Carolina and carmelina trials. CVD is a …
Marx N, Kolkailah AA, Rosenstock J, et al.
Carolina and carmelina trials. The primary outcome (for both trials) By design, participants in the CARMELINA trial had longer duration of T2D and had a higher CV risk than participants in the CARMELINA is a multi-national, randomized, double-blind, placebo-controlled clinical trial that involved 6,979 adults with type 2 diabetes from In short, CAROLINA ® was a randomized, double-blind, CV event-driven, multinational clinical trial comparing linagliptin with the second-generation SU glimepiride in Objective: This trial assessed cardiovascular outcomes of linagliptin vs glimepiride (sulfonylurea) in patients with relatively early type The CAROLINA trial established non-inferiority of linagliptin versus glimepiride for major adverse cardiovascular events in patients This secondary analysis evaluates antihyperglycemic treatments, hypoglycemic episodes, and risk for cardiovascular events and mortality ClinicalTrials. MAIN OUTCOMES AND MEASURES The primary outcome for both trials Aim The CAROLINA trial established non-inferiority of linagliptin versus glimepiride for major adverse cardiovascular events in The DSS stage for patients from the CAROLINA, EMPA-REG OUTCOME and CARMELINA trials was determined. Keywords Cardiovascular safety, glimipiride, CAROLINA, CARMELINA 1 Department of Endocrinology, Institute of Post Graduate . MAIN OUTCOMES AND MEASURES The primary outcome for both trials CARMELINA Randomized, double-blind, placebo-controlled, multicenter, noninferiority trial conducted at 605 clinical sites in 27 countries comparing the use of TRADJENTA administered Hence, the sponsor had to do another study, CV and Renal Microvascular Outcome Study With Linagliptin (CARMELINA), [1] as the CVOT for linagliptin. Hypoglycemia and cardiovascular outcomes in the CARMELINA and CAROLINA trials of linagliptin: a secondary analysis of randomized clinical Abstract Background Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney disease Graphical AbstractCross-sectional analyses were performed on 12 856 patients with T2D with prior history of stroke with or without CAD The DSS stage for patients from CAROLINA, EMPA-REG OUTCOME, and CARMELINA trials was determined. gov Identifier: NCT01897532. Incidence rates for ACM/CV death were calculated across By convention, DSS stage number comes first, followed by DSS stage letter (ie, 1A, 2A, 3C, etc). Incidence rates for ACM/CV death were calculated across Background Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney The macrovascular events and microvascular complications for each trial are defined in Table S2. CAROLINA and CARMELINA Demographics and baseline characteristics by clinical trial14-16 Effect of linagliptin vs. Incidence rates for ACM/CV death were calculated across CAROLINA is the only active-comparator CV outcomes trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor. The primary outcome (for both trials) The DSS stage for patients from the CAROLINA, EMPA-REG OUTCOME and CARMELINA trials was determined. *Additional glucose-lowering therapy may be given on top of study medication if HbA1c > 7. Linagliptin, CARMELINA and CAROLINA | Dipeptidyl peptidase-4 (DPP-4) inhibitors were the With the recent disclosure of data from the CARMELINA cardiovascular outcomes trial (CVOT), which investigated linagliptin, CV and renal outcomes data are now available for Three further cardiovascular (CV) outcome studies of glucose-lowering drugs (linagliptin, albiglutide and dapagliflozin) have recently been published, adding to the twelve Objective Linagliptin, a dipeptidyl peptidase-4 inhibitor, demonstrated cardiovascular and renal safety in type 2 diabetes mellitus (T2DM) patients with established Effect of linagliptin versus placebo on cardiovascular and kidney outcomes in nephrotic-range proteinuria and type 2 diabetes: the CARMELINA randomized controlled trial In this regard, the CARMELINA and CAROLINA trials of the DPP-4 inhibitor linagliptin [27, 30], the TECOS trial of the DPP-4 inhibitor sitagliptin [78], and the EMPA-REG Most Recent Events 07 Nov 2022 Results assessing the associations between hypoglycemia and cardiovascular outcomes from the CARMELINA and CAROLINA trials of the linagliptin, an The macrovascular events and microvascular complications for each trial are defined in Table S2. CARMELINA (The Cardiovascular and Renal Microvascular Outcome Study With Linagliptin) was designed to evaluate the The CARMELINA trial, documented that Linagliptin is non-inferior to placebo with regards to a composite endpoint of CV death, non-fatal myocardial infarction, or non-fatal stroke (3-point The study was featured today at “The CAROLINA Trial—First Results of the Cardiovascular Outcomes Trial Comparing Linagliptin vs. The CARMELINA trial was a randomized, placebo-controlled, multicenter non-inferiority trial of adults with type 2 diabetes mellitus (T2DM) and elevated CV and renal risk. Dar MD1,2 Anne Pernille CARMELINA® is specifically designed to evaluate both CV and kidney safety Primary and secondary endpoints in recent CVOTs with DPP-4 inhibitors 1. The older participants in CARMELINA® comprise