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Author Stefan Kaspers

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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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Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial

Antonio Ceriello, Anne Pernille Ofstad, Isabella Zwiener, Stefan Kaspers, Jyothis George, Antonio Nicolucci,

Abstract Background: Glucose variability has been associated with cardiovascular outcomes in type 2 diabetes, however, the interplay between glucose variability, empagliflozin and cardiovascular death has not been explored. In the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of cardiovascular death by 38%. We explore post-hoc the association between HbA1c variability ... Read more >>

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Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial.

Antonio Ceriello, Anne Pernille Ofstad, Isabella Zwiener, Stefan Kaspers, Jyothis George, Antonio Nicolucci,

BACKGROUND:Glucose variability has been associated with cardiovascular outcomes in type 2 diabetes, however, the interplay between glucose variability, empagliflozin and cardiovascular death has not been explored. In the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of cardiovascular death by 38%. We explore post-hoc the association between HbA1c variability and cardiovascular ... Read more >>

Cardiovasc Diabetol (Cardiovascular diabetology)
[2020, 19(1):176]

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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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Cost-effectiveness of empagliflozin in the UK in an EMPA-REG OUTCOME subgroup with type 2 diabetes and heart failure.

Odette S Reifsnider, Anuraag R Kansal, Jennifer Franke, Joseph Lee, Jyothis T George, Martina Brueckmann, Stefan Kaspers, Sarah B Brand, Anastasia Ustyugova, Stephan Linden, Matthew Stargardter, Nikco Hau,

AIMS:Heart failure (HF) and type 2 diabetes (T2D), common co-morbidities, translate into worse patient prognoses and higher direct costs than for either condition alone. Empagliflozin has been shown to markedly reduce cardiovascular (CV) deaths and HF hospitalizations (HHF) in HF patients with T2D. This study evaluated the lifetime cost-effectiveness of ... Read more >>

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

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

Ona Kinduryte Schorling, Douglas Clark, Isabella Zwiener, Stefan Kaspers, Jisoo Lee, Hristo Iliev,

INTRODUCTION:The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials. METHODS:Pooled data from 20 trials were analyzed for patients with T2DM treated with empagliflozin 10 mg (n = 4858), empagliflozin ... Read more >>

Adv Ther (Advances in therapy)
[2020, 37(8):3463-3484]

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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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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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Cost-effectiveness Analysis of Empagliflozin in Japan Based on Results From the Asian subpopulation in the EMPA-REG OUTCOME Trial.

Kohei Kaku, Masakazu Haneda, Hiroyuki Sakamaki, Atsutaka Yasui, Tatsunori Murata, Anastasia Ustyugova, Rina Chin, Tetsuaki Hirase, Tsunehisa Shibahara, Naoyuki Hayashi, Anuraag Kansal, Stefan Kaspers, Tomoo Okamura,

PURPOSE:The goal of this study was to assess the cost-effectiveness of empagliflozin in Japan based on the Asian subpopulation in the EMPA-REG OUTCOME trial. METHODS:The trial has shown a reduction in the risk for cardiovascular (CV) and renal events with empagliflozin in patients with type 2 diabetes mellitus and established ... Read more >>

Clin Ther (Clinical therapeutics)
[2019, 41(10):2021-2040.e11]

Cited: 2 times

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Effect of Empagliflozin on Free Fatty Acids and Ketone Bodies in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial.

Rimei Nishimura, Yuko Tanaka, Kazuki Koiwai, Kosuke Ishida, Afshin Salsali, Stefan Kaspers, Sven Kohler, Søren S Lund,

INTRODUCTION:We report a randomized, double-blind, placebo-controlled, 4-week study to investigate the effect of empagliflozin on free fatty acids and blood ketone bodies in Japanese patients with type 2 diabetes mellitus. METHODS:Patients (baseline mean [standard deviation] glycated hemoglobin 7.91% [0.80%]; body mass index 24.3 [3.2] kg/m2) were randomized to empagliflozin 10 mg ... Read more >>

Adv Ther (Advances in therapy)
[2019, 36(10):2769-2782]

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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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Retinopathy Outcomes With Empagliflozin Versus Placebo in the EMPA-REG OUTCOME Trial.

Silvio E Inzucchi, Christoph Wanner, Uwe Hehnke, Isabella Zwiener, Stefan Kaspers, Douglas Clark, Jyothis T George, Bernard Zinman,

Diabetes Care (Diabetes care)
[2019, 42(4):e53-e55]

Cited: 3 times

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Development and validation of algorithms to identify newly diagnosed type 1 and type 2 diabetes in pediatric population using electronic medical records and claims data.

