2020

DOI: 10.1016/j.metabol.2019.154045

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Differential indication for SGLT-2 inhibitors versus GLP-1 receptor agonists in patients with established atherosclerotic heart disease or at risk for congestive heart failure

Francesco Giorgino

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Julia Moellmann

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et al.

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Glucagon-like Peptide-1 Receptor Agonist Cvots1

Pascal Alexander Mann and Michael Lehrke MD1

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Cited by 24 publications

(18 citation statements)

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“…Prior GLP-1RA CVOT comprehensive reports have primarily focused on the heterogeneity of primary results, 17 the generalizability of results to the overall T2D population, 18,19 potential pathophysiological mechanisms associated with the cardioprotective properties of GLP-1 RAs, 20,21 comparisons with sodium-glucose co-transporter-2 inhibitor CVOTs 22,23 and meta-analyses of completed trials. 24,25 The present review provides a thorough description of the individual GLP-1RA CVOTs included in this report with regard to inclusion and exclusion criteria and emphasis on study design.…”

Section: Glucagon-like Peptide-1 Receptor Agonist Cvotsmentioning

confidence: 99%

Cardiovascular outcomes trials with glucagon‐like peptide‐1 receptor agonists: A comparison of study designs, populations and results

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et al. 2020

Diabetes Obesity Metabolism

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Despite treatment advances leading to improved outcomes over the past 2 decades, cardiovascular (CV) disease (CVD) remains the leading cause of morbidity and mortality in people with diabetes. People with type 2 diabetes (T2D) have a 2-to 4-fold increased risk of CVD and CV death. Individuals with T2D have not seen the same improvements in CV morbidity and mortality as those without T2D. Given this, it is important to understand the CV impact of drugs used to treat T2D. In patients with T2D, glucagon-like peptide-1 receptor agonists (GLP-1RAs) have shown a reduction in HbA1c and body weight regardless of their differences in chemical structure and pharmacokinetic variables. Glycaemic efficacy, accompanied by the potential for weight reduction and a low risk of hypoglycaemia, has moved GLP-1RAs to the first treatment of choice following metformin monotherapy in the latest American Diabetes Association treatment guidelines. Additionally, all GLP-1RAs have shown CV safety and several have proven CV benefit. GLP-1RAs have been evaluated in cardiovascular outcomes trials (CVOTs) of varying sizes, designs and patient populations with differing reported effects on CV outcomes. The purpose of this article is to review the completed GLP-1RA CVOTs with special attention to how their design, size, patient populations and conduct may influence the interpretation of results.

“…Prior GLP-1RA CVOT comprehensive reports have primarily focused on the heterogeneity of primary results, 17 the generalizability of results to the overall T2D population, 18,19 potential pathophysiological mechanisms associated with the cardioprotective properties of GLP-1 RAs, 20,21 comparisons with sodium-glucose co-transporter-2 inhibitor CVOTs 22,23 and meta-analyses of completed trials. 24,25 The present review provides a thorough description of the individual GLP-1RA CVOTs included in this report with regard to inclusion and exclusion criteria and emphasis on study design.…”

Section: Glucagon-like Peptide-1 Receptor Agonist Cvotsmentioning

confidence: 99%

Cardiovascular outcomes trials with glucagon‐like peptide‐1 receptor agonists: A comparison of study designs, populations and results

¹

,

²

,

³

et al. 2020

Diabetes Obesity Metabolism

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Despite treatment advances leading to improved outcomes over the past 2 decades, cardiovascular (CV) disease (CVD) remains the leading cause of morbidity and mortality in people with diabetes. People with type 2 diabetes (T2D) have a 2-to 4-fold increased risk of CVD and CV death. Individuals with T2D have not seen the same improvements in CV morbidity and mortality as those without T2D. Given this, it is important to understand the CV impact of drugs used to treat T2D. In patients with T2D, glucagon-like peptide-1 receptor agonists (GLP-1RAs) have shown a reduction in HbA1c and body weight regardless of their differences in chemical structure and pharmacokinetic variables. Glycaemic efficacy, accompanied by the potential for weight reduction and a low risk of hypoglycaemia, has moved GLP-1RAs to the first treatment of choice following metformin monotherapy in the latest American Diabetes Association treatment guidelines. Additionally, all GLP-1RAs have shown CV safety and several have proven CV benefit. GLP-1RAs have been evaluated in cardiovascular outcomes trials (CVOTs) of varying sizes, designs and patient populations with differing reported effects on CV outcomes. The purpose of this article is to review the completed GLP-1RA CVOTs with special attention to how their design, size, patient populations and conduct may influence the interpretation of results.

