EXenatide Study of Cardiovascular Event Lowering

Using QALYs as an outcome for assessing global prediction accuracy in diabetes simulation models
Helen A Dakin, Ni Gao, José Leal, Rury R Holman, An Tran-Duy, Philip Clarke
Med Decis Making 2024. Epub:30-Oct-2024. PMID:39474832. doi:10.1177/0272989X241285866

Cardiovascular Outcomes with Exenatide in Type 2 Diabetes according to Ejection Fraction: the EXSCEL trial
João Sérgio Neves, Ana Rita Leite, Robert K Mentz, Rury R Holman, Faiez Zannad, Javed Butler, Milton Packer, João Pedro Ferreira
Eur J Heart Fail 2024. Epub:09-Oct-2024. PMID:39381950. doi:10.1002/ejhf.3478

Proteomic Pathways across Ejection Fraction Spectrum in Heart Failure: an EXSCEL Substudy
Peters AE, Nguyen M, Green JB, Pearson ER, Buse J, Sourij H, Hernandez AF, Sattar N, Holman RR, Mentz RJ, Shah SH
medRxiv 2023. Epub:16-May-2023. PMID:37293003. doi:10.1101/2023.05.16.23288273

Inflammatory proteins associated with Alzheimer's disease reduced by a GLP1 receptor agonist: a post hoc analysis of the EXSCEL randomized placebo controlled trial
Ivan Koychev, Graham Reid, Maggie Nguyen, Robert J. Menz, Dan Joyce, Svati H. Sha, Rury R. Holman
Alzheimers Res Ther. 2024;16:212. Published:02-Oct-2024. PMID:39358806. doi:10.1186/s13195-024-01573-x

Estimated glomerular filtration rate slope and risk of primary and secondary major adverse cardiovascular events and heart failure hospitalization in people with type 2 diabetes: An analysis of the EXSCEL trial
Abderrahim Oulhaj, Faisal Aziz, Abubaker Suliman, Kathrin Eller, Rachid Bentoumi, John B. Buse, Wael Al Mahmeed, Dirk von Lewinski, Ruth L. Coleman, Rury R. Holman, Harald Sourij
Diabetes Obes Metab. 2024;26:4602-4612. Published:Oct-2024. Epub:31-Jul-2024. PMID:39086032. doi:10.1111/dom.15817

Estimating Risk Factor Time Paths Among People with Type 2 Diabetes and QALY Gains from Risk Factor Management
Ni Gao, Helen A. Dakin, Rury R. Holman, Lee Ling Lim, José Leal, Philip Clarke
PharmacoEconomics 2024;42:1017-1028. Published:Sep-2024. Epub:26-Jun-2024. PMID:38922488. doi:10.1007/s40273-024-01398-4

Are the cardiovascular properties of GLP-1 receptor agonists differentially modulated by sulfonylureas? insights from post-hoc analysis of EXSCEL
K.M. Gooding, S. Stevens, Y. Lokhnygina, A. Giczewska, A.C. Shore, R.R. Holman
Diabetes Res Clin Pract. 2024;212:111685. Published:02-May-2024. Epub:25-Apr-2024. PMID:38670496. doi:10.1016/j.diabres.2024.111685

Regional variation in cause of death in patients with type 2 diabetes: insights from EXSCEL: Cause of Death in Type 2 Diabetes
Vishal N Rao, Abhinav Sharma, Amanda Stebbins, John B. Buse, Brian G. Katona, Neha J. Pagidipati, Rury R. Holman, Adrian Hernandez, Robert J. Mentz, Renato D. Lopes
Am Heart J. 2024;271:123-135. Published:May-2024. Epub:21-Feb-2024. PMID:38395292. doi:10.1016/j.ahj.2024.02.013

Mitochondrial Metabolites Predict Major Adverse Cardiovascular Events in Individuals with Type 2 Diabetes Mellitus
Jessica A Regan, Robert J Mentz, Maggie Nguyen, Jennifer B Green, Lauren K Truby, Olga Ilkayeva, Christopher Newgard, John B Buse, Harald Sourij, C David Sjostrom, Naveed Sattar, Robert W McGarrah, Yinggan Zheng, Darren K McGuire, Eberhard Standl, Paul Armstrong, Eric Peterson, Adrian Hernandez, Rury R Holman, Svati H Shah
JCI Insight 2023;8:e168563. Published:08-Sep-2023. Epub:08-Aug-2023. PMID:37552540. doi:10.1172/jci.insight.168563

Sex differences in complications, care, and clinical outcomes of patients with type 2 diabetes in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)
Jennifer B. Green, Peter Merrill, Yuliya Lokhnygina, Robert J. Mentz, Joakim Alfredsson, Rury R. Holman; EXSCEL Study Group
Diabetes Obes Metab. 2023;25:1473-1484. Published:Jun-2023. Epub:14-Feb-2023. PMID:36700460. doi:10.1111/dom.14993

