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1,046 results on '"LEWIS, ELDRIN F."'

2. A Synopsis of the Evidence for the Science and Clinical Management of Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Scientific Statement From the American Heart Association

Author

Ndumele, Chiadi E., Neeland, Ian J., Tuttle, Katherine R., Chow, Sheryl L., Mathew, Roy O., Khan, Sadiya S., Coresh, Josef, Baker-Smith, Carissa M., Carnethon, Mercedes R., Després, Jean-Pierre, Ho, Jennifer E., Joseph, Joshua J., Kernan, Walter N., Khera, Amit, Kosiborod, Mikhail N., Lekavich, Carolyn L., Lewis, Eldrin F., Lo, Kevin B., Ozkan, Bige, Palaniappan, Latha P., Patel, Sonali S., Pencina, Michael J., Powell-Wiley, Tiffany M., Sperling, Laurence S., Virani, Salim S., Wright, Jackson T., Rajgopal Singh, Radhika, Elkind, Mitchell S.V., and Rangaswami, Janani

Published
2023
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3. Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory From the American Heart Association

Author

Ndumele, Chiadi E., Rangaswami, Janani, Chow, Sheryl L., Neeland, Ian J., Tuttle, Katherine R., Khan, Sadiya S., Coresh, Josef, Mathew, Roy O., Baker-Smith, Carissa M., Carnethon, Mercedes R., Despres, Jean-Pierre, Ho, Jennifer E., Joseph, Joshua J., Kernan, Walter N., Khera, Amit, Kosiborod, Mikhail N., Lekavich, Carolyn L., Lewis, Eldrin F., Lo, Kevin B., Ozkan, Bige, Palaniappan, Latha P., Patel, Sonali S., Pencina, Michael J., Powell-Wiley, Tiffany M., Sperling, Laurence S., Virani, Salim S., Wright, Jackson T., Rajgopal Singh, Radhika, and Elkind, Mitchell S.V.

Published
2023
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8. Abstract 12936: Quality of Life Assessments as Inclusion Criteria in Heart Failure Clinical Trials

Author

Dimond, Matthew, Khan, Mohammad S, Fiuzat, Mona, Cleland, John G, Bhatt, Ankeet, Psotka, Mitchell, Anker, Stefan D, Butler, Javed, Felker, Michael, Mark, Daniel B, Carson, Peter E, Abraham, William T, Ahmad, Tariq, Lindenfeld, Joann, Vaduganathan, Muthiah, Whellan, David J, Vardeny, Orly, Solomon, Scott, Lewis, Eldrin F, Filippatos, Gerasimos, and OConnor, Christopher M

Published
2023
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9. Abstract 12701: Safety and Tolerability of Angiotensin Receptor Neprilysin Inhibitor Initiation in High-Risk Acute Myocardial Infarction Relative to Drug Initiation Setting: A Subgroup Analysis of the PARADISE-MI Trial

Author

De Pasquale, Carmine, Claggett, Brian, Jering, Karola, McMurray, John J, Mann, Douglas L, Granger, Christopher, Kober, Lars, Lewis, Eldrin F, Maggioni, Aldo Pietro P, Rouleau, Jean L, Solomon, Scott, Steg, Philippe G, van der meer, peter, Braunwald, Eugene, and Pfeffer, Marc A

Published
2023
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15. Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel

Author

Psotka, Mitchell A., Abraham, William T., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Ahmad, Tariq, Felker, G. Michael, Jacob, Richard, Kitzman, Dalane W., Leifer, Eric S., Lewis, Eldrin F., Mentz, Robert J., Nkulikiyinka, Richard, Ni, Wei, Schaber, Daniel E., Sharma, Abhinav, Solomon, Scott D., Stockbridge, Norman, Teerlink, John R., Unger, Ellis F., Whellan, David J., Wittes, Janet, Anker, Stefan D., and O’Connor, Christopher M.

