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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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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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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 Inzucchi,

Abstract 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 ... Read more >>

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Heart failure and renal outcomes according to baseline and achieved blood pressure in patients with type 2 diabetes: results from EMPA-REG OUTCOME.

Michael Böhm, David Fitchett, Anne Pernille Ofstad, Martina Brueckmann, Stefan Kaspers, Jyothis T George, Isabella Zwiener, Bernard Zinman, Christoph Wanner, Nikolaus Marx, Giuseppe Mancia, Stefan D Anker, Felix Mahfoud,

BACKGROUND:The sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin reduced cardiovascular death or heart failure hospitalizations in type 2 diabetes (T2D) in addition to a reduction of SBP. As heart failure patients often present with low SBP, which can challenge treatment initiation, we explored if empagliflozin's effect on SBP was independent of ... Read more >>

J Hypertens (Journal of hypertension)
[2020, 38(9):1829-1840]

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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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Early benefits of empagliflozin in patients with or without heart failure: findings from EMPA-REG OUTCOME.

Pierpaolo Pellicori, Anne Pernille Ofstad, David Fitchett, Cordula Zeller, Christoph Wanner, Jyothis George, Bernard Zinman, Martina Brueckmann, JoAnn Lindenfeld,

AIMS:The EMPA-REG OUTCOME trial demonstrated reductions in cardiovascular (CV) death and heart failure (HF) outcomes with empagliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes and established CV disease over a study period of 3 years. We aimed to investigate the early benefit-risk profile of empagliflozin in patients ... Read more >>

ESC Heart Fail (ESC heart failure)
[2020, :]

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Empagliflozin for Patients with Presumed Resistant Hypertension: a Post Hoc Analysis of the EMPA-REG OUTCOME Trial.

João Pedro Ferreira, David Fitchett, Anne Pernille Ofstad, Bettina Johanna Kraus, Christoph Wanner, Isabella Zwiener, Bernard Zinman, Sabine Lauer, Jyothis T George, Patrick Rossignol, Faiez Zannad,

BACKGROUND:Type 2 diabetes (T2D) and resistant hypertension (rHT) often coexist, greatly increasing risk of target-organ damage and death. We explored the effects of empagliflozin in patients with and without presumed resistant hypertension (prHT) in a post hoc analysis of EMPA-REG OUTCOME (NCT01131676). METHODS:Overall, 7020 patients received empagliflozin 10mg, 25mg, or ... Read more >>

Am J Hypertens (American journal of hypertension)
[2020, :]

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Glucose-lowering drugs or strategies, atherosclerotic cardiovascular events, and heart failure in people with or at risk of type 2 diabetes: an updated systematic review and meta-analysis of randomised cardiovascular outcome trials.

Olivia R Ghosh-Swaby, Shaun G Goodman, Lawrence A Leiter, Alice Cheng, Kim A Connelly, David Fitchett, Peter Jüni, Michael E Farkouh, Jacob A Udell,

BACKGROUND:In our 2015 systematic review and meta-analysis of cardiovascular outcome trials for glucose-lowering drugs or strategies in people with or at risk of type 2 diabetes, we reported a modest reduction in atherosclerotic cardiovascular events and an increased risk of heart failure, but with heterogeneous effects by drug or intervention ... Read more >>

Lancet Diabetes Endocrinol (The lancet. Diabetes & endocrinology)
[2020, 8(5):418-435]

Cited: 2 times

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Update to Evidence-Based Secondary Prevention Strategies After Acute Coronary Syndrome.

David H Fitchett, Lawrence A Leiter, Peter Lin, Jennifer Pickering, Robert Welsh, James Stone, Jean Gregoire, Philip McFarlane, Anatoly Langer, Anil Gupta, Shaun G Goodman,

A recent acute coronary syndrome provides an opportunity to optimise secondary prevention strategies to reduce the risk of future cardiovascular events. This review provides an updated synopsis of current evidence-based approaches. New clinical trial data on the use of antiplatelet and anticoagulants allow choices of the selection and duration of ... Read more >>

CJC Open (CJC open)
[2020, 2(5):402-415]

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Update to Evidence-Based Secondary Prevention Strategies After Acute Coronary Syndrome

David H. Fitchett, Lawrence A. Leiter, Peter Lin, Jennifer Pickering, Robert Welsh, James Stone, Jean Gregoire, Philip McFarlane, Anatoly Langer, Anil Gupta, Shaun G. Goodman,

A recent acute coronary syndrome provides an opportunity to optimise secondary prevention strategies to reduce the risk of future cardiovascular events. This review provides an updated synopsis of current evidence-based approaches. New clinical trial data on the use of antiplatelet and anticoagulants allow choices of the selection and duration of ... Read more >>

CJC Open (CJC open)
[2020, 2(5):402-415]

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Association between uric acid levels and cardio-renal outcomes and death in patients with type 2 diabetes: A subanalysis of EMPA-REG OUTCOME.

