48
Views
2
CrossRef citations to date
0
Altmetric
Clinical Focus: Diabetes and Concomitant Disorders

Exenatide Once Weekly: Opportunities in the Primary Care Setting

, MD, , BS & , MD
Pages 68-78 | Published online: 13 Mar 2015

References

  • . Schappert SM, Rechtsteiner EA; US Department of Health and Human Services; Centers for Disease Control and Prevention; National Center for Health Statistics. Ambulatory medical care utilization estimates for 2007. http://www.cdc.gov/nchs/data/series/sr_13/srl3_169.pdf. 2011. Accessed November 12, 2012
  • . US Department of Health and Human Services; Centers for Disease Control and Prevention. Number (in millions) of civilian, noninstitutionalized persons with diagnosed diabetes, United States, 1980–2010. http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm. Updated December 9, 2011. Accessed November 12, 2012
  • . US Department of Health and Human Services; Centers for Disease Control and Prevention. National diabetes fact sheet, 2011. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. 2011. Accessed November 12, 2012
  • . Fox CS, Pencina MJ, Meigs JB, Vasan RS, Levitzky YS, D'Agostino RB Sr. Trends in the incidence of type 2 diabetes mellitus from the 1970s to the 1990s: the Framingham Heart Study. Circulation. 2006;113(25):2914–2918
  • . Siminerio LM, Drab SR, Gabbay RA, ; AADE. Diabetes educators: implementing the chronic care model. Diabetes Educ. 2008;34(3):451–456
  • . Rodbard HW, Jellinger PS, Davidson JA, . Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract. 2009;15(6):540–559
  • . Inzucchi SE, Bergenstal RM, Buse JB, ; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6):1364–1379
  • . Cheung BM, Ong KL, Cherny SS, Sham PC, Tso AW, Lam KS. Diabetes prevalence and therapeutic target achievement in the United States, 1999 to 2006. Am J Med. 2009;122(5):443–453
  • . Davidson JA. Incorporating incretin-based therapies into clinical practice: differences between glucagon-like peptide 1 receptor agonists and dipeptidyl peptidase 4 inhibitors. Mayo Clin Proc. 2010;85( 12 suppl):S27–S37
  • . Nauck MA. Unraveling the science of incretin biology. Eur J Intern Med. 2009;20( suppl 2):S303–S308
  • . Shah P, Basu A, Basu R, Rizza R. Impact of lack of suppression of glucagon on glucose tolerance in humans. Am J Physiol. 1999;277(2 pt 1):E283–E290
  • . Mitrakou A Kelley D, Veneman T, . Contribution of abnormal muscle and liver glucose metabolism to postprandial hyperglycemia in NIDDM. Diabetes. 1990;39(11):1381–1390
  • . Nauck M, Stöckmann F, Ebert R, Creutzfeldt W. Reduced incretin effect in type 2 (non-insulin-dependent) diabetes. Diabetologia. 1986;29(1):46–52
  • . Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP Gastroenterology. 2007;132(6):2131–2157
  • . De Young MB, MacConell L, Sarin V, Trautmann M, Herbert P. Encapsulation of exenatide in poly-(D, L-lactide-co-glycolide) microspheres produced an investigational long-acting once-weekly formulation for type 2 diabetes. Diabetes Technol Ther. 2011;13(11):1145–1154
  • . Nielsen LL, Young AA, Parkes DG. Pharmacology of exenatide (synthetic exendin-4): a potential therapeutic for improved glycemic control of type 2 diabetes. Regul Pept. 2004;117(2):77–88
  • . DeFronzo RA, Okerson T, Viswanathan P, Guan X, Holcombe JH, MacConell L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin. 2008;24(10):2943–2952
  • . Fineman M, Flanagan S, Taylor K, . Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing. Clin Pharmacokinet. 2011;50(1):65–74
  • . Copley K, McCowen K, Hiles R, Nielsen LL, Young A, Parkes DG. Investigation of exenatide elimination and its in vivo and in vitro degradation. Curr Drug Metab. 2006;7(4):367–374
  • . Buse JB, Drucker DJ, Taylor KL, ; DURATION-1 Study Group. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010;33(6):1255–1261
  • . Bydureon® (exenatide extended-release for injectable suspension) [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc.; 2012
