Exenatide once weekly: Sustained improvement in glycemic control and cardiometabolic measures through 3 years

Diabetes, Metabolic Syndrome and Obesity

Volumn 6, Issue , 2013, Pages 31-41

  Macconell, Leigh ^a   Pencek, Richard ^a   Li, Yan ^a   Maggs, David ^a   Porter, Lisa ^a  

^a AMYLIN PHARMACEUTICALS INC   (United States)

Author keywords

Diabetes; Duration 1; Exenatide; GLP 1 receptor agonist; Hyperglycemia

Indexed keywords

CHOLESTEROL; EXENDIN 4; GLUCOSE; HEMOGLOBIN A1C; LOW DENSITY LIPOPROTEIN CHOLESTEROL; TRIACYLGLYCEROL;

ABDOMINAL PAIN; ADULT; ARTHRALGIA; ARTICLE; BACKACHE; BLOOD PRESSURE REGULATION; BRONCHITIS; CARDIOTOXICITY; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONSTIPATION; COUGHING; DEPRESSION; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; FALLING; FATIGUE; FEMALE; GASTROESOPHAGEAL REFLUX; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HEART DISEASE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INFLUENZA; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE PRURITUS; INSOMNIA; LIMB PAIN; LIVER TOXICITY; LUNG TOXICITY; MAJOR CLINICAL STUDY; MALE; MUSCLE SPASM; MUSCULOSKELETAL PAIN; NAUSEA; NEPHROLITHIASIS; NEPHROTOXICITY; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS CANCER; PANCREAS ISLET BETA CELL; PANCREAS ISLET CELL FUNCTION; PANCREATITIS; PERIPHERAL EDEMA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHINOPHARYNGITIS; SIDE EFFECT; SINUSITIS; SORE THROAT; SYSTOLIC BLOOD PRESSURE; THYROID CANCER; TRIACYLGLYCEROL BLOOD LEVEL; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VIRAL GASTROENTERITIS; VOMITING; WEIGHT REDUCTION;

EID: 84872944068     PISSN: 11787007     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (36)

1. 1c assay in the diagnosis of diabetes. Diabetes Care. 2009;32(7):1327-1334.
2. Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355(23):2427-2443.
3. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359(15):1577-1589.
4. BYETTA® exenatide injection [prescribing information]. San Diego, CA: Amylin Pharmaceuticals, Inc; 2011.
5. Apovian CM, Bergenstal RM, Cuddihy RM, et al. Effects of exenatide combined with lifestyle modification in patients with type 2 diabetes. Am J Med. 2010;123(5):468.e9-468.e17.
6. Cervera A, Wajcberg E, Sriwijitkamol A, et al. Mechanism of action of exenatide to reduce postprandial hyperglycemia in type 2 diabetes. Am J Physiol Endocrinol Metab. 2008;294(5):E846-E852.
7. 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.
8. DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005;28(5):1092-1100.
9. Kendall DM, Riddle MC, Rosenstock J, et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005;28(5):1083-1091.
10. Edwards CM, Stanley SA, Davis R, et al. Exendin-4 reduces fasting and postprandial glucose and decreases energy intake in healthy volunteers. Am J Physiol Endocrinol Metab. 2001;281(1):E155-E161.
11. Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology. 2007;132(6):2131-2157.
12. Bunck MC, Corner A, Eliasson B, et al. Effects of exenatide on measures of β-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011;34(9):2041-2047.
13. Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD; Exenatide-113 Clinical Study Group. Effects of exenatide (exendin-4) on glycemic control and safety over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004;27(11):2628-2635.
14. Buse JB, Klonoff DC, Nielsen LL, et al. Metabolic effects of two years of exenatide treatment on diabetes, obesity and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials. Clin Ther. 2007;29(1):139-153.
15. Klonoff DC, Buse JB, Nielsen LL, et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008;24(1):275-286.
16. 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. Diabetes Technol Ther. 2011;13(11): 1145-1154.
17. Drucker DJ, Buse JB, Taylor K, et al. 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.
18. Buse JB, Drucker DJ, Taylor KL, et al. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010;33(6):1255-1261.
19. 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.
20. World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA. 1997;277(11):925-926.
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: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. 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. Ahrén B, Foley JE, Ferrannini E, et al. Changes in prandial glucagon levels after a 2-year treatment with vildagliptin or glimepiride in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Diabetes Care. 2010;33(4):730-732.
24. Kooy A, de Jager J, Lehert P, et al. Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus. Arch Intern Med. 2009;169(6):616-625.
25. Seck T, Nauck M, Sheng D, et al. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract. 2010;64(5): 562-576.
26. Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12(5):442-451.
27. Diamant M, Van Gaal L, Stranks S, et al. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012;35(4): 683-689.
28. Patel A; ADVANCE Collaborative Group. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet. 2007; 370(9590):829-840.
29. Ginsberg HN. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) lipid trial: what we learn from subgroup analyses. Diabetes Care. 2011;34(Suppl 2):S107-S108.
30. Curb JD, Pressel SL, Cutler JA, et al; Systolic Hypertension in the Elderly Program Cooperative Research Group. Effect of diuretic-based antihypertensive treatment on cardiovascular disease risk in older diabetic patients with isolated systolic hypertension. JAMA. 1996;276(23): 1886-1892.
31. Aalbers J. ACCORD lipid study results strengthen guideline approach of adding fenofibrate to therapy of dyslipidaemic type 2 diabetic patients. Cardiovasc J Afr. 2010;21(2):118-119.
32. Elam M, Lovato LC, Ginsberg H. Role of fibrates in cardiovascular disease prevention, the ACCORD-Lipid perspective. Curr Opin Lipidol. 2011;22(1):55-61.
33. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998;317(7160):703-713.
34. Gaede P, Vedel P, Parving HH, Pedersen O. Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study. Lancet. 1999; 353(9153):617-622.
35. Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348(5):383-393.
36. Elashoff M, Matveyenko AV, Gier B, Elashoff R, Butler PC. Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies. Gastroenterology. 2011;141(1):150-156.