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Source: American Heart Journal
Condition: Diabetes Type 2

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Total 31 results found since Jan 2013.

Rationale and design of the Cardiovascular Inflammation Reduction Trial: A test of the inflammatory hypothesis of atherothrombosis
Background: Inflammation plays a fundamental role in atherothrombosis. Yet, whether direct inhibition of inflammation will reduce the occurrence of adverse cardiovascular outcomes is not known.Design: The Cardiovascular Inflammation Reduction Trial (CIRT) (ClinicalTrials.gov NCT01594333) will randomly allocate 7,000 patients with prior myocardial infarction (MI) and either type 2 diabetes or the metabolic syndrome to low-dose methotrexate (target dose 15-20 mg/wk) or placebo over an average follow-up period of 3 to 5 years. Low-dose methotrexate is a commonly used anti-inflammatory regimen for the treatment of rheumatoid a...
Source: American Heart Journal - May 6, 2013 Category: Cardiology Authors: Brendan M. Everett, Aruna D. Pradhan, Daniel H. Solomon, Nina Paynter, Jean MacFadyen, Elaine Zaharris, Milan Gupta, Michael Clearfield, Peter Libby, Ahmed A.K. Hasan, Robert J. Glynn, Paul M. Ridker 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

The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE) –TIMI 58 Trial
Conclusion The DECLARE–TIMI 58 trial is testing the hypotheses that dapagliflozin is safe (does not increase) and may reduce the occurrence of major CV events. DECLARE–TIMI 58 is the largest study to address this question with an SGLT-2 inhibitor in patients with T2DM and with established CV disease and without CV disease but with multiple risk factors.
Source: American Heart Journal - May 8, 2018 Category: Cardiology Source Type: research

Harmony Outcomes: A randomized, double blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus —rationale, design, and baseline characteristics
Conclusions Harmony Outcomes will assess the CV safety of albiglutide in patients with T2DM and CV disease. Trials of other agents in the GLP-1 RA class have shown CV benefit for only some of these medications, possibly due to differences in trial design or instead due to differences in drug structure or metabolism. Harmony Outcomes will provide information critical to our understanding of this heterogenous class of glucose-lowering agents.
Source: American Heart Journal - June 13, 2018 Category: Cardiology Source Type: research

Harmony Outcomes: A randomized, double blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus—rationale, design, and baseline characteristics
ConclusionsHarmony Outcomes will assess the CV safety of albiglutide in patients with T2DM and CV disease. Trials of other agents in the GLP-1 RA class have shown CV benefit for only some of these medications, possibly due to differences in trial design or instead due to differences in drug structure or metabolism. Harmony Outcomes will provide information critical to our understanding of this heterogenous class of glucose-lowering agents.
Source: American Heart Journal - July 5, 2018 Category: Cardiology Source Type: research

Harmony Outcomes: A randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus—Rationale, design, and baseline characteristics
ConclusionsHarmony Outcomes will assess the CV safety of albiglutide in patients with T2DM and CV disease. Trials of other agents in the glucagon-like peptide-1 receptor agonist class have shown CV benefit for only some of these medications, possibly due to differences in trial design or instead due to differences in drug structure or metabolism. Harmony Outcomes will provide information critical to our understanding of this heterogenous class of glucose-lowering agents.
Source: American Heart Journal - July 10, 2018 Category: 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

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

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

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

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

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