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Author Jyothis T George

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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 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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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]

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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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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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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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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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Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial.

Vlado Perkovic, Robert Toto, Mark E Cooper, Johannes F E Mann, Julio Rosenstock, Darren K McGuire, Steven E Kahn, Nikolaus Marx, John H Alexander, Bernard Zinman, Egon Pfarr, Sven Schnaidt, Thomas Meinicke, Maximillian von Eynatten, Jyothis T George, Odd Erik Johansen, Christoph Wanner, ,

OBJECTIVE:Type 2 diabetes is a leading cause of kidney failure, but few outcome trials proactively enrolled individuals with chronic kidney disease (CKD). We performed secondary analyses of cardiovascular (CV) and kidney outcomes across baseline estimated glomerular filtration rate (eGFR) categories (≥60, 45 to <60, 30 to <45, and <30 mL/min/1.73 ... Read more >>

Diabetes Care (Diabetes care)
[2020, 43(8):1803-1812]

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Kisspeptin and neurokinin B interactions in modulating gonadotropin secretion in women with polycystic ovary syndrome.

Karolina Skorupskaite, Jyothis T George, Johannes D Veldhuis, Robert P Millar, Richard A Anderson,

STUDY QUESTION:What is the role of the hypothalamic neuropeptide neurokinin B (NKB) and its interaction with kisspeptin on GnRH/LH secretion in women with polycystic ovary syndrome (PCOS)? SUMMARY ANSWER:Administration of neurokinin 3 receptor antagonist (NK3Ra) for 7 days reduced LH and FSH secretion and LH pulse frequency in women with ... Read more >>

Hum Reprod (Human reproduction (Oxford, England))
[2020, 35(6):1421-1431]

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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 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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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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Low-dose empagliflozin as adjunct-to-insulin therapy in type 1 diabetes: A valid modelling and simulation analysis to confirm efficacy.

Bruce A Perkins, Nima Soleymanlou, Julio Rosenstock, Jay S Skyler, Lori M Laffel, Karl-Heinz Liesenfeld, Dietmar Neubacher, Matthew M Riggs, Curtis K Johnston, Rena J Eudy-Byrne, Ahmed Elmokadem, Jyothis T George, Jan Marquard, Valerie Nock,

AIM:To confirm the observed reduction in HbA1c for the 2.5 mg dose in EASE-3 by modelling and simulation analyses. MATERIALS AND METHODS:Independent of data from EASE-3 that tested 2.5 mg, we simulated the effect of a 2.5 mg dose through patient-level, exposure-response modelling in the EASE-2 clinical study. A primary semi-mechanistic model evaluated ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, 22(3):427-433]

Cited: 1 time

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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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Linagliptin and cardiorenal outcomes in Asians with type 2 diabetes mellitus and established cardiovascular and/or kidney disease: subgroup analysis of the randomized CARMELINA® trial.

Nobuya Inagaki, Wenying Yang, Hirotaka Watada, Linong Ji, Sven Schnaidt, Egon Pfarr, Tomoo Okamura, Odd Erik Johansen, Jyothis T George, Maximilian von Eynatten, Julio Rosenstock, Vlado Perkovic, Christoph Wanner, Mark E Cooper, John H Alexander, Issei Komuro, Masaomi Nangaku,

Objective:Linagliptin, a dipeptidyl peptidase-4 inhibitor, demonstrated cardiovascular and renal safety in type 2 diabetes mellitus (T2DM) patients with established cardiovascular disease (CVD) with albuminuria and/or kidney disease in the multinational CARMELINA® trial. We investigated the effects of linagliptin in Asian patients in CARMELINA®. Methods:T2DM patients with HbA1c 6.5-10.0% and established ... Read more >>

Diabetol Int (Diabetology international)
[2020, 11(2):129-141]

Cited: 1 time

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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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Addressing cardiovascular risk in type 2 diabetes mellitus: a report from the European Society of Cardiology Cardiovascular Roundtable.

Francesco Cosentino, Antonio Ceriello, Florian M M Baeres, Paola Fioretto, Alan Garber, Wendy Gattis Stough, Jyothis T George, Peter J Grant, Kamlesh Khunti, Anna Maria Langkilde, Jorge Plutzky, Lars Rydén, André Scheen, Eberhard Standl, Jaakko Tuomilehto, Faiez Zannad,

Eur Heart J (European heart journal)
[2019, 40(34):2907-2919]

Cited: 3 times

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Effect of Linagliptin on Cognitive Performance in Patients With Type 2 Diabetes and Cardiorenal Comorbidities: The CARMELINA Randomized Trial.

Geert Jan Biessels, Chloë Verhagen, Jolien Janssen, Esther van den Berg, Bernard Zinman, Julio Rosenstock, Jyothis T George, Anna Passera, Sven Schnaidt, Odd Erik Johansen, ,

OBJECTIVE:Type 2 diabetes is associated with cognitive dysfunction and an increased dementia risk, particularly in individuals with concomitant cardiovascular and/or kidney disease. Incretin therapies may modulate this risk via glycemic and nonglycemic pathways. We explored if the dipeptidyl peptidase 4 inhibitor linagliptin could prevent cognitive decline in people with type ... Read more >>

Diabetes Care (Diabetes care)
[2019, 42(10):1930-1938]

Cited: 5 times

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Exploring Patient Preferences for Adjunct-to-Insulin Therapy in Type 1 Diabetes.

Bruce A Perkins, Julio Rosenstock, Jay S Skyler, Lori M Laffel, David Z Cherney, Chantal Mathieu, Chantal Mathieu, Christianne Pang, Richard Wood, Ona Kinduryte, Jyothis T George, Jan Marquard, Nima Soleymanlou,

OBJECTIVE:While sodium-glucose cotransporter inhibitor (SGLTi) therapy has been evaluated in type 1 diabetes (T1D) trials, patient reactions to benefits and risks are unknown. Using established methodology, we evaluated patient preferences for different adjunct-to-insulin therapy options in T1D. RESEARCH DESIGN AND METHODS:An online survey, completed by 701 respondents with T1D (231 ... Read more >>

Diabetes Care (Diabetes care)
[2019, 42(9):1716-1723]

Cited: 0 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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