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https://www.readbyqxmd.com/read/28331351/long-term-management-of-type-2-diabetes-with-glucagon-like-peptide-1-receptor-agonists
#1
REVIEW
Hamish Courtney, Rahul Nayar, Chinnadorai Rajeswaran, Ravi Jandhyala
Continuously reducing excess blood glucose is a primary goal for the management of type 2 diabetes (T2D). Most patients with T2D require glucose-lowering medications to achieve and maintain adequate glycemic control; however, treatment failure may occur, limiting treatment options. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are an emerging therapeutic class that can be prescribed for patients instead of basal insulin after the failure of oral therapies. Recent studies have focused on the durability and tolerability of long-term GLP-1RA therapy...
2017: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
https://www.readbyqxmd.com/read/28303626/lixisenatide-as-add-on-treatment-among-patients-with-different-%C3%AE-cell-function-levels-as-assessed-by-homa-%C3%AE-index
#2
Riccardo C Bonadonna, Lawrence Blonde, Mikhail Antsiferov, Rachele Berria, Pierre Gourdy, Mensud Hatunic, Viswanathan Mohan, Michael Horowitz
BACKGROUND: The effect of lixisenatide - a prandial once-daily glucagon-like peptide-1 receptor agonist - on glycaemic control in patients with inadequately controlled type 2 diabetes (T2DM), stratified by baseline β-cell function was assessed. METHODS: The 24-week GetGoal-M, -P and -S trials evaluated the efficacy and safety of lixisenatide in combination with oral antidiabetic agents. This post hoc analysis used data from patients receiving lixisenatide in these trials, divided into matched cohorts by propensity scoring and stratified according to baseline homeostasis model assessment of β-cell function (HOMA-β) index levels (high HOMA-β: > median HOMA-β [28...
March 17, 2017: Diabetes/metabolism Research and Reviews
https://www.readbyqxmd.com/read/28296201/satisfaction-of-switching-to-combination-therapy-with-lixisenatide-and-basal-insulin-in-patients-with-type-2-diabetes-receiving-multiple-daily-insulin-injection-therapy-a-randomized-controlled-trial
#3
REVIEW
Aika Miya, Akinobu Nakamura, Hideaki Miyoshi, Kyu Yong Cho, So Nagai, Yoshio Kurihara, Shin Aoki, Masataka Taguri, Yasuo Terauchi, Tatsuya Atsumi
AIMS/INTRODUCTION: We compared the satisfaction levels of patients with type 2 diabetes undergoing combination therapy with lixisenatide (LIX) and basal insulin with that of patients undergoing multiple daily insulin injection (MDI) therapy. MATERIALS AND METHODS: The study was a 12-week open-label, randomized, multicenter, controlled trial. Participants were Japanese patients with type 2 diabetes receiving MDI for more than 3 months. Patients were randomly assigned to each treatment cohort: (1) a group that continued MDI (MDI group); and (2) a group that switched from MDI to combination therapy with LIX and basal insulin (LIX group)...
March 10, 2017: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/28291655/the-cardiovascular-safety-trials-of-dpp-4-inhibitors-glp-1-agonists-and-sglt2-inhibitors
#4
REVIEW
Matthew H Secrest, Jacob A Udell, Kristian B Filion
In this paper, we review the results of large, double-blind, placebo-controlled randomized trials mandated by the US Food and Drug Administration to examine the cardiovascular safety of newly-approved antihyperglycemic agents in patients with type 2 diabetes. The cardiovascular effects of dipeptidyl peptidase-4 (DPP-4) inhibitors remain controversial: while these drugs did not reduce or increase the risk of primary, pre-specified composite cardiovascular outcomes, one DPP-4 inhibitor (saxagliptin) increased the risk of hospitalization for heart failure in the overall population; another (alogliptin) demonstrated inconsistent effects on heart failure hospitalization across subgroups of patients, and a third (sitagliptin) demonstrated no effect on heart failure...
January 28, 2017: Trends in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28285800/perspectives-on-cardiovascular-effects-of-incretin-based-drugs-from-bedside-to-bench-return-trip
#5
Michaela Luconi, Giulia Cantini, Antonio Ceriello, Edoardo Mannucci
Recently, cardiovascular outcome trials with glucose-lowering drugs used in type 2 diabetes mellitus, namely glucagon-like peptide-1 receptor agonists (GLP-1RA), liraglutide and semaglutide, showed a reduction in cardiovascular events, which had not been observed in trials with other incretin-based drugs, such as lixisenatide or with dipeptidyl peptidase-4 inhibitors (DPP4i). Mechanisms underlying the observed cardiovascular differences between DPP4i and GLP1-RA, and across individual GLP1-RA are poorly understood...
March 2, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28281244/effectiveness-of-liraglutide-and-lixisenatide-in-the-treatment-of-type-2-diabetes-real-world-evidence-from-the-health-improvement-network-thin-database-in-the-united-kingdom
#6
Michael Feher, Gabriela Vega-Hernandez, Emina Mocevic, Brian Buysse, Melissa Myland, Geraldine S Power, Lise L Nystrup Husemoen, Joseph Kim, Daniel R Witte
INTRODUCTION: The glucagon-like peptide-1 receptor agonists liraglutide and lixisenatide are effective at reducing glycated hemoglobin (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Although liraglutide has demonstrated superior efficacy in head-to-head clinical trials, real-world evidence of comparative effectiveness is lacking. This observational study aimed to assess the effectiveness of liraglutide versus lixisenatide in UK clinical practice. METHODS: Electronic medical records from The Health Improvement Network (THIN) UK primary care database were analyzed...
