Literature DB >> 27037706

Safety and Tolerability of Glucagon-Like Peptide-1 Receptor Agonists Utilizing Data from the Exenatide Clinical Trial Development Program.

Hui Peng1,2,3, Laura L Want1, Vanita R Aroda4,5.   

Abstract

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have demonstrated benefits for patients with type 2 diabetes including A1C reduction and weight loss with minimal risk of hypoglycemia. This article provides an evidence-based update of safety and tolerability considerations for the clinical use of GLP-1RAs as a class, with a specific detailed review of data from the exenatide clinical trial development program, which has the longest history and availability of safety and tolerability data as the first-approved GLP-1RA. Specific areas covered include comparative risk of hypoglycemia, as well as pancreatic, thyroid, and cardiovascular safety data; clinical guidance regarding current safety and tolerability data is also reviewed.

Entities:  

Keywords:  Cardiovascular; Exenatide; GLP-1 receptor agonists; Incretin; Pancreatitis; Safety

Mesh:

Substances:

Year:  2016        PMID: 27037706     DOI: 10.1007/s11892-016-0728-4

Source DB:  PubMed          Journal:  Curr Diab Rep        ISSN: 1534-4827            Impact factor:   4.810


  82 in total

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2.  Glucagon-like peptide containing pathways in the regulation of feeding behaviour.

Authors:  M Tang-Christensen; N Vrang; P J Larsen
Journal:  Int J Obes Relat Metab Disord       Date:  2001-12

3.  Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study.

Authors:  John B Buse; Michael Nauck; Thomas Forst; Wayne H-H Sheu; Sylvia K Shenouda; Cory R Heilmann; Byron J Hoogwerf; Aijun Gao; Marilyn K Boardman; Mark Fineman; Lisa Porter; Guntram Schernthaner
Journal:  Lancet       Date:  2012-11-07       Impact factor: 79.321

Review 4.  A meta-analysis of placebo-controlled clinical trials assessing the efficacy and safety of incretin-based medications in patients with type 2 diabetes.

Authors:  Walid K H Fakhoury; Corinne Lereun; Donna Wright
Journal:  Pharmacology       Date:  2010-07-12       Impact factor: 2.547

5.  Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.

Authors:  Michael Grimm; Jenny Han; Carole Weaver; Pete Griffin; Christine T Schulteis; Haiying Dong; Jaret Malloy
Journal:  Postgrad Med       Date:  2013-05       Impact factor: 3.840

6.  Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes.

Authors:  Silvio E Inzucchi; Richard M Bergenstal; John B Buse; Michaela Diamant; Ele Ferrannini; Michael Nauck; Anne L Peters; Apostolos Tsapas; Richard Wender; David R Matthews
Journal:  Diabetes Care       Date:  2015-01       Impact factor: 19.112

7.  DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks.

Authors:  John B Buse; Daniel J Drucker; Kristin L Taylor; Terri Kim; Brandon Walsh; Hao Hu; Ken Wilhelm; Michael Trautmann; Larry Z Shen; Lisa E Porter
Journal:  Diabetes Care       Date:  2010-03-09       Impact factor: 19.112

8.  Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.

Authors:  Michaela Diamant; Michael A Nauck; Rimma Shaginian; James K Malone; Simon Cleall; Matthew Reaney; Danielle de Vries; Byron J Hoogwerf; Leigh MacConell; Bruce H R Wolffenbuttel
Journal:  Diabetes Care       Date:  2014-07-10       Impact factor: 19.112

9.  Exenatide Protects Against Glucose- and Lipid-Induced Endothelial Dysfunction: Evidence for Direct Vasodilation Effect of GLP-1 Receptor Agonists in Humans.

Authors:  Juraj Koska; Michelle Sands; Camelia Burciu; Karen M D'Souza; Kalyani Raravikar; James Liu; Seth Truran; Daniel A Franco; Eric A Schwartz; Dawn C Schwenke; David D'Alessio; Raymond Q Migrino; Peter D Reaven
Journal:  Diabetes       Date:  2015-02-26       Impact factor: 9.461

10.  Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study.

