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 … Change from baseline and analysis of covariance revisited. Is it time to REWIND the cardiorenal clock in diabetes? Glucagon-like peptide-1 receptor agonists and cardiovascular events: class effects versus individual patterns. SUSTAIN, Trial to Evaluate Cardiovascular and Other Longterm Outcomes With Semaglutide in Subjects With Type 2 Diabetes. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. Diabetes Obes Metab. Major trial(s) to support findings/Outcomes* REWIND . Group sequential methods with applications to clinical 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. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2019. ... PowerPoint Presentation 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. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. n=10142 / 3.6 yr. CREDENCE . Protection against stroke with glucagon-like peptide 1 receptor agonists: a systematic review and meta-analysis. vs placebo (PIONEER-6 . Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. The trial design has been previously published. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Glucagon-like peptide-1 receptor action in the vasculature. 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. Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests. 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. 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. 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 . 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. Background: Albiglutide is a long-acting glucagon-like peptide-1 receptor agonist that improves glycemic control in patients with type 2 diabetes mellitus (T2DM). Cardiovascular outcomes trials in type 2 diabetes: where do we go from here? 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. 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. Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests. 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. list of trial inclusion and exclusion criteria is given in the appendix (pp 151–55). Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. 9 million people. Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review. The primary major … Hertzel C Gerstein. Prof Hertzel C Gerstein, MD. n=9340 / 3.8 yr . 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. n=4401 / 2.6 yr . Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review. A graphical approach to sequentially rejective multiple test procedures. 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. Both sodium-glucose co-transporter-2 (SGLT-2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor … 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. A graphical approach to sequentially rejective multiple test procedures. 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 … n=3297 / 2 yr . Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. Designing and analyzing clinical trials with composite outcomes: consideration of possible treatment differences between the individual outcomes. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The trial was carefully monitored by members of an independent data monitoring committee who reviewed accruing and Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis. 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. GLP-1RAs in type 2 diabetes: mechanisms that underlie cardiovascular effects and overview of cardiovascular outcome data. Change from baseline and analysis of covariance revisited. 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. 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. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. ; 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. composite outcome that slightly differs based on the trial. Epub 2017 Jul 14. T2D, Type 2 diabetes. We performed this multicenter, double-blind, placebo-controlled trial at 410 sites in 32 countries. 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. 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. 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. 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… Glucagon-like peptide-1 receptor action in the vasculature. (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- 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 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, … Recommend Lancet journals to your librarian, Diabetes Canada Clinical Practice Guidelines Expert Committee. vs placebo (b ut↑ in sl e) SUSTAIN-6 . Reflections from a. Liraglutide and cardiovascular outcomes in type 2 diabetes. 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. 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. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. Glucagon-like peptide-1 receptor agonists and cardiovascular events: class effects versus individual patterns. In fact, the risk reduction was the same for both the primary and secondary prevention cohorts, a slightly puzzling finding. The REWIND protocol was approved by research ethics boards for all sites and all participants provided written informed consent. Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis. 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. 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. Pharmacologic glycemic management of type 2 diabetes in adults. All were evaluated with the intention-to-treat model. © 2019 Elsevier Ltd. All rights reserved. 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 … © 2019 Elsevier Ltd. All rights reserved. n=3183 / 1.3 yr. CANVAS . Is it time to REWIND the cardiorenal clock in diabetes? Protection against stroke with glucagon-like peptide 1 receptor agonists: a systematic review and meta-analysis. Trial Design and Oversight. Designing and analyzing clinical trials with composite outcomes: consideration of possible treatment differences between the individual outcomes. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. 9. Advanced multiplicity adjustment methods in clinical trials. . 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. Recommend Lancet journals to your librarian, Diabetes Canada Clinical Practice Guidelines Expert Committee. 5%) with previous cardiovascular disease, a high proportion of . 9 GLP-1RAs in type 2 diabetes: mechanisms that underlie cardiovascular effects and overview of cardiovascular outcome data. Reflections from a. Liraglutide and cardiovascular outcomes in type 2 diabetes. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. n=9901 / 5.4 yr. LEADER . Advanced multiplicity adjustment methods in clinical trials. 2018 Jan;20(1):42-49. doi: 10.1111/dom.13028. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2019. ... SGLT2, sodium glucose cotransporter 2. 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. 9 million people. Cardiovascular outcomes trials in type 2 diabetes: where do we go from here? 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 . DECLARE-TIMI . 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. Chloé Zhao Father - Temuera Morrison Will Play Aquaman's Father | Movies | Empire : Songs my brothers taught me (2015). Pharmacologic glycemic management of type 2 diabetes in adults. 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. 9. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. 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. 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. REWIND, Researching Cardiovascular Events With a Weekly Incretin in Diabetes. 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. n=17160 / 4.2 yr. DAPA-HF . Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials to the overall type 2 diabetes population in the United States. renal dx pts. Group sequential methods with applications to clinical trials. Correspondence. 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. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials to the overall type 2 diabetes population in the United States. Title - Author - Subject - Keywords - Created Date: 10/5/2016 12:29:00 PM Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. 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. 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.
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