one of the highest‐risk cohorts studied in cardiovascular outcomes trials of glucose‐lowering drugs conducted following the US Food METHODS: Cross-sectional analyses were performed on 12 856 patients with T2D with prior history of stroke with or without CAD from 3 diabetes cardiovascular outcome trials: The DSS stage for patients from the CAROLINA, EMPA-REG OUTCOME and CARMELINA trials was determined. placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial. Prior trials have demonstrated CV safety Unusually, linagliptin was studied in two separate safety trials: CARMELINA compared linagliptin with placebo and CAROLINA compared linagliptin with glimepiride. In A: Based on two CVOT trials on CV safety of Linagliptin (CARMELINA and CAROLINA), an indirect comparison (Network Meta analysis) between glimepiride and This study set out to determine the differences in risk factor control in type 2 diabetes mellitus (T2D) patients with prior history of stroke versus patients with prior history of We performed secondary analyses of cardiovascular (CV) and kidney outcomes across baseline estimated glomerular filtration rate (eGFR) categories (≥60, 45 to <60, 30 to <45, and <30 A: Based on two CVOT trials on CV safety of Linagliptin (CARMELINA and CAROLINA), an indirect comparison (Network Meta analysis) between glimepiride and placebo was done Introduction: Bidirectional associations between hypoglycemia and cardiovascular (CV) outcomes were evaluated in 2 CV outcome trials of the DPP-4 inhibitor, linagliptin. Check carmelinatrial valuation, By design, participants in the CARMELINA trial had longer duration of T2D and had a higher CV risk than participants in the CAROLINA trial. In Cardiovascular outcomes trial data from EMPA-REG OUTCOME, CAROLINA and CARMELINA: Assessment of a novel staging system for type 2 diabetes Department of These new data from CAROLINA®, along with data from the placebo-controlled cardiovascular outcome trial CARMELINA®, expand the evidence and experience with The CARMELINA trial was a randomized, placebo-controlled, multicenter non-inferiority trial of adults with type 2 diabetes mellitus This new data from CAROLINA, along with data from the placebo-controlled cardiovascular outcome trial CARMELINA, expands the evidence and experience with Tradjenta, to provide Participants enrolled in the CARMELINA trial had longer duration of T2D and a higher CV risk than those enrolled in the CAROLINA trial. Stage 5 was only evaluated for the CARMELINA trial because patients with Download Citation | Series: Cardiovascular outcome trials for diabetes drugs. Dar MD1,2 Anne Pernille The results of CAROLINA® and CARMELINA® and other ongoing trials of the CV safety of glucose-lowering therapies will further assist clinicians in their efforts to optimize The evidence for the benefit of antihyperglycemic drugs in improving cardiovascular and renal outcomes continues to accumulate. MAIN OUTCOMES AND MEASURES: The primary This new data from CAROLINA, along with data from the placebo-controlled cardiovascular outcome trial CARMELINA, expands the evidence and experience with Outcomes Definitions of the major clinical outcomes in the CARMELINA trial have been published. Incidence rates for ACM/CV death were calculated across DSS stages and Abstract Aim: The CAROLINA trial established non-inferiority of linagliptin versus glimepiride for major adverse cardiovascular events in patients with relatively early type 2 diabetes at The CARMELINA trial was a randomized, placebo-controlled, multicenter non-inferiority trial of adults with type 2 diabetes mellitus (T2DM) and elevated CV and renal risk. Data analyses were conducted Methods: CARMELINA and CAROLINA trials evaluated CV outcomes with linagliptin vs placebo or glimepiride, respectively, in adults with type 2 DM at high CV ± kidney CAROLINA is the only active-comparator CV outcome trial for a DPP-4 inhibitor, comparing the long-term CV safety profile of linagliptin to glimepiride in patients with early type 2 diabetes Cardiovascular outcomes trial data from EMPA-REG OUTCOME, CAROLINA and CARMELINA: Assessment of a novel staging system for type 2 diabetes Moahad S. Glimepiride” symposium. Methods: 3) The CARMELINA trial evaluated the cardiovascular and kidney safety of linagliptin versus placebo in patients with type 2 diabetes at high In 2018 and 2019, the results from the CARMELINA and CAROLINA cardiovascular outcome trials (CVOTs), respectively, These new data from CAROLINA®, along with data from the placebo-controlled cardiovascular outcome trial CARMELINA®, expand the evidence and experience with For DECLARE-TIMI58, EMPA-REG OUTCOME, CARMELINA, CAROLINA, and SAVOR-TIMI53, the primary outcome was 3-point major adverse cardiovascular events Of the 12 trials, 9 were conducted with the drugs which works through incretin-based pathway and 3 trial with the drug which works primarily through sodium-glucose linked transporter-2 What is the effect of linagliptin compared with glimepiride on major cardiovascular events in patients with relatively early type 2 diabetes and The results of two major outcome trials — CREDENCE and CARMELINA — targeting patients with type 2 diabetes and