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2. Dapagliflozin and Days of Full Health Lost in the DAPA-HF Trial

Author

Kondo, Toru, Mogensen, Ulrik M., Talebi, Atefeh, Gasparyan, Samvel B., Campbell, Ross T., Docherty, Kieran F., de Boer, Rudolf A., Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Martinez, Felipe A., Sabatine, Marc S., Bengtsson, Olof, Sjöstrand, Mikaela, Vaduganathan, Muthiah, Solomon, Scott D., Jhund, Pardeep S., and McMurray, John J.V.

Published
2024
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3. Heart Failure, Investigator-Reported Sleep Apnea and Dapagliflozin: A Patient-Level Pooled Meta-Analysis of DAPA-HF and DELIVER

Author

BUTT, JAWAD H., JERING, KAROLA, DE BOER, RUDOLF A., CLAGGETT, BRIAN L., DESAI, AKSHAY S., HERNANDEZ, ADRIAN F., INZUCCHI, SILVIO E., JHUND, PARDEEP S., KØBER, LARS, KOSIBOROD, MIKHAIL N., LAM, CAROLYN S.P., MARTINEZ, FELIPE A., PONIKOWSKI, PIOTR, SABATINE, MARC S., SHAH, SANJIV J., VADUGANATHAN, MUTHIAH, LANGKILDE, ANNA MARIA, BENGTSSON, OLOF, PETERSSON, MAGNUS, SJÖSTRAND, MIKAELA, WILDERÄNG, ULRICA, SOLOMON, SCOTT D., and MCMURRAY, JOHN J.V.

Published
2024
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4. Adjusted Win Ratio with Stratification: Calculation Methods and Interpretation

Author

Gasparyan, Samvel B., Folkvaljon, Folke, Bengtsson, Olof, Buenconsejo, Joan, and Koch, Gary G.

Subjects
Statistics - Methodology, Statistics - Applications, 62G10
Abstract

The win ratio is a general method of comparing locations of distributions of two independent, ordinal random variables, and it can be estimated without distributional assumptions. In this paper we provide a unified theory of win ratio estimation in the presence of stratification and adjustment by a numeric variable. Building step by step on the estimate of the crude win ratio we compare corresponding tests with well known nonparametric tests of group difference (Wilcoxon rank-sum test, Fligner-Plicello test, Cochran-Mantel-Haenszel test, test based on the regression on ranks and the rank ANCOVA test). We show that the win ratio gives an interpretable treatment effect measure with corresponding test to detect treatment effect difference under minimal assumptions.

Published
2019
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6. Dapagliflozin across the range of ejection fraction in patients with heart failure: a patient-level, pooled meta-analysis of DAPA-HF and DELIVER

Author

Jhund, Pardeep S., Kondo, Toru, Butt, Jawad H., Docherty, Kieran F., Claggett, Brian L., Desai, Akshay S., Vaduganathan, Muthiah, Gasparyan, Samvel B., Bengtsson, Olof, Lindholm, Daniel, Petersson, Magnus, Langkilde, Anna Maria, de Boer, Rudolf A., DeMets, David, Hernandez, Adrian F., Inzucchi, Silvio E., Kosiborod, Mikhail N., Køber, Lars, Lam, Carolyn S. P., Martinez, Felipe A., Sabatine, Marc S., Shah, Sanjiv J., Solomon, Scott D., and McMurray, John J. V.

Published
2022
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8. Efficacy and safety of dapagliflozin in patients with heart failure with mildly reduced or preserved ejection fraction by baseline glycaemic status (DELIVER): a subgroup analysis from an international, multicentre, double-blind, randomised, placebo-controlled trial

Author

Inzucchi, Silvio E, Claggett, Brian L, Vaduganathan, Muthiah, Desai, Akshay S, Jhund, Pardeep S, de Boer, Rudolf A, Hernandez, Adrian F, Kosiborod, Mikhail N, Lam, Carolyn S P, Martinez, Felipe, Shah, Sanjiv J, Verma, Subodh, Han, Yaling, Kerr Saraiva, Jose F, Bengtsson, Olof, Petersson, Magnus, Langkilde, Anna Maria, McMurray, John J V, and Solomon, Scott D

Published
2022
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9. Effects of Dapagliflozin According to the Heart Failure Collaboratory Medical Therapy Score: Insights From DAPA-HF

Author

Butt, Jawad H., Dewan, Pooja, DeFilippis, Ersilia M., Biering-Sørensen, Tor, Docherty, Kieran F., Jhund, Pardeep S., Kosiborod, Mikhail N., Martinez, Felipe A., Bengtsson, Olof, Johansen, Niklas Dyrby, Langkilde, Anna Maria, Sjöstrand, Mikaela, Vaduganathan, Muthiah, Solomon, Scott D., Sabatine, Marc S., Køber, Lars, Fiuzat, Mona, and McMurray, John J.V.

