Sitagliptin: A review of its use in patients with type 2 diabetes mellitus

Drugs

Volumn 74, Issue 2, 2014, Pages 223-242

  Plosker, Greg L ^a  

^a NONE   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLACTIV; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; METFORMIN PLUS SITAGLIPTIN; PIOGLITAZONE; PLACEBO; SITAGLIPTIN; UNCLASSIFIED DRUG; DRUG COMBINATION; PYRAZINE DERIVATIVE; TRIAZOLE DERIVATIVE;

ABDOMINAL PAIN; ACUTE KIDNEY FAILURE; ADD ON THERAPY; ARTICLE; BODY WEIGHT; BODY WEIGHT DISORDER; CARDIOVASCULAR DISEASE; DIABETIC PATIENT; DIET RESTRICTION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG METABOLISM; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; DRUG USE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; MONOTHERAPY; NAUSEA AND VOMITING; NEOPLASM; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PANCREATITIS; PHARMACODYNAMICS; POSTMARKETING SURVEILLANCE; WEIGHT CHANGE; DIABETES MELLITUS, TYPE 2; DRUG COMBINATION;

DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; HUMANS; PYRAZINES; TRIAZOLES;

EID: 84895736410     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-013-0169-1     Document Type: Article

References (127)

1. Inzucchi SE, Bergenstal RM, Buse JB, et al. 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):1364-79.
2. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012;35 Suppl 1:S64-71.
3. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2012;35 Suppl 1:S11-63.
4. International Diabetes Federation. Global diabetes plan 2011-2021. http://www.idf.org/sites/default/files/Global-Diabetes-Plan-Final.pdf. Accessed 11 Jul 2013.
5. Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010;87(1):4-14.
6. Roglic G, Unwin N. Mortality attributable to diabetes: estimates for the year 2010. Diabetes Res Clin Pract. 2010;87(1):15-9.
7. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321(7258):405-12.
8. Moss SE, Klein R, Klein BE, et al. The association of glycemia and cause-specific mortality in a diabetic population. Arch Intern Med. 1994;154(21):2473-9.
9. Turner RC, Cull CA, Frighi V, et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999;281(21):2005-12.
10. Inzucchi SE, McGuire DK. New drugs for the treatment of diabetes: part II. Incretin-based therapy and beyond. Circulation. 2008;117(4):574-84.
11. Ahren B. Dipeptidyl peptidase-4 inhibitors: clinical data and clinical implications. Diabetes Care. 2007;30(6):1344-50.
12. Campbell RK. Rationale for dipeptidyl peptidase 4 inhibitors: a new class of oral agents for the treatment of type 2 diabetes mellitus. Ann Pharmacother. 2007;41(1):51-60.
13. Rosenstock J, Zinman B. Dipeptidyl peptidase-4 inhibitors and the management of type 2 diabetes mellitus. Curr Opin Endocrinol Diabetes Obes. 2007;14(2):98-107.
14. Dhillon S. Sitagliptin: a review of its use in the management of type 2 diabetes mellitus. Drugs. 2010;70(4):489-512.
15. Sitagliptin (Januvia) US prescribing information. 2013. http://www.merck.com/product/usa/pi-circulars/j/januvia/januvia-pi.pdf. Accessed 9 Jul 2013.
16. Sitagliptin summary of product characteristics. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/000722/WC500039054.pdf. Accessed 9 Jul 2013.
17. Kim D, Wang L, Beconi M, et al. (2R)-4-oxo-4-[3-(trifluoromethyl)-5,6- dihydro[1, 2, 4]triazolo[4,3-a]pyrazin-7(8H)- yl]-1-(2,4,5-trifluorophenyl) butan-2-amine: a potent, orally active dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes. J Med Chem. 2005;48(1):141-51.
18. Bergman AJ, Stevens C, Zhou Y, et al. Pharmacokinetic and pharmacodynamic properties of multiple oral doses of sitagliptin, a dipeptidyl peptidase-IV inhibitor: a double-blind, randomized, placebo-controlled study in healthy male volunteers. Clin Ther. 2006;28(1):55-72.
