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https://www.readbyqxmd.com/read/28197977/interpreting-cardiovascular-endpoints-in-trials-of-antihyperglycemic-drugs
#1
REVIEW
Himika Chawla, Nikhil Tandon
In view of the significant cardiovascular (CV) morbidity and mortality in patients with type 2 diabetes mellitus, and concerns raised about the CV safety of some glucose-lowering drugs, the US Food and Drug Administration (FDA) issued guidance for the industry in 2008 to demonstrate CV safety for the approval of all new antihyperglycemic drugs. Seven randomized controlled trials involving around 60,000 participants have been completed so far and have demonstrated the CV safety of dipeptidyl peptidase 4 inhibitors (saxagliptin, alogliptin and sitagliptin), glucagon-like peptide-1 receptor agonists (lixisenatide, liraglutide and semaglutide) and a sodium-glucose co-transporter 2 inhibitor (empagliflozin) in patients with type 2 diabetes...
February 14, 2017: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/28151519/-results-of-the-leader-study-current-evidence-and-perspectives-in-research
#2
Edoardo Mannucci
The LEADER study is a trial performed to demonstrate the cardiovascular safety of the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide. The study was performed on patients with type 2 diabetes and high cardiovascular risk, mostly with prior cardiovascular events. Although the primary goal was the demonstration of non-inferiority versus placebo, the LEADER study revealed a significant reduction of the overall incidence of major cardiovascular events, as well as a reduction of all-cause and cardiovascular mortality...
December 2016: Giornale Italiano di Cardiologia
https://www.readbyqxmd.com/read/28151518/-type-2-diabetes-treatment-and-cardiovascular-risk-what-can-we-learn-from-trials
#3
Agostino Consoli, Fabrizio Febo
Diabetes treatment should include drugs with absolutely no adverse effects toward cardiovascular risk. Indeed, it would be advisable to use drugs with intrinsic protective effect against the risk of cardiovascular events. Intervention trials aiming at demonstrating a protective cardiovascular effect of very tight glucose control have produced controversial results. It is commonly perceived, however, that early intervention with safe treatment strategies is likely to be beneficial. In regard to safety, in the attempt to firmly establish cardiovascular safety of new drugs for diabetes, Government Authorities have mandated that cardiovascular safety trials need to be performed for all new drugs registered for diabetes treatment...
December 2016: Giornale Italiano di Cardiologia
https://www.readbyqxmd.com/read/28151516/-cardiovascular-disease-in-diabetic-patients-risk-factors-clinical-history-and-prevention
#4
Angelo Avogaro
Cardiovascular disease (CVD) is the leading cause of death in patients with diabetes mellitus (DM) in which there is a rapid evolution and widespread early atherosclerosis, whose causes are manifold. In the presence of hyperglycemia there is the activation of multiple signaling responses involving, first endothelial activation and later dysfunction, which are the first detectable step toward the atherosclerotic disease. A healthy lifestyle is the cornerstone for the prevention and control of CVD in patients with DM, in whom we must pursue the control, not only of blood sugar levels, but also of all risk factors for CVD...
December 2016: Giornale Italiano di Cardiologia
https://www.readbyqxmd.com/read/28131656/integration-of-recent-evidence-into-management-of-patients-with-atherosclerotic-cardiovascular-disease-and-type-2-diabetes
#5
REVIEW
Eberhard Standl, Oliver Schnell, Darren K McGuire, Antonio Ceriello, Lars Rydén
Cardiovascular outcome trials of antihyperglycaemic drugs and non-statin LDL-cholesterol-lowering drugs in patients with type 2 diabetes who have, or who are at high risk of, atherosclerotic cardiovascular disease have provided new evidence that has substantially affected the management of cardiovascular risk in these patients. On the basis of proven cardiovascular and renal benefit, the antihyperglycaemic drugs empagliflozin, liraglutide, and semaglutide-the latter being under review for approval by the US Food and Drug Administration and the European Medicines Agency-should be preferentially used as second-line treatments in these patient populations, typically in addition to metformin...
January 25, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28121469/savor-timi-to-sustain-6-a-critical-comparison-of-cardiovascular-outcome-trials-of-antidiabetic-drugs
#6
Awadhesh Kumar Singh, Ritu Singh
Since the inception of mandatory cardiovascular (CV) safety outcome trial (CVOT) promulgated by US FDA in 2008, seven trials have so far been published with three different classes of antidiabetic drugs in type 2 diabetes mellitus (T2DM). This mini-review aims to critically analyse these CVOTs in terms of different outcomes achieved. Areas covered: An electronic search pertaining to the subject was conducted till September 2016. The three CVOT conducted with saxagliptin, alogliptin and sitagliptin respectively, found them to be CV-neutral...