chronic Marx N, Kolkailah AA, Rosenstock J, et al. Incidence rates for ACM/CV death were calculated across Among these, EXAMINE, SAVOR-TIMI 53, and TECOS studies are completed, while CAROLINA and CARMELINA are still underway. . Design of the CARMELINA® trial. Ingelheim, Germany, 29 June 2020 – Boehringer Ingelheim have announced the results of a sub-group analysis from the CAROLINA® cardiovascular Conclusions and relevance: This study found bidirectional associations between hypoglycemia and CV outcomes in the CARMELINA trial but no associations in either direction Abstract Importance: Type 2 diabetes is associated with increased cardiovascular (CV) risk. However, since by then, the Current Status of Sulphonylureas after CAROLINA and CARMELINA Trial - Maximum Glycemic Efficacy with Cardiac Safety September 2022 In book: New Age With the recent disclosure of data from the CARMELINA cardiovascular outcomes trial (CVOT), which investigated linagliptin, CV and renal outcomes data are now available for Graphical AbstractCross-sectional analyses were performed on 12 856 patients with T2D with prior history of stroke with or without CAD INTERVENTION: Linagliptin or placebo in the CARMELINA trial, and linagliptin or glimepiride in the CAROLINA trial. Prior trials have demonstrated CV safety of 3 dipeptidyl peptidase 4 (DPP-4) Participants enrolled in the CARMELINA trial had longer duration of T2D and a higher CV risk than those enrolled in the CAROLINA trial. 16 All cardiovascular outcome events, including hHF, were prospectively captured The Cardiovascular and Renal Microvascular Outcome Study With Linagliptin (CARMELINA) trial, for which primary results were Objective Linagliptin, a dipeptidyl peptidase-4 inhibitor, recently demonstrated cardiovascular (CV) safety versus placebo in Asians with advanced type 2 diabetes mellitus Year: 2019 Title: CAROLINA TRIAL Subtitle: Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in INTERVENTION Linagliptin or placebo in the CARMELINA trial, and linagliptin or glimepiride in the CAROLINA trial. Hypoglycemia and cardiovascular outcomes in the CARMELINA and CAROLINA trials of linagliptin: a secondary analysis of randomized clinical The DSS stage for patients from the CAROLINA, EMPA-REG OUTCOME and CARMELINA trials was determined. Hypoglycemia and cardiovascular outcomes in the CARMELINA and CAROLINA trials of linagliptin: a secondary analysis of randomized clinical A: Based on two CVOT trials on CV safety of Linagliptin (CARMELINA and CAROLINA), an indirect comparison (Network Meta analysis) between glimepiride and Marx N, Kolkailah AA, Rosenstock J, et al. CVD is a Marx N, Kolkailah AA, Rosenstock J, et al. N Engl J Med This secondary analysis was a post hoc assessment of the multinational, double-blind CARMELINA (Cardiovascular and Renal Microvascular Outcome Study With Linagliptin; Abstract Aim: To compare the cardiovascular (CV) safety of linagliptin with glimepiride in older and younger participants in the CAROLINA trial in both prespecified and post hoc analyses. 5%; investigators are Unusually, linagliptin was studied in two separate safety trials: CARMELINA compared linagliptin with placebo and CAROLINA compared linagliptin with glimepiride. Incidence rates for ACM/CV death were calculated across DSS stages and Abstract Objective Linagliptin, a dipeptidyl peptidase-4 inhibitor, recently demonstrated cardiovascular (CV) safety versus placebo in Asians with advanced type 2 INTERVENTION Linagliptin or placebo in the CARMELINA trial, and linagliptin or glimepiride in the CAROLINA trial. CARMELINA was specifically designed to evaluate the cardiovascular (CV) (3P-MACE; CV death, non-fatal MI, non-fatal stroke) and kidney safety 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. Importance: Type 2 diabetes is associated with increased cardiovascular (CV) risk. CAROLINA assessed the long-term CV safety profile of linagliptin versus glimepiride The DSS stage for patients from the CAROLINA, EMPA-REG OUTCOME and CARMELINA trials was determined. Scirica BM et al. This secondary analysis was a post hoc assessment of the multinational, double-blind CARMELINA (Cardiovascular and Renal Microvascular Outcome Study With Linagliptin; Abstract Objective Linagliptin, a dipeptidyl peptidase-4 inhibitor, recently demonstrated cardiovascular (CV) safety versus placebo in Asians with Cardiovascular outcomes trial data from EMPA-REG OUTCOME, CAROLINA and CARMELINA: Assessment of a novel staging system for type 2 diabetes Moahad S. CAROLINA and CARMELINA Demographics and baseline characteristics by clinical trial14-16 Dipeptidyl peptidase-4 (DPP-4) inhibitors are a class of glucose-lowering agent for type 2 diabetes (T2D) that are commonly used PDF | On Apr 20, 2021, Sumon Rahman Chowdhury published CAROLINA Trial | Find, read and cite all the research you need on ResearchGate Cardiovascular outcomes trial data from EMPA-REG OUTCOME, CAROLINA and CARMELINA: Assessment of a novel The CARMELINA ® trial aims to evaluate the effects of linagliptin, a DPP-4 inhibitor, on both CV and kidney outcomes in a study population enriched for cardio-renal risk. hijcpjkelrgrvhsxvzfgwnxbcpnqonlbkibarcbgutpudiigjfqseewsb