved glycemic control, 83.9% were females, 48.4% were from age group (15-44y). Among the moderately improved glycemic control, 68.4% were females, 54.3% were from age group (45-64 y) with no significant difference. The total number of the patients with positive UTIs was 55 (26.4%) while the total number of patients with negative was UTIs 153 (73.6%). Among the positive UTIs, 76.3% were with poor glycemic control while only 12.3% and 11% were moderate and good improved glycemic control respectively. Among the negative UTIs, 65.3% were with poor glycemic control while only 19% and 15.7% were with moderate and good improved glycemic control respectively. Prevalence of UTIs among diabetic patients was not significant (p > 0.05). It was concluded that HbA1c was useful monitoring tool for diabetes mellitus and may lead to improved outcomes. Using a HbA1c test may overcome many of the practical issues that affect the blood glucose tests.

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Prognostic value of myocardial perfusion scintigraphy in asymptomatic patients with diabetes mellitus at high cardiovascular risk: 5-year follow-up of the prospective multicenter BARDOT trial

European Journal of Nuclear Medicine and Molecular Imaging ◽

10.1007/s00259-021-05349-5 ◽

2021 ◽

Author(s):

Federico Caobelli ◽

◽

Philip Haaf ◽

Gianluca Haenny ◽

Matthias Pfisterer ◽

...

Keyword(s):

Cardiovascular Risk ◽

Myocardial Perfusion ◽

Cardiovascular Events ◽

Prognostic Value ◽

Myocardial Perfusion Scintigraphy ◽

Major Adverse Cardiovascular Events ◽

Diabetic Patients ◽

Perfusion Scintigraphy ◽

High Cardiovascular Risk

Abstract Background The Basel Asymptomatic High-Risk Diabetics’ Outcome Trial (BARDOT) demonstrated that asymptomatic diabetic patients with an abnormal myocardial perfusion scintigraphy (MPS) were at increased risk of major adverse cardiovascular events (MACEs) at 2-year follow-up. It remains unclear whether this finding holds true even for a longer follow-up. Methods Four hundred patients with type 2 diabetes, neither history nor symptoms of coronary artery disease (CAD), were evaluated clinically and with MPS. Patients were followed up for 5 years. Major adverse cardiovascular events (MACEs) were defined as all-cause death, myocardial infarction, or late coronary revascularization. Results At baseline, an abnormal MPS (SSS ≥ 4 or SDS ≥ 2) was found in 87 of 400 patients (22%). MACE within 5 years occurred in 14 patients with abnormal MPS (16.1%) and in 22 with normal scan (1.7%), p = 0.009; 15 deaths were recorded. Patients with completely normal MPS (SSS and SDS = 0) had lower rates of MACEs than patients with abnormal scans (2.5% vs. 7.0%, p = 0.032). Patients with abnormal MPS who had undergone revascularization had a lower mortality rate and a better event-free survival from MI and revascularization than patients with abnormal MPS who had either undergone medical therapy only or could not be revascularized (p = 0.002). Conclusions MPS may have prognostic value in asymptomatic diabetic patients at high cardiovascular risk over a follow-up period of 5 years. Patients with completely normal MPS have a low event rate and may not need retesting within 5 years. Patients with an abnormal MPS have higher event rates and may benefit from a combined medical and revascularization approach.

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