Dana Y Teltsch, Soulmaz Fazeli Farsani, Richard S Swain, Stefan Kaspers, Samuel Huse, Christina Cristaldi, Beth L Nordstrom, Kimberly G Brodovicz,

PURPOSE:To develop and validate algorithms to classify diabetes type in newly diagnosed pediatric patients with DM. METHOD:Data from the United States Department of Defense health system were used to identify patients aged 10 to 18 years with incident DM. Two independent sets of 200 children were randomly sampled for algorithm ... Read more >>

Pharmacoepidemiol Drug Saf (Pharmacoepidemiology and drug safety)
[2019, 28(2):234-243]

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Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials.

Julio Rosenstock, Jan Marquard, Lori M Laffel, Dietmar Neubacher, Stefan Kaspers, David Z Cherney, Bernard Zinman, Jay S Skyler, Jyothis George, Nima Soleymanlou, Bruce A Perkins,

OBJECTIVE:To evaluate the safety and efficacy of empagliflozin 10- and 25-mg doses plus a unique lower dose (2.5 mg) as adjunct to intensified insulin in patients with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS:The EASE (Empagliflozin as Adjunctive to inSulin thErapy) program (N = 1,707) included two double-blind, placebo-controlled ... Read more >>

Diabetes Care (Diabetes care)
[2018, 41(12):2560-2569]

Cited: 31 times

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Safety and tolerability of empagliflozin in East Asian patients with type 2 diabetes: Pooled analysis of phase I-III clinical trials.

Daisuke Yabe, Atsutaka Yasui, Linong Ji, Moon-Kyu Lee, Ronald Ching Wan Ma, Tien-Jyun Chang, Tomoo Okamura, Cordula Zeller, Stefan Kaspers, Jisoo Lee, Sven Kohler, Yutaka Seino,

AIMS/INTRODUCTION:We investigated the safety and tolerability of empagliflozin (EMPA) in East Asian patients with type 2 diabetes. MATERIALS AND METHODS:Data were pooled from participants with type 2 diabetes evenly randomized to a placebo, EMPA 10 mg or EMPA 25 mg in 15 phase I-III trials. Adverse events (AEs) were analyzed ... Read more >>

J Diabetes Investig (Journal of diabetes investigation)
[2019, 10(2):418-428]

Cited: 5 times

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Improvement in Cardiovascular Outcomes With Empagliflozin Is Independent of Glycemic Control.

Silvio E Inzucchi, Mikhail Kosiborod, David Fitchett, Christoph Wanner, Uwe Hehnke, Stefan Kaspers, Jyothis T George, Bernard Zinman,

Circulation (Circulation)
[2018, 138(17):1904-1907]

Cited: 15 times

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Analysis of Fractures in Patients With Type 2 Diabetes Treated With Empagliflozin in Pooled Data From Placebo-Controlled Trials and a Head-to-Head Study Versus Glimepiride.

Sven Kohler, Stefan Kaspers, Afshin Salsali, Cordula Zeller, Hans J Woerle,

OBJECTIVE:To assess the effect of empagliflozin on bone fractures and bone mineral density in patients with type 2 diabetes in pooled placebo-controlled trial data and a head-to-head study versus glimepiride. RESEARCH DESIGN AND METHODS:Pooled data were analyzed from patients who were randomized 1:1:1 to empagliflozin 10 mg, empagliflozin 25 mg, ... Read more >>

Diabetes Care (Diabetes care)
[2018, 41(8):1809-1816]

Cited: 12 times

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Empagliflozin Induces Transient Diuresis Without Changing Long-Term Overall Fluid Balance in Japanese Patients With Type 2 Diabetes.

Atsutaka Yasui, Ganghyuck Lee, Tetsuaki Hirase, Tatsuroh Kaneko, Stefan Kaspers, Maximilian von Eynatten, Tomoo Okamura,

INTRODUCTION:Empagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, ameliorates hyperglycemia in patients with type 2 diabetes (T2D) by inducing sustained glucosuria. Empagliflozin treatment was previously associated with a transient increase in 24-h urine volume in Caucasian patients with T2D, however comparable evidence in Japanese T2D individuals is scarce. We therefore ... Read more >>

Diabetes Ther (Diabetes therapy : research, treatment and education of diabetes and related disorders)
[2018, 9(2):863-871]

Cited: 7 times

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Population Pharmacokinetic- Pharmacodynamic Analysis to Characterize the Effect of Empagliflozin on Renal Glucose Threshold in Patients With Type 1 Diabetes Mellitus.