February 6, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28114464/semaglutide-reduced-a-composite-of-cv-events-at-2-years-in-patients-with-type-2-diabetes-and-high-cv-risk
#7
Anthony A Donato
No abstract text is available yet for this article.
January 17, 2017: Annals of Internal Medicine
https://www.readbyqxmd.com/read/28110912/semaglutide-a-promising-new-glucagon-like-peptide-1-receptor-agonist
#8
André J Scheen
No abstract text is available yet for this article.
January 16, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28110911/efficacy-and-safety-of-once-weekly-semaglutide-monotherapy-versus-placebo-in-patients-with-type-2-diabetes-sustain-1-a-double-blind-randomised-placebo-controlled-parallel-group-multinational-multicentre-phase-3a-trial
#9
Christopher Sorli, Shin-Ichi Harashima, George M Tsoukas, Jeffrey Unger, Julie Derving Karsbøl, Thomas Hansen, Stephen C Bain
BACKGROUND: Despite a broad range of pharmacological options for the treatment of type 2 diabetes, optimum glycaemic control remains challenging for many patients and new therapies are necessary. Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue in phase 3 development for type 2 diabetes. We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone...
January 16, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28102093/cardiovascular-safety-and-benefits-of-glp-1-receptor-agonists
#10
Niels B Dalsgaard, Andreas Brønden, Tina Vilsbøll, Filip K Knop
Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1RAs) constitute a class of drugs for the treatment of type 2 diabetes, and currently, six different GLP-1RAs are approved. Besides improving glycemic control, the GLP-1RAs have other beneficial effects such as weight loss and a low risk of hypoglycemia. Treatment with the GLP-1RA lixisenatide has been shown to be safe in patients with type 2 diabetes and recent acute coronary syndrome. Furthermore, liraglutide and semaglutide have been shown to reduce cardiovascular (CV) disease (CVD) risk in type 2 diabetes patients with established and/or high risk of CVD...
January 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27981757/efficacy-and-safety-of-glucagon-like-peptide-1-receptor-agonists-in-type-2-diabetes-systematic-review-and-mixed-treatment-comparison-analysis
#11
Zin Z Htike, Francesco Zaccardi, Dimitris Papamargaritis, David R Webb, Kamlesh Khunti, Melanie J Davies
AIMS: To compare efficacy and safety of glucagon-like peptide-1 receptor agonists (GLP-1RAs) in subjects with type 2 diabetes MATERIALS AND METHODS: We electronically searched, up to June 3(rd) , 2016, published randomised clinical trials lasting between 24 and 32 weeks and comparing a GLP-1RA (albiglutide, dulaglutide, twice-daily (EBID) and once-weekly exenatide, liraglutide, lixisenatide, semaglutide, and taspoglutide) with placebo or another GLP-1RA. Data on cardiometabolic and safety outcomes were analysed using a mixed-treatment comparison meta-analysis RESULTS: 34 trials (14464 participants) met the inclusion criteria; no published data for semaglutide were available...
December 15, 2016: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27921428/-promising-molecules-for-treatment-of-hyperglycemia-in-patients-with-type-2-diabetes
#12
Milan Kvapil
New antidiabetic drugs are being developed today that expand the range of pharmacological intervention, in particular for patients with type 2 diabetes (imeglimin, semaglutide, dulaglutide, FGF 21 analogue). At the same time innovations take place that "better" the well-proven molecules, they offer new application forms we have no experience of diabetology (osmotic pump for exenatide, faster acting insulin aspart). New properties are brought by just the change of concentration (insulin glargine in a concentration of 300 U/ml), unexpected positive results are also brought by new fixed-ratio combinations of antidiabetics (fixed-ratio combination of insulin degludec and liraglutide, fixed-ratio combination of insulin glargine and lixisenatide)...
2016: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/27863704/cardiovascular-effects-of-glucose-lowering-therapies-for-type-2-diabetes-new-drugs-in-perspective
#13
REVIEW
Peter L Thompson, Timothy M E Davis
PURPOSE: The purpose of this study was to review the results of clinical trials assessing the cardiovascular effects of drugs for type 2 diabetes and the cardiovascular effects of newer available drugs. METHODS: We performed a detailed search of PubMed-listed publications, reports from international meetings, and ongoing studies from clinical trials.gov. FINDINGS: Currently available drugs have neutral or, in some cases, negative effects on cardiovascular outcomes...
