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Author Silvio E Inzucchi

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Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial.

Darren K McGuire, Bernard Zinman, Silvio E Inzucchi, Christoph Wanner, David Fitchett, Stefan D Anker, Stuart Pocock, Stefan Kaspers, Jyothis T George, Maximilian von Eynatten, Odd Erik Johansen, Waheed Jamal, Michaela Mattheus, Ulrich Elsasser, Stefan Hantel, Søren S Lund,

BACKGROUND:Patients with type 2 diabetes and atherosclerotic cardiovascular disease are at high clinical risk. We assessed the effect of the sodium-glucose co-transporter-2 inhibitor, empagliflozin, on total cardiovascular events and admissions to hospital in the EMPA-REG OUTCOME trial. METHODS:The EMPA-REG OUTCOME trial was a randomised, double-blind, non-inferiority trial of patients (aged ... Read more >>

Lancet Diabetes Endocrinol (The lancet. Diabetes & endocrinology)
[2020, 8(12):949-959]

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Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.

Deepak L Bhatt, Michael Szarek, Bertram Pitt, Christopher P Cannon, Lawrence A Leiter, Darren K McGuire, Julia B Lewis, Matthew C Riddle, Silvio E Inzucchi, Mikhail N Kosiborod, David Z I Cherney, Jamie P Dwyer, Benjamin M Scirica, Clifford J Bailey, Rafael Díaz, Kausik K Ray, Jacob A Udell, Renato D Lopes, Pablo Lapuerta, P Gabriel Steg, ,

BACKGROUND:The efficacy and safety of sodium-glucose cotransporter 2 inhibitors such as sotagliflozin in preventing cardiovascular events in patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied. METHODS:We conducted a multicenter, double-blind trial in which patients with type 2 diabetes mellitus (glycated hemoglobin level, ... Read more >>

N Engl J Med (The New England journal of medicine)
[2020, :]

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Metabolic syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a post hoc analyses of the EMPA-REG OUTCOME trial.

João Pedro Ferreira, Subodh Verma, David Fitchett, Anne Pernille Ofstad, Sabine Lauer, Isabella Zwiener, Jyothis George, Christoph Wanner, Bernard Zinman, Silvio E Inzucchi,

BACKGROUND:Patients with type 2 diabetes (T2D) and metabolic syndrome (MetS) are at greater cardiovascular risk than those with T2D without MetS. In the current report we aim to study the characteristics, cardio-renal outcomes and the effect of empagliflozin in patients with MetS enrolled in the EMPA-REG OUTCOME trial. METHODS:A total ... Read more >>

Cardiovasc Diabetol (Cardiovascular diabetology)
[2020, 19(1):200]

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Characterization and implications of the initial estimated glomerular filtration rate 'dip' upon sodium-glucose co-transporter-2 inhibition with empagliflozin in the EMPA-REG OUTCOME trial.

Bettina J Kraus, Matthew R Weir, George L Bakris, Michaela Mattheus, David Z I Cherney, Naveed Sattar, Hiddo J L Heerspink, Ivana Ritter, Maximilian von Eynatten, Bernard Zinman, Silvio E Inzucchi, Christoph Wanner, Audrey Koitka-Weber,

Treatment with sodium-glucose co-transporter-2 inhibitors induces an initial 3-5 ml/min/1.73 m2 decline in estimated glomerular filtration rate (eGFR). Although considered to be of hemodynamic origin and largely reversible, this 'eGFR dip' may cause concern in clinical practice, which highlights the need to better understand its incidence and clinical implications. In ... Read more >>

Kidney Int (Kidney international)
[2020, :]

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Patient Characteristics, Clinical Outcomes, and Effect of Dapagliflozin in Relation to Duration of Heart Failure: Is It Ever Too Late to Start a New Therapy?

Su E Yeoh, Pooja Dewan, Pardeep S Jhund, Silvio E Inzucchi, Lars Køber, Mikhail N Kosiborod, Felipe A Martinez, Piotr Ponikowski, Marc S Sabatine, Scott D Solomon, Olof Bengtsson, Mikaela Sjöstrand, Anna Maria Langkilde, John Jv McMurray,

Background: The impact of heart failure (HF) duration on outcomes and treatment effect is largely unknown. We aim to compare baseline patient characteristics, outcomes and the efficacy and safety of dapagliflozin, in relation to time from diagnosis of HF in DAPA-HF. Methods: HF duration was categorized as ≥2 to ≤12 ... Read more >>

Circ Heart Fail (Circulation. Heart failure)
[2020, :]

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Efficacy of Dapagliflozin on Renal Function and Outcomes in Patients with Heart Failure with Reduced Ejection Fraction: Results of DAPA-HF.

