CAROLINA ® is one of two cardiovascular outcome trials with the DPP-4 inhibitor, linagliptin. These prior trials evaluating DPP-4 inhibitors enrolled limited numbers of patients with concomitant chronic kidney disease, who are at very high CV risk. Rosenstock J, Kahn SE, Johansen OE, et al. Online ahead of print. 2 unique CVOTs - CARMELINA ® and CAROLINA ® - have been designed to establish long-term safety of TRAJENTA in a broad range of T2D patients 1,2. © 2020 American College of Cardiology Foundation. The CAROLINA trial showed that the DPP-4 inhibitor linagliptin was noninferior to glimepiride; however, it was not superior. 2015;12(3):164-174. doi: 10.1177/1479164115570301 PubMed Google Scholar Crossref Copyright © 2020 Springer Healthcare Limited. Whatever the fine print may be, the CAROLINA trial has done great service to diabetes care. 2 and 3 randomized clinical trials. The CAROLINA trial, also being presented at ADA, is reporting the results of a head-to-head comparison of the cardiovascular safety/efficacy of linagliptin and glimepiride. ABOUT CAROLINA (NCT01243424) Patients were randomised between 2010 and 2012 from approximately 600 trial centres in 43 different countries. This site is intended for healthcare professionals only, CREDENCE and CARMELINA trial overview | ADA 2019 | Medicine Matters diabetes | diabetes.medicinematters.com, Canagliflozin may offer renal protection in people with type 2 diabetes and CKD, WATCH: Diabetes expert commentary on the CREDENCE trial, LISTEN: Researcher comment on the CREDENCE trial, LISTEN: A primary care diabetes expert on the CREDENCE trial, LISTEN: A nephrologist discusses the CREDENCE trial, WATCH: Nephrologist Katherine Tuttle shares practice tips with Jay Shubrook, CARMELINA findings confirmed in highest CV risk subgroups, Favorable long-term cardiovascular safety profile of linagliptin in type 2 diabetes, Round-up of the DPP-4 inhibitor CV outcome trials. The researchers will present these results in full, along with an analysis of outcomes by baseline cardiovascular disease. These trials typically enrolled younger cohorts with relatively recent onset of diabetes and low CV risk. 3,4 CAROLINA ® and the CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk trial (CARMELINA ®) 14,15 provide one of the most comprehensive datasets on the long-term safety of a DPP-4-inhibitor. The CREDENCE primary findings, published in April this year, showed that the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin significantly reduced the risk for renal failure and cardiovascular disease in people with type 2 diabetes and chronic kidney disease. CAROLINA is the only active-comparator CV outcomes trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor. Presenters: Rajiv Agarwal, MD, MBBS, FASN, BRCU; Meg Jardine, MD, PhD; Bruce Neal, MB, ChB, PhD; Kenneth W. Mahaffey, MD, PhD; Bernard Zinman, CM, MD. Patients with type 2 diabetes and elevated cardiovascular risk were randomized to linagliptin 5 mg daily (n = 3,028) versus glimepiride 4 mg daily (n = 3,014). The goal of the trial was to evaluate the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin compared with the sulfonylurea glimepiride among patients with type 2 diabetes and elevated cardiovascular risk. The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without >2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase. The researchers will present new renal analyses at this year's ADA. Please enable JavaScript on your browser, so that you can use all features of this website. a comprehensive CV outcomes trial programme CARMELINA and CAROLINA constitute a comprehensive CVOT programme demonstrating the long-term safety profile of linagliptin in … Options for a second-line agent include a sulfonylurea or a DPP-4 inhibitor. Effect of linagliptin vs glimepiride on major adverse cardiovascular outcomes in patients with type 2 diabetes: the CAROLINA Randomized Clinical Trial. The CARMELINA trial was powered to detect cardioprotective effects of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, but it showed only that it was noninferior to placebo. Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Pulmonary Hypertension and Venous Thromboembolism, CardioSource Plus for Institutions and Practices, Nuclear Cardiology and Cardiac CT Meeting on Demand, Annual Scientific Session and Related Events, ACC Quality Improvement for Institutions Program, National Cardiovascular Data Registry (NCDR), Congenital Heart Disease and     Pediatric Cardiology, Invasive Cardiovascular Angiography    and Intervention, Pulmonary Hypertension and Venous     Thromboembolism, Type 2 diabetes (glycated hemoglobin 6.5-8.5%), Elevated cardiovascular risk (established cardiovascular risk, ≥2 cardiovascular risk factors [diabetes duration >10 years, systolic blood pressure >140 mm Hg, current smoker, low-density lipoprotein cholesterol ≥135 mg/dl or on lipid-lowering therapy], ≥70 years of age, or microvascular complications), Previous exposure to DPP-4 inhibitors, glucagonlike peptide-1 receptor agonists, New York Heart Association class III or IV heart failure, Cardiovascular death: 4.3% with linagliptin vs. 4.2% with glimepiride, Myocardial infarction: 4.7% with linagliptin vs. 4.6% with glimepiride, Stroke: 2.8% with linagliptin vs. 3.4% with glimepiride, Hypoglycemia: 10.6% with linagliptin vs. 37.7% with glimepiride (p < 0.001), Weighted average mean difference in body weight: -1.54 kg for linagliptin vs. glimepiride (p < 0.05). 