November 15, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27835045/cardiovascular-outcomes-of-new-medications-for-type-2-diabetes
#14
Jennifer M Trujillo, Sara A Wettergreen, Wesley A Nuffer, Samuel L Ellis, Michael T McDermott
Cardiovascular (CV) disease remains the leading cause of death in people with diabetes, highlighting the importance of using treatment options that do not increase CV risk or possibly decrease CV outcomes. Since 2008, the Food and Drug Administration has required demonstration of CV safety for all new medications developed for the glycemic management of diabetes. Seven trials have been published that have established CV safety for three DPP-4 inhibitors (alogliptin, saxagliptin, and sitagliptin), three GLP-1 receptor agonists (liraglutide, lixisenatide, and semaglutide), and one sodium-glucose cotransporter-2 inhibitor (empagliflozin)...
December 2016: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/27817160/novel-anti-glycemic-drugs-and-reduction-of-cardiovascular-risk-in-diabetes-expectations-realized-promises-unmet
#15
REVIEW
James H Flory, Jenny K Ukena, James S Floyd
PURPOSE OF REVIEW: The purpose is to review evidence on cardiovascular risks and benefits of new treatments for type 2 diabetes mellitus. RECENT FINDINGS: In response to guidance issued by the Food and Drug Administration, thousands of patients have been enrolled in large randomized trials evaluating the cardiovascular effects of the three newest diabetes drug classes: glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose cotransporter 2 (SGLT-2) inhibitors, and dipeptidyl peptidase-4 (DPP-4) inhibitors...
December 2016: Current Atherosclerosis Reports
https://www.readbyqxmd.com/read/27708277/diabetes-cardiovascular-benefits-of-semaglutide
#16
Gregory B Lim
No abstract text is available yet for this article.
December 2016: Nature Reviews. Cardiology
https://www.readbyqxmd.com/read/27633186/semaglutide-and-cardiovascular-outcomes-in-patients-with-type-2-diabetes
#17
RANDOMIZED CONTROLLED TRIAL
Steven P Marso, Stephen C Bain, Agostino Consoli, Freddy G Eliaschewitz, Esteban Jódar, Lawrence A Leiter, Ildiko Lingvay, Julio Rosenstock, Jochen Seufert, Mark L Warren, Vincent Woo, Oluf Hansen, Anders G Holst, Jonas Pettersson, Tina Vilsbøll
Background Regulatory guidance specifies the need to establish cardiovascular safety of new diabetes therapies in patients with type 2 diabetes in order to rule out excess cardiovascular risk. The cardiovascular effects of semaglutide, a glucagon-like peptide 1 analogue with an extended half-life of approximately 1 week, in type 2 diabetes are unknown. Methods We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks...
November 10, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27432074/optimizing-management-of-glycaemia
#18
REVIEW
Sudesna Chatterjee, Kamlesh Khunti, Melanie J Davies
The global epidemic of type 2 diabetes (T2DM) continues largely unabated due to an increasingly sedentary lifestyle and obesogenic environment. A cost-effective patient-centred approach, incorporating glucose-lowering therapy and modification of cardiovascular risk factors, could help prevent the inevitable development and progression of macrovascular and microvascular complications. Glycaemic optimization requires patient structured education, self-management and empowerment, and psychological support along with early and proactive use of glucose lowering therapies, which should be delivered in a system of care as shown by the Chronic Care Model...
June 2016: Best Practice & Research. Clinical Endocrinology & Metabolism
https://www.readbyqxmd.com/read/27183953/weekend-therapy-in-diabetes
#19
Sanjay Kalra, Yashdeep Gupta
This article introduces the concept of "weekend therapy", which has now become reality in diabetes. It briefly describes injectable and oral drugs which are currently available, or are in advanced stages of development, for use in once weekly administration. These include dulaglutide, exenatide QW, semaglutide, omarigliptin and trelagliptin.
May 2016: JPMA. the Journal of the Pakistan Medical Association
https://www.readbyqxmd.com/read/27042424/glucagon-like-peptide-1-receptor-agonists-in-the-treatment-of-type-2-diabetes-past-present-and-future
#20
REVIEW
Sanjay Kalra, Manash P Baruah, Rakesh K Sahay, Ambika Gopalakrishnan Unnikrishnan, Shweta Uppal, Omolara Adetunji
Glucagon-like peptide-1 (GLP-1)-based therapy improves glycaemic control through multiple mechanisms, with a low risk of hypoglycaemia and the additional benefit of clinically relevant weight loss. Since Starling and Bayliss first proposed the existence of intestinal secretions that stimulate the pancreas, tremendous progress has been made in the area of incretins. As a number of GLP-1 receptor agonists (GLP-1 RAs) continue to become available, physicians will soon face the challenge of selecting the right option customized to their patient's needs...
March 2016: Indian Journal of Endocrinology and Metabolism
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