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Source: American Heart Journal
Condition: Diabetes Type 2
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Total 31 results found since Jan 2013.
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
Ischemic Cardiac Outcomes and Hospitalizations According to Prior Macrovascular Disease Status in Patients with Type 2 Diabetes and Recent Acute Coronary Syndrome from the EXAMINE trial
Conclusions EXAMINE demonstrates that there was no increase in the risk of cardiac ischemic events and cardiovascular hospitalizations with alogliptin in a high-risk post-ACS patient population. Since these are major driver of overall healthcare costs, these data suggest that there would be no adverse impact on healthcare resource utilization.
Source: American Heart Journal - January 25, 2016 Category: Cardiology Source Type: research
Rationale and Design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) Trial
Publication date: Available online 21 December 2015 Source:American Heart Journal Author(s): 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. Hernandez Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide (GLP)-1 receptor agonist, which can improve glycemic con...
Source: American Heart Journal - December 22, 2015 Category: Cardiology Source Type: research
Race and Ethnicity Influences on Cardiovascular and Renal Events in Patients with Diabetes Mellitus
Conclusion Despite similar access to care and lower CV event rates, the risk of ESRD was higher among blacks and Hispanics than whites. For blacks, but not Hispanics, this increase was independent of known attributable risk factors.
Source: American Heart Journal - May 23, 2015 Category: Cardiology Source Type: research
Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo
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.
Source: American Heart Journal - March 10, 2015 Category: Cardiology Source Type: research
Rationale, design, and baseline characteristics in Elixa, a long-term cardiovascular endpoint trial of Lixisenatide versus Placebo
Conclusion ELIXA will be the first trial to report the safety and efficacy of a GLP-1RA in people with T2DM and high CV-event risk.
Source: American Heart Journal - February 13, 2015 Category: Cardiology Source Type: research
Cardiovascular prognosis in patients with type 2 diabetes: Contribution of heart and kidney subclinical damage
Conclusions Electrocardiographic LVH is complementary to kidney damage for MACE prediction in T2D.
Source: American Heart Journal - December 9, 2014 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
Change in enrollment patterns, patient selection, and clinical outcomes with the availability of drug-eluting stents in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial
Background: In the BARI 2D trial, patients with type 2 diabetes and stable coronary artery disease were randomized to prompt revascularization versus intensive medical therapy (IMT). This analysis sought to evaluate how the availability of drug-eluting stents (DESs) has changed practice and outcomes.Methods: In BARI 2D, 1,605 patients were in the percutaneous coronary intervention (PCI)–intended stratum. As DES became available midway through recruitment, we report clinical outcomes among patients who underwent IMT versus prompt PCI with bare-metal stents (BMSs) or DES up to 4 years.Results: In North America, after DES b...
Source: American Heart Journal - August 7, 2013 Category: Cardiology Authors: Binita Shah, Vankeepuram S. Srinivas, Jiang Lu, Maria M. Brooks, Eric R. Bates, Zoran S. Nedeljkovic, Jorge Escobedo, Gladwin S. Das, John J. Lopez, Frederick Feit Tags: Interventional Cardiology 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