Published
2022
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10. Endothelin-1, Outcomes in Patients With Heart Failure and Reduced Ejection Fraction, and Effects of Dapagliflozin: Findings From DAPA-HF

Author

Yeoh, Su Ern, Docherty, Kieran F., Campbell, Ross T., Jhund, Pardeep S., Hammarstedt, Ann, Heerspink, Hiddo J.L., Jarolim, Petr, Køber, Lars, Kosiborod, Mikhail N., Martinez, Felipe A., Ponikowski, Piotr, Solomon, Scott D., Sjöstrand, Mikaela, Bengtsson, Olof, Greasley, Peter J., Sattar, Naveed, Welsh, Paul, Sabatine, Marc S., Morrow, David A., and McMurray, John J.V.

Published
2023
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12. Effects of Dapagliflozin in Asian Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF

Author

Docherty, Kieran F., Anand, Inder S., Chiang, Chern-En, Chopra, Vijay K., Desai, Akshay S., Kitakaze, Masafumi, Verma, Subodh, Vinh, Pham N., Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Martinez, Felipe A., Bengtsson, Olof, Ponikowski, Piotr, Sabatine, Marc S., Sjöstrand, Mikaela, Solomon, Scott D., Langkilde, Anna Maria, Jhund, Pardeep S., and McMurray, John J.V.

Published
2022
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14. Dapagliflozin and new-onset type 2 diabetes in patients with chronic kidney disease or heart failure: pooled analysis of the DAPA-CKD and DAPA-HF trials

Author

Rossing, Peter, Inzucchi, Silvio E, Vart, Priya, Jongs, Niels, Docherty, Kieran F, Jhund, Pardeep S, Køber, Lars, Kosiborod, Mikhail N, Martinez, Felipe A, Ponikowski, Piotr, Sabatine, Marc S, Solomon, Scott D, DeMets, David L, Bengtsson, Olof, Lindberg, Magnus, Langkilde, Anna Maria, Sjöstrand, Mikaela, Stefansson, Bergur V, Karlsson, Cecilia, Chertow, Glenn M, Hou, Fan Fan, Correa-Rotter, Ricardo, Toto, Robert D, Wheeler, David C, McMurray, John J V, and Heerspink, Hiddo J L

Published
2022
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15. Efficacy of Dapagliflozin in Black Versus White Patients With Heart Failure and Reduced Ejection Fraction

Author

Docherty, Kieran F., Ogunniyi, Modele O., Anand, Inder S., Desai, Akshay S., Diez, Mirta, Howlett, Jonathan G., Nicolau, Jose C., O’Meara, Eileen, Verma, Subodh, Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Lindholm, Daniel, Martinez, Felipe A., Bengtsson, Olof, Ponikowski, Piotr, Sabatine, Marc S., Sjöstrand, Mikaela, Solomon, Scott D., Langkilde, Anna Maria, Jhund, Pardeep S., and McMurray, John J.V.

Published
2022
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18. Dapagliflozin in HFrEF Patients Treated With Mineralocorticoid Receptor Antagonists: An Analysis of DAPA-HF

Author

Shen, Li, Kristensen, Søren Lund, Bengtsson, Olof, Böhm, Michael, de Boer, Rudolf A., Docherty, Kieran F., Inzucchi, Silvio E., Katova, Tzvetana, Køber, Lars, Kosiborod, Mikhail N., Langkilde, Anna Maria, Lindholm, Daniel, Martinez, M. Felipe A., O’Meara, Eileen, Nicolau, Jose C., Petrie, Mark C., Ponikowski, Piotr, Sabatine, Marc S., Schou, Morten, Sjöstrand, Mikaela, Solomon, Scott D., Jhund, Pardeep S., and McMurray, John J.V.