John Mondick, Matthew Riggs, Stefan Kaspers, Nima Soleymanlou, Jan Marquard, Valerie Nock,

Sodium glucose cotransporter 2 inhibitors increase urinary glucose excretion (UGE) by lowering the renal threshold for glucose (RTG ). We aimed to quantify the effect of the sodium glucose cotransporter inhibitor empagliflozin on renal glucose reabsorption in patients with type 1 diabetes mellitus (T1DM) using a mechanistic population pharmacokinetic-pharmacodynamic (PK-PD) ... Read more >>

J Clin Pharmacol (Journal of clinical pharmacology)
[2018, 58(5):640-649]

Cited: 3 times

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Randomized, double-blind, placebo-controlled dose-finding study of the dipeptidyl peptidase-4 inhibitor linagliptin in pediatric patients with type 2 diabetes.

William V Tamborlane, Lori Mb Laffel, Jacques Weill, Maud Gordat, Dietmar Neubacher, Silke Retlich, Willem Hettema, Cornelia E Hoesl, Stefan Kaspers, Jan Marquard,

OBJECTIVE:To identify the dose of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin in pediatric patients with type 2 diabetes (T2D). METHODS:Double-blind, randomized, controlled parallel group study comparing linagliptin 1 and 5 mg once daily, with placebo in 39 patients with T2D aged 10 to below 18 years. The primary efficacy endpoint was ... Read more >>

Pediatr Diabetes (Pediatric diabetes)
[2018, 19(4):640-648]

Cited: 0 times

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Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes: Pooled Analysis of Phase I-III Clinical Trials.

Sven Kohler, Cordula Zeller, Hristo Iliev, Stefan Kaspers,

INTRODUCTION:We characterized the safety and tolerability of empagliflozin in patients with type 2 diabetes (T2DM) randomized 1:1:1 to placebo, empagliflozin 10 mg, or empagliflozin 25 mg in clinical trials. METHODS:Pooled data were analyzed from patients with T2DM treated with placebo (N = 4203), empagliflozin 10 mg (N = 4221), or empagliflozin 25 mg (N = 4196) in 15 randomized phase ... Read more >>

Adv Ther (Advances in therapy)
[2017, 34(7):1707-1726]

Cited: 50 times

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Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors and Stroke - Reply.

Kohei Kaku, Jisoo Lee, Stefan Kaspers, Hans J Woerle, Jyothis T George,

Circ J (Circulation journal : official journal of the Japanese Circulation Society)
[2017, 81(6):899]

Cited: 1 time

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Glucose Exposure and Variability with Empagliflozin as Adjunct to Insulin in Patients with Type 1 Diabetes: Continuous Glucose Monitoring Data from a 4-Week, Randomized, Placebo-Controlled Trial (EASE-1).

Susanne Famulla, Thomas R Pieber, Jens Eilbracht, Dietmar Neubacher, Nima Soleymanlou, Hans J Woerle, Uli C Broedl, Stefan Kaspers,

We evaluated the effect of empagliflozin as adjunct to insulin on 24-h glucose exposure and variability in patients with type 1 diabetes.Patients (N = 75) with HbA1c ≥7.5% to ≤10.5% were randomized to receive empagliflozin 2.5 mg, empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily as adjunct to insulin for 4 weeks. Insulin ... Read more >>

Diabetes Technol. Ther. (Diabetes technology & therapeutics)
[2017, 19(1):49-60]

Cited: 12 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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The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes.

David Cherney, Søren S Lund, Bruce A Perkins, Per-Henrik Groop, Mark E Cooper, Stefan Kaspers, Egon Pfarr, Hans J Woerle, Maximilian von Eynatten,

Sodium glucose cotransporter 2 (SGLT2) inhibition lowers HbA1c, systolic BP (SBP) and weight in patients with type 2 diabetes and reduces renal hyperfiltration associated with type 1 diabetes, suggesting decreased intraglomerular hypertension. As lowering HbA1c, SBP, weight and intraglomerular pressure is associated with anti-albuminuric effects in diabetes, we hypothesised that ... Read more >>

Diabetologia (Diabetologia)
[2016, 59(9):1860-1870]

Cited: 60 times

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