Joint longitudinal and time-to-event modeling compared with standard Cox modeling in patients with type 2 diabetes with and without established cardiovascular disease: an analysis of the EXSCEL trial
Abderrahim Oulhaj, Faisal Aziz, Abubaker Suliman, Nayyar Iqbal, Ruth L Coleman, Rury R Holman, Harald Sourij
Diabetes Obes Metab. 2023;25:1261-1270. Published:May-2023. Epub:12-Jan-2023. PMID:36635232. doi:10.1111/dom.14975

Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)
Timothy M. E. Davis, Anna Giczewska, Yuliya Lokhnygina, Robert J. Mentz, Naveed Sattar, Rury R. Holman and for the EXSCEL Study Group
Cardiovasc Diabetol. 2022;21:116. Published:27-Jun-2022. PMID:35761271. doi:10.1186/s12933-022-01555-z

Lifetime cost-effectiveness simulation of once-weekly exenatide in type 2 diabetes: a cost-utility analysis based on the EXSCEL trial
Frauke Becker, Helen A. Dakin, Shelby D. Reed, Yanhong Li, José Leal, Stephanie M. Gustavson, Eric Wittbrodt, Adrian F. Hernandez, Alastair M. Gray, Rury R. Holman
Diabetes Res Clin Pract. 2022;183:109152. Published:01-Jan-2022. Epub:21-Nov-2021. PMID:34813910. doi:10.1016/j.diabres.2021.109152

Polyvascular disease and increased risk of cardiovascular events in patients with type 2 diabetes: Insights from the EXSCEL trial
Marc D. Samskya, Robert J. Mentza, Amanda Stebbins, Yuliya Lokhnygina, Aaron W. Aday, Neha J. Pagidipati, W. Schuyler Jonesa, Brian G. Katona, Manesh R. Patel, Rury R. Holman, Adrian F. Hernandez, Jorge Antonio Gutierrez
Atherosclerosis 2021;338:1-6. Published:Dec-2021. Epub:03-Nov-2021. PMID:34741929. doi:10.1016/j.atherosclerosis.2021.10.011

Predicting Major Adverse Limb Events in Individuals With Type 2 Diabetes: Insights From the EXSCEL Trial
E. Hope Weissler, Robert M. Clare, Yuliya Lokhnygina, John B. Buse, Shaun G. Goodman, Brian Katona, Nayyar Iqbal, Neha J. Pagidipati, Naveed Sattar, Rury R. Holman, Adrian F. Hernandez, Robert J. Mentz, Manesh R. Patel, W. Schuyler Jones
Diab Med. 2021;38:e14552. Published:Oct-2021. Epub:10-Mar-2021. PMID:33690915. doi:10.1111/dme.14552

Effect of once-weekly exenatide on hospitalization for acute coronary syndrome or coronary revascularization in patients with type 2 diabetes mellitus
Carlos E Barbery, Anna Giczewska, Jennifer White, Yuliya Lokhnygina, Robert John Mentz, Rury R Holman, Neha Pagidipati, Adrian F Hernandez, W Schuyler Jones
Am Heart J. 2021;239:59-63. Published:Sep-2021. Epub:24-Apr-2021. PMID:33905751. doi:10.1016/j.ahj.2021.03.013

Cardiovascular and renal safety of metformin in patients with diabetes and moderate-to-severe chronic kidney disease: observations from the EXSCEL and SAVOR-TIMI 53 cardiovascular outcomes trials
Lindsay E. Clegg, Yankang Jing, R. Chris Penland, David W. Boulton, Adrian F. Hernandez, Rury R. Holman, Jiten Vora
Diabetes Obes Metab. 2021;23:1101-1110. Published:May-2021. Epub:04-Jan-2021. PMID:33394543. doi:10.1111/dom.14313

Effect of once-weekly exenatide on estimated glomerular filtration rate slope depends on baseline renal risk: A post hoc analysis of the EXSCEL trial
Annemarie B. van der Aart-van der Beek, Lindsay E. Clegg, Robert C. Penland, David W. Boulton, C. David Sjöström, Robert J. Mentz, Rury R. Holman, Hiddo J L Heerspink
Diabetes Obes Metab. 2020;22:2493-2498. Published:Dec-2020. Epub:15-Sep-2020. PMID:32803900. doi:10.1111/dom.14175

Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes
M. Angelyn Bethel, Susanna R. Stevens, John B. Buse, Jasmine Choi, Stephanie M. Gustavson, Nayyar Iqbal, Yuliya Lokhnygina, Robert J. Mentz, Rishi A. Patel, Peter Öhman, Guntram Schernthaner, Albert LeCube, Adrian F. Hernandez, Rury R. Holman
Circulation 2020;141:1360-1370. Published:28-Apr-2020. Epub:26-Feb-2020. PMID:32098501. doi:10.1161/CIRCULATIONAHA.119.043353