Published
2021
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19. Initial Decline (Dip) in Estimated Glomerular Filtration Rate After Initiation of Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction: Insights From DAPA-HF

Author

Adamson, Carly, Docherty, Kieran F., Heerspink, Hiddo J.L., de Boer, Rudolf A., Damman, Kevin, Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Martinez, Felipe A., Petrie, Mark C., Ponikowski, Piotr, Sabatine, Marc S., Schou, Morten, Solomon, Scott D., Verma, Subodh, Bengtsson, Olof, Langkilde, Anna Maria, Sjöstrand, Mikaela, Vaduganathan, Muthiah, Jhund, Pardeep S., and McMurray, John J.V.

Published
2022
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21. Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to N-Terminal Pro-B-Type Natriuretic Peptide: Insights From the DAPA-HF Trial

Author

Butt, Jawad H., Adamson, Carly, Docherty, Kieran F., de Boer, Rudolf A., Petrie, Mark C., Inzucchi, Silvio E., Kosiborod, Mikhail N., Maria Langkilde, Anna, Lindholm, Daniel, Martinez, Felipe A., Bengtsson, Olof, Schou, Morten, O’Meara, Eileen, Ponikowski, Piotr, Sabatine, Marc S., Sjöstrand, Mikaela, Solomon, Scott D., Jhund, Pardeep S., McMurray, John J.V., and Køber, Lars

Published
2021
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22. Use of Win Statistics to Analyze Outcomes in the DAPA-HF and DELIVER Trials

Author

Kondo, Toru, primary, Gasparyan, Samvel B., additional, Jhund, Pardeep S., additional, Bengtsson, Olof, additional, Claggett, Brian L., additional, de Boer, Rudolf A., additional, Hernandez, Adrian F., additional, Inzucchi, Silvio E., additional, Kosiborod, Mikhail N., additional, Køber, Lars, additional, Lam, Carolyn S.P., additional, Langkilde, Anna Maria, additional, Martinez, Felipe A., additional, Petersson, Magnus, additional, Ponikowski, Piotr, additional, Sabatine, Marc S., additional, Shah, Sanjiv J., additional, Sjostrand, Mikaela, additional, Wilderang, Ulrica, additional, Vaduganathan, Muthiah, additional, Solomon, Scott D., additional, and McMurray, John J.V., additional

Published
2023
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24. Association of Dapagliflozin vs Placebo With Individual Kansas City Cardiomyopathy Questionnaire Components in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction

Author

Peikert, Alexander, primary, Chandra, Alvin, additional, Kosiborod, Mikhail N., additional, Claggett, Brian L., additional, Desai, Akshay S., additional, Jhund, Pardeep S., additional, Lam, Carolyn S. P., additional, Inzucchi, Silvio E., additional, Martinez, Felipe A., additional, de Boer, Rudolf A., additional, Hernandez, Adrian F., additional, Shah, Sanjiv J., additional, Janssens, Stefan P., additional, Bělohlávek, Jan, additional, Borleffs, C. Jan Willem, additional, Dobreanu, Dan, additional, Langkilde, Anna Maria, additional, Bengtsson, Olof, additional, Petersson, Magnus, additional, McMurray, John J. V., additional, Solomon, Scott D., additional, and Vaduganathan, Muthiah, additional

Published
2023
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25. Efficacy of Dapagliflozin on Renal Function and Outcomes in Patients With Heart Failure With Reduced Ejection Fraction: Results of DAPA-HF

Author

Jhund, Pardeep S., Solomon, Scott D., Docherty, Kieran F., Heerspink, Hiddo J.L., Anand, Inder S., Böhm, Michael, Chopra, Vijay, de Boer, Rudolf A., Desai, Akshay S., Ge, Junbo, Kitakaze, Masafumi, Merkley, Bela, OʼMeara, Eileen, Shou, Morten, Tereshchenko, Sergey, Verma, Subodh, Vinh, Pham Nguyen, Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Martinez, Felipe A., Ponikowski, Piotr, Sabatine, Marc S., Bengtsson, Olof, Langkilde, Anna Maria, Sjöstrand, Mikaela, and McMurray, John J.V.