Pardeep S Jhund, Scott D Solomon, Kieran F Docherty, Hiddo J L Heerspink, Inder S Anand, Michael Böhm, Vijay Chopra, Rudolf A de Boer, Akshay S Desai, Junbo Ge, Masafumi Kitakaze, Bela Merkely, Eileen O'Meara, Morten Schou, Sergey Tereshchenko, Subodh Verma, Pham Nguyen Vinh, Silvio E Inzucchi, Lars Køber, Mikhail N Kosiborod, Felipe A Martinez, Piotr Ponikowski, Marc S Sabatine, Olof Bengtsson, Anna Maria Langkilde, Mikaela Sjöstrand, John J V McMurray,

Background: Many patients with heart failure and reduced ejection fraction (HFrEF) have chronic kidney disease (CKD) which complicates pharmacological management and is associated with worse outcomes. We assessed the safety and efficacy of dapagliflozin in patients with HFrEF, according to baseline kidney function, in the Dapagliflozin and Prevention of Adverse-outcomes ... Read more >>

Circulation (Circulation)
[2020, :]

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Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes.

Silvio E Inzucchi, Melanie J Davies, Kamlesh Khunti, Prabhav Trivedi, Jyothis T George, Isabella Zwiener, Odd Erik Johansen, Naveed Sattar,

AIM:To investigate the association of different categories of baseline cardio-metabolic risk factors on the treatment effects of empagliflozin 10 and 25 mg when added as second-line therapy to metformin in patients with type 2 diabetes (T2D). MATERIALS AND METHODS:Patients aged 18 years or older with HbA1c 7.0%-10.0% were included. Analysis of covariance ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, :]

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The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial.

Ian J Neeland, Bjorn Eliasson, Takatoshi Kasai, Nikolaus Marx, Bernard Zinman, Silvio E Inzucchi, Christoph Wanner, Isabella Zwiener, Brian S Wojeck, Henry K Yaggi, Odd Erik Johansen, ,

OBJECTIVE:To explore the effects of empagliflozin on the incidence of obstructive sleep apnea (OSA) and its effects on metabolic, cardiovascular (CV), and renal outcomes among participants with or without OSA in the EMPA-REG OUTCOME trial. RESEARCH DESIGN AND METHODS:Participants with diabetes and CV disease were randomized to empagliflozin (10 and ... Read more >>

Diabetes Care (Diabetes care)
[2020, 43(12):3007-3015]

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Response to Comment on Flory et al. Reports of Lactic Acidosis Attributed to Metformin, 2015-2018. Diabetes Care 2020;43:244-246.

James H Flory, Sean Hennessy, Clifford J Bailey, Silvio E Inzucchi,

Diabetes Care (Diabetes care)
[2020, 43(10):e159]

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Short-Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial.

Simke W Waijer, Di Xie, Silvio E Inzucchi, Bernard Zinman, Audrey Koitka-Weber, Michaela Mattheus, Maximillian von Eynatten, Lesley A Inker, Christoph Wanner, Hiddo J L Heerspink,

Background Early reduction in albuminuria with an SGLT2 (sodium-glucose cotransporter 2) inhibitor may be a positive indicator of long-term cardiovascular and renal benefits. We assessed changes in albuminuria during the first 12 weeks of treatment and subsequent long-term cardiovascular and renal risks associated with the SGLT2 inhibitor, empagliflozin, in the EMPA-REG ... Read more >>

J Am Heart Assoc (Journal of the American Heart Association)
[2020, 9(18):e016976]

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Effect of Dapagliflozin in DAPA-HF According to Background Glucose-Lowering Therapy.

Kieran F Docherty, Pardeep S Jhund, Olof Bengtsson, David L DeMets, Silvio E Inzucchi, Lars Køber, Mikhail N Kosiborod, Anna Maria Langkilde, Felipe A Martinez, Marc S Sabatine, Mikaela Sjöstrand, Scott D Solomon, John J V McMurray, ,

OBJECTIVE:To determine whether the benefits of dapagliflozin in patients with heart failure and reduced ejection fraction (HFrEF) and type 2 diabetes in the Dapagliflozin And Prevention of Adverse-Outcomes in Heart Failure trial (DAPA-HF) varied by background glucose-lowering therapy (GLT). RESEARCH DESIGN AND METHODS:We examined the effect of study treatment by ... Read more >>

Diabetes Care (Diabetes care)
[2020, 43(11):2878-2881]

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Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial.