Confirming the Bidirectional Nature of the Association Between Severe Hypoglycemic and Cardiovascular Events in Type 2 Diabetes: Insights from EXSCEL
Eberhard Standl, Susanna R. Stevens, Yuliya Lokhnygina, Angelyn Bethel, John B. Buse, Stephanie M. Gustavson, Aldo P. Maggioni, Robert J. Mentz, Adrian F. Hernandez, Rury R. Holman, for the EXSCEL Study Group
Diabetes Care 2020;43:643-652. Published:Mar-2020. Epub:27-Dec-2019. PMID:31882409. doi:10.2337/dc19-1079

Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)
Shelby D. Reed, Yanhong Li, Helen A. Dakin, Frauke Becker, Jose Leal, Stephanie M. Gustavson, Bernt Kartman, Eric Wittbrodt, Robert J. Mentz, Neha J. Pagidipati, M. Angelyn Bethel, Alastair M. Gray, Rury R. Holman, Adrian F. Hernandez, for the EXSCEL Study Group
Diabetes Care 2020;43:374-381. Published:Feb-2020. Epub:05-Dec-2019. PMID:31806653. doi:10.2337/dc19-0950

Microvascular and Cardiovascular Outcomes According to Renal Function in Patients Treated With Once-Weekly Exenatide: Insights From the EXSCEL Trial
M. Angelyn Bethel, Robert J. Mentz, Peter Merrill, John B. Buse, Juliana C. Chan, Shaun G. Goodman, Nayyar Iqbal, Neli Jakuboniene, Brian Katona, Yuliya Lokhnygina, Renato D. Lopes, Aldo P. Maggioni, Peter Ohman, Tsvetalina Tankova, George L. Bakris, Adrian F. Hernandez, and Rury R. Holman
Diabetes Care 2020;43:446-452. Published:Feb-2020. Epub:22-Nov-2019. PMID:31757838. doi:10.2337/dc19-1065

Prediction and validation of exenatide risk marker effects on progression of renal disease: Insights from EXSCEL
Idzerda NMA, Clegg LE, Hernandez AF, Bakris G, Penland RC, Boulton DW, Bethel MA, Holman RR, Heerspink HJL
Diabetes Obes Metab. 2020;22:798-806. Epub:07-Jan-2020. PMID:31912603. doi:10.1111/dom.13958

Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease: Results From the EXSCEL Trial
Badjatiya A, Merrill P, Buse JB, Goodman SG, Katona B, Iqbal N, Pagidipati NJ, Sattar N, Holman RR, Hernandez AF, Mentz RJ, Patel MR, Jones WS
Circ Cardiovasc Interv. 2019;12:e008018. Published:Dec-2019. Epub:22-Nov-2019. PMID:31752517. doi:10.1161/CIRCINTERVENTIONS.119.008018

Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial
Fudim M, White J, Pagidipati NJ, Lokhnygina Y, Wainstein J, Murin J, Iqbal N, Öhman P, Lopes RD, Reicher B, Holman RR, Hernandez AF, Mentz RJ
Circulation 2019;140:1613-1622. Published:12-Nov-2019. Epub:23-Sep-2019. PMID:31542942. doi:10.1161/CIRCULATIONAHA.119.041659

Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial
Clegg LE, Penland RC, Bachina S, Boulton DW, Thuresson M, Heerspink HJL, Gustavson S, Sjöström CD, Ruggles JA, Hernandez AF, Buse JB, Mentz RJ, Holman RR.
Cardiovasc Diabetol 2019;18:138. Published:22-Oct-2019. PMID:31640705. doi:10.1186/s12933-019-0942-x

Changes in Serum Calcitonin Concentrations, Incidence of Medullary Thyroid Carcinoma, and Impact of Routine Calcitonin Concentration Monitoring in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL)
M. Angelyn Bethel, Rishi A Patel, Brian G. Katona, Vivian P. Thompson, Stephanie M. Gustavson, Peter Ohman, Nayyar Iqbal John B. Buse, Rury R. Holman; for the EXSCEL Study Group
Diabetes Care 2019;42 :1075-1080. Published:Jun-2019. Epub:22-Apr-2019. PMID:31010875. doi:10.2337/dc18-2028

Reduction of Cardiovascular Risk and Improved Estimated Glomerular Filtration Rate by SGLT2 Inhibitors, Including Dapagliflozin, Is Consistent Across the Class: An Analysis of the Placebo Arm of EXSCEL
Lindsay E. Clegg, Hiddo J.L. Heerspink, Robert C. Penland, Weifeng Tang, David W. Boulton, Srinivas Bachina, Robert D. Fox, Peter Fenici Marcus Thuresson, Robert J. Mentz, Adrian F. Hernandez, and Rury R. Holman
Diabetes Care 2019;42:318-326. Published:Feb-2019. Epub:06-Dec-2018. PMID:30523029. doi:10.2337/dc18-1871