2019 Sep 19;322(12):1155-1166. doi: 10.1001/jama.2019.13772. The CARMELINA-COG substudy was an integral part of the CARMELINA trial . N Engl J Med 2013; 369: 1317–1326 White WB et al. The researchers will present these results in full, along with an a… Compared with CARMELINA, other cardiovascular outcome trials of DPP-4 inhibitors enrolled a smaller percentage of patients who had prevalent kidney disease (eGFR < 60 mL/min/1.73m 2) … 3,4 CAROLINA ® and the CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk trial (CARMELINA ®) 14,15 provide one of the most comprehensive datasets on the long-term safety of a DPP-4-inhibitor. 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 healthcare professionals with confidence in the long-term safety profile across a broad range of patients with type 2 diabetes." The primary outcome of cardiovascular death, myocardial infarction, or stroke occurred in 11.8% of the linagliptin group compared with 12.0% of the glimepiride group (p for noninferiority < 0.001, p for superiority = 0.76). Update 06-12-2019 | CARMELINA findings confirmed in highest CV risk subgroups. CARMELINA is one of two cardiovascular outcome trials with the DPP-4 inhibitor Tradjenta. Such additional evidence from randomised controlled studies, as well as real-world … CAROLINA ®, will be the first DPP-4 inhibitor cardiovascular outcome trial to compare commonly used second line treatments – Tradjenta and the sulfonylurea glimepiride. Editorial, see p 362 Type 2 diabetes mellitus (T2DM) is commonly complicated by atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease,1,2 and is also associated with an increased risk of hospitalization for heart failure (hHF) and heart failure (HF)–related outcomes.3–5 The increased risk for hHF is particularly strong in people with coexisting chronic kidney disease,6,7 or with pre-existing HF.4,5 Since 2008, evaluation of the cardiovascular safety of new glucose-lowering medicat… Guidelines JAMA 2019;322:1155-66. CAROLINA, will be the first DPP-4 inhibitor cardiovascular outcome trial to compare commonly used second line treatments — Tradjenta and the sulfonylurea glimepiride. DPP4 Inhibitor Trials: MACE Scirica BM et al. All rights reserved. Generic Trade Name Trial Sitagliptin Januvia TECOS Saxagliptin Onglyza SAVOR-TIMI 53 Alogliptin Nesina EXAMINE Linagliptin Tradjenta CARMELINA DPP4 Inhibitors 7. Description: The goal of the trial was to evaluate the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin compared with the sulfonylurea glimepiride among patients with type 2 diabetes and elevated cardiovascular risk. The CAROLINA trial showed that the DPP-4 inhibitor linagliptin was noninferior to glimepiride; however, it was not superior. Lower cost would favor the former category, while less hypoglycemia and weight gain would favor the latter category. Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA(®)): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk. Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Lipid Metabolism, Nonstatins, Heart Failure and Cardiac Biomarkers, Smoking, Keywords: Blood Pressure, Cholesterol, LDL, Diabetes Mellitus, Type 2, Dipeptidyl Peptidase 4, Dipeptidyl-Peptidase IV Inhibitors, Hypoglycemia, Metabolic Syndrome X, Metformin, Myocardial Infarction, Primary Prevention, Risk Factors, Smoking, Stroke, Sulfonylurea Compounds, Weight Gain. CAROLINA is one of two cardiovascular outcome trials with the DPP-4 inhibitor Tradjenta. N Engl J Med 2013; 369: 1327–1335 Green JB et al. Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes: The CAROLINA Randomized Clinical Trial JAMA. Diab Vasc Dis Res . The trial included adults with early type 2 diabetes: Adults with a median disease duration of 6.2 years who either received no treatment or received one or two glucose-lowering agents, e.g., metf… Previous CV outcome trials of DPP-4 inhibitors have demonstrated a noninferior risk of a composite CV outcome vs. placebo, but not incremental CV efficacy. Thus, these studies had low CV event rates, and the events that did … The trial involved 6,033 adults with type 2 diabetes observed for a median duration of more than six years. The results of two major outcome trials — CREDENCE and CARMELINA — targeting patients with type 2 diabetes and chronic kidney disease (CKD) were presented on Tuesday, June 11, the final day of the 79th Scientific Sessions in San Francisco, CA. Presenters: Rajiv Agarwal, MD, MBBS, FASN, BRCU; Meg Jardine, MD, PhD; Bruce Neal, MB, ChB, PhD; Kenneth W. Mahaffey, MD, PhD; Bernard Zinman, CM, MD. 2018 Mar 14;17(1):39. doi: 10.1186/s12933-018-0682-3. This news … CAROLINA assessed the long-term CV safety profile of linagliptin versus glimepiride in patients with early type 2 diabetes at increased CV risk. Objective: To evaluate the effect of linagliptin, a selective DPP-4 inhibitor, on CV outcomes