March 9, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28276830/bariatric-surgery-time-to-replace-with-glp-1
#7
Dominic-Luc Webb, Niclas Abrahamsson, Magnus Sundbom, Per M Hellström
Obesity with a body mass index (BMI) over 30 kg/m(2) represents a significant risk for increased morbidity and mortality, with reduced life expectancy of about 10 years. Until now, surgical treatment has been the only effective longterm intervention. The currently standardized method of bariatric surgery, gastric bypass, means that many gastrointestinal peptide hormones are activated, yielding net reductions in appetite and food intake. Among the most important gut peptide hormones in this perspective is glucagon-like peptide-1 (GLP-1), which rises sharply after gastric bypass...
February 24, 2017: Scandinavian Journal of Gastroenterology
https://www.readbyqxmd.com/read/28271733/evaluating-drug-cost-per-responder-and-number-needed-to-treat-associated-with-lixisenatide-on-top-of-glargine-when-compared-to-rapid-acting-insulin-intensification-regimens-on-top-of-glargine-in-patients-with-type-2-diabetes-in-uk-italy-and-spain
#8
Marion Afonso, Fay Ryan, Ashley Pitcher, Elisheva Lew
OBJECTIVES: This study investigated the cost per responder and number needed to treat (NNT) in type 2 diabetes mellitus (T2DM) patients for lixisenatide compared to insulin intensification regimens using composite endpoints in the UK, Italy, and Spain. METHODS: Efficacy and safety outcomes were obtained from GetGoal Duo-2, a 26-week phase 3 trial comparing lixisenatide versus insulin glulisine (IG) once daily (QD) and three times daily (TID). Response at week 26 was extrapolated to 52 weeks assuming a maintained treatment effect, based on long-term evidence in other T2DM populations...
March 8, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28256054/lixisenatide-reduces-glycemic-variability-in-insulin-treated-patients-with-type-2-diabetes
#9
Guillermo Umpierrez, David O'Neal, Andres DiGenio, Ronald Goldenberg, Eric Hernandez-Triana, Jay Lin, Cheol-Young Park, Eric Renard, Boris Kovatchev
Chronic hyperglycemia and glucose variability are associated with the development of chronic diabetes-related complications. We conducted a pooled analysis of patient-level data from three 24-week, randomized, phase 3 clinical trials to evaluate the impact of lixisenatide (LIXI) on glycemic variability (GV) vs. placebo as add-on to basal insulin. The main outcome GV measures were standard deviation (SD), mean amplitude of glycemic excursions (MAGE), mean absolute glucose (MAG), area under the curve-fasting glucose (AUC-F), and high and low blood glucose indices (HBGI/LBGI)...
March 3, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28244632/safety-issues-with-glucagon-like-peptide-1-receptor-agonists-pancreatitis-pancreatic-cancer-and-cholelithiasis-data-from-randomised-controlled-trials
#10
Matteo Monami, Besmir Nreu, Alessia Scatena, Barbara Cresci, Francesco Andreozzi, Giorgio Sesti, Edoardo Mannucci
AIM: Glucagon-like Peptide 1 Receptor Agonists (GLP1-RA) has been associated with an increased risk of pancreatitis and pancreatic cancer. Prior meta-analyses of randomized controlled trials failed to show any significant increase of risk; however, those meta-analyses did not include the recently published cardiovascular outcome trials (CVOT) with GLP1-RA, which provide a substantial additional body of data. The aim of the present meta-analysis is to assess the effect of GLP1-RA on pancreatitis, pancreatic cancers and cholelithiasis...
February 28, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28224463/liraglutide-versus-lixisenatide-long-term-cost-effectiveness-of-glp-1-receptor-agonist-therapy-for-the-treatment-of-type-2-diabetes-in-spain
#11
Pedro Mezquita-Raya, Antonio Ramírez de Arellano, Nana Kragh, Gabriela Vega-Hernandez, Johannes Pöhlmann, William J Valentine, Barnaby Hunt
INTRODUCTION: Glucagon-like peptide-1 (GLP-1) receptor agonists are used successfully in the treatment of patients with type 2 diabetes as they are associated with low hypoglycemia rates, weight loss and improved glycemic control. This study compared, in the Spanish setting, the cost-effectiveness of liraglutide 1.8 mg versus lixisenatide 20 μg, both GLP-1 receptor agonists, for patients with type 2 diabetes who had not achieved glycemic control targets on metformin monotherapy. METHODS: The IMS CORE Diabetes Model was used to project clinical outcomes and costs, expressed in 2015 Euros, over patient lifetimes...
February 21, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28213092/prediction-of-thyroid-c-cell-carcinogenicity-after-chronic-administration-of-glp1-r-agonists-in-rodents
#12
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 16, 2017: Toxicology and Applied Pharmacology
https://www.readbyqxmd.com/read/28197977/interpreting-cardiovascular-endpoints-in-trials-of-antihyperglycemic-drugs
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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