  • . Bergenstal RM, Wysham C, Macconell L, ; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010;376(9739):431–439
  • . Blevins T, Pullman J, Malloy J, . DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011;96(5):1301–1310
  • . Buse JB, Nauck M, Forst T, . Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013;381(9861):117–124
  • . Diamant M, Van Gaal L, Stranks S, . Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010;375(9733):2234–2243
  • . Drucker DJ, Buse JB, Taylor K, ; DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008;372(9645):1240–1250
  • . Russell-Jones D, Cuddihy RM, Hanefeld M, ; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012;35(2):252–258
  • . Odegard PS, Capoccia K. Medication taking and diabetes: a systematic review of the literature. Diabetes Educ.2007;33(6): 1014–1029; discussion 1030–1011
  • . Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M. Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocr Disord. 2011;11:9
  • . Wysham C, Bergenstal R, Malloy J, . DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011;28(6):705–714
  • . MacConell L, Pencek R, Li Y, Maggs D, Porter L. Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years. Diabetes Metab Syndr Obes. 2013;6:31–41
  • . Sivertsen J, Rosenmeier J, Hoist JJ, Vilsbøll T. The effect of glucagon-like peptide 1 on cardiovascular risk. Nat Rev Cardiol. 2012;9(4):209–222
  • . www.ClinicalTrials.gov. Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus. NCT01144338. Acccessed March 27, 2013
  • . Campbell RK. Clarifying the role of incretin-based therapies in the treatment of type 2 diabetes mellitus. Clin Ther. 2011;33(5):511–527
  • . Harrower AD. Comparison of efficacy, secondary failure rate, and complications of sulfonylureas. J Diabetes Complications. 1994;8(4):201–203
  • . Gallwitz B, Guzman J, Dotta F, . Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet. 2012;379(9833):2270–2278
  • . MacConell L, Li Y, Pencek R, Schulteis C, Porter L. Exenatide once weekly resulted in sustained improvement in glycemic control with weight loss through 4 years [ADA abstract 1156-P]. Diabetes. 2012;61( suppl 1):A298
  • . Ridge T, Moretto T, MacConell L, . Comparison of safety and tolerability with continuous (exenatide once weekly) or intermittent (exenatide twice daily) GLP-1 receptor agonism in patients with type 2 diabetes [published online ahead of print June 26, 2012]. Diabetes Obes Metab
  • . Fineman MS, Shen LZ, Taylor K, Kim DD, Baron AD. Effectiveness of progressive dose-escalation of exenatide (exendin-4) in reducing dose-limiting side effects in subjects with type 2 diabetes. Diabetes Metab Res Rev. 2004;20(5):411–417
  • . Shive MS, Anderson JM. Biodegradation and biocompatibility of PLA and PLGA microspheres. Adv Drug Deliv Rev. 1997;28(1):5–24
  • . Best JH, Boye KS, Rubin RR, Cao D, Kim TH, Peyrot M. Improved treatment satisfaction and weight-related quality of life with exenatide once weekly or twice daily. Diabet Med. 2009;26(7):722–728
  • . Best JH, Rubin RR, Peyrot M, Li Y, Malloy J, Garrison LP. Weight-related quality of life, health utility, psychological well-being, and satisfaction with exenatide once weekly compared with sitagliptin or pioglitazone after 26 weeks of treatment. Diabetes Care. 2011;34(2):314–319
  • . Meloni AR, De Young MB, Lowe C, Parkes DG. GLP-1 receptor activated insulin secretion from pancreatic β-cells: mechanism and glucose dependence. Diabetes Obes Metab. 2013;15(1):15–27
  • . Stonehouse A, Walsh B, Cuddihy R. Exenatide once-weekly clinical development: safety and efficacy across a range of background therapies. Diabetes Technol Ther. 2011;13(10):1063–1069
  • . Raz I, Eldor R. Rational therapy for diabetes: early recognition of adverse effects and avoidance of disruptive false alarms. Diabetes Metab Res Rev. 2012;28(4):321–324
