Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial.
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Background In the EXSCEL (Exenatide Study of Cardiovascular Event Lowering), exenatide once-weekly resulted in a nonsignificant reduction in major adverse cardiovascular events ( MACEs ) and a nominal 14% reduction in all-cause mortality in 14 752 patients with type 2 diabetes mellitus (T2 DM ) with and without cardiovascular disease. Whether patients at increased risk for events experienced a comparatively greater treatment benefit with exenatide is unknown. Methods and Results In the EXSCEL population, we created risk scores for MACEs and all-cause mortality using step-wise selection of baseline characteristics. A risk score was calculated for each patient, and a time-to-event model for each end point was developed including the risk score, treatment assignment, and risk-treatment interaction. Interaction P values evaluating for a differential treatment effect by baseline risk were reported. Over a median follow-up of 3.2 years (interquartile range, 2.2, 4.4), 1091 (7.4%) patients died and 1744 (11.8%) experienced a MACE . Independent predictors of MACEs and all-cause mortality included age, sex, comorbidities (eg, previous cardiovascular event), body mass index, blood pressure, hemoglobin A1c, and estimated glomerular filtration rate. The all-cause mortality and MACE risk models had modest discrimination with optimism-corrected c-indices of 0.73 and 0.71, respectively. No interaction was observed between treatment effect and risk profile for either end point (both interactions, P>0.1). Conclusions Baseline characteristics (eg, age, previous cardiovascular events) and routine laboratory values (eg, hemoglobin A1c, estimated glomerular filtration rate) provided modest prognostic value for mortality and MACEs in a broad population of patients with type 2 diabetes mellitus. Exenatide's effects on mortality and MACEs were consistent across the spectrum of baseline risk. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT 01144338.
SubjectEXSCEL Study Group
Diabetes Mellitus, Type 2
Drug Administration Schedule
Cause of Death
Dose-Response Relationship, Drug
Glycated Hemoglobin A
Published Version (Please cite this version)10.1161/JAHA.118.009304
Publication InfoMentz, Robert J; Bethel, M Angelyn; Merrill, Peter; Lokhnygina, Yuliya; Buse, John B; Chan, Juliana C; ... EXSCEL Study Group (2018). Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial. Journal of the American Heart Association, 7(19). pp. e009304. 10.1161/JAHA.118.009304. Retrieved from https://hdl.handle.net/10161/19763.
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Professor of Medicine
Assistant Professor of Biostatistics and Bioinformatics
Statistical methods in clinical trials, survival analysis, adaptive designs, adaptive treatment strategies, causal inference in observational studies, semiparametric inference
Professor of Medicine
Atrial Fibrillation Antithrombotic Therapy in patients with Acute Coronary Syndromes Elderly patients with Heart Disease Biomarkers in Acute Coronary Syndromes and Atrial Fibrillation Thrombosis and Anticoagulation and novel antithrombotic agents Metabolomics in Cardiovascular Medicine
Associate Professor of Medicine
I am a cardiologist with a clinical and research interest in heart failure, including advanced therapies such as cardiac transplantation and mechanical assist devices or “heart pumps." I serve our group as Chief of the Heart Failure Section. I became a heart failure cardiologist in order to help patients manage their chronic disease over many months and years. I consider myself strongly committed to compassionate patient care with a focus on quality of life and patient preference.<br
Assistant Professor of Medicine
Neha J. Pagidipati, MD MPH is an Assistant Professor of Medicine and cardiovascular prevention specialist at the DCRI. She served as the Chief Research Fellow at the DCRI between 2016 and 2017 and has been involved with cardiovascular prevention research since 2011. Prior to coming to Duke, she trained at Brigham and Women’s Hospital for internal medicine residency, and then completed a two-year research fellowship in Global Women’s Health at the Brigham. During that time, she als
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