19. Herman GA, Bergman A, Liu F, et al. Pharmacokinetics and pharmacodynamic effects of the oral DPP-4 inhibitor sitagliptin in middle-aged obese subjects. J Clin Pharmacol. 2006;46(8):876-86.
20. Herman GA, Bergman A, Stevens C, et al. Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on incretin and plasma glucose levels after an oral glucose tolerance test in patients with type 2 diabetes. J Clin Endocrinol Metab. 2006;91(11):4612-9.
21. Herman GA, Stevens C, Van Dyck K, et al. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther. 2005;78(6):675-88.
22. Lyseng-Williamson KA. Sitagliptin. Drugs. 2007;67(4):587-97.
23. Golightly LK, Drayna CC, McDermott MT. Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors. Clin Pharmacokinet. 2012;51(8):501-14.
24. Bergman A, Mistry GC, Luo WL, et al. Dose-proportionality of a final market image sitagliptin formulation, an oral dipeptidyl peptidase-4 inhibitor, in healthy volunteers. Biopharm Drug Dispos. 2007;28(6):307-13.
25. Bergman A, Ebel D, Liu F, et al. Absolute bioavailability of sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, in healthy volunteers. Biopharm Drug Dispos. 2007;28(6):315-22.
26. Vincent SH, Reed JR, Bergman AJ, et al. Metabolism and excretion of the dipeptidyl peptidase 4 inhibitor [14C]sitagliptin in humans. Drug Metab Dispos. 2007;35(4):533-8.
27. Migoya EM, Stevens CH, Bergman AJ, et al. Effect of moderate hepatic insufficiency on the pharmacokinetics of sitagliptin. Can J Clin Pharmacol. 2009;16(1):e165-70.
28. Bergman AJ, Cote J, Yi B, et al. Effect of renal insufficiency on the pharmacokinetics of sitagliptin, a dipeptidyl peptidase-4 inhibitor. Diabetes Care. 2007;30(7):1862-4.
29. Fraser I, Neufeld N, Fox LA, et al. Pharmacokinetics and pharmacodynamics of sitagliptin in adolescents with type 2 diabetes [abstract]. 73rd Annual Meeting of the American Diabetes Association; 21-25 June 2013; Chicago (IL).
30. Herman GA, Mistry GC, Yi B, et al. Evaluation of pharmacokinetic parameters and dipeptidyl peptidase-4 inhibition following single doses of sitagliptin in healthy, young Japanese males. Br J Clin Pharmacol. 2011;71(3):429-36.
31. Migoya E, Larson P, Bergman A, et al. Sitagliptin, a dipeptidyl peptidase-4 inhibitor, does not affect the pharmacokinetics of ethinyl estradiol or norethindrone in healthy female subjects. J Clin Pharmacol. 2011;51(9):1319-25.
32. Mistry GC, Bergman AJ, Zheng W, et al. Sitagliptin, an dipeptidyl peptidase-4 inhibitor, does not alter the pharmacokinetics of the sulphonylurea, glyburide, in healthy subjects. Br J Clin Pharmacol. 2008;66(1):36-42.
33. Cerra M, Luo WL, Li S, et al. Effect of simvastatin on the pharmacokinetics of sitagliptin. J Popul Ther Clin Pharmacol. 2012;19(3):e356-60.
34. Migoya EM, Miller JL, Gutierrez M, et al. Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study. Clin Drug Investig. 2010;30(12):855-66.
35. Iwamoto Y, Taniguchi T, Nonaka K, et al. Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Endocr J. 2010;57(5):383-94.
36. Hanefeld M, Herman GA, Wu M, et al. Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Curr Med Res Opin. 2007;23(6):1329-39.
37. Scott R, Wu M, Sanchez M, et al. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 2007;61(1):171-80.
38. Aschner P, Kipnes MS, Lunceford JK, et al. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006;29(12):2632-7.
39. Barzilai N, Guo H, Mahoney EM, et al. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011;27(5):1049-58.
40. Mohan V, Yang W, Son HY, et al. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract. 2009;83(1):106-16.
