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Author Stefan Hantel

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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]

Cited: 0 times

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Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial.

Adeera Levin, Vlado Perkovic, David C Wheeler, Stefan Hantel, Jyothis T George, Maximilian von Eynatten, Audrey Koitka-Weber, Christoph Wanner, ,

BACKGROUND AND OBJECTIVES:In the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG Outcome), empagliflozin, in addition to standard of care, significantly reduced risk of cardiovascular death by 38%, hospitalization for heart failure by 35%, and incident or worsening nephropathy by 39% compared with placebo in patients ... Read more >>

Clin J Am Soc Nephrol (Clinical journal of the American Society of Nephrology : CJASN)
[2020, 15(10):1433-1444]

Cited: 0 times

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Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting.

Trevor A Lentz, Lesley H Curtis, Frank W Rockhold, David Martin, Tomas L G Andersson, Carolyn Arias, Jesse A Berlin, Cherie Binns, Andrea Cook, Mark Cziraky, Ricardo Dent, Manisha Desai, Andrew Emmett, Denise Esserman, Jyothis George, Stefan Hantel, Patrick Heagerty, Adrian F Hernandez, Thomas Hucko, Naeem Khan, Shun Fu Lee, Robert LoCasale, Jack Mardekian, Debbe McCall, Keri Monda, Sharon-Lise Normand, Jeffrey Riesmeyer, Matthew Roe, Lothar Roessig, Rob Scott, Harald Siedentop, Joanne Waldstreicher, Lin Wang, Govinda Weerakkody, Myles Wolf, Susan S Ellenberg,

In late 2018, the Food and Drug Administration (FDA) outlined a framework for evaluating the possible use of real-world evidence (RWE) to support regulatory decision-making. This framework was created to facilitate studies that would generate high-quality RWE, including pragmatic clinical trials (PCTs), which are randomized trials designed to inform clinical ... Read more >>

Ther Innov Regul Sci (Therapeutic innovation & regulatory science)
[2020, 54(6):1477-1488]

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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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The authors reply.

Gert J Mayer, Christoph Wanner, Matthew R Weir, Silvio E Inzucchi, Audrey Koitka-Weber, Stefan Hantel, Maximilian von Eynatten, Bernard Zinman, David Z I Cherney,

Kidney Int (Kidney international)
[2020, 97(1):213-214]

Cited: 0 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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Restricted mean survival time for the analysis of cardiovascular outcome trials assessing non-inferiority: Case studies from antihyperglycemic drug development.

David H Manner, Chakib Battioui, Stefan Hantel, B Nhi Beasley, Lee-Jen Wei, Mary Jane Geiger, J Rick Turner, Markus Abt,

Cardiovascular outcome trials (CVOTs) have been employed in multiple therapeutic areas to explore whether a noncardiovascular drug increases the risk for cardiovascular events. These studies are now a central part of drug development programs for antihyperglycemic drugs. These programs are expected to demonstrate that new antihyperglycemic drugs for patients with ... Read more >>

Am Heart J (American heart journal)
[2019, 215:178-186]

Cited: 0 times

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Glucose Control and the Effect of Empagliflozin on Kidney Outcomes in Type 2 Diabetes: An Analysis From the EMPA-REG OUTCOME Trial.

Mark E Cooper, Silvio E Inzucchi, Bernard Zinman, Stefan Hantel, Maximilian von Eynatten, Christoph Wanner, Audrey Koitka-Weber,

Am. J. Kidney Dis. (American journal of kidney diseases : the official journal of the National Kidney Foundation)
[2019, 74(5):713-715]

Cited: 5 times

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Analysis from the EMPA-REG OUTCOME® trial indicates empagliflozin may assist in preventing the progression of chronic kidney disease in patients with type 2 diabetes irrespective of medications that alter intrarenal hemodynamics.

