Rhonda Bentley-Lewis1, David Aguilar2, Matthew C Riddle3, Brian Claggett4, Rafael Diaz5, Kenneth Dickstein6, Hertzel C Gerstein7, Peter Johnston8, Lars V Køber9, Francesca Lawson8, Eldrin F Lewis4, Aldo P Maggioni10, John J V McMurray11, Lin Ping8, Jeffrey L Probstfield12, Scott D Solomon4, Jean-Claude Tardif13, Yujun Wu8, Marc A Pfeffer4. 1. Department of Medicine/Diabetes Unit, Massachusetts General Hospital, Boston, MA. Electronic address: rbentleylewis@partners.org. 2. Department of Medicine, Baylor College of Medicine, Houston, TX. 3. Department of Medicine, Oregon Health & Science University, Portland, OR. 4. Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Boston MA. 5. Estudios Cardiologicos Latinoamerica, Rosario, Santa Fe, Argentina. 6. University of Bergen, Stavanger University Hospital, Stavanger, Norway. 7. Department of Medicine and Population Health Research Institute, McMaster University & Hamilton Health Sciences, Hamilton, Ontario, Canada. 8. Sanofi-Aventis, Bridgewater, NJ. 9. The Heart Centre, Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark. 10. ANMCO Research Center, Florence, Italy. 11. British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. 12. Department of Medicine/Cardiology, University of Washington Medical Center, Seattle, WA. 13. Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada.
Abstract
BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. METHODS:ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. RESULTS:Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. CONCLUSION:ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk.
RCT Entities:
BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. METHODS: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. RESULTS: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. CONCLUSION: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk.
Authors: Emil Wolsk; Brian Claggett; Rafael Diaz; Kenneth Dickstein; Hertzel C Gerstein; Lars Køber; Eldrin F Lewis; Aldo P Maggioni; John J V McMurray; Jeffrey L Probstfield; Matthew C Riddle; Scott D Solomon; Jean-Claude Tardif; Marc A Pfeffer Journal: J Am Heart Assoc Date: 2022-04-06 Impact factor: 6.106
Authors: Ling Li; Sheyu Li; Jiali Liu; Ke Deng; Jason W Busse; Per Olav Vandvik; Evelyn Wong; Zahra N Sohani; Malgorzata M Bala; Lorena P Rios; German Malaga; Shanil Ebrahim; Jiantong Shen; Longhao Zhang; Pujing Zhao; Qunfei Chen; Yingqiang Wang; Gordon H Guyatt; Xin Sun Journal: BMC Cardiovasc Disord Date: 2016-05-11 Impact factor: 2.298