Full Text Journal Articles by
Author Michaela Mattheus

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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, :]

Cited: 0 times

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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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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]

Cited: 0 times

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Cardiovascular outcomes and safety with linagliptin, a dipeptidyl peptidase-4 inhibitor, compared with the sulphonylurea glimepiride in older people with type 2 diabetes: a subgroup analysis of the randomized CAROLINA trial.

Mark A Espeland, Richard E Pratley, Julio Rosenstock, Takashi Kadowaki, Yutaka Seino, Bernard Zinman, Nikolaus Marx, Darren K McGuire, Knut Robert Andersen, Michaela Mattheus, Annett Keller, Maria Weber, Odd Erik Johansen,

AIMS:Safety is a key consideration for glucose-lowering agents for older people with type 2 diabetes, yet comparative data are limited. We compared the cardiovascular (CV) safety of linagliptin with glimepiride in older and younger participants in the CAROLINA trial in both pre-specified and post-hoc analyses. MATERIALS AND METHODS:People aged 40-85 years ... Read more >>

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

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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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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, :]

Cited: 0 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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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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Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes: The CAROLINA Randomized Clinical Trial.

Julio Rosenstock, Steven E Kahn, Odd Erik Johansen, Bernard Zinman, Mark A Espeland, Hans J Woerle, Egon Pfarr, Annett Keller, Michaela Mattheus, David Baanstra, Thomas Meinicke, Jyothis T George, Maximilian von Eynatten, Darren K McGuire, Nikolaus Marx, ,

Importance:Type 2 diabetes is associated with increased cardiovascular risk. In placebo-controlled cardiovascular safety trials, the dipeptidyl peptidase-4 inhibitor linagliptin demonstrated noninferiority, but it has not been tested against an active comparator. Objective:This trial assessed cardiovascular outcomes of linagliptin vs glimepiride (sulfonylurea) in patients with relatively early type 2 diabetes and ... Read more >>

JAMA (JAMA)
[2019, :]

Cited: 25 times

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HbA1c, Insulin Resistance, and β-Cell Function in Relation to Cognitive Function in Type 2 Diabetes: The CAROLINA Cognition Substudy.

Jolien Janssen, Esther van den Berg, Bernard Zinman, Mark A Espeland, Stefan L C Geijselaers, Michaela Mattheus, Odd Erik Johansen, Geert Jan Biessels,

Diabetes Care (Diabetes care)
[2019, 42(1):e1-e3]

Cited: 0 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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Rationale and design of the CAROLINA® - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus.

Geert Jan Biessels, Jolien Janssen, Esther van den Berg, Bernard Zinman, Mark A Espeland, Michaela Mattheus, Odd Erik Johansen, ,

BACKGROUND:Type 2 diabetes mellitus is associated with cognitive dysfunction and an increased risk of dementia. Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive decline, because it may potentially benefit the brain through pleiotropic effects, beyond ... Read more >>

BMC Neurol (BMC neurology)
[2018, 18(1):7]

Cited: 7 times

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Cardiovascular Mortality Reduction With Empagliflozin in Patients With Type 2 Diabetes and Cardiovascular Disease.

David Fitchett, Silvio E Inzucchi, John M Lachin, Christoph Wanner, Philippe van de Borne, Michaela Mattheus, Odd Erik Johansen, Hans J Woerle, Uli C Broedl, Jyothis T George, Bernard Zinman, ,

J. Am. Coll. Cardiol. (Journal of the American College of Cardiology)
[2018, 71(3):364-367]

Cited: 10 times

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Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA®): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk.