“…On the other hand, a clear benefit was not documented with dapagliflozin in the DECLARE-TIMI 58 study [14] for the same outcome. In this regard, the consensus obtained in the preference for GLP-1RAs in patients with the subclinical atherosclerotic disease may reflect these results from the CV outcomes trials as well as the documented mechanisms of action of the two classes of drugs from experimental and preclinical studies [57,58].…”

Section: Discussionmentioning

confidence: 96%

“…The beneficial effects of GLP-1RAs and SGLT2 inhibitors on multiple CV risk factors have been well documented including advantages with respect to body weight, blood pressure, lipids, uric acid, and inflammatory markers, with some differences between the two classes in terms of efficacy on selected risk factors [58,59]; accordingly, these beneficial effects were acknowledged by the Delphi panelists.…”

Section: Discussionmentioning

confidence: 99%

The “Early Treatment” Approach Reducing Cardiovascular Risk in Patients with Type 2 Diabetes: A Consensus From an Expert Panel Using the Delphi Technique

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et al. 2021

Diabetes Ther

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Introduction There is no consensus on the optimal therapeutic approach to adopt in patients with newly diagnosed type 2 diabetes mellitus (T2DM) to prevent cardiovascular disease (CVD). The study aimed to gather an expert consensus on the hypoglycemic treatment and CV risk management in patients with newly diagnosed T2DM through the Delphi methodology. Methods To address this issue, a list of 30 statements concerning the definition of “early T2DM patient”, early treatment, CV risk in T2DM, treat-to-benefit approach, and indications for treatment with glucagon-like peptide 1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter 2 (SGLT2) inhibitors was developed. Using a two-round Delphi methodology, the survey was distributed to 80 Italian diabetes specialists who rated their level of agreement with each statement on a 5-point Likert scale. Consensus was predefined as more than 66% of the panel agreeing/disagreeing with any given statement. Results A total of 27/30 statements achieved consensus. A patient was defined as “early” according to pathophysiological or clinical interpretation, and/or the timing of the diagnosis. There was agreement on the importance to reach the lowest possible HbA1c level, since diagnosis, also using combination therapy with hypoglycemic drugs with a proven CV benefit. There was a consensus that a treat-to-benefit approach involves the addition of a glucose-lowering agent with proven CV benefits to metformin since diagnosis. The use of GLP-1RAs and SGLT2 inhibitors was considered a key strategy in this approach and the benefits were recognized also for patients with T2DM without established CVD. GLP-1RAs should be used at an earlier stage than SGLT2 inhibitors to prevent CVD, especially in patients with evidence of subclinical atherosclerotic disease. Conclusion This Delphi consensus recognized the importance to adopt a tailored hypoglycemic treatment of patients with T2DM according to their CVD risk and the key role of glucose-lowering agents with proven CV efficacy, GLP-1RAs and SGLT2 inhibitors, in the context of an early treat-to-benefit approach. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01045-7.

“…Recent CVOTs have provided useful information on cardio- and nephro-protection conferred by the new antidiabetic drugs. 6 , 10 In this context, an accurate evaluation of the diabetic disease and correct determination of pancreatic reserves are crucial to ensure optimal care. C-peptide is the part of pro-insulin cleaved prior to co-secretion with insulin by pancreatic β-cells.…”

Section: Discussionmentioning

confidence: 99%

When Inappropriate Use of Insulin is Dangerous: The Utility of C-Peptide Assay in the Era of Cardioprotective Antidiabetic Drugs

et al. 2021

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Introduction New antidiabetic drugs have simplified treatment regimens in patients with type-2 diabetes (T2D). More importantly, they have proven to reduce cardiovascular risk by lowering insulin-resistance, blood pressure and body weight, in addition to avoiding inappropriate insulin therapy, responsible for hypoglycemic episodes and weight gain. In this context, accurate assessment of the metabolic status of T2D patients becomes essential. The C-peptide assay is a simple but often overlooked test that can provide a fundamental contribution to the correct disease classification and optimal therapeutic management of diabetic patients. Clinical Case We report the case of a 72-year-old patient, treated with insulin for 26 years after a diagnosis of type-1 diabetes (T1D), resulting in inadequate glycemia control and a severe evolution of cardiovascular complications. After an accurate evaluation of the clinical history, phenotype and laboratory data, including the determination of C-peptide serum levels, a diagnosis was made of T2D not T1D. Considering the patient’s very high cardiovascular risk and dysmetabolic profile, insulin therapy was discontinued and more appropriate therapy with dulaglutide and metformin was instituted. These overall therapeutic modifications yielded remarkable clinical advantages in terms of the glycometabolic profile, weight reduction, abdominal circumference and body mass index decrease, as well as a better quality of life, with complete resolution of the dangerous hypoglycemic episodes. Conclusion In the era of new cardioprotective antidiabetic drugs, we believe the importance of the C-peptide assay should be re-evaluated in order to avoid misdiagnosis and to improve the therapeutic approach to T2D.

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