Gert J Mayer, Christoph Wanner, Matthew R Weir, Silvio E Inzucchi, Audrey Koitka-Weber, Stefan Hantel, Maximilian von Eynatten, Bernard Zinman, David Z I Cherney,

In patients with type 2 diabetes mellitus (T2DM) and cardiovascular (CV) disease, empagliflozin (EMPA) decreased progression of chronic kidney disease (CKD), likely via a reduction in intraglomerular pressure. Due to prevalent comorbidities, such as hypertension and albuminuria, patients often receive other agents that alter intrarenal hemodynamics, including angiotensin converting enzyme ... Read more >>

Kidney Int (Kidney international)
[2019, 96(2):489-504]

Cited: 12 times

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Empagliflozin and Kidney Function Decline in Patients with Type 2 Diabetes: A Slope Analysis from the EMPA-REG OUTCOME Trial.

Christoph Wanner, Hiddo J L Heerspink, Bernard Zinman, Silvio E Inzucchi, Audrey Koitka-Weber, Michaela Mattheus, Stefan Hantel, Hans-Juergen Woerle, Uli C Broedl, Maximilian von Eynatten, Per-Henrik Groop, ,

BACKGROUND:Empagliflozin slowed the progression of CKD in patients with type 2 diabetes and cardiovascular disease in the EMPA-REG OUTCOME Trial. In a prespecified statistical approach, we assessed treatment differences in kidney function by analyzing slopes of eGFR changes. METHODS:Participants (n=7020) were randomized (1:1:1) to empagliflozin 10 mg/d, empagliflozin 25 mg/d, ... Read more >>

J Am Soc Nephrol (Journal of the American Society of Nephrology : JASN)
[2018, 29(11):2755-2769]

Cited: 14 times

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Empagliflozin and kidney outcomes in Asian patients with type 2 diabetes and established cardiovascular disease: Results from the EMPA-REG OUTCOME® trial.

Takashi Kadowaki, Masaomi Nangaku, Stefan Hantel, Tomoo Okamura, Maximilian von Eynatten, Christoph Wanner, Audrey Koitka-Weber,

AIMS/INTRODUCTION:In the EMPA-REG OUTCOME® trial, empagliflozin added to standard of care improved clinically relevant kidney outcomes by 39%, slowed progression of chronic kidney disease, and reduced albuminuria in patients with type 2 diabetes and established cardiovascular disease. This exploratory analysis investigated the effects of empagliflozin on the kidneys in Asian patients. ... Read more >>

J Diabetes Investig (Journal of diabetes investigation)
[2019, 10(3):760-770]

Cited: 7 times

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Long-Term Benefit of Empagliflozin on Life Expectancy in Patients With Type 2 Diabetes Mellitus and Established Cardiovascular Disease.

Brian Claggett, John M Lachin, Stefan Hantel, David Fitchett, Silvio E Inzucchi, Hans J Woerle, Jyothis T George, Bernard Zinman,

Circulation (Circulation)
[2018, 138(15):1599-1601]

Cited: 5 times

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Empagliflozin is associated with improvements in liver enzymes potentially consistent with reductions in liver fat: results from randomised trials including the EMPA-REG OUTCOME® trial.

Naveed Sattar, David Fitchett, Stefan Hantel, Jyothis T George, Bernard Zinman,

AIMS/HYPOTHESIS:In addition to beneficial effects on glycaemia and cardiovascular death, empagliflozin improves adiposity indices. We investigated the effect of empagliflozin on aminotransferases (correlates of liver fat) in individuals with type 2 diabetes. METHODS:Changes from baseline alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed in the EMPA-REG OUTCOME® trial (n = 7020), ... Read more >>

Diabetologia (Diabetologia)
[2018, 61(10):2155-2163]

Cited: 23 times

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Acute Effect of Empagliflozin on Fractional Excretion of Sodium and eGFR in Youth With Type 2 Diabetes.

Petter Bjornstad, Lori Laffel, William V Tamborlane, Gudrun Simons, Stefan Hantel, Maximilian von Eynatten, Jyothis George, Jan Marquard, David Z I Cherney,

Diabetes Care (Diabetes care)
[2018, 41(8):e129-e130]

Cited: 4 times

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Slope of change in HbA1c from baseline with empagliflozin compared with sitagliptin or glimepiride in patients with type 2 diabetes.