Julio Rosenstock, Vlado Perkovic, John H Alexander, Mark E Cooper, Nikolaus Marx, Michael J Pencina, Robert D Toto, Christoph Wanner, Bernard Zinman, David Baanstra, Egon Pfarr, Michaela Mattheus, Uli C Broedl, Hans-Juergen Woerle, Jyothis T George, Maximilian von Eynatten, Darren K McGuire, ,

BACKGROUND:Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney disease (CKD), leading to uncertainty regarding their kidney efficacy and safety. The CARMELINA® trial aims to evaluate the effects of linagliptin, a DPP-4 inhibitor, on both CV and kidney outcomes in a study population enriched ... Read more >>

Cardiovasc Diabetol (Cardiovascular diabetology)
[2018, 17(1):39]

Cited: 30 times

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Empagliflozin and Clinical Outcomes in Patients With Type 2 Diabetes Mellitus, Established Cardiovascular Disease, and Chronic Kidney Disease.

Christoph Wanner, John M Lachin, Silvio E Inzucchi, David Fitchett, Michaela Mattheus, Jyothis George, Hans J Woerle, Uli C Broedl, Maximilian von Eynatten, Bernard Zinman, ,

BACKGROUND:Empagliflozin, a sodium-glucose cotransporter 2 inhibitor, reduced cardiovascular morbidity and mortality in patients with type 2 diabetes mellitus and established cardiovascular disease in the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients). Urinary glucose excretion with empagliflozin decreases with declining renal function, resulting in ... Read more >>

Circulation (Circulation)
[2018, 137(2):119-129]

Cited: 81 times

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The effect of empagliflozin on muscle sympathetic nerve activity in patients with type II diabetes mellitus.

Jens Jordan, Jens Tank, Karsten Heusser, Tim Heise, Christoph Wanner, Martina Heer, Sreeraj Macha, Michaela Mattheus, Søren S Lund, Hans J Woerle, Uli C Broedl,

Inhibition of sodium glucose cotransporter 2 with empagliflozin results in caloric loss by increasing urinary glucose excretion and has a mild diuretic effect. Diuretic effects are usually associated with reflex-mediated increases in sympathetic tone, whereas caloric loss is associated with decreased sympathetic tone. In an open-label trial, muscle sympathetic nerve ... Read more >>

J Am Soc Hypertens (Journal of the American Society of Hypertension : JASH)
[2017, 11(9):604-612]

Cited: 11 times

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Effects of empagliflozin on the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and established cardiovascular disease: an exploratory analysis from the EMPA-REG OUTCOME randomised, placebo-controlled trial.

David Z I Cherney, Bernard Zinman, Silvio E Inzucchi, Audrey Koitka-Weber, Michaela Mattheus, Maximilian von Eynatten, Christoph Wanner,

In a pooled analysis of short-term trials, short-term treatment with the sodium-glucose co-transporter-2 (SGLT2) inhibitor empagliflozin reduced albuminuria in patients with type 2 diabetes and prevalent albuminuria. In this exploratory analysis of the EMPA-REG OUTCOME trial, we report the short-term and long-term effects of empagliflozin on albuminuria in patients with ... Read more >>

Lancet Diabetes Endocrinol (The lancet. Diabetes & endocrinology)
[2017, 5(8):610-621]

Cited: 79 times

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Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.

Bernard Zinman, Silvio E Inzucchi, John M Lachin, Christoph Wanner, David Fitchett, Sven Kohler, Michaela Mattheus, Hans J Woerle, Uli C Broedl, Odd Erik Johansen, Gregory W Albers, Hans Christoph Diener, ,

In the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients), empagliflozin added to standard of care in patients with type 2 diabetes mellitus and high cardiovascular risk reduced the risk of 3-point major adverse cardiovascular events, driven by a reduction in cardiovascular mortality, with ... Read more >>

Stroke (Stroke)
[2017, 48(5):1218-1225]

Cited: 29 times

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Relative bioavailability of an empagliflozin 25-mg/linagliptin 5-mg fixed-dose combination tablet
.

Stephan Glund, Michaela Mattheus, Frank Runge, Peter Rose, Christian Friedrich,

This relative bioavailability study compared a fixed-dose combination (FDC) tablet of empagliflozin 25 mg/linagliptin 5 mg with the corresponding individual components. In addition, the effect of food on the bioavailability of the FDC was studied, and the standard-dissolving formulation FDC was compared with a slow-dissolving side batch.An open-label, randomized, crossover study design ... Read more >>

Int J Clin Pharmacol Ther (International journal of clinical pharmacology and therapeutics)
[2017, 55(4):355-367]

Cited: 4 times

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Acute Pharmacodynamic Effects of Empagliflozin With and Without Diuretic Agents in Patients With Type 2 Diabetes Mellitus.

