cvot diabetes - People with type 2 diabetes aged best rice diabetes 40 years with established atherosclerotic CV disease HbA1c 7 to 105 and body mass index 25 kgm 2 were randomized 11 to once weekly subcutaneous injection of either tirzepatide up to 15 mg or dulaglutide 15 mg The cardiovascular safety profile of dapagliflozin a selective inhibitor of sodiumglucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes is undefined The 2008 FDA guidance required longterm cardiovascular outcome trial CVOT evidence or other equivalent evidence to rule out increased risk of a major adverse cardiovascular event MACE for all new T2DM glucoselowering therapies Table 1 CVOT Summit 2022 Report new cardiovascular kidney and Cardiovascular outcomes trials a paradigm shift in the Cardiovascular disease CVD is the leading cause of mortality and morbidity in patients with type 2 diabetes T2D Historical concerns about cardiovascular CV risks associated with certain glucoselowering medications gave rise to the Comparison of tirzepatide and dulaglutide on major adverse The data from all CVOTs discussed fulfill the FDA criteria of establishing CV safety for lixisenatide liraglutide semaglutide exenatide extended release albiglutide dulaglutide empagliflozin canagliflozin and dapagliflozin in patients with type 2 diabetes at high CV risk As some glucoselowering medications raised concerns of elevated micro and macrovascular risk the American Food and Drug Administration FDA mandated Cardiovascular Outcome Trials CVOTs in diabetes in 2008 to prevent an undesired increase of CV risk 5 The novel T2D subgroups severe insulindeficient diabetes SIDD severe insulinresistant diabetes SIRD mild obesityrelated diabetes MOD and mild agerelated diabetes MARD have been found to be predisposed to different risks of developing CVD CKD or diabetic retinopathy Patients with type 2 diabetes who were at high risk for cardiovascular disease were randomly assigned in a 11 ratio to receive liraglutide or placebo The minimum planned followup was 42 Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes Cardiovascular outcomes trials a paradigm shift in the Cardiovascular disease CVD is the leading cause of mortality and morbidity in patients with type 2 diabetes T2D Historical concerns about cardiovascular CV risks associated with certain glucoselowering medications gave rise to the introduction of cardiovascular outcomes trials CVOTs Key CVOTs with Semaglutide SUSTAIN 6 and PIONEER 6 Report from the 5th cardiovascular outcome trial CVOT summit Semaglutide and Cardiovascular Outcomes in Patients with Type Impact of Regulatory Guidance on Evaluating Cardiovascular Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes Comparison of tirzepatide and dulaglutide on major adverse Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes Cardiovascular outcomes trials a paradigm shift in the GLP1 Receptor Agonists for the Reduction of Atherosclerotic In a multicenter doubleblind trial we randomly assigned patients with type 2 diabetes and atherosclerotic cardiovascular disease to receive 5 mg or 15 mg of ertugliflozin or recipes for ckd and diabetes placebo once Current perspectives on cardiovascular outcome trials in diabetes Report from the CVOT Summit 2020 new cardiovascular and Volume 267 January 2024 Pages 111 Trial Designs Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease SURPASSCVOT design and baseline characteristics Stephen J Nicholls MBBS PhD a Deepak L Bhatt MD b John B Buse MD c CVD CKD and diabetes represent leading global causes of death showing more than 25 increase for CVD associated deaths and nearly twofold increase for CKD and diabetes associated deaths since 1990 T2D results in a reduced life expectancy by 10 years with CVD and by 16 years with CKD the latter being the most prominent comorbidity in T2D 6 Both subcutaneous semaglutide Ozempic and oral semaglutide Rybelsus are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 12 Both are not recommended as firstline therapy for patients inadequately controlled on diet and exercise The Ozempic label states that there have Cardiovascular Outcomes Trials in Type 2 Diabetes Where Do Cardiovascular Outcome Trials in Type 2 Diabetes What Do Among diabetesrelated complications cardiovascular disease CVD stands as the leading cause for mortality and adverse outcomes in patients with type 2 diabetes T2D More than 60 die from CVD while an even greater proportion suffer serious CVassociated complications 1 Cardiovascular disease CVD is the leading cause of death and morbidity in people with diabetes In 2017 the total cost of diagnosed diabetes in the United States was 327 billion 1 and CVD is the largest contributor to the direct and indirect costs of diabetes 2 3 In June 2016 a Diabetes Care Editors Expert Forum convened and began to review the processes and challenges of CVOTs discuss the benefits and drawbacks of their current designs and weigh the merits of potential modifications that might improve the efficiency and clinical value of future trials This process continued through September Cardiovascular Outcome Trials in Type 2 Diabetes What Do Cardiovascular disease CVD is the leading cause of mortality and morbidity in patients with type 2 diabetes T2D Historical concerns about cardiovascular CV risks associated with certain glucoselowering medications gave rise to the introduction of cardiovascular outcomes trials CVOTs Over the past several years multiple large cardiovascular outcome trials CVOTs with novel glucoselowering agents namely SGLT2i SGLT2 inhibitors and GLP1 RA GLP1 receptor agonists have demonstrated robust and significant reductions of major adverse cardiovascular events MACE and additional cardiovascular outcomes such as hospitaliz In patients with type 2 diabetes who were at high cardiovascular risk the rate of cardiovascular death nonfatal myocardial infarction or nonfatal stroke was apa artinya diabetes significantly lower among patients
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