Ralph A DeFronzo, Ele Ferrannini, Guntram Schernthaner, Stefan Hantel, Ulrich Elsasser, Christopher Lee, Thomas Hach, Søren S Lund,

Aims:To analyse the effect of baseline glycated haemoglobin (HbA1c) on the reduction in HbA1c with empagliflozin compared with sitagliptin or glimepiride in patients with type 2 diabetes. Materials and methods:Using regression analyses of individual patient data from two Phase III studies, we compared the change in HbA1c according to a ... Read more >>

(Endocrinology, diabetes & metabolism)
[2018, 1(2):e00016]

Cited: 2 times

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Effects of empagliflozin on risk for cardiovascular death and heart failure hospitalization across the spectrum of heart failure risk in the EMPA-REG OUTCOME® trial.

David Fitchett, Javed Butler, Philippe van de Borne, Bernard Zinman, John M Lachin, Christoph Wanner, Hans J Woerle, Stefan Hantel, Jyothis T George, Odd Erik Johansen, Silvio E Inzucchi, ,

Aims:Empagliflozin reduced the risk of cardiovascular (CV) death and heart failure (HF) hospitalizations in patients with type 2 diabetes (T2D) and established CV disease (CVD) in the EMPA-REG OUTCOME® trial. We investigated whether the benefit of empagliflozin was observed across the spectrum of HF risk. Methods and results:Seven thousand and ... Read more >>

Eur. Heart J. (European heart journal)
[2018, 39(5):363-370]

Cited: 55 times

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How Does Empagliflozin Reduce Cardiovascular Mortality? Insights From a Mediation Analysis of the EMPA-REG OUTCOME Trial.

Silvio E Inzucchi, Bernard Zinman, David Fitchett, Christoph Wanner, Ele Ferrannini, Martin Schumacher, Claudia Schmoor, Kristin Ohneberg, Odd Erik Johansen, Jyothis T George, Stefan Hantel, Erich Bluhmki, John M Lachin,

OBJECTIVE:In the BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) trial involving 7,020 patients with type 2 diabetes and established cardiovascular (CV) disease, empagliflozin given in addition to standard of care reduced the risk of CV death by 38% versus placebo (hazard ratio ... Read more >>

Diabetes Care (Diabetes care)
[2018, 41(2):356-363]

Cited: 101 times

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Net clinical benefit of dabigatran vs. warfarin in venous thromboembolism: analyses from RE-COVER®, RE-COVER™ II, and RE-MEDY™.

Martin Feuring, Sam Schulman, Henry Eriksson, Ajay J Kakkar, Sebastian Schellong, Stefan Hantel, Elke Schueler, Jörg Kreuzer, Samuel Z Goldhaber,

The direct oral anticoagulants, e.g., dabigatran etexilate (DE), are effective and well tolerated treatments for venous thromboembolism (VTE). Net clinical benefit (NCB) is a useful concept in weighing potential benefits against potential harm of comparator drugs. The NCB of DE vs. warfarin in VTE treatment was compared. Post-hoc analyses were ... Read more >>

J. Thromb. Thrombolysis (Journal of thrombosis and thrombolysis)
[2017, 43(4):484-489]

Cited: 2 times

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Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME® trial.

David Fitchett, Bernard Zinman, Christoph Wanner, John M Lachin, Stefan Hantel, Afshin Salsali, Odd Erik Johansen, Hans J Woerle, Uli C Broedl, Silvio E Inzucchi, ,

AIMS:We previously reported that in the EMPA-REG OUTCOME(®) trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular events, cardiovascular and all-cause death, and hospitalization for heart failure in patients with type 2 diabetes and high cardiovascular risk. We have now further investigated heart failure ... Read more >>

Eur Heart J (European heart journal)
[2016, 37(19):1526-1534]

Cited: 302 times

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Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes.