Published
2022
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16. The trial to assess chelation therapy 2 (TACT2): Rationale and design

Author

Lamas, Gervasio A., Anstrom, Kevin J., Navas-Acien, Ana, Boineau, Robin, Kim, Hwasoon, Rosenberg, Yves, Stylianou, Mario, Jones, Teresa L.Z., Joubert, Bonnie R., Santella, Regina M., Escolar, Esteban, Aude, Y. Wady, Fonseca, Vivian, Elliott, Thomas, Lewis, Eldrin F., Farkouh, Michael E., Nathan, David M., Mon, Ana C., Gosnell, Leigh, Newman, Jonathan D., and Mark, Daniel B.

Published
2022
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18. 2022 AHA/ACC Key Data Elements and Definitions for Cardiovascular and Noncardiovascular Complications of COVID-19: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards

Author

Bozkurt, Biykem, Das, Sandeep R., Addison, Daniel, Gupta, Aakriti, Jneid, Hani, Khan, Sadiya S., Koromia, George Augustine, Kulkarni, Prathit A., LaPoint, Kathleen, Lewis, Eldrin F., Michos, Erin D., Peterson, Pamela N., Turagam, Mohit K., Wang, Tracy Y., and Yancy, Clyde W.

Published
2022
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20. Plasma renin activity, response to aliskiren, and clinical outcomes in patients hospitalized for heart failure: the ASTRONAUT trial

Author

Vaduganathan, Muthiah, Cheema, Baljash, Cleveland, Erin, Sankar, Kamya, Subacius, Haris, Fonarow, Gregg C, Solomon, Scott D, Lewis, Eldrin F, Greene, Stephen J, Maggioni, Aldo P, Böhm, Michael, Zannad, Faiez, Butler, Javed, and Gheorghiade, Mihai

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Cardiovascular, Heart Disease, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Amides, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Fumarates, Heart Failure, Humans, Inpatients, Male, Middle Aged, Prospective Studies, Renin, Renin-Angiotensin System, Stroke Volume, Treatment Outcome, Clinical outcomes, Heart failure, Neurohormones, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

AimsThe direct renin inhibitor, aliskiren, is known to reduce plasma renin activity (PRA), but whether the efficacy of aliskiren varies based on an individual's baseline PRA in patients hospitalized for heart failure (HF) is presently unknown. We characterized the prognostic value of PRA and determined if this risk is modifiable with use of aliskiren.Methods and resultsThis pre-specified neurohormonal substudy of ASTRONAUT analysed all patients hospitalized for HF with ejection fraction (EF) ≤40% with available baseline PRA data (n = 1306, 80.9%). Risk associated with baseline PRA and short-term changes in PRA from baseline to 1 month was modelled with respect to 12-month clinical events. Median baseline PRA was 3.0 (interquartile range 0.6-16.4) ng/mL/h. Aliskiren significantly reduced PRA early after treatment initiation through 12-month follow-up compared with placebo (P

Published
2018

21. Pre‐discharge and early post‐discharge troponin elevation among patients hospitalized for heart failure with reduced ejection fraction: findings from the ASTRONAUT trial

Author

Greene, Stephen J, Butler, Javed, Fonarow, Gregg C, Subacius, Haris P, Ambrosy, Andrew P, Vaduganathan, Muthiah, Triggiani, Marco, Solomon, Scott D, Lewis, Eldrin F, Maggioni, Aldo P, Böhm, Michael, Chioncel, Ovidiu, Nodari, Savina, Senni, Michele, Zannad, Faiez, Gheorghiade, Mihai, and Investigators and Coordinators, for the ASTRONAUT

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Heart Disease, Cardiovascular, Clinical Research, Good Health and Well Being, Aged, Biomarkers, Cause of Death, Europe, Female, Follow-Up Studies, Heart Failure, Humans, Male, Middle Aged, Patient Discharge, Prognosis, Prospective Studies, Risk Factors, Stroke Volume, Survival Rate, Time Factors, Troponin, United States, Heart failure, Post-discharge, Outcomes, Hospitalization, ASTRONAUT Investigators and Coordinators, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

