Clinical implications of exenatide as a twice-daily or once-weekly therapy for type 2 diabetes

Postgraduate Medicine

Volumn 123, Issue 5, 2011, Pages 228-238

  Aroda, Vanita R ^a   de young, Mary Beth ^b  

^a MEDSTAR RESEARCH INSTITUTE   (United States)

^b AMYLIN PHARMACEUTICALS INC   (United States)

Author keywords

Exenatide; Fasting plasma glucose; HbA1c; Postprandial glucose; Type 2 diabetes

Indexed keywords

BIOLOGICAL MARKER; C REACTIVE PROTEIN; EXENDIN 4; GLUCOSE; INSULIN; INSULIN GLARGINE; MONOCYTE CHEMOTACTIC PROTEIN 1; ORAL ANTIDIABETIC AGENT; PLACEBO; PROSTAGLANDIN F2 ALPHA; WARFARIN;

ACUTE PANCREATITIS; BODY WEIGHT; CARDIOVASCULAR RISK; DIABETIC DIET; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; EXERCISE; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEART RATE; HUMAN; HYPOGLYCEMIA; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE NODULE; INJECTION SITE PRURITUS; INJECTION SITE REACTION; KIDNEY DISEASE; NAUSEA AND VOMITING; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PATIENT PREFERENCE; PERCEPTION; PROTHROMBIN TIME; QT INTERVAL; REVIEW; SIDE EFFECT; SLOW DRUG RELEASE; STOMACH EMPTYING;

BLOOD GLUCOSE; BODY WEIGHT; CARDIOVASCULAR DISEASES; DELAYED-ACTION PREPARATIONS; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; MICROSPHERES; PATIENT PREFERENCE; PEPTIDES; RISK FACTORS; VENOMS;

EID: 80052700320     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.3810/pgm.2011.09.2479     Document Type: Review

References (48)