Sven Kohler, Afshin Salsali, Stefan Hantel, Stefan Kaspers, Hans J Woerle, Gabriel Kim, Uli C Broedl,

PURPOSE:The aim of this analysis was to establish the safety profile and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) according to pooled data from several clinical trials. METHODS:Pooled data were analyzed from patients with T2DM treated with placebo (n = 3695), empagliflozin 10 mg (n = ... Read more >>

Clin Ther (Clinical therapeutics)
[2016, 38(6):1299-1313]

Cited: 40 times

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Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials.

Bengt I Eriksson, Ola E Dahl, Nadia Rosencher, Andreas Clemens, Stefan Hantel, Martin Feuring, Jörg Kreuzer, Michael Huo, Richard J Friedman,

BACKGROUND:Two phase 3 trials compared 28-35 days of treatment with oral dabigatran 220 mg or 150 mg (RE-NOVATE) or 220 mg (RE-NOVATE II) once daily with subcutaneous enoxaparin 40 mg once daily for prevention of venous thromboembolism (VTE) after elective total hip arthroplasty. METHODS:This prespecified pooled analysis compared the outcomes for the dabigatran 220 mg ... Read more >>

Thromb J (Thrombosis journal)
[2015, 13:36]

Cited: 9 times

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Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.

Bernard Zinman, Christoph Wanner, John M Lachin, David Fitchett, Erich Bluhmki, Stefan Hantel, Michaela Mattheus, Theresa Devins, Odd Erik Johansen, Hans J Woerle, Uli C Broedl, Silvio E Inzucchi, ,

BACKGROUND:The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known. METHODS:We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. ... Read more >>

N Engl J Med (The New England journal of medicine)
[2015, 373(22):2117-2128]

Cited: 2411 times

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Treatment with dabigatran or warfarin in patients with venous thromboembolism and cancer.

Sam Schulman, Samuel Z Goldhaber, Clive Kearon, Ajay K Kakkar, Sebastian Schellong, Henry Eriksson, Stefan Hantel, Martin Feuring, Jörg Kreuzer,

The efficacy and safety of dabigatran for treatment of venous thromboembolism (VTE) were demonstrated in two trials. It is unclear if the results pertain to patients with cancer and VTE. Data from two randomised trials comparing dabigatran and warfarin for acute VTE were pooled. Primary efficacy outcome was symptomatic recurrent ... Read more >>

Thromb. Haemost. (Thrombosis and haemostasis)
[2015, 114(1):150-157]

Cited: 53 times

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Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes.

Mary Jane Geiger, Cyrus Mehta, J Rick Turner, Christophe Arbet-Engels, Stefan Hantel, Boaz Hirshberg, Joerg Koglin, Boaz Mendzelevski, Philip T Sager, Deborah Shapiro, Murray Stewart, Thomas G Todaro, Brenda Gaydos,

In December 2008, the US Food and Drug Administration (FDA) issued a guidance for industry requiring sponsors to demonstrate that a new antidiabetic therapy being developed to treat type 2 diabetes does not increase cardiovascular (CV) risk to an unacceptable extent. CV events reported during phase 2 and phase 3 ... Read more >>

Ther Innov Regul Sci (Therapeutic innovation & regulatory science)
[2015, 49(1):50-64]

Cited: 4 times

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SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials.

Silvio E Inzucchi, Bernard Zinman, Christoph Wanner, Roberto Ferrari, David Fitchett, Stefan Hantel, Rosa-Maria Espadero, Hans-Jürgen Woerle, Uli C Broedl, Odd Erik Johansen,

Given the multi-faceted pathogenesis of atherosclerosis in type 2 diabetes mellitus (T2DM), it is likely that interventions to mitigate this risk must address cardiovascular (CV) risk factors beyond glucose itself. Sodium glucose cotransporter-2 (SGLT-2) inhibitors are newer antihyperglycaemic agents with apparent multiple effects. Inherent in their mode of action to ... Read more >>

Diab Vasc Dis Res (Diabetes & vascular disease research)
[2015, 12(2):90-100]

Cited: 156 times

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