AimsTroponin levels are commonly elevated among patients hospitalized for heart failure (HF), but the prevalence and prognostic significance of early post-discharge troponin elevation are unclear. This study sought to describe the frequency and prognostic value of pre-discharge and post-discharge troponin elevation, including persistent troponin elevation from the inpatient to outpatient settings.Methods and resultsThe ASTRONAUT trial (NCT00894387; http://www.clinicaltrials.gov) enrolled hospitalized HF patients with ejection fraction ≤40% and measured troponin I prior to discharge (i.e. study baseline) and at 1-month follow-up in a core laboratory (elevation defined as >0.04 ng/mL). This analysis included 1469 (91.0%) patients with pre-discharge troponin data. Overall, 41.5% and 29.9% of patients had elevated pre-discharge [median: 0.09 ng/mL; interquartile range (IQR): 0.06-0.19 ng/mL] and 1-month (median: 0.09 ng/mL; IQR: 0.06-0.15 ng/mL) troponin levels, respectively. Among patients with pre-discharge troponin elevation, 60.4% had persistent elevation at 1 month. After adjustment, pre-discharge troponin elevation was not associated with 12-month clinical outcomes. In contrast, 1-month troponin elevation was independently predictive of increased all-cause mortality [hazard ratio (HR) 1.59, 95% confidence interval (CI) 1.18-2.13] and cardiovascular mortality or HF hospitalization (HR 1.28, 95% CI 1.03-1.58) at 12 months. Associations between 1-month troponin elevation and outcomes were similar among patients with newly elevated (i.e. normal pre-discharge) and persistently elevated levels (interaction P ≥ 0.16). The prognostic value of 1-month troponin elevation for 12-month mortality was driven by a pronounced association among patients with coronary artery disease (interaction P = 0.009).ConclusionsIn this hospitalized HF population, troponin I elevation was common during index hospitalization and at 1-month follow-up. Elevated troponin I level at 1 month, but not pre-discharge, was independently predictive of increased clinical events at 12 months. Early post-discharge troponin I measurement may offer a practical means of risk stratification and should be investigated as a therapeutic target.

Published
2018

23. The Effects of Angiotensin Receptor-Neprilysin Inhibition on Major Coronary Events in Patients With Acute Myocardial Infarction: Insights From the PARADISE-MI Trial

Author

Mehran, Roxana, Steg, Philippe Gabriel, Pfeffer, Marc A., Jering, Karola, Claggett, Brian, Lewis, Eldrin F., Granger, Christopher, Køber, Lars, Maggioni, Aldo, Mann, Douglas L., McMurray, John J.V., Rouleau, Jean-Lucien, Solomon, Scott D., Ducrocq, Gregory, Berwanger, Otavio, De Pasquale, Carmine G., Landmesser, Ulf, Petrie, Mark, Leng, David Sim Kheng, van der Meer, Peter, Lefkowitz, Martin, Zhou, Yinong, and Braunwald, Eugene

Published
2022
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26. Influence of atrial fibrillation on post‐discharge natriuretic peptide trajectory and clinical outcomes among patients hospitalized for heart failure: insights from the ASTRONAUT trial

Author

Greene, Stephen J, Fonarow, Gregg C, Solomon, Scott D, Subacius, Haris P, Ambrosy, Andrew P, Vaduganathan, Muthiah, Maggioni, Aldo P, Böhm, Michael, Lewis, Eldrin F, Zannad, Faiez, Butler, Javed, Gheorghiade, Mihai, and Investigators and Coordinators, for the ASTRONAUT

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Heart Disease, Aged, Amides, Antihypertensive Agents, Atrial Fibrillation, Atrial Flutter, Disease Progression, Female, Fumarates, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Natriuretic Peptide, Brain, Peptide Fragments, Prognosis, Randomized Controlled Trials as Topic, Heart failure, Natriuretic peptide, Atrial fibrillation, Outcomes, ASTRONAUT Investigators and Coordinators, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

