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Association of obesity with cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease: Insights from TECOS
ConclusionsThe majority of TECOS participants with ASCVD and T2D were overweight or obese, yet overweight or obese class I individuals had lower CV risk than those who were under/normal weight. These results suggest the presence of an obesity paradox, but this paradox may reflect an epidemiological artifact rather than a true negative association between normal weight and clinical outcomes.
Source: American Heart Journal - October 21, 2019 Category: Cardiology Source Type: research

Effect of adding GLP-1RA on mortality, cardiovascular events, and metabolic outcomes among insulin-treated patients with type 2 diabetes: A large retrospective UK cohort study
Conclusion Based on a large UK cohort in routine clinical practice, adding a GLP-1RA to insulin therapy is associated with a reduction in risk of composite CV events and all-cause mortality but a nonsignificant higher risk of hospitalization for heart failure in overweight patients with T2D.
Source: American Heart Journal - December 1, 2017 Category: Cardiology Source Type: research

Effect of adding GLP-1RA on mortality, cardiovascular events and metabolic outcomes among insulin-treated patients with Type 2 Diabetes: A Large Retrospective UK Cohort Study
Conclusion Based on a large UK cohort in routine clinical practice, adding a GLP-1RA to insulin therapy is associated with a reduction in risk of composite CV events and all-cause mortality, but non-significant higher risk of hospitalisation for heart failure in overweight patients with Type 2 diabetes.
Source: American Heart Journal - October 10, 2017 Category: Cardiology Source Type: research

Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) – DEVOTE 1
Publication date: September 2016 Source:American Heart Journal, Volume 179 Author(s): Steven P. Marso, Darren K. McGuire, Bernard Zinman, Neil R. Poulter, Scott S. Emerson, Thomas R. Pieber, Richard E. Pratley, Poul-Martin Haahr, Martin Lange, Kirstine Brown Frandsen, Rasmus Rabøl, John B. Buse DEVOTE was designed to evaluate the cardiovascular safety of insulin degludec (IDeg) vs insulin glargine U100 (IGlar) in patients with T2D at high risk of cardiovascular events. DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven t...
Source: American Heart Journal - July 30, 2016 Category: Cardiology Source Type: research

Cardiovascular safety of insulin degludec versus insulin glargine in patients at high risk of cardiovascular events: Design of the DEVOTE Cardiovascular Outcomes Trial (DEVOTE 1)
Publication date: Available online 18 June 2016 Source:American Heart Journal Author(s): Steven P. Marso, Darren K. McGuire, Bernard Zinman, Neil R. Poulter, Scott S. Emerson, Thomas R. Pieber, Richard E. Pratley, Poul-Martin Haahr, Martin Lange, Kirstine Brown Frandsen, Rasmus Rabøl, John B. Buse The Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) was designed to evaluate the cardiovascular safety of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes at high risk of c...
Source: American Heart Journal - June 17, 2016 Category: Cardiology Source Type: research

Design of the liraglutide effect and action in diabetes: Evaluation of cardiovascular outcome results (LEADER) trial
Conclusions LEADER commenced in September 2010, and enrollment concluded in April 2012. There were 9,340 patients enrolled at 410 sites in 32 countries. The mean age of patients was 64.3 ± 7.2 years, 64.3% were men, and mean body mass index was 32.5 ± 6.3 kg/m2. There were 7,592 (81.3%) patients with prior CVD and 1,748 (18.7%) who were high risk but without prior CVD. It is expected that LEADER will provide conclusive data regarding the cardiovascular safety of liraglutide relative to the current standard of usual care for a global population of patients with T2DM.
Source: American Heart Journal - October 20, 2014 Category: Cardiology Source Type: research

Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease
Sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, lowers blood glucose when administered as monotherapy or in combination with other antihyperglycemic agents. TECOS will evaluate the effects of adding sitagliptin to usual diabetes care on cardiovascular outcomes and clinical safety. TECOS is a pragmatic, academically run, multinational, randomized, double-blind, placebo-controlled, event-driven trial recruiting approximately 14,000 patients in 38 countries who have type 2 diabetes (T2DM), are at least 50 years old, have cardiovascular disease, and have an hemoglobin A1c value between 6.5% and 8.0%. Eligible participan...
Source: American Heart Journal - October 25, 2013 Category: Cardiology Authors: Jennifer B. Green, M. Angelyn Bethel, Sanjoy K. Paul, Arne Ring, Keith D. Kaufman, Deborah R. Shapiro, Robert M. Califf, Rury R. Holman Tags: Trial Design Source Type: research

Design of the liraglutide effect and action in diabetes: Evaluation of cardiovascular outcome results (LEADER) trial
Conclusions: LEADER commenced in September 2010, and enrollment concluded in April 2012. There were 9,340 patients enrolled at 410 sites in 32 countries. The mean age of patients was 64.3 ± 7.2 years, 64.3% were men, and mean body mass index was 32.5 ± 6.3 kg/m2. There were 7,592 (81.3%) patients with prior CVD and 1,748 (18.7%) who were high risk but without prior CVD. It is expected that LEADER will provide conclusive data regarding the cardiovascular safety of liraglutide relative to the current standard of usual care for a global population of patients with T2DM.
Source: American Heart Journal - October 4, 2013 Category: Cardiology Authors: Steven P. Marso, Neil R. Poulter, Steven E. Nissen, Michael A. Nauck, Bernard Zinman, Gilbert H. Daniels, Stuart Pocock, William M. Steinberg, Richard M. Bergenstal, Johannes F.E. Mann, Lasse Steen Ravn, Kirstine Brown Frandsen, Alan C. Moses, John B. Bus Tags: Trial Design Source Type: research

Evaluation of the dual peroxisome proliferator–activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: Rationale and design of the AleCardio trial
Conclusions: AleCardio will establish whether the PPAR-α/γ agonist aleglitazar improves cardiovascular outcomes in patients with diabetes and high-risk coronary disease.
Source: American Heart Journal - July 29, 2013 Category: Cardiology Authors: A. Michael Lincoff, Jean-Claude Tardif, Bruce Neal, Stephen J. Nicholls, Lars Rydén, Gregory G. Schwartz, Klas Malmberg, John B. Buse, Robert R. Henry, Hans Wedel, Arlette Weichert, Ruth Cannata, Diederick E. Grobbee Tags: Trial Design Source Type: research