Published
2021
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27. Heart failure, peripheral artery disease, and dapagliflozin: a patient-level meta-analysis of DAPA-HF and DELIVER

Author

Butt, Jawad H, primary, Kondo, Toru, additional, Yang, Mingming, additional, Jhund, Pardeep S, additional, Docherty, Kieran F, additional, Vaduganathan, Muthiah, additional, Claggett, Brian L, additional, Hernandez, Adrian F, additional, Lam, Carolyn S P, additional, Inzucchi, Silvio E, additional, Martinez, Felipe A, additional, de Boer, Rudolf A, additional, Kosiborod, Mikhail N, additional, Desai, Akshay S, additional, Køber, Lars, additional, Ponikowski, Piotr, additional, Sabatine, Marc S, additional, Shah, Sanjiv J, additional, Zaozerska, Natalia, additional, Wilderäng, Ulrica, additional, Bengtsson, Olof, additional, Solomon, Scott D, additional, and McMurray, John J V, additional

Published
2023
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28. Effect of Dapagliflozin on Total Heart Failure Events in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction

Author

Jhund, Pardeep S., primary, Claggett, Brian L., additional, Talebi, Atefeh, additional, Butt, Jawad H., additional, Gasparyan, Samvel B., additional, Wei, Lee-Jen, additional, McCaw, Zachary R., additional, Wilderäng, Ulrica, additional, Bengtsson, Olof, additional, Desai, Akshay S., additional, Petersson, Magnus, additional, Langkilde, Anna Maria, additional, de Boer, Rudolf A., additional, Hernandez, Adrian F., additional, Inzucchi, Silvio E., additional, Kosiborod, Mikhail N., additional, Lam, Carolyn S. P., additional, Martinez, Felipe A., additional, Shah, Sanjiv J., additional, Vaduganathan, Muthiah, additional, Solomon, Scott D., additional, and McMurray, John J. V., additional

Published
2023
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29. Endothelin-1, Outcomes in Patients With Heart Failure and Reduced Ejection Fraction, and Effects of Dapagliflozin: Findings From DAPA-HF

Author

Ern Yeoh, Su, primary, Docherty, Kieran F., additional, Campbell, Ross T., additional, Jhund, Pardeep S., additional, Hammarstedt, Ann, additional, Heerspink, Hiddo J.L., additional, Jarolim, Petr, additional, Køber, Lars, additional, Kosiborod, Mikhail N., additional, Martinez, Felipe A., additional, Ponikowski, Piotr, additional, Solomon, Scott D., additional, Sjöstrand, Mikaela, additional, Bengtsson, Olof, additional, Greasley, Peter J., additional, Sattar, Naveed, additional, Welsh, Paul, additional, Sabatine, Marc S., additional, Morrow, David A., additional, and McMurray, John J.V., additional

Published
2023
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34. Effect of Dapagliflozin on Outpatient Worsening of Patients With Heart Failure and Reduced Ejection Fraction: A Prespecified Analysis of DAPA-HF

Author

Docherty, Kieran F., Jhund, Pardeep S., Anand, Inder, Bengtsson, Olof, Böhm, Michael, de Boer, Rudolf A., DeMets, David L., Desai, Akshay S., Drozdz, Jaroslaw, Howlett, Jonathan, Inzucchi, Silvio E., Johanson, Per, Katova, Tzvetana, Køber, Lars, Kosiborod, Mikhail N., Langkilde, Anna Maria, Lindholm, Daniel, Martinez, Felipe A., Merkely, Béla, Nicolau, Jose C., O’Meara, Eileen, Ponikowski, Piotr, Sabatine, Marc S., Sjöstrand, Mikaela, Solomon, Scott D., Tereshchenko, Sergey, Verma, Subodh, and McMurray, John J.V.