AimsChange in NT-proBNP level is a common surrogate endpoint in early phase heart failure (HF) trials, but whether this endpoint is influenced by atrial fibrillation/flutter (AFF) is unclear.Methods and resultsThis analysis included 1358 patients from the ASTRONAUT trial, which randomized patients hospitalized for HF with EF ≤40% to aliskiren or placebo in addition to standard care. Patients were stratified by presence of AFF on baseline ECG. NT-proBNP was measured longitudinally by a core laboratory at baseline, 1 month, 6 months, and 12 months. Compared with non-AFF patients, AFF patients experienced greater reduction from baseline in log-transformed NT-proBNP (interaction P < 0.001), but this difference was not significant after adjustment (interaction P = 0.726). The ability of aliskiren to lower NT-proBNP during follow-up differed by AFF status (interaction P = 0.001), with aliskiren lowering NT-proBNP more than placebo among non-AFF patients only. After adjustment, baseline AFF was not associated with mortality or HF hospitalization at 12 months (all P ≥ 0.152).ConclusionIn this hospitalized HF cohort, AFF status did not influence post-discharge NT-proBNP trajectory or clinical outcomes after adjustment for patient characteristics. Aliskiren lowered follow-up NT-proBNP levels in patients without AFF, but had no influence among patients with AFF. This study generates the hypothesis that the ability of a HF trial to meet an NT-proBNP defined endpoint may be influenced by the prevalence of AFF in the population. Because aliskiren did not improve outcomes in patients without AFF, this analysis suggests changes in NT-proBNP induced by investigational therapies may be dissociated from clinical effects.

Published
2017

27. Creation of the American Heart Association Journals’ Equity, Diversity, and Inclusion Editorial Board: The Next Step to Achieving the 2024 Impact Goal

Author

Lewis, Eldrin F., Beaty, Christine, Boltze, Johannes, Breathett, Khadijah, Clair, Walter K., de las Fuentes, Lisa, Essien, Utibe R., Goodell, Heather, Hinson, H.E., Kershaw, Kiarri N., Knowles, Joshua W., Mazimba, Sula, Mujahid, Mahasin, Okafor, Henry E., Woo Park, Kyung, and Schultz, Jonathan

Published
2022
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28. Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium

Author

Abraham, William T., Psotka, Mitchell A., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Mehran, Roxana, Ambardekar, Amrut V., Carson, Peter E., Jacob, Richard, Januzzi, James L., Jr., Konstam, Marvin A., Krucoff, Mitchell W., Lewis, Eldrin F., Piccini, Jonathan P., Solomon, Scott D., Stockbridge, Norman, Teerlink, John R., Unger, Ellis F., Zeitler, Emily P., Anker, Stefan D., and O’Connor, Christopher M.

Published
2020
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31. American Heart Association Cardiogenic Shock Registry: Design and Implementation.

Author

Morrow, David A., Jessup, Mariell, Abraham, William T., Acker, Michael, Aringo, Angeline, Batchelor, Wayne, Chikwe, Joanna, Costello, Shaina, Drakos, Stavros G., Farmer, Steven, Gelijns, Annetine, Gillette, Nicole, Hochman, Judith S., Isler, Maria, Kapur, Navin K., Kilic, Arman, Kormos, Robert, Lewis, Eldrin F., Lindenfeld, JoAnn, and Lombardi, Pierluca