Subodh Verma, Qiuhe Ji, Deepak L Bhatt, C David Mazer, Mohammed Al-Omran, Silvio E Inzucchi, Christoph Wanner, Anne Pernille Ofstad, Isabella Zwiener, Jyothis T George, Bernard Zinman, David Fitchett,

In the EMPA-REG OUTCOME trial, we explored the association between pre-randomization uric acid level tertile (<309.30 μmol/L; 309.30 to <387.21 μmol/L; ≥387.21 μmol/L) and cardiovascular (CV) death, hospitalization for heart failure (HHF), HHF or CV death, all-cause mortality, three-point major adverse CV events (MACE), and incident or worsening nephropathy. Patients with type 2 ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, 22(7):1207-1214]

Cited: 1 time

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Empagliflozin reduces the risk of mortality and hospitalization for heart failure across Thrombolysis In Myocardial Infarction Risk Score for Heart Failure in Diabetes categories: Post hoc analysis of the EMPA-REG OUTCOME trial.

Subodh Verma, Abhinav Sharma, Bernard Zinman, Anne Pernille Ofstad, David Fitchett, Martina Brueckmann, Christoph Wanner, Isabella Zwiener, Jyothis T George, Silvio E Inzucchi, Javed Butler, C David Mazer,

AIM:To investigate the association of the Thrombolysis In Myocardial Infarction (TIMI) Risk Score for Heart Failure in Diabetes (TRS-HFDM ) with mortality using data from the EMPA-REG OUTCOME trial. MATERIALS AND METHODS:In EMPA-REG OUTCOME, patients with type 2 diabetes and atherosclerotic cardiovascular (CV) disease (N = 7020) received the sodium-glucose ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, 22(7):1141-1150]

Cited: 2 times

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Can the cardiovascular risk reductions observed with empagliflozin in the EMPA-REG OUTCOME trial be explained by concomitant changes seen in conventional cardiovascular risk factor levels?

Ruth L Coleman, Alastair M Gray, Uli C Broedl Md, David Fitchett, Jyothis T George, Hans J Woerle, Bernard Zinman, Rury R Holman,

AIM:To perform post-hoc analyses of the EMPA-REG OUTCOME trial examining the degree to which empagliflozin-induced changes in conventional cardiovascular (CV) risk factors might explain the observed CV benefits. MATERIALS AND METHODS:We estimated 3-year EMPA-REG OUTCOME CV event rates using a type 2 diabetes-specific clinical outcomes simulation model applied to annual ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, 22(7):1151-1156]

Cited: 2 times

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Are the cardiovascular and kidney benefits of empagliflozin influenced by baseline glucose-lowering therapy?

Silvio E Inzucchi, David Fitchett, Dubravka Jurišić-Eržen, Vincent Woo, Stefan Hantel, Christina Janista, Stefan Kaspers, Jyothis T George, Bernard Zinman, ,

AIMS:In the EMPA-REG OUTCOME® trial, the sodium-glucose cotransporter 2 inhibitor empagliflozin when given in addition to standard care improved cardiovascular (CV) and renal outcomes, and reduced mortality. Trial participants were on a variety of glucose-lowering therapies at baseline, some of which could potentially affect CV risk. This analysis investigated whether ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, 22(4):631-639]

Cited: 3 times

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Relationship between hypoglycaemia, cardiovascular outcomes, and empagliflozin treatment in the EMPA-REG OUTCOME® trial.

David Fitchett, Silvio E Inzucchi, Christoph Wanner, Michaela Mattheus, Jyothis T George, Ola Vedin, Bernard Zinman, Odd Erik Johansen,

AIMS:Hypoglycaemia, in patients with Type 2 diabetes (T2D) is associated with an increased risk for cardiovascular (CV) events. In EMPA-REG OUTCOME, the sodium-glucose co-transporter-2 inhibitor empagliflozin reduced the risk of CV death by 38% and heart failure hospitalization (HHF) by 35%, while decreasing glycated haemoglobin (HbA1c) without increasing hypoglycaemia. We ... Read more >>

Eur Heart J (European heart journal)
[2020, 41(2):209-217]

Cited: 4 times

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Efficacy of empagliflozin on heart failure and renal outcomes in patients with atrial fibrillation: data from the EMPA-REG OUTCOME trial.

Michael Böhm, Jonathan Slawik, Martina Brueckmann, Michaela Mattheus, Jyothis T George, Anne Pernille Ofstad, Silvio E Inzucchi, David Fitchett, Stefan D Anker, Nikolaus Marx, Christoph Wanner, Bernard Zinman, Subodh Verma,

AIMS:Atrial fibrillation (AF) is common in patients with diabetes and heart failure (HF) and increases the future risk of adverse cardiovascular (CV) outcomes. This analysis from the EMPA-REG OUTCOME trial explores CV and renal outcomes in patients with vs. without AF at baseline and assesses the benefits of empagliflozin. METHODS ... Read more >>

Eur. J. Heart Fail. (European journal of heart failure)
[2020, 22(1):126-135]

Cited: 4 times

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Efficacy and safety of empagliflozin in older patients in the EMPA-REG OUTCOME® trial.