Silvio E Inzucchi, Kamlesh Khunti, David H Fitchett, Christoph Wanner, Michaela Mattheus, Jyothis T George, Anne Pernille Ofstad, Bernard Zinman,

CONTEXT:Control of multiple cardiovascular (CV) risk factors reduces CV events in individuals with type 2 diabetes. OBJECTIVE:To investigate this association in a contemporary clinical trial population, including how CV risk factor control affects the CV benefits of empagliflozin, a sodium-glucose cotransporter-2 inhibitor. DESIGN:Post hoc analysis. SETTING:Randomized CV outcome trial (EMPA-REG ... Read more >>

J Clin Endocrinol Metab (The Journal of clinical endocrinology and metabolism)
[2020, 105(9):]

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Effect of Dapagliflozin on Outpatient Worsening of Patients With Heart Failure and Reduced Ejection Fraction: A Prespecified Analysis of DAPA-HF.

Kieran F Docherty, Pardeep S Jhund, Inder Anand, Olof Bengtsson, Michael Böhm, Rudolf A de Boer, David L DeMets, Akshay S Desai, Jaroslaw Drozdz, Jonathan Howlett, Silvio E Inzucchi, Per Johanson, Tzvetana Katova, Lars Køber, Mikhail N Kosiborod, Anna Maria Langkilde, Daniel Lindholm, Felipe A Martinez, Béla Merkely, Jose C Nicolau, Eileen O'Meara, Piotr Ponikowski, Marc S Sabatine, Mikaela Sjöstrand, Scott D Solomon, Sergey Tereshchenko, Subodh Verma, John J V McMurray,

BACKGROUND:In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure), dapagliflozin, added to guideline-recommended therapies, reduced the risk of mortality and heart failure (HF) hospitalization. We examined the frequency and significance of episodes of outpatient HF worsening, requiring the augmentation of oral therapy, and the effects of ... Read more >>

Circulation (Circulation)
[2020, 142(17):1623-1632]

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Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF).

Matteo Serenelli, Michael Böhm, Silvio E Inzucchi, Lars Køber, Mikhail N Kosiborod, Felipe A Martinez, Piotr Ponikowski, Marc S Sabatine, Scott D Solomon, David L DeMets, Olof Bengtsson, Mikaela Sjöstrand, Anna Maria Langkilde, Inder S Anand, Chern-En Chiang, Vijay K Chopra, Rudolf A de Boer, Mirta Diez, Andrej Dukát, Junbo Ge, Jonathan G Howlett, Tzvetana Katova, Masafumi Kitakaze, Charlotta E A Ljungman, Subodh Verma, Kieran F Docherty, Pardeep S Jhund, John J V McMurray,

AIMS:Concern about hypotension often leads to withholding of beneficial therapy in patients with heart failure and reduced ejection fraction (HFrEF). We evaluated the efficacy and safety of dapagliflozin, which lowers systolic blood pressure (SBP),according to baseline SBP in Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF). METHODS ... Read more >>

Eur Heart J (European heart journal)
[2020, 41(36):3402-3418]

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Consistent effects of empagliflozin on cardiovascular and kidney outcomes irrespective of diabetic kidney disease categories: Insights from the EMPA-REG OUTCOME trial.

Christoph Wanner, Silvio E Inzucchi, Bernard Zinman, Audrey Koitka-Weber, Michaela Mattheus, Jyothis T George, Maximilian von Eynatten, Sibylle J Hauske, ,

AIM:To explore the cardiovascular (CV) and kidney effects of empagliflozin in patients with different clinical phenotypes of diabetic kidney disease (DKD) (i.e. with the presence or absence of overt albuminuria) participating in the EMPA-REG OUTCOME trial. MATERIALS AND METHODS:EMPA-REG OUTCOME randomized participants (1:1:1) to empagliflozin 10 mg, 25 mg or placebo, ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, :]

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Effect of Dapagliflozin in Patients With HFrEF Treated With Sacubitril/Valsartan: The DAPA-HF Trial.