Abstract

BACKGROUND: Cardiogenic shock is a morbid complication of heart disease that claims the lives of more than 1 in 3 patients presenting with this syndrome. Supporting a unique collaboration across clinical specialties, federal regulators, payors, and industry, the American Heart Association volunteers and staff have launched a quality improvement registry to better understand the clinical manifestations of shock phenotypes, and to benchmark the management patterns, and outcomes of patients presenting with cardiogenic shock to hospitals across the United States. METHODS: Participating hospitals will enroll consecutive hospitalized patients with cardiogenic shock, regardless of etiology or severity. Data are collected through individual reviews of medical records of sequential adult patients with cardiogenic shock. The electronic case record form was collaboratively designed with a core minimum data structure and aligned with Shock Academic Research Consortium definitions. This registry will allow participating health systems to evaluate patientlevel data including diagnostic approaches, therapeutics, use of advanced monitoring and circulatory support, processes of care, complications, and in-hospital survival. Participating sites can leverage these data for onsite monitoring of outcomes and benchmarking versus other institutions. The registry was concomitantly designed to provide a high-quality longitudinal research infrastructure for pragmatic randomized trials as well as translational, clinical, and implementation research. An aggregate deidentified data set will be made available to the research community on the American Heart Association's Precision Medicine Platform. On March 31, 2022, the American Heart Association Cardiogenic Shock Registry received its first clinical records. At the time of this submission, 100 centers are participating. CONCLUSIONS: The American Heart Association Cardiogenic Shock Registry will serve as a resource using consistent data structure and definitions for the medical and research community to accelerate scientific advancement through shared learning and research resulting in improved quality of care and outcomes of shock patients. [ABSTRACT FROM AUTHOR]

Published
2024
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33. Endpoints in Heart Failure Drug Development: History and Future

Author

Fiuzat, Mona, Lowy, Naomi, Stockbridge, Norman, Sbolli, Marco, Latta, Federica, Lindenfeld, JoAnn, Lewis, Eldrin F., Abraham, William T., Teerlink, John, Walsh, Mary, Heidenreich, Paul, Bozkurt, Biykem, Starling, Randall C., Solomon, Scott, Felker, G. Michael, Butler, Javed, Yancy, Clyde, Stevenson, Lynne W., O'Connor, Christopher, Unger, Ellis, Temple, Robert, and McMurray, John

Published
2020
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35. Who Are We Missing? Reporting of Transgender and Gender‐Expansive Populations in Clinical Trials

Author

Rice, Eli N., primary, Lan, Roy H., additional, Nunes, Julio C., additional, Shah, Rushil, additional, Clark, Kira, additional, Periyakoil, Vyjeyanthi S., additional, Chen, Jonathan H., additional, Lin, Bryant, additional, Echols, Melvin, additional, Awad, Christopher, additional, Idris, Muhammed Y., additional, Cruz, Erin Rose, additional, Poullos, Peter D., additional, Lewis, Eldrin F., additional, Brown‐Johnson, Cati, additional, Igwe, Joseph, additional, Shen, Sa, additional, Palaniappan, Latha, additional, Stefanick, Marcia L., additional, Ritter, Victor, additional, Pemu, Priscilla, additional, Rodriguez, Fatima, additional, Deb, Brototo, additional, Pundi, Krishna, additional, and Wang, Paul J., additional

Published
2023
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36. Disabilities Reporting in Cardiac Clinical Trials: How Are We Doing?

Author

Lan, Roy H., primary, Rice, Eli N., additional, Nunes, Julio C., additional, Shah, Rushil, additional, Igwe, Joseph‐Kevin, additional, Clark, Kira, additional, Periyakoil, Vyjeyanthi S., additional, Chen, Jonathan H., additional, Lin, Bryant, additional, Awad, Christopher, additional, Idris, Muhammed, additional, Cruz, Erin Rose, additional, Lewis, Eldrin F., additional, Johnson, Cati Brown, additional, and Wang, Paul J., additional

Published
2023
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39. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial

Author

Chandra, Alvin, Vaduganathan, Muthiah, Lewis, Eldrin F., Claggett, Brian L., Rizkala, Adel R., Wang, Wenyan, Lefkowitz, Martin P., Shi, Victor C., Anand, Inder S., Ge, Junbo, Lam, Carolyn S.P., Maggioni, Aldo P., Martinez, Felipe, Packer, Milton, Pfeffer, Marc A., Pieske, Burkert, Redfield, Margaret M., Rouleau, Jean L., Van Veldhuisen, Dirk J., Zannad, Faiez, Zile, Michael R., McMurray, John J.V., and Solomon, Scott D.