  • . Drucker DJ, Sherman SI, Bergenstal RM, Buse JB. The safety of incretin-based therapies—review of the scientific evidence. J Clin Endocrinol Metab. 2011;96(7):2027–2031
  • . Aroda VR, Ratner R. The safety and tolerability of GLP-1 receptor agonists in the treatment of type 2 diabetes: a review. Diabetes Metab Res Rev. 2011;27(6):528–542
  • . Weise WJ, Sivanandy MS, Block CA Comi RJ. Exenatide-associated ischemic renal failure. Diabetes Care. 2009;32(2):e22–e23
  • . Dore DD, Bloomgren GL, Wenten M, . A cohort study of acute pancreatitis in relation to exenatide use. Diabetes Obes Metab. 2011;13(6):559–566
  • . Dore DD, Seeger JD, Arnold Chan K. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin. 2009;25(4):1019–1027
  • . Garg R, Chen W, Pendergrass M. Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis. Diabetes Care. 2010;33(11):2349–2354
  • . Wenten M, Gaebler JA, Hussein M, . Relative risk of acute pancreatitis in initiators of exenatide twice daily compared with other anti-diabetic medication: a follow-up study. Diabet Med. 2012;29(11):1412–1418
  • . MacConell L, Brown C, Gurney K, Han J. Safety and tolerability of exenatide twice daily in patients with type 2 diabetes: integrated analysis of 5594 patients from 19 placebo-controlled and comparator-controlled clinical trials. Diabetes Metab Syndr Obes. 2012;5:29–41
  • . Pendergrass M, Fenton C, Haffner SM, Chen W. Exenatide and sitagliptin are not associated with increased risk of acute renal failure: a retrospective claims analysis. Diabetes Obes Metab. 2012;14(7):596–600
  • . Noel RA, Braun DK, Patterson RE, Bloomgren GL. Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes: a retrospective cohort study. Diabetes Care. 2009;32(5):834–838
  • . Byetta® (exenatide injection) [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc.; 2011
  • . Waser B, Beetschen K, Pellegata NS, Reubi JC. Incretin receptors in non-neoplastic and neoplastic thyroid C cells in rodents and humans: relevance for incretin-based diabetes therapy. Neuroendocrinology. 2011;94(4):291–301
  • . Madsen LW, Knauf JA, Gotfredsen C, . GLP-1 receptor agonists and the thyroid: C-cell effects in mice are mediated via the GLP-1 receptor and not associated with RET activation. Endocrinology. 2012;153(3):1538–1547
  • . Dore DD, Seeger JD, Chan KA. Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. Ther Adv Drug Saf. 2012;3(4):157–164
  • . Romley JA Goldman DP, Solomon M, McFadden D, Peters AL. Exenatide therapy and the risk of pancreatitis and pancreatic cancer in a privately insured population. Diabetes Technol Ther. 2012;14(10):904–911
  • . Davies M, Speight J. Patient-reported outcomes in trials of incretin-based therapies in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2012;14(10):882–892
  • . Polonsky WH, Fisher L, Hessler D, Bruhn D, Best JH. Patient perspectives on once-weekly medications for diabetes. Diabetes Obes Metab. 2011;13(2):144–149
  • . Kripalani S, Yao X, Haynes RB. Interventions to enhance medication adherence in chronic medical conditions: a systematic review. Arch Intern Med. 2007;167(6):540–550
  • . Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1296–1310
  • . Briesacher BA, Andrade SE, Harrold LR, Fouayzi H, Yood RA. Adoption of once-monthly oral bisphosphonates and the impact on adherence. Am J Med. 2010;123(3):275–280
  • . Victoza® (liraglutide [rDNA origin] injection) [package insert]. Princeton, NJ: Novo Nordisk A/S; 2012
  • . Lorenzi G, Schreiner B, Osther J, Boardman M. Application of adult-learning principles to patient instructions: a usability study for an exenatide once-weekly injection device. Clin Diabetes. 2010;28(4):157–162
  • . Frid A, Hirsch L, Gaspar R, ; Scientific Advisory Board for the Third Injection Technique Workshop. New injection recommendations for patients with diabetes. Diabetes Metab. 2010;36( suppl 2):S3–S18

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.