Published
2020
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35. A VNA-Based Wideband Measurement System for Large-Signal Characterization of Multiport Circuits

Author

Schulze, Christoph, Mengozzi, Mattia, Gibiino, Gian Piero, Angelotti, Alberto Maria, Florian, Corrado, Santarelli, Alberto, Heinrich, Wolfgang, and Bengtsson, Olof

Abstract

This work reports on a wideband (WB) measurement system based on a vector network analyzer (VNA) topology for multiport large-signal measurements. The setup exploits a modified commercial VNA with WB intermediate frequency (IF) outputs that allow for more than 5-GHz analysis bandwidth (BW), where the IF is captured using an external high-speed oscilloscope. A three-port configuration using six receivers is described, together with the signal processing to achieve the high dynamic range required for WB signal measurements. The calibration procedure to establish reference planes at the three ports of the device-under-test (DUT) is shown. A comparison is made between single-tone continuous-wave (CW) calibration and WB calibration using multitone signals, illustrating advantages, challenges, and limitations. The system is then demonstrated for on-wafer WB characterization and linearization of a dual input Doherty power amplifier (DIDPA) using a 100-MHz instantaneous BW excitation signal at millimeter-wave frequencies. By leveraging on the error-corrected WB waves, an algorithm is proposed for modulated input signal control across a 600-MHz acquisition BW at the DUT on-wafer reference planes. The algorithm enables a user-defined emulated splitting of the input WB signals. The linearization performance of such an emulated PA configuration is finally evaluated.

Published
2024
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36. Iron Deficiency in Heart Failure and Effect of Dapagliflozin

Author

Docherty, Kieran F., Welsh, Paul, Verma, Subodh, De Boer, Rudolf A., O'Meara, Eileen, Bengtsson, Olof, Køber, Lars, Kosiborod, Mikhail N., Hammarstedt, Ann, Langkilde, Anna Maria, Lindholm, Daniel, Little, Dustin J., Sjöstrand, Mikaela, Martinez, Felipe A., Ponikowski, Piotr, Sabatine, Marc S., Morrow, David A., Schou, Morten, Solomon, Scott D., Sattar, Naveed, Jhund, Pardeep S., McMurray, John J.V., and Cardiovascular Centre (CVC)

Subjects
ferritin, heart failure, Stroke Volume, Iron Deficiencies, sodium-glucose cotransporter 2 inhibitor, anemia, iron, Glucosides, Hepcidins, Physiology (medical), Ferritins, Receptors, Transferrin, Receptors, Erythropoietin, Humans, Transferrins, transferrin, hepcidin, Benzhydryl Compounds, Cardiology and Cardiovascular Medicine, Biomarkers, erythropoiesis
Abstract

Background: Iron deficiency is common in heart failure and associated with worse outcomes. We examined the prevalence and consequences of iron deficiency in the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure) and the effect of dapagliflozin on markers of iron metabolism. We also analyzed the effect of dapagliflozin on outcomes, according to iron status at baseline. Methods: Iron deficiency was defined as a ferritin level Results: Of the 4744 patients randomized in DAPA-HF, 3009 had ferritin and transferrin saturation measurements available at baseline, and 1314 of these participants (43.7%) were iron deficient. The rate of the primary outcome was higher in patients with iron deficiency (16.6 per 100 person-years) compared with those without (10.4 per 100 person-years; P P -interaction=0.59). Similar findings were observed for cardiovascular death, heart failure hospitalization, and all-cause mortality. Transferrin saturation, ferritin, and hepcidin were reduced and total iron-binding capacity and soluble transferrin receptor increased with dapagliflozin compared with placebo. Conclusions: Iron deficiency was common in DAPA-HF and associated with worse outcomes. Dapagliflozin appeared to increase iron use but improved outcomes, irrespective of iron status at baseline. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03036124.

Published
2022

37. Dapagliflozin and Diuretic Use in Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF

Author

Jackson, Alice M., Dewan, Pooja, Anand, Inder S., Bělohlávek, Jan, Bengtsson, Olof, de Boer, Rudolf A., Böhm, Michael, Boulton, David W., Chopra, Vijay K., DeMets, David L., Docherty, Kieran F., Dukát, Andrej, Greasley, Peter J., Howlett, Jonathan G., Inzucchi, Silvio E., Katova, Tzvetana, Køber, Lars, Kosiborod, Mikhail N., Langkilde, Anna Maria, Lindholm, Daniel, Ljungman, Charlotta E.A., Martinez, Felipe A., O’Meara, Eileen, Sabatine, Marc S., Sjöstrand, Mikaela, Solomon, Scott D., Tereshchenko, Sergey, Verma, Subodh, Jhund, Pardeep S., and McMurray, John J.V.