1. Rachman J, Barrow BA, Levy JC, Turner RC. Near-normalisation of diurnal glucose concentrations by continuous administration of glucagon-like peptide-1 (GLP-1) in subjects with NIDDM. Diabetologia. 1997;40(2):205-211.
2. Zander M, Madsbad S, Madsen JL, Holst JJ. Effect of 6-week course of glucagon-like peptide 1 on glycaemic control, insulin sensitivity, and beta-cell function in type 2 diabetes: a parallel-group study. Lancet. 2002;359(9309):824-830.
3. Eng J, Kleinman WA, Singh L, Singh G, Raufman JP. Isolation and characterization of exendin-4, an exendin-3 analogue from Heloderma suspectum venom. J Biol Chem. 1992;267(11):7402-7405.
4. Kim W, Egan JM. The role of incretins in glucose homeostasis and diabetes treatment. Pharmacol Rev. 2008;60(4):470-512.
5. Aronoff SL, Berkowitz K, Shreiner B, Want L. Glucose metabolism and regulation: beyond insulin and glucagon. Diabetes Spectrum. 2004; 17(2):183-190.
6. Drucker D, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, Porter L; DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomized, openlabel, non-inferiority study. Lancet. 2008;372(9645):1240-1250.
7. Nielsen LL, Young AA, Parkes DG. Pharmacology of exenatide (synthetic exendin-4): a potential therapeutic for improved glycemic control of type 2 diabetes. Regul Peptides. 2004;117(2):77-88.
8. Byetta [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc; 2010. http://pi.lilly.com/us/byetta-pi.pdf. Accessed January 17, 2011.
9. Fineman M, Flanagan S, Taylor K, et al. Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing. Clin Pharmacokinet. 2010;50(1):65-74.
10. Kim D, MacConell L, Zhuang D, et al. Effects of once-weekly dosing of a long-acting release formulation of exenatide on glucose control and body weight in subjects with type 2 diabetes. Diabetes Care. 2007;30(6):1487-1493.
11. Anderson JM, Shive MS. Biodegradation and biocompatibility of PLA and PLGA microspheres. Adv Drug Deliv Rev. 1997;28(1):5-24.
12. Swainston Harrison T, Plosker GL, Keam SJ. Extended-release intramuscular naltrexone. Drugs. 2006;66(13):1741-1751.
13. Mannelli P, Peindl K, Masand PS, Patkar AA. Long-acting injectable naltrexone for the treatment of alcohol dependence. Expert Rev Neurother. 2007;7(10):1265-1277.
14. Risperdal Consta (risperidone) long-acting injection [package insert]. Wallingstown, Little Island, County Cork, Ireland: Janssen Pharmaceutical Ltd; Revised December 2010.
15. Möller HJ. Long-acting injectable risperidone for the treatment of schizophrenia: clinical perspectives. Drugs. 2007;67(11):1541-1566.
16. Sandostatin LAR Depot [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2009. http://www.pharma.us.novartis.com/product/pi/pdf/sandostatin_lar.pdf. Accessed April 29, 2011.
17. Kolterman OG, Kim DD, Ruggles JA, Nielsen LL, Fineman MS, Baron AD. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus. Am J Health-Syst Pharm. 2005;62(2):173-181.
18. Blevins T, Pullman J, Malloy J, et al. 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.
19. Buse JB, Drucker DJ, Taylor KL, et al; 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.
20. Mazze R, Strock E, Morgan B, Wesley D, Bergenstal R, Cuddihy R. Diurnal glucose patterns of exenatide once weekly: a 1-year study using continuous glucose monitoring with ambulatory glucose profi le analysis. Endocr Pract. 2009;15(4):326-334.
21. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. Diabetes Care. 2009;32(1):193-203.
22. Rodbard HW, Jellinger PS, Davidson JA, et al. 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.
23. 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.
24. Croom KF, McCormack PL. Liraglutide: a review of its use in type 2 diabetes mellitus. Drugs. 2009;69(14):1985-2004.
25. Okerson T, Yan P, Stonehouse A, Brodows R. Effects of exenatide on systolic blood pressure in subjects with type 2 diabetes. Am J Hypertens. 2010;23(3):334-339.
26. Wu JD, Xu XH, Zhu J, et al. Effect of exenatide on infl ammatory and oxidative stress markers in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2011;13(2):143-148.
27. Derosa G, Maffioli P, Salvadeo SA, et al. Exenatide versus glibenclamide in patients with diabetes. Diabetes Technol Ther. 2010; 12(3):233-240.
28. Bunck MC, Diamant M, Eliasson B, et al. Exenatide affects circulating cardiovascular risk biomarkers independently of changes in body composition. Diabetes Care. 2010;33(8):1734-1737.
29. Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes. A randomized, controlled trial. Ann Intern Med. 2011;154(2):103-112.
30. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1297-1310.
31. McDonald HG, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptitons. JAMA. 2002;288(22): 2868-2879.
32. Lee WC, Balu S, Cobden D, Joshi AV, Pashos CL. Prevalence and economic consequences of medication adherence in diabetes: a systematic literature review. Manag Care Interface. 2006;19(7):31-41.
33. Rubin R. Adherence to pharmacologic therapy in patients with type 2 diabetes mellitus. Am J Med. 2005;118(suppl 5A):27S-34S.
34. 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.
35. 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.
36. Horton ES, Silberman C, Davis KL, Berria R. Weight loss, glycemic control, and changes in cardiovascular biomarkers in patients with type 2 diabetes receiving incretin therapies or insulin in a large cohort database. Diabetes Care. 2010;33:1759-1765.
37. Varanasi A, Chaudhuri A, Dhindsa S, et al. Durability of effects of exenatide treatment on glycemic control, body weight, systolic blood pressure, C-reactive protein, and triglyceride concentrations. Endocr Pract. 2011;17(2):192-200.
38. McAdam-Marx C, Ye X, Brixner DI, et al. A1C and weight outcomes at 18 months in patients with type 2 diabetes treated with exenatide in an ambulatory care setting. Diabetes Obes Metab. 2009;11(12): 1173-1174.
39. DeYoung 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 [published online ahead of print July 13, 2011]. Diabetes Technol Ther.
40. Ratner R, Han J, Nicewarner D, Yushmanova I, Hoogwerf BJ, Shen L. Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes. Cardiovasc Diabetol. 2011;10:22.
41. Linnebjerg H, Seger M, Kothare PA, Hunt T, Wolka AM, Mitchell MI. A thorough QT study to evaluate the effects of single-dose exenatide 10 μg on cardiac repolarization in healthy subjects. Int J Clin Pharmacol Ther. 2011;49(2):99-108.
42. Sager P, Darpö B, Han J, et al. Exenatide once weekly did not affect corrected QT interval in patients with type 2 diabetes. Diabetes. 2011;60(suppl 1):A294. Abstract 1070-P.
43. 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.
44. Dore DD, Bloomgren GL, Wenten M, et al. A cohort study of acute pancreatitis in relation to exenatide use. Diabetes Obes Metab. 2011;13(6):559-566.
45. Mayo Clinic. Pancreatitis: causes. http://www.mayoclinic.com/health/pancreatitis/DS00371/DSECTION=causes. Accessed June 29, 2011.
46. 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.
47. Knudsen LB, Madsen LW, Andersen S, et al. Glucagon-like peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Endocrinology. 2010;151(4): 1473-1486.
48. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). Diabetes Care. 2003;26(3):881-885