Published
2019
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41. Impact of Sacubitril/Valsartan Versus Ramipril on Total Heart Failure Events in the PARADISE-MI Trial

Author

Pfeffer, Marc A., Claggett, Brian, Lewis, Eldrin F., Granger, Christopher B., Køber, Lars, Maggioni, Aldo P., Mann, Douglas L., McMurray, John J.V., Rouleau, Jean-Lucien, Solomon, Scott D., Steg, Philippe Gabriel, Berwanger, Otavio, Cikes, Maja, De Pasquale, Carmine G., Fernandez, Alberto, Filippatos, Gerasimos, Jering, Karola, Landmesser, Ulf, Menon, Venugopal, Merkely, Béla, Petrie, Mark C., Petrov, Ivo, Schou, Morten, Senni, Michele, Sim, David, van der Meer, Peter, Lefkowitz, Martin, Zhou, Yinong, Wang, Yi, and Braunwald, Eugene

Published
2022
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45. Meta‐analysis of risk of major adverse cardiovascular events in adults with type 2 diabetes treated with bexagliflozin.

Author

McMurray, John J. V., Solomon, Scott D., Lock, J. Paul, Massaro, Joseph M., Zhu, Fang, Zhou, Wenjiong, Skali, Hicham, Lewis, Eldrin F., Freeman, Mason W., and Halvorsen, Yuan‐Di C.

Subjects
MAJOR adverse cardiovascular events, TYPE 2 diabetes, ANGINA pectoris
Abstract

Aim: To explore the risk of major adverse cardiovascular events (MACE) associated with exposure to bexagliflozin. Methods: The analysis included 4090 participants with type 2 diabetes (T2D) enrolled in nine phase 2 and 3 double‐blind randomized controlled trials. All potential MACE were adjudicated by a blinded committee. The primary endpoint for the meta‐analysis was the hazard ratio (HR) for the time to first occurrence of non‐fatal stroke, non‐fatal myocardial infarction (MI), cardiovascular (CV) death or hospitalization for unstable angina (MACE+), tested for non‐inferiority to a ratio of 1.8. The secondary endpoints were time to first occurrence of (i) non‐fatal stroke, non‐fatal MI or CV death (MACE), tested for non‐inferiority to a ratio of 1.3; and (ii) CV death or hospitalization for heart failure, tested for superiority. Results: The HR for the primary endpoint of MACE+ was 0.80 (95% confidence interval [CI] 0.58, 1.09), which fulfilled the non‐inferiority objective with a P value of less than 0.0001. Non‐inferiority for the first key secondary endpoint of MACE was also shown (HR = 0.82; 95% CI 0.59, 1.13; P = 0.0023). Superiority for time to CV death or first hospitalization for heart failure was not shown. Conclusions: Bexagliflozin did not increase the risk of MACE in participants with T2D when compared with placebo or active control. Both the preapproval and postapproval thresholds for CV safety were met and bexagliflozin has been approved by the US Food and Drug Administration. [ABSTRACT FROM AUTHOR]

Published
2024
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47. Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE‐MI

Author

Wang, Xiaowen, primary, Jering, Karola S., additional, Cikes, Maja, additional, Tokmakova, Mariya P., additional, Mehran, Roxana, additional, Han, Yaling, additional, East, Cara, additional, Mody, Freny Vaghaiwalla, additional, Wang, Yi, additional, Lewis, Eldrin F., additional, Claggett, Brian, additional, McMurray, John J. V., additional, Granger, Christopher B., additional, Pfeffer, Marc A., additional, and Solomon, Scott D., additional

Published
2023
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