Published
2020
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38. Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to Age: Insights From DAPA-HF

Author

Martinez, Felipe A., Serenelli, Matteo, Nicolau, Jose C., Petrie, Mark C., Chiang, Chern-En, Tereshchenko, Sergey, Solomon, Scott D., Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Ponikowski, Piotr, Sabatine, Marc S., DeMets, David L., Dutkiewicz-Piasecka, Monika, Bengtsson, Olof, Sjöstrand, Mikaela, Langkilde, Anna Maria, Jhund, Pardeep S., and McMurray, John J.V.

Published
2020
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39. Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction: Results From the DAPA-HF Trial

Author

Kosiborod, Mikhail N., Jhund, Pardeep S., Docherty, Kieran F., Diez, Mirta, Petrie, Mark C., Verma, Subodh, Nicolau, Jose C., Merkely, Béla, Kitakaze, Masafumi, DeMets, David L., Inzucchi, Silvio E., Køber, Lars, Martinez, Felipe A., Ponikowski, Piotr, Sabatine, Marc S., Solomon, Scott D., Bengtsson, Olof, Lindholm, Daniel, Niklasson, Anna, Sjöstrand, Mikaela, Langkilde, Anna Maria, and McMurray, John J.V.

Published
2020
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40. Effect of Dapagliflozin on Health Status in Patients With Preserved or Mildly Reduced Ejection Fraction

Author

Kosiborod, Mikhail N., primary, Bhatt, Ankeet S., additional, Claggett, Brian L., additional, Vaduganathan, Muthiah, additional, Kulac, Ian J., additional, Lam, Carolyn S.P., additional, Hernandez, Adrian F., additional, Martinez, Felipe A., additional, Inzucchi, Silvio E., additional, Shah, Sanjiv J., additional, de Boer, Rudolf A., additional, Jhund, Pardeep S., additional, Desai, Akshay S., additional, Fang, James C., additional, Han, Yaling, additional, Comin-Colet, Josep, additional, Vardeny, Orly, additional, Lindholm, Daniel, additional, Wilderäng, Ulrica, additional, Bengtsson, Olof, additional, McMurray, John J.V., additional, and Solomon, Scott D., additional

Published
2023
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42. Radiofrequency Electromagnetic Fields Cause Non-Temperature-Induced Physical and Biological Effects in Cancer Cells

Author

Wust, Peter, primary, Veltsista, Paraskevi D., additional, Oberacker, Eva, additional, Yavvari, Prabhusrinivas, additional, Walther, Wolfgang, additional, Bengtsson, Olof, additional, Sterner-Kock, Anja, additional, Weinhart, Marie, additional, Heyd, Florian, additional, Grabowski, Patricia, additional, Stintzing, Sebastian, additional, Heinrich, Wolfgang, additional, Stein, Ulrike, additional, and Ghadjar, Pirus, additional

Published
2022
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43. Initial decline ('dip') in estimated glomerular filtration rate following initiation of dapagliflozin in patients with heart failure and reduced ejection fraction: insights from DAPA-HF

Author

Adamson, Carly, Docherty, Kieran F., Heerspink, Hiddo J.L., de Boer, Rudolf A., Damman, Kevin, Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Martinez, Felipe A., Petrie, Mark C., Ponikowski, Piotr, Sabatine, Marc S., Schou, Morten, Solomon, Scott D., Verma, Subodh, Bengtsson, Olof, Langkilde, Anna Maria, Sjöstrand, Mikaela, Vaduganathan, Muthiah, Jhund, Pardeep S., and McMurray, John J.V.