Scott D Solomon, Pardeep S Jhund, Brian L Claggett, Pooja Dewan, Lars Køber, Mikhail N Kosiborod, Felipe A Martinez, Piotr Ponikowski, Marc S Sabatine, Silvio E Inzucchi, Akshay S Desai, Olof Bengtsson, Daniel Lindholm, Mikaela Sjostrand, Anna Maria Langkilde, John J V McMurray,

OBJECTIVES:This study assessed the efficacy and safety of dapagliflozin in patients who were or were not taking sacubitril/valsartan at baseline in the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial. BACKGROUND:Both the angiotensin ... Read more >>

JACC Heart Fail (JACC. Heart failure)
[2020, 8(10):811-818]

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Dapagliflozin and Diuretic Use in Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF.

Alice M Jackson, Pooja Dewan, Inder S Anand, Jan Bělohlávek, Olof Bengtsson, Rudolf A de Boer, Michael Böhm, David W Boulton, Vijay K Chopra, David L DeMets, Kieran F Docherty, Andrej Dukát, Peter J Greasley, Jonathan G Howlett, Silvio E Inzucchi, Tzvetana Katova, Lars Køber, Mikhail N Kosiborod, Anna Maria Langkilde, Daniel Lindholm, Charlotta E A Ljungman, Felipe A Martinez, Eileen O'Meara, Marc S Sabatine, Mikaela Sjöstrand, Scott D Solomon, Sergey Tereshchenko, Subodh Verma, Pardeep S Jhund, John J V McMurray,

BACKGROUND:In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure), the sodium-glucose cotransporter 2 inhibitor dapagliflozin reduced the risk of worsening heart failure and death in patients with heart failure and reduced ejection fraction. We examined the efficacy and tolerability of dapagliflozin in relation to background diuretic treatment ... Read more >>

Circulation (Circulation)
[2020, 142(11):1040-1054]

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Effects of dapagliflozin in DAPA-HF according to background heart failure therapy.

Kieran F Docherty, Pardeep S Jhund, Silvio E Inzucchi, Lars Køber, Mikhail N Kosiborod, Felipe A Martinez, Piotr Ponikowski, David L DeMets, Marc S Sabatine, Olof Bengtsson, Mikaela Sjöstrand, Anna Maria Langkilde, Akshay S Desai, Mirta Diez, Jonathan G Howlett, Tzvetana Katova, Charlotta E A Ljungman, Eileen O'Meara, Mark C Petrie, Morten Schou, Subodh Verma, Pham Nguyen Vinh, Scott D Solomon, John J V McMurray,

AIMS:In the DAPA-HF trial, the SGLT2 inhibitor dapagliflozin reduced the risk of worsening heart failure (HF) and death in patients with HF and reduced ejection fraction. We examined whether this benefit was consistent in relation to background HF therapy. METHODS AND RESULTS:In this post hoc analysis, we examined the effect ... Read more >>

Eur Heart J (European heart journal)
[2020, 41(25):2379-2392]

Cited: 3 times

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Efficacy and safety of sodium-glucose co-transporter 2 inhibition according to left ventricular ejection fraction in DAPA-HF.

Pooja Dewan, Scott D Solomon, Pardeep S Jhund, Silvio E Inzucchi, Lars Køber, Mikhail N Kosiborod, Felipe A Martinez, Piotr Ponikowski, David L DeMets, Marc S Sabatine, Olof Bengtsson, Mikaela Sjöstrand, Anna Maria Langkilde, Inder S Anand, Jan Bělohlávek, Vijay K Chopra, Andrej Dukát, Masafumi Kitakaze, Béla Merkely, Eileen O'Meara, Morten Schou, Pham Nguyen Vinh, John J V McMurray, ,

AIMS:The aim of this study was to examine whether left ventricular ejection fraction (LVEF) modified efficacy and safety of dapagliflozin 10 mg compared with placebo in the 4744 patients with LVEF ≤40% randomized in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF). METHODS AND RESULTS:We examined whether LVEF, analysed ... Read more >>

Eur J Heart Fail (European journal of heart failure)
[2020, 22(7):1247-1258]

Cited: 1 time

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Relative frequency of cardiology vs. endocrinology visits by type 2 diabetes patients with cardiovascular disease in the USA: implications for implementing evidence-based use of glucose-lowering medications.