and kidney outcomes in patients with type 2 diabetes at high risk of CV and kidney events. Marx N, Rosenstock J, Kahn SE, et al. N Engl J Med 2015; 373: 232-42 Metformin remains the first-line agent for treatment of type 2 diabetes. A unique CV outcome trial in T2D, as it also included a key secondary composite kidney endpoint to evaluate the long-term kidney safety of TRAJENTA ®1 CAROLINA and CARMELINA (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk) provide one of the most comprehensive datasets on the long-term safety of a DPP-4-inhibitor across a broad range of patients with type 2 diabetes. Among patients with type 2 diabetes and elevated cardiovascular risk, the DPP-4 inhibitor linagliptin was noninferior to the sulfonylurea glimepiride on prevention of major adverse cardiovascular events over a median of 6.3 years. While CARMELINA is the first CVOT to provide evidence in a majority population with prevalent renal risk, further studies with DPP-4 inhibitors would be welcome, and results are expected shortly from the CAROLINA CVOT, which will compare linagliptin with a sulfonylurea as an active comparator . Prior trials have demonstrated CV safety of 3 dipeptidyl peptidase 4 (DPP-4) inhibitors but have included limited numbers of patients with high CV risk and chronic kidney disease. The CAROLINA® trial is a randomised, active comparator, double blind study to evaluate the cardiovascular safety of linagliptin versus glimepiride in patients with T2DM at elevated cardiovascular risk. ... (10%) cutoff for accelerated decline. Eli Lilly and Boehringer Ingelheim have announced top-line results from the CAROLINA cardiovascular outcome trial, which evaluated the cardiovascular safety of the drug compared to the sulphonylurea glimepiride, on top of standard of care in 6,033 adults with type II diabetes and increased cardiovascular risk or established cardiovascular disease. CAROLINA ® and CARMELINA ® make up the two cardiovascular outcome trials for linagliptin, providing one of the most comprehensive datasets on the long-term safety of a DPP-4-inhibitor. CAROLINA ® is one of two cardiovascular outcome trials with the DPP-4 inhibitor, linagliptin. Background:Despite having unquestionable glucose lowering efficacy, current guidelines no more favour the uses of sulphonylureas for CV safety concern, except when cost is an issue. Presenters: Steven E. Kahn, MB, ChB; Nikolaus Marx, MD, FESC, FAHA; Darren K. McGuire, MD, MHSc; Robert D. Toto, MD; Christoph Wanner, MD; Mark E. Cooper, MBBS, PhD. Currently, 4 large cardiovascular outcome trials have established the cardiovascular safety of DPP-4 inhibitors vs placebo in patients with type 2 diabetes at a high cardiovascular risk, 20-23 including the Cardiovascular and Renal Microvascular Outcome Study with Linagliptin (CARMELINA). In brief, CARMELINA was a multicenter, international, randomized, double-blind study in patients with type 2 diabetes at high cardiorenal risk. In a similar group of patients, the ongoing CAROLINA study is assessing the CV safety of linaglitin compared to the sulfonylurea glimepiride. It has provided robust proof that two commonly prescribed drugs, linagliptin and glimepiride, can continue to be used for the benefit of persons with diabetes. In presenting findings from CARMELINA, a randomized controlled CV outcomes trial enrolling 6,979 adults across 605 centers in 27 countries, … The CREDENCE primary findings, published in April this year, showed that the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin significantly reduced the risk for renal failure and cardiovascular disease in people with type 2 diabetes and chronic kidney disease. For the CARMELINA trial, Rosenstock and colleagues analyzed data from 6,979 adults with type 2 diabetes with a history of vascular disease and a … 5,6 A sub-analysis of the CARMELINA ® trial, published in Diabetology International in October 2019, demonstrated that linagliptin did not increase risk for cardiovascular or kidney events compared to placebo in Asian … Indeed, individuals with established CVD were usually excluded. Design and baseline characteristics of the Cardiovascular Outcome Trial of Linagliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA). Linagliptin was not superior to glimepiride on prevention of major adverse cardiovascular events; however, it was associated with a lower frequency of hypoglycemia and less weight gain compared with glimepiride. The ongoing CARMELINA trial is examining the CV and renal safety of linagliptin in diabetic patients with high CV risk as compared to placebo. Cardiovasc Diabetol. CARMELINA is one of two cardiovascular outcome trials with the DPP-4 inhibitor Tradjenta. CARMELINA (CArdiovascular and Renal Microvascular outcomE study with LINAgliptin) is the first CV outcomes trial … Part of the Springer Nature Group. Dr. Rosenstock:CAROLINA is a randomized, double-blind, active-controlled, multicenter clinical trial designed to test the cardiovascular safety of a DDP-4 inhibitor (linagliptin) versus a sulfonylurea (glimepiride). 2018 Mar 14 ; 17 ( 1 ):39. doi: 10.1001/jama.2019.13772 ;! 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