Abstract

Background: In a post hoc analysis, the frequency of occurrence of an early decline ("dip") in estimated glomerular filtration rate (eGFR) after initiation of dapagliflozin, and its association with outcomes, was evaluated in patients with heart failure and reduced ejection fraction (HFrEF) randomized in the Dapagliflozin and Prevention of Adverse outcomes in Heart Failure trial. Methods: HFrEF patients with or without type 2 diabetes and an eGFR ≥30 mL/min/1.73m2 were randomized to placebo or dapagliflozin 10mg daily. The primary outcome was the composite of worsening heart failure or cardiovascular death. The extent of the dip in eGFR between baseline and 2 weeks, patient characteristics associated with a >10% decline, and cardiovascular outcomes and eGFR slopes in participants experiencing this decline were investigated. Time-to-event outcomes were assessed in Cox regression from 14 days; eGFR slopes were assessed using repeated measure mixed effect models. Results: The mean change in eGFR between day 0 and 14 was -1.1 ml/min/1.73m2 (95% CI -1.5,-0.7) with placebo and -4.2 ml/min/1.73m2 (-4.6,-3.9) with dapagliflozin, giving a between treatment difference of 3.1 (2.6, 3.7) ml/min/1.73m2. The proportions of patients randomized to dapagliflozin experiencing a >10%, >20% and >30% decline in eGFR were: 38.2%, 12.6%, and 3.4%, respectively; for placebo they were 21.0%, 6.4% and 1.3%, respectively. The odds ratio for a >10% early decline in eGFR with dapagliflozin, compared with placebo, was 2.36 (95%CI 2.07-2.69), P10% decline in eGFR on dapagliflozin were older age, lower eGFR, higher ejection fraction, and type 2 diabetes. The hazard ratio for the primary outcome in patients in the placebo group experiencing a >10% decline in eGFR, compared with ≤10% decline in eGFR was 1.45 (95% CI 1.19-1.78). The corresponding hazard ratio in the dapagliflozin group was 0.73 (95% CI 0.59-0.91), P-interaction 10% initial decline in eGFR was not associated with greater long-term decline in eGFR or more adverse events. Conclusions: The average dip in eGFR after starting dapagliflozin was small and associated with better clinical outcomes, compared with a similar decline on placebo in patients with HFrEF. Large declines in eGFR were uncommon with dapagliflozin.

Published
2022

45. Liver tests and outcomes in heart failure with reduced ejection fraction: findings from DAPA‐HF

Author

Adamson, Carly, primary, Cowan, Lorna M., additional, de Boer, Rudolf A., additional, Diez, Mirta, additional, Drożdż, Jarosław, additional, Dukát, Andre, additional, Inzucchi, Silvio E., additional, Køber, Lars, additional, Kosiborod, Mikhail N., additional, Ljungman, Charlotta E.A., additional, Martinez, Felipe A., additional, Ponikowski, Piotr, additional, Sabatine, Marc S., additional, Lindholm, Daniel, additional, Bengtsson, Olof, additional, Boulton, David W., additional, Greasley, Peter J., additional, Langkilde, Anna Maria, additional, Sjöstrand, Mikaela, additional, Solomon, Scott D., additional, McMurray, John J.V., additional, and Jhund, Pardeep S., additional

Published
2022
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46. Dapagliflozin and Recurrent Heart Failure Hospitalizations in Heart Failure With Reduced Ejection Fraction

Author

Jhund, Pardeep S., Ponikowski, Piotr, Docherty, Kieran F., Gasparyan, Samvel B., Böhm, Michael, Chiang, Chern-En, Desai, Akshay S., Howlett, Jonathon, Kitakaze, Masafumi, Petrie, Mark C., Verma, Subodh, Bengtsson, Olof, Langkilde, Anna-Maria, Sjöstrand, Mikaela, Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Martinez, Felipe A., Sabatine, Marc S., Solomon, Scott D., and McMurray, John J.V.

Subjects
Heart Failure, Male, recurrence, heart failure, Hospitalization, Glucosides, Original Research Articles, 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol, sodium-glucose transporter 2 inhibitors, Humans, Female, Benzhydryl Compounds, Sodium-Glucose Transporter 2 Inhibitors, Aged
Abstract

Background: Patients with heart failure (HF) and reduced ejection fraction will experience multiple hospitalizations for heart failure during the course of their disease. We assessed the efficacy of dapagliflozin on reducing the rate of total (ie, first and repeat) hospitalizations for heart failure in the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure). Methods: The total number of HF hospitalizations and cardiovascular deaths was examined by using the proportional-rates approach of Lei-Wei-Yang-Ying and a joint frailty model for each of recurrent HF hospitalizations and time to cardiovascular death. Variables associated with the risk of recurrent hospitalizations were explored in a multivariable Lei-Wei-Yang-Ying model. Results: Of 2371 participants randomly assigned to placebo, 318 experienced 469 hospitalizations for HF; of 2373 assigned to dapagliflozin, 230 patients experienced 340 admissions. In a multivariable model, factors associated with a higher risk of recurrent HF hospitalizations included higher heart rate, higher N-terminal pro-B-type natriuretic peptide, and New York Heart Association class. In the Lei-Wei-Yang-Ying model, the rate ratio for the effect of dapagliflozin on recurrent HF hospitalizations or cardiovascular death was 0.75 (95% CI, 0.65–0.88), P=0.0002. In the joint frailty model, the rate ratio for total HF hospitalizations was 0.71 (95% CI, 0.61–0.82), P

