Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2019. The REWIND trial differs from other trials of the cardiovascular effects of GLP-1 receptor agonists by having recruited a large number of people who have not had a previous cardiovascular event and whose A1C level at baseline is, on average, … Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. Change from baseline and analysis of covariance revisited. Pharmacologic glycemic management of type 2 diabetes in adults. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. Trial Design and Oversight. Is it time to REWIND the cardiorenal clock in diabetes? Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review. GLP-1RAs in type 2 diabetes: mechanisms that underlie cardiovascular effects and overview of cardiovascular outcome data. The REWIND trial showed that dulaglutide is superior to placebo in improving glycemic control and reducing CV events in patients with type 2 diabetes and higher CV risk. Cardiovascular outcomes trials in type 2 diabetes: where do we go from here? Semaglutide, a GLP-1 analogue with an extended half-life of approximately 1 week (which permits once-weekly subcutaneous administration),4 is currently in development but not yet approved for the treatment of type 2 diabetes. stratification by trial and CV disease history • Pooled data from canagliflozin doses compared with placebo • CV event (90% power) and time (>78 weeks) driven study • Homogeneity of treatment effects across the two trials was evaluated • Sequential testing prespecified . Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Design and baseline characteristics of participants in the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. Protection against stroke with glucagon-like peptide 1 receptor agonists: a systematic review and meta-analysis. Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis. ; The REWIND trial assessed the effect of dulaglutide on major adverse CV events when added to the existing antihyperglycemic regimens in individuals with type 2 diabetes with and without previous CV disease and a wide range of glycemic control. 12 In brief, this was a multicenter, randomized, double-blind, active-controlled clinical trial conducted at 607 centers across 43 countries, aimed to continue until at least 631 participants had an adjudication-confirmed primary outcome event. The results from this trial demonstrate than the GLP-1 agonist dulaglutide (in addition to standard therapy) is superior to placebo in terms of reducing cardiovascular outcomes. renal dx pts. Glucagon-like peptide-1 receptor action in the vasculature. Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests. 9 Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Is it time to REWIND the cardiorenal clock in diabetes? Comparison of the effects of glucagon-like peptide receptor agonists and sodium-glucose cotransporter 2 inhibitors for prevention of major adverse cardiovascular and renal outcomes in type 2 diabetes mellitus. Recommend Lancet journals to your librarian, Diabetes Canada Clinical Practice Guidelines Expert Committee. Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program. ... PowerPoint Presentation Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2019. Reflections from a. Liraglutide and cardiovascular outcomes in type 2 diabetes. Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests. Major trial(s) to support findings/Outcomes* REWIND . Diabetes Obes Metab. A graphical approach to sequentially rejective multiple test procedures. The Lancet Regional Health – Western Pacific, Advancing women in science, medicine and global health, Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial, Access any 5 articles from the Lancet Family of journals, https://doi.org/10.1016/S0140-6736(19)31149-3, Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial, http://dx.doi.org/10.1016/S0140-6736(19)31150-X. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials to the overall type 2 diabetes population in the United States. Three different GLP-1 RAs have been shown to reduce CV outcomes in people with type 2 diabetes at high CV risk with elevated HbA 1c levels. Correspondence. Advanced multiplicity adjustment methods in clinical trials. Cardiovascular outcomes trials in type 2 diabetes: where do we go from here? Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. © 2019 Elsevier Ltd. All rights reserved. The trial design has been previously published. Design and baseline characteristics of participants in the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. T2D, Type 2 diabetes. REWIND (Researching cardiovascular Events with a Weekly INcretin in Diabetes) was a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the effect of Trulicity 1.5 mg, a weekly glucagon-like peptide 1 receptor agonist (GLP-1 RA), compared to placebo, both added to standard of care (according to local standard of care guidelines), on cardiovascular (CV) events in … Dr. Gerstein:The REWIND trial was designed to determine whether the GLP-1 receptor agonist dulaglutide can reduce the incidence of major cardiovascular events in people with type 2 diabetes. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. DECLARE-TIMI . 9. Designing and analyzing clinical trials with composite outcomes: consideration of possible treatment differences between the individual outcomes. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Background: Albiglutide is a long-acting glucagon-like peptide-1 receptor agonist that improves glycemic control in patients with type 2 diabetes mellitus (T2DM). CAROLINA ® (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) is a multi-national, randomised, double-blind, active-controlled clinical trial that involved 6,033 adults with type 2 diabetes from 43 countries at more than 600 sites observed for a median duration of more than 6 years. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. CARMELINA is a long-term cardiovascular outcome trial that evaluates the impact of treatment with linagliptin on CV and kidney safety for type 2 diabetes. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. None of the trials were fully representative of the reference population, which included commercially insured patients <65 years of age, but may not be aligned to the general population. Results from early trials evaluating CV outcomes under glucose-lowering therapies could not ascertain a clear relationship between HbA1c target levels, hypoglycemia incidence and CV risk, despite a tendency for intense glucose control being beneficial in the long-term [6, 29–39].Therefore, to avoid confounding results derived from glycemic values and the drugs themselves, CVOTs started … Glucagon-like peptide-1 receptor agonists and cardiovascular events: class effects versus individual patterns. A plus for Lilly was that Rewind showed a benefit in patients both with and without existing cardiovascular disease; 69% of trial subjects had cardiovascular risk factors but no underlying disease. Title - Author - Subject - Keywords - Created Date: 10/5/2016 12:29:00 PM The trial was carefully monitored by members of an independent data monitoring committee who reviewed accruing and The Lancet Regional Health – Western Pacific, Advancing women in science, medicine and global health, Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial, Access any 5 articles from the Lancet Family of journals, https://doi.org/10.1016/S0140-6736(19)31149-3, Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial, http://dx.doi.org/10.1016/S0140-6736(19)31150-X. Protection against stroke with glucagon-like peptide 1 receptor agonists: a systematic review and meta-analysis. Designing and analyzing clinical trials with composite outcomes: consideration of possible treatment differences between the individual outcomes. . 9. n=10142 / 3.6 yr. CREDENCE . © 2019 Elsevier Ltd. All rights reserved. Epub 2017 Jul 14. n=9901 / 5.4 yr. LEADER . Eli Lilly has announced top line results from REWIND, a multicenter, randomized, double-blind, placebo-controlled trial designed to study dulaglutide ().The cardiovascular outcomes trial, which had a median follow-up period of more than 5 years, evaluated cardiovascular outcomes in nearly 10,000 patients with type 2 diabetes. In participants with type 2 diabetes (T2D) in the REWIND trial, dulaglutide (DU) use for median follow-up of 5.4 years was associated with reduced composite renal outcomes, defined as the first occurrence of new macroalbuminuria, sustained decline in estimated glomerular filtration rate (eGFR) of ≥30%, or chronic renal replacement therapy. Both sodium-glucose co-transporter-2 (SGLT-2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor … 2018 Jan;20(1):42-49. doi: 10.1111/dom.13028. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Comparison of the effects of glucagon-like peptide receptor agonists and sodium-glucose cotransporter 2 inhibitors for prevention of major adverse cardiovascular and renal outcomes in type 2 diabetes mellitus. The Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial of the glucagon-like peptide 1 (GLP-1) receptor agonist dulaglutide included a greater proportion of individuals with type 2 diabetes with high cardiovascular risk but without prior established cardiovascular disease (CVD) (68.5%) and with longer follow-up (median 5.4 years) than prior CVOTs . Hertzel C Gerstein. Glucagon-like peptide-1 receptor agonists and cardiovascular events: class effects versus individual patterns. Group sequential methods with applications to clinical trials. n=9340 / 3.8 yr . ... SGLT2, sodium glucose cotransporter 2. Change from baseline and analysis of covariance revisited. Pharmacologic glycemic management of type 2 diabetes in adults. Chloé Zhao Father - Temuera Morrison Will Play Aquaman's Father | Movies | Empire : Songs my brothers taught me (2015). Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. REWIND’s primary CV outcome was the first occurrence of MACE, the composite of CV death or non-fatal myocardial infarction or non-fatal stroke. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials to the overall type 2 diabetes population in the United States. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. GLP-1RAs in type 2 diabetes: mechanisms that underlie cardiovascular effects and overview of cardiovascular outcome data. (REWIND) trial of the glucagon-like peptide 1 (GLP-1) receptor agonist dulaglutide 1Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC 2Department of Medicine and Diabetes Unit, Massachusetts General Hospital, Boston, MA 3Harvard Medical School, Boston, MA 4Second Medical Department, Aristotle Univer- Prof Hertzel C Gerstein, MD. The recent REWIND (Researching Cardiovascular Events with a Weekly Incretin in Diabetes) trial provides ample opportunity to pause and reflect on the recent data on novel glucose-lowering medications and their associated cardiovascular outcomes—a topic of intense interest. n=17160 / 4.2 yr. DAPA-HF . In fact, the risk reduction was the same for both the primary and secondary prevention cohorts, a slightly puzzling finding. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review. list of trial inclusion and exclusion criteria is given in the appendix (pp 151–55). REWIND, Researching Cardiovascular Events With a Weekly Incretin in Diabetes. vs placebo (b ut↑ in sl e) SUSTAIN-6 . SUSTAIN, Trial to Evaluate Cardiovascular and Other Longterm Outcomes With Semaglutide in Subjects With Type 2 Diabetes. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. 9 million people. The primary major … 5%) with previous cardiovascular disease, a high proportion of . Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program. Reflections from a. Liraglutide and cardiovascular outcomes in type 2 diabetes. A graphical approach to sequentially rejective multiple test procedures. 9 million people. vs placebo (PIONEER-6 . Regulatory guidance specifies the need to establish the cardiovascular safety of new therapies for type 2 diabetes in order to rule out excess cardiovascular risk.5 The preapproval Trial to Evaluate Cardiovascular and O… We performed this multicenter, double-blind, placebo-controlled trial at 410 sites in 32 countries. Glucagon-like peptide-1 receptor action in the vasculature. n=4401 / 2.6 yr . The REWIND trial aimed to assess whether dulaglutide could reduce major cardiovascular events (MACE) and other serious outcomes in people with T2D, when added to their anti-hyperglycemic regimen. CAArdIoV sCuLAr ou TCoMes TrIALs Lixisenatide: eLIXA The first CVOT among the GLP-1 RAs was the evaluation of lixisenatide in acute coronary syndrome (ELIXA) trial, published in 2016.17 Participants included were those with T2D who also Description: The goal of the trial was to assess the cardiovascular (CV) safety of dulaglutide, a glucagon-like peptide-1 (GLP-1) agonist, in patients with type 2 diabetes mellitus at higher risk for CV events. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. composite outcome that slightly differs based on the trial. Harmony Outcomes is a randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major adverse cardiovascular (CV) events in patients with T2DM and established CV disease. All were evaluated with the intention-to-treat model. The REWIND protocol was approved by research ethics boards for all sites and all participants provided written informed consent. Recommend Lancet journals to your librarian, Diabetes Canada Clinical Practice Guidelines Expert Committee. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. Advanced multiplicity adjustment methods in clinical trials. n=3297 / 2 yr . n=3183 / 1.3 yr. CANVAS . Group sequential methods with applications to clinical trials. The REWIND study investigated the effect of the glucagon-like peptide 1 (GLP-1) receptor agonist dulaglutide on major adverse cardiovascular events (MACE) in individuals with type 2 diabetes (T2D) with and without previous cardiovascular disease and with a wide range of glycemic control. Based on its criteria, 42.6% of the reference population were eligible for enrollment in REWIND, versus 15.9% in EXSCEL, 13.0% in SUSTAIN-6, and 12.9% in LEADER. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. REWIND is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the effect of weekly dulaglutide 1.5 mg, both added to standard of care, on CV events in …
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