Tim Heise, Jens Jordan, Christoph Wanner, Martina Heer, Sreeraj Macha, Michaela Mattheus, Søren S Lund, Hans J Woerle, Uli C Broedl,

PURPOSE:The goal of this study was to investigate the pharmacodynamic effects of co-administration of empagliflozin, a sodium glucose cotransporter 2 inhibitor, with diuretic agents. METHODS:In a randomized, open-label cross-over study, 22 patients with type 2 diabetes mellitus received empagliflozin 25 mg for 5 days and either hydrochlorothiazide 25 mg for ... Read more >>

Clin Ther (Clinical therapeutics)
[2016, 38(10):2248-2264.e5]

Cited: 16 times

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Empagliflozin and Cardiovascular Outcomes in Asian Patients With Type 2 Diabetes and Established Cardiovascular Disease - Results From EMPA-REG OUTCOME®.

Kohei Kaku, Jisoo Lee, Michaela Mattheus, Stefan Kaspers, Jyothis George, Hans-Juergen Woerle, ,

In the EMPA-REG OUTCOME®trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular (CV) events (3-point MACE: composite of CV death, non-fatal myocardial infarction, or non-fatal stroke) by 14%, CV death by 38%, hospitalization for heart failure by 35%, and all-cause mortality by 32% in ... Read more >>

Circ. J. (Circulation journal : official journal of the Japanese Circulation Society)
[2017, 81(2):227-234]

Cited: 32 times

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Pharmacodynamic Effects of Single and Multiple Doses of Empagliflozin in Patients With Type 2 Diabetes.

Tim Heise, Jens Jordan, Christoph Wanner, Martina Heer, Sreeraj Macha, Michaela Mattheus, Søren S Lund, Hans J Woerle, Uli C Broedl,

PURPOSE:Our aim was to investigate the effects of the sodium glucose cotransporter 2 inhibitor empagliflozin on urinary and serum glucose and electrolytes, urinary volume, osmolality, and the renin-angiotensin system in patients with type 2 diabetes. METHODS:In an open-label study, 22 patients receiving metformin (median age 56 years; range 40-65 years) ... Read more >>

Clin Ther (Clinical therapeutics)
[2016, 38(10):2265-2276]

Cited: 31 times

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Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.

Christoph Wanner, Silvio E Inzucchi, John M Lachin, David Fitchett, Maximilian von Eynatten, Michaela Mattheus, Odd Erik Johansen, Hans J Woerle, Uli C Broedl, Bernard Zinman, ,

Diabetes confers an increased risk of adverse cardiovascular and renal events. In the EMPA-REG OUTCOME trial, empagliflozin, a sodium-glucose cotransporter 2 inhibitor, reduced the risk of major adverse cardiovascular events in patients with type 2 diabetes at high risk for cardiovascular events. We wanted to determine the long-term renal effects ... Read more >>

N. Engl. J. Med. (The New England journal of medicine)
[2016, 375(4):323-334]

Cited: 782 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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Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®).

Nikolaus Marx, Julio Rosenstock, Steven E Kahn, Bernard Zinman, John J Kastelein, John M Lachin, Mark A Espeland, Erich Bluhmki, Michaela Mattheus, Bart Ryckaert, Sanjay Patel, Odd Erik Johansen, Hans-Juergen Woerle,

CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (NCT01243424) is an ongoing, randomized trial in subjects with early type 2 diabetes and increased cardiovascular risk or established complications that will determine the long-term cardiovascular impact of linagliptin versus the sulphonylurea glimepiride. Eligible patients were sulphonylurea-naïve with HbA1c ... Read more >>

Diab Vasc Dis Res (Diabetes & vascular disease research)
[2015, 12(3):164-174]

Cited: 99 times

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