Published
2021

48. Efficacy and Safety of Dapagliflozin According to Frailty in Heart Failure With Reduced Ejection Fraction

Author

Butt, Jawad H., primary, Dewan, Pooja, additional, Merkely, Béla, additional, Belohlávek, Jan, additional, Drożdż, Jarosław, additional, Kitakaze, Masafumi, additional, Inzucchi, Silvio E., additional, Kosiborod, Mikhail N., additional, Martinez, Felipe A., additional, Tereshchenko, Sergey, additional, Ponikowski, Piotr, additional, Bengtsson, Olof, additional, Lindholm, Daniel, additional, Langkilde, Anna Maria, additional, Schou, Morten, additional, Sjöstrand, Mikaela, additional, Solomon, Scott D., additional, Sabatine, Marc S., additional, Chiang, Chern-En, additional, Docherty, Kieran F., additional, Jhund, Pardeep S., additional, Køber, Lars, additional, and McMurray, John J.V., additional

Published
2022
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49. Relationship of Dapagliflozin With Serum Sodium:Findings From the DAPA-HF Trial

Author

Yeoh, Su Ern, Docherty, Kieran F., Jhund, Pardeep S., Petrie, Mark C., Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Martinez, Felipe A., Ponikowski, Piotr, Sabatine, Marc S., Bengtsson, Olof, Boulton, David W., Greasley, Peter J., Langkilde, Anna Maria, Sjöstrand, Mikaela, Solomon, Scott D., and McMurray, John J. V.

Subjects
hyponatremia, heart failure, dapagliflozin, sodium, sodium glucose cotransporter 2 inhibitor
Abstract

Objectives: This study aimed to assess the prognostic importance of hyponatremia and the effects of dapagliflozin on serum sodium in the DAPA-HF (Dapagliflozin And Prevention of Adverse outcomes in Heart Failure) trial. Background: Hyponatremia is common and prognostically important in hospitalized patients with heart failure with reduced ejection fraction, but its prevalence and importance in ambulatory patients are uncertain. Methods: We calculated the incidence of the primary outcome (cardiovascular death or worsening heart failure) and secondary outcomes according to sodium category (≤135 and >135 mmol/L). Additionally, we assessed: 1) whether baseline serum sodium modified the treatment effect of dapagliflozin; and 2) the effect of dapagliflozin on serum sodium. Results: Of 4,740 participants with a baseline measurement, 398 (8.4%) had sodium ≤135 mmol/L. Participants with hyponatremia were more likely to have diabetes, be treated with diuretics, and have lower systolic blood pressure, left ventricular ejection fraction, and estimated glomerular filtration rate. Hyponatremia was associated with worse outcomes even after adjustment for predictive variables (adjusted HRs for the primary outcome 1.50 [95% CI: 1.23-1.84] and all-cause death 1.59 [95% CI: 1.26-2.01]). The benefits of dapagliflozin were similar in patients with and without hyponatremia (HR for primary endpoint: 0.83 [95% CI: 0.57-1.19] and 0.73 [95% CI: 0.63-0.84], respectively, P for interaction = 0.54; HR for all-cause death: 0.85 [95% CI: 0.56-1.29] and 0.83 [95% CI: 0.70-0.98], respectively, P for interaction = 0.96). Between baseline and day 14, more patients on dapagliflozin developed hyponatremia (11.3% vs 9.4%; P = 0.04); thereafter, this pattern reversed and at 12 months fewer patients on dapagliflozin had hyponatremia (4.6% vs 6.7%; P = 0.003). Conclusions: Baseline serum sodium concentration was prognostically important, but did not modify the benefits of dapagliflozin on morbidity and mortality in heart failure with reduced ejection fraction. (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure [DAPA-HF]: NCT03036124)

Published
2022

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