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https://www.readbyqxmd.com/read/28213092/prediction-of-thyroid-c-cell-carcinogenicity-after-chronic-administration-of-glp1-r-agonists-in-rodents
#1
Willem van den Brink, Annette Emerenciana, Francesco Bellanti, Oscar Della Pasqua, Jan Willem van der Laan
Increased incidence of C-cell carcinogenicity has been observed for glucagon-like-protein-1 receptor (GLP-1r) agonists in rodents. It is suggested that the duration of exposure is an indicator of carcinogenic potential in rodents of the different products on the market. Furthermore, the role of GLP-1-related mechanisms in the induction of C-cell carcinogenicity has gained increased attention by regulatory agencies. This study proposes an integrative pharmacokinetic/pharmacodynamic (PKPD) framework to identify explanatory factors and characterize differences in carcinogenic potential of the GLP-1r agonist products...
February 14, 2017: Toxicology and Applied Pharmacology
https://www.readbyqxmd.com/read/28197977/interpreting-cardiovascular-endpoints-in-trials-of-antihyperglycemic-drugs
#2
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/28195447/safety-tolerability-and-efficacy-of-lixisenatide-as-monotherapy-in-japanese-patients-with-type-2-diabetes-mellitus-an-open-label-multicenter-study
#3
Yutaka Seino, Yasuo Terauchi, Xiangling Wang, Daisuke Watanabe, Elisabeth Niemoeller
AIM/INTRODUCTION: To assess overall safety of lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus. MATERIALS AND METHODS: Patients with type 2 diabetes mellitus, previously treated with ≤1 oral antidiabetic drugs, were enrolled in an uncontrolled, open-label, single-arm study over 24 and 52 weeks. Any oral antidiabetic drug treatment was stopped at the start of the 6-week run-in period. From baseline, patients received once-daily lixisenatide monotherapy (10 μg for 1 week, 15 μg for 1 week, 20 μg thereafter) for 52 weeks (first 140 patients enrolled) or 24 weeks (subsequently enrolled patients)...
February 13, 2017: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/28188240/lixisenatide-therapy-in-older-patients-with-type-2-diabetes-inadequately-controlled-on-their-current-antidiabetic-treatment-the-getgoal-o-randomized-trial
#4
Graydon S Meneilly, Christine Roy-Duval, Hasan Alawi, George Dailey, Diego Bellido, Carlos Trescoli, Helard Manrique Hurtado, Hailing Guo, Valerie Pilorget, Riccardo Perfetti, Hamish Simpson
OBJECTIVE: To evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment. RESEARCH DESIGN AND METHODS: In this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged ≥70 years were randomized to receive once-daily lixisenatide 20 μg or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks...
February 10, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28179743/lixisenatide
#5
Danial E Baker, Terri L Levien
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are are available online to subscribers...
January 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28151519/-results-of-the-leader-study-current-evidence-and-perspectives-in-research
#6
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
#7
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/28133970/lixisenatide
#8
Delilah McCarty, Megan Coleman, Cassie L Boland
OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of the glucagon-like peptide-1 receptor agonist (GLP-1RA), lixisenatide, in the treatment of type 2 diabetes mellitus. DATA SOURCES: A PubMed (1966-2016) search was conducted using the following keywords: lixisenatide, AVE0010, glucagon-like peptide-1 agonist, and type 2 diabetes. References were reviewed to identify additional sources. STUDY SELECTION AND DATA EXTRACTION: Articles written in English were included if they evaluated the pharmacology, pharmacokinetics, efficacy, or safety of lixisenatide in human subjects...
January 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28131656/integration-of-recent-evidence-into-management-of-patients-with-atherosclerotic-cardiovascular-disease-and-type-2-diabetes
#9
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/28124820/evaluation-of-the-long-term-cost-effectiveness-of-liraglutide-versus-lixisenatide-for-treatment-of-type-2-diabetes-mellitus-in-the-uk-setting
#10
B Hunt, G Vega-Hernandez, W J Valentine, N Kragh
AIMS: Glucagon-like peptide-1 (GLP-1) receptor agonists represent an attractive treatment option for patients with type 2 diabetes mellitus as they are associated with improved glycemic control, weight loss and low risk of hypoglycemia. The present analysis aimed to compare the cost-effectiveness of two GLP-1 receptor agonists, liraglutide 1.8 mg and lixisenatide 20 µg, in the UK setting based on the LIRA-LIXI(TM) trial (NCT01973231). MATERIALS AND METHODS: Projections of costs (in 2015 pound sterling [GBP]) and clinical outcomes were made over patient lifetimes using the IMS CORE Diabetes Model...
January 26, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28121469/savor-timi-to-sustain-6-a-critical-comparison-of-cardiovascular-outcome-trials-of-antidiabetic-drugs
#11
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/28120022/-cardiovascular-aspects-of-diabetes-treatment-finally-a-reason-for-cardiologists-to-be-pleased
#12
T Forst, L Plum-Mörschel, M M Weber
Cardiovascular disease significantly determines morbidity and mortality in patients with diabetes mellitus type 2. Large clinical trials in the past left controversial evidence about the effect of blood glucose-lowering treatments on cardiovascular outcomes. In 2008, the regulatory authorities defined new requirements on cardiovascular safety data for the approval of new drugs for the treatment of type 2 diabetes mellitus. Since then, numerous large safety studies have been initiated to prove cardiovascular noninferiority of new antidiabetic drugs...