Effects of Once-Weekly Exenatide on Clinical Outcomes in Patients with Preexisting Cardiovascular Disease: A Prespecified Analysis From EXSCEL
Robert J Mentz, Vivian P. Thompson, David Aguilar, Jasmine Choi, Stephanie M. Gustavson, Nayyar Iqbal, Alice P. S. Kong, Peter Öhman, Naveed Sattar, Russell S Scott, Yee Weng Wong, Rury R. Holman, and Adrian F. Hernandez
Circulation 2018;138:2576-2578. Published:27-Nov-2018. Epub:28-Aug-2018. PMID:30571356. doi:10.1161/CIRCULATIONAHA.118.036811

Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial
Robert J. Mentz, M. Angelyn Bethel, Peter Merrill, Yuliya Lokhnygina, John B. Buse, Juliana C. Chan, João S. Felício, Shaun G. Goodman, Jasmine Choi, Stephanie M. Gustavson, Nayyar Iqbal, Renato D. Lopes, Aldo P. Maggioni, Peter Öhman, Neha J. Pagidipati, Neil R. Poulter, Ambady Ramachandran, Barry Reicher, Rury R. Holman, Adrian F. Hernandez, on behalf of the EXSCEL Study Group
J Am Heart Assoc 2018;7:e009304.. Published:02-Oct-2018. Epub:20-Sep-2018. PMID:30371301. doi:10.1161/JAHA.118.009304

Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis
M. Angelyn Bethel, Rishi A. Patel, Peter Merrill, Yuliya Lokhnygina, John B. Buse, Robert J. Mentz, Neha J. Pagidipati, Juliana C. Chan, Stephanie M. Gustavson, Nayyar Iqbal, Aldo P. Maggioni, Peter Öhman, Neil R. Poulter, Ambady Ramachandran, Bernard Zinman, Adrian F. Hernandez, and Rury R. Holman, for the EXSCEL Study Group
Lancet Diabetes Endocrinol. 2018;6:105-113. Published:Feb-2018. Epub:06-Dec-2017. PMID:29221659. doi:10.1016/S2213-8587(17)30412-6
[Slides]

Once-Weekly Exenatide and Cardiovascular Outcomes in Type 2 Diabetes – Authors' reply
Rury R. Holman, M. Angelyn Bethel, Adrian F. Hernandez,
N Eng J Med 2017;377:2502. Published:21-Dec-2017. PMID:29262286. doi:10.1056/NEJMc1714163

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes
Rury R. Holman, M. Angelyn Bethel, Robert J. Mentz, Vivian P. Thompson, Yuliya Lokhnygina, John B. Buse, Juliana C. Chan, Jasmine Choi, Stephanie M. Gustavson, Nayyar Iqbal, Aldo P. Maggioni, Steven P. Marso, Peter Öhman, Neha J. Pagidipati, Neil Poulter, Ambady Ramachandran, Bernard Zinman, and Adrian F. Hernandez, for the EXSCEL Study Group
N Engl J Med 2017;377:1228-39. Published:28-Sep-2017. Epub:14-Sep-2017. PMID:28910237. doi:10.1056/NEJMoa1612917
[Slides]

Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)
Robert J. Mentz , M. Angelyn Bethel, Stephanie Gustavson, Vivian P. Thompson, Neha J. Pagidipati, John B. Buse, Juliana C. Chan, Nayyar Iqbal, Aldo P. Maggioni, Steve P. Marso, Peter Ohman, Neil Poulter, Ambady Ramachandran, Bernard Zinman, Adrian F. Hernandez, Rury R. Holman
Am Heart J. 2017;187:1-9. Published:14-Sep-2017. Epub:12-Feb-2017. PMID:28454792. doi:10.1016/j.ahj.2017.02.005

Rationale and Design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) Trial
Rury R. Holman, M. Angelyn Bethel, Jyothis George, Harald Sourij, Zoë Doran, Joanne Keenan, Nardev S. Khurmi, Robert J. Mentz, Abderrahim Oulhaj, John B. Buse, Juliana C. Chan, Nayyar Iqbal, Sudeep Kundu, Aldo P. Maggioni, Steven P. Marso, Peter Öhman, Michael J. Pencina, Neil Poulter, Lisa E. Porter, Ambady Ramachandran, Bernard Zinman, Adrian F.Hernande
American Heart Journal 2016;174:103-110. Published:Apr-2016. Epub:21-Dec-2015. PMID:26995376. doi:10.1016/j.ahj.2015.12.009