Authors:  Anne Gill; Byron J Hoogwerf; Jude Burger; Simon Bruce; Leigh Macconell; Ping Yan; Daniel Braun; Joseph Giaconia; James Malone
Journal:  Cardiovasc Diabetol       Date:  2010-01-28       Impact factor: 9.951

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  8 in total

Review 1.  Effect of hyperglycaemia and diabetes on acute myocardial ischaemia-reperfusion injury and cardioprotection by ischaemic conditioning protocols.

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Journal:  Br J Pharmacol       Date:  2020-03-09       Impact factor: 8.739

2.  Chronic Pancreatitis in the 21st Century - Research Challenges and Opportunities: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop.

Authors:  Aliye Uc; Dana K Andersen; Melena D Bellin; Jason I Bruce; Asbjørn M Drewes; John F Engelhardt; Christopher E Forsmark; Markus M Lerch; Mark E Lowe; Brent A Neuschwander-Tetri; Stephen J OʼKeefe; Tonya M Palermo; Pankaj Pasricha; Ashok K Saluja; Vikesh K Singh; Eva M Szigethy; David C Whitcomb; Dhiraj Yadav; Darwin L Conwell
Journal:  Pancreas       Date:  2016-11       Impact factor: 3.327

Review 3.  Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).

Authors:  Melanie J Davies; Vanita R Aroda; Billy S Collins; Robert A Gabbay; Jennifer Green; Nisa M Maruthur; Sylvia E Rosas; Stefano Del Prato; Chantal Mathieu; Geltrude Mingrone; Peter Rossing; Tsvetalina Tankova; Apostolos Tsapas; John B Buse
Journal:  Diabetologia       Date:  2022-09-24       Impact factor: 10.460

4.  Sitagliptin Treatment After Total Pancreatectomy With Islet Autotransplantation: A Randomized, Placebo-Controlled Study.

Authors:  M D Bellin; G J Beilman; T B Dunn; T L Pruett; D E R Sutherland; S Chinnakotla; J S Hodges; A Lane; P Ptacek; K L Berry; B J Hering; A Moran
Journal:  Am J Transplant       Date:  2016-08-26       Impact factor: 8.086

5.  Exenatide Add-on to Continuous Subcutaneous Insulin Infusion Therapy Reduces Bolus Insulin Doses in Patients with Type 2 Diabetes: A Randomized, Controlled, Open-Label Trial.

Authors:  Feng-Fei Li; Lanlan Jiang; Liyuan Fu; Hong-Hong Zhu; Peihua Zhou; Danfeng Zhang; Xiao-Fei Su; Jin-Dan Wu; Lei Ye; Jian-Hua Ma
Journal:  Diabetes Ther       Date:  2016-12-19       Impact factor: 2.945

6.  Pharmacokinetics of Exenatide in nonhuman primates following its administration in the form of sustained-release PT320 and Bydureon.

Authors:  Yazhou Li; Kelli L Vaughan; David Tweedie; Jin Jung; Hee Kyung Kim; Ho-Il Choi; Dong Seok Kim; Julie A Mattison; Nigel H Greig
Journal:  Sci Rep       Date:  2019-11-20       Impact factor: 4.379

7.  Incretin-Based Therapy and Risk of Pancreatic Cancer in Patients with Type 2 Diabetes Mellitus: A Meta-analysis of Randomized Controlled Trials.

Authors:  Han Chen; Xiaoying Zhou; Tao Chen; Bingtuan Liu; Wujuan Jin; Huiyuan Gu; Tianyuan Hong; Guoxin Zhang
Journal:  Diabetes Ther       Date:  2016-09-21       Impact factor: 2.945

8.  Post-treatment with PT302, a long-acting Exendin-4 sustained release formulation, reduces dopaminergic neurodegeneration in a 6-Hydroxydopamine rat model of Parkinson's disease.

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Journal:  Sci Rep       Date:  2018-07-16       Impact factor: 4.379

  8 in total

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