Pedro Monteiro, Richard M Bergenstal, Elvira Toural, Silvio E Inzucchi, Bernard Zinman, Stefan Hantel, Sanja Giljanovic Kiš, Stefan Kaspers, Jyothis T George, David Fitchett,

OBJECTIVE:The risks of cardio-renal complications of diabetes increase with age. In the EMPA-REG OUTCOME® trial, empagliflozin reduced cardiovascular (CV) mortality by 38% in patients with type 2 diabetes (T2D) and CV disease. Here we compare outcomes with empagliflozin in older patients in EMPA-REG OUTCOME. METHODS:Patients with T2D and CV disease ... Read more >>

Age Ageing (Age and ageing)
[2019, 48(6):859-866]

Cited: 3 times

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Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial.

Subodh Verma, C David Mazer, Andrew T Yan, Tamique Mason, Vinay Garg, Hwee Teoh, Fei Zuo, Adrian Quan, Michael E Farkouh, David H Fitchett, Shaun G Goodman, Ronald M Goldenberg, Mohammed Al-Omran, Richard E Gilbert, Deepak L Bhatt, Lawrence A Leiter, Peter Jüni, Bernard Zinman, Kim A Connelly,

BACKGROUND:SGLT2 (sodium-glucose cotransporter 2) inhibitors lower cardiovascular events in type 2 diabetes mellitus but whether they promote direct cardiac effects remains unknown. We sought to determine if empagliflozin causes a decrease in left ventricular (LV) mass in people with type 2 diabetes mellitus and coronary artery disease. METHODS:Between November 2016 ... Read more >>

Circulation (Circulation)
[2019, 140(21):1693-1702]

Cited: 17 times

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Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure.

Javed Butler, Faiez Zannad, David Fitchett, Bernard Zinman, Audrey Koitka-Weber, Maximilian von Eynatten, Isabella Zwiener, Jyothis George, Martina Brueckmann, Alfred K Cheung, Christoph Wanner,

Background In EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) empagliflozin significantly reduced the risk of cardiovascular and kidney outcomes in patients with type 2 diabetes mellitus and established cardiovascular disease. Post hoc, we evaluated empagliflozin on kidney outcomes in patients with or without heart ... Read more >>

Circ Heart Fail (Circulation. Heart failure)
[2019, 12(6):e005875]

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Influence of Microvascular Disease on Cardiovascular Events in Type 2 Diabetes.

Subodh Verma, Christoph Wanner, Isabella Zwiener, Anne Pernille Ofstad, Jyothis T George, David Fitchett, Bernard Zinman, ,

J. Am. Coll. Cardiol. (Journal of the American College of Cardiology)
[2019, 73(21):2780-2782]

Cited: 4 times

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A safety update on sodium glucose co-transporter 2 inhibitors.

David Fitchett,

Sodium glucose co-transporter 2 inhibitors (SGLT2is) are the first class of glucose lowering agent to be shown to reduce cardiovascular events. They are generally well tolerated with infrequent serious adverse events. The most frequent side effect is genital mycotic infections with candida species that are usually mild to moderate in ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2019, 21 Suppl 2:34-42]

Cited: 9 times

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Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial.

David Fitchett, Silvio E Inzucchi, Christopher P Cannon, Darren K McGuire, Benjamin M Scirica, Odd Erik Johansen, Steven Sambevski, Stefan Kaspers, Egon Pfarr, Jyothis T George, Bernard Zinman,

BACKGROUND:In the EMPA-REG OUTCOME trial (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) in patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease, in comparison with placebo, empagliflozin reduced the risks of 3-point major adverse cardiovascular events (3-point MACE), cardiovascular and all-cause death, and ... Read more >>

Circulation (Circulation)
[2019, 139(11):1384-1395]

Cited: 20 times

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Empagliflozin Is Associated With a Lower Risk of Post-Acute Heart Failure Rehospitalization and Mortality.

Gianluigi Savarese, Naveed Sattar, James Januzzi, Subodh Verma, Lars H Lund, David Fitchett, Cordula Zeller, Jyothis T George, Martina Brueckmann, Anne Pernille Ofstad, Silvio E Inzucchi, Christoph Wanner, Bernard Zinman, Javed Butler,

Circulation (Circulation)
[2019, 139(11):1458-1460]

Cited: 3 times

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Empagliflozin reduces the risk of a broad spectrum of heart failure outcomes regardless of heart failure status at baseline.

James Januzzi, João Pedro Ferreira, Michael Böhm, Sanjay Kaul, Christoph Wanner, Martina Brueckmann, Mark C Petrie, Anne Pernille Ofstad, Cordula Zeller, Jyothis George, David Fitchett, Faiez Zannad,

Eur. J. Heart Fail. (European journal of heart failure)
[2019, 21(3):386-388]

Cited: 1 time

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To Risk Stratify or Not for Statin Therapy.

David Fitchett,

Can J Cardiol (The Canadian journal of cardiology)
[2019, 35(5):550-551]

Cited: 0 times

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