January 24, 2017: Der Internist
https://www.readbyqxmd.com/read/28118649/lixisenatide-for-type-2-diabetes
#13
REVIEW
(no author information available yet)
No abstract text is available yet for this article.
January 30, 2017: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/28118069/rationale-for-treatment-options-for-mealtime-glucose-control-in-patients-with-type-2-diabetes
#14
Stephen L Aronoff
While glycemic control is routinely assessed using HbA1c and fasting glucose measures, postprandial glucose (PPG) is also an important contributor of overall glycemia. Furthermore, PPG excursions have been linked to complications of diabetes. This review examines the effects of glucose-lowering therapies (including treatments administered at mealtime) on postprandial hyperglycemia in patients with type 2 diabetes. A PubMed search was conducted to identify clinical studies of treatments for mealtime glucose control in type 2 diabetes...
January 24, 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/28115994/is-there-a-justification-for-classifying-glp-1-receptor-agonists-as-basal-and-prandial
#15
REVIEW
Inka Miñambres, Antonio Pérez
Several GLP-1 receptor agonists are currently available for treatment of type 2 diabetic patients. Based on their pharmacokinetic/pharmacodynamic profile, these drugs are classified as short-acting GLP-1 receptor agonists (exenatide and lixisenatide) or long-acting GLP-1 receptor agonists (exenatide-LAR, liraglutide, albiglutide, and dulaglutide). In clinical practice, they are also classified as basal or prandial GLP-1 receptor agonists to differentiate between patients who would benefit more from one or another based on characteristics such as previous treatment and the predominance of fasting or postprandial hyperglycemia...
2017: Diabetology & Metabolic Syndrome
https://www.readbyqxmd.com/read/28102093/cardiovascular-safety-and-benefits-of-glp-1-receptor-agonists
#16
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...
March 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28097882/antidiabetic-agents-and-cardiovascular-outcomes-in-patients-with-heart-diseases
#17
Judy W M Cheng, Hisham A Badreldin, Dhiren K Patel, Snehal H Bhatt
This article reviews evidence of benefits and risk of antidiabetic agents in cardiovascular (CV) outcomes, with a focus on medications approved by the FDA since 2008. Peer-reviewed articles were identified from MEDLINE and Current Content database (both 1966 to October 1, 2016) using the search terms insulin, metformin, rosiglitazone, pioglitazone, glyburide, glipizide, glimepiride, acarbose, miglitol, albiglutide, exenatide, liraglutide, lixisenatide, dulaglutide, pramlintide, meglitinide, alogliptin, linagliptin, saxagliptin, sitagliptin, canagliflozin, dapagliflozin, empagliflozin, colesevalam, bromocriptine, mortality, myocardial infarction (MI), heart failure, (HF) and stroke...
January 18, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28086882/differential-effects-of-glucagon-like-peptide-1-receptor-agonists-on-heart-rate
#18
REVIEW
Martin Lorenz, Francesca Lawson, David Owens, Denis Raccah, Christine Roy-Duval, Anne Lehmann, Riccardo Perfetti, Lawrence Blonde
While glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are known to increase heart rate (HR), it is insufficiently recognized that the extent varies greatly between the various agonists and is affected by the assessment methods employed. Here we review published data from 24-h time-averaged HR monitoring in healthy individuals and subjects with type 2 diabetes mellitus (T2DM) treated with either short-acting GLP-1 RAs, lixisenatide or exenatide, or long-acting GLP-1 RAs, exenatide LAR, liraglutide, albiglutide, or dulaglutide (N = 1112; active-treatment arms)...
January 13, 2017: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/28070733/glp-1-ra-treatment-patterns-among-type-2-diabetes-patients-in-five-european-countries
#19
Victoria Divino, Mitch DeKoven, Farhad Ali Khan, Kristina S Boye, Hélène Sapin, Kirsi Norrbacka
INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a relatively new class of injectable drugs used in the treatment of type 2 diabetes (T2D). This retrospective database study evaluated real-world treatment patterns of T2D patients initiating GLP-1 RAs in Belgium (BE), France (FR), Germany (DE), The Netherlands (NL) and Sweden (SE). METHODS: Adult T2D patients initiating exenatide twice daily (exBID), exenatide once weekly (exQW), liraglutide (LIRA) or lixisenatide (LIXI) during 2013 were identified using the QuintilesIMS (QuintilesIMS, Durham, NC, and Danbury, CT, USA) longitudinal retail pharmacy databases (LRx; BE/FR/DE/NL) and national health register data (SE)...
February 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28058656/evaluating-the-long-term-cost-effectiveness-of-daily-administered-glp-1-receptor-agonists-for-the-treatment-of-type-2-diabetes-in-the-united-kingdom
#20
Barnaby Hunt, Qing Ye, William J Valentine, Donna Ashley
INTRODUCTION: The glucagon-like peptide-1 (GLP-1) receptor agonist class has grown in the last decade, with several agents available in the UK. However there is currently a paucity of evidence regarding the relative cost-effectiveness of liraglutide 1.2 mg versus other daily administered GLP-1 receptor agonists, due to a lack of head-to-head trial data. Therefore the present analysis was performed, using results from a network meta-analysis (NMA), to compare the cost-effectiveness of three currently available daily administered GLP-1 receptor agonists for treatment of diabetes in the UK setting...
February 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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