Felona Gunawan, Michael E Nassif, Caitlin Partridge, Tariq Ahmad, Mikhail Kosiborod, Silvio E Inzucchi,

Cardiovascular disease (CVD) is a leading cause of morbidity and mortality in type 2 diabetes (T2D) patients. Recent cardiovascular outcome trials demonstrated clear cardiovascular benefits of novel classes of glucose-lowering agents. We performed retrospective electronic health record review at two major healthcare systems in the USA to determine the relative ... Read more >>

(Cardiovascular endocrinology & metabolism)
[2020, 9(2):56-59]

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Sodium glucose cotransporter 2 inhibitors as diuretic adjuvants in acute decompensated heart failure: a case series.

Matthew Griffin, Ralph Riello, Veena S Rao, Juan Ivey-Miranda, James Fleming, Christopher Maulion, Wendy McCallum, Mark Sarnak, Sean Collins, Silvio E Inzucchi, Jeffrey M Testani,

AIMS:Diuretic resistance is common in acute decompensated heart failure (ADHF). When loop diuretic monotherapy is ineffective, thiazides are often recommended as adjunctive therapy, but these agents have many side effects and are associated with worsened survival. In contrast, sodium glucose cotransporter 2 inhibitors (SGLT-2i's), initially developed as glucose-lowering medications for ... Read more >>

ESC Heart Fail (ESC heart failure)
[2020, 7(4):1966-1971]

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MON-645 Association of Baseline Cardio-Metabolic Parameters on the Treatment Effects of Empagliflozin When Added to Metformin in Patients with T2D.

Silvio E Inzucchi, Melanie Davies, Kamlesh Khunti, Prabhav Trivedi, Jyothis T George, Isabella Zwiener, Odd Erik Johansen, Naveed Sattar,

AbstractSodium-glucose co-transporter-2 inhibitors (SGLT2i) are commonly used as 2nd-line therapy after metformin (MET) in patients with type 2 diabetes (T2D), and are now recommended in those with co-existing cardiovascular (CV) and/or chronic kidney disease (CKD). A better understanding of their clinical efficacy across the spectrum of cardio-metabolic characteristics may help ... Read more >>

J Endocr Soc (Journal of the Endocrine Society)
[2020, 4(Suppl 1):]

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Empagliflozin in Heart Failure: Diuretic and Cardiorenal Effects.

Matthew Griffin, Veena S Rao, Juan Ivey-Miranda, James Fleming, Devin Mahoney, Christopher Maulion, Nisha Suda, Krishmita Siwakoti, Tariq Ahmad, Daniel Jacoby, Ralph Riello, Lavanya Bellumkonda, Zachary Cox, Sean Collins, Sangchoon Jeon, Jeffrey M Turner, F Perry Wilson, Javed Butler, Silvio E Inzucchi, Jeffrey M Testani,

BACKGROUND:Sodium-glucose cotransporter-2 inhibitors improve heart failure-related outcomes. The mechanisms underlying these benefits are not well understood, but diuretic properties may contribute. Traditional diuretics such as furosemide induce substantial neurohormonal activation, contributing to the limited improvement in intravascular volume often seen with these agents. However, the proximal tubular site of action ... Read more >>

Circulation (Circulation)
[2020, 142(11):1028-1039]

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SAT-258 Surprising Transformation of a Microprolactinoma to a Macroprolactinoma.

Diana Athonvarangkul, Hillary Wyeth Hosier, Brian Wojeck, Silvio E Inzucchi,

Abstract Background: Microprolactinomas are typically benign tumors that rarely become macroprolactinomas. We present a rare case of a microprolactinoma that, after discontinuation of dopamine agonist (DA) therapy, transformed into a macroprolactinoma over a period of 6 years.Clinical Case: A 16-year-old woman initially presented for evaluation of galactorrhea without menstrual irregularities ... Read more >>

J Endocr Soc (Journal of the Endocrine Society)
[2020, 4(Suppl 1):]

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Clinical Management of Stable Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus: A Scientific Statement From the American Heart Association.

Suzanne V Arnold, Deepak L Bhatt, Gregory W Barsness, Alexis L Beatty, Prakash C Deedwania, Silvio E Inzucchi, Mikhail Kosiborod, Lawrence A Leiter, Kasia J Lipska, Jonathan D Newman, Francine K Welty, ,

Although cardiologists have long treated patients with coronary artery disease (CAD) and concomitant type 2 diabetes mellitus (T2DM), T2DM has traditionally been considered just a comorbidity that affected the development and progression of the disease. Over the past decade, a number of factors have shifted that have forced the cardiology ... Read more >>

Circulation (Circulation)
[2020, 141(19):e779-e806]

Cited: 2 times

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