41. Nonaka K, Kakikawa T, Sato A, et al. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008;79(2):291-8.
42. Raz I, Hanefeld M, Xu L, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006;49(11):2564-71.
43. Aschner P, Katzeff HL, Guo H, et al. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12(3):252-61.
44. Iwamoto Y, Tajima N, Kadowaki T, et al. Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial. Diabetes Obes Metab. 2010;12(7):613-22.
45. Russell-Jones D, Cuddihy RM, Hanefeld M, et al. 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):252-8.
46. Arjona Ferreira JC, Marre M, Barzilai N, et al. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes andmoderate-to-severe chronic renal insufficiency. Diabetes Care. 2013;36(5):1067-73.
47. Arjona Ferreira JC, Corry D, Mogensen CE, et al. Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial. Am J Kidney Dis. 2013;61(4):579-87.
48. Arjona Ferreira JC, Engel SS, Guo H, et al. Consistency of the A1C-lowering effects of sitagliptin versus glipizide in patients with type 2 diabetes and chronic renal insufficiency across a variety of baseline characteristics [abstract no. 1089-P]. Diabetes. 2012;61 Suppl 1:A281.
49. Arjona Ferreira JC, Engel SS, Guo H, et al. Sitagliptin more effectively achieves a composite endpoint of a1c reduction, no body weight gain, and lack of hypoglycemia in patients with type 2 diabetes and renal insufficiency compared to glipizide [abstract no. 1009-P). Diabetes. 2012;61 Suppl 1:A258.
50. Chan JC, Scott R, Arjona Ferreira JC, et al. Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency. Diabetes Obes Metab. 2008;10(7):545-55.
51. Engel SS, Xu L, Golm GT, et al. Comparison of treatment with sitagliptin (SITA) or sulfonylurea (SU) in patients with type 2 diabetes mellitus (T2DM) and mild renal insufficiency [abstract]. 73rd Annual Meeting of the American Diabetes Association; 21-25 June 2013; Chicago (IL).
52. Kubota A, Maeda H, Kanamori A, et al. Efficacy and safety of sitagliptin monotherapy and combination therapy in Japanese type 2 diabetes patients. J Diabetes Investig. 2012;3(6):503-9.
53. Arase Y, Suzuki F, Suzuki Y, et al. Efficacy and safety in sitagliptin therapy for diabetes complicated by chronic liver disease caused by hepatitis C virus. Hepatol Res. 2011;41(6):524-9.
54. Odawara M, Kadowaki T, Tajima N, et al. Long-term safety, tolerability, and efficacy of the dipeptidyl peptidase-4 inhibitor sitagliptin in Japanese patients with type 2 diabetes. Diabetol Int. 2011;2(2):94-105.
55. Goldstein BJ, Feinglos MN, Lunceford JK, et al. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007;30(8):1979-87.
56. Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes: a 54-week study. Curr Med Res Opin. 2009;25(3):569-83.
57. 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):442-51.
58. Reasner C, Olansky L, Seck TL, et al. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011;13(7):644-52.
59. Olansky L, Reasner C, Seck TL, et al. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes Obes Metab. 2011;13(9):841-9.
60. Wainstein J, Katz L, Engel SS, et al. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012;14(5):409-18.
61. http://www.merck.com/product/usa/pi-circulars/j/janumet/janumet-pi.pdf Accessed 25 Jul 2013
62. Sitagliptin and metformin extended-release (Janumet XR) US prescribing information. 2013. http://www.merck.com/product/usa/pi-circulars/j/janumet-xr/ janumet-xr-pi.pdf. Accessed 25 Jul 2013.
63. Sitagliptin/metformin (Efficib) summary of product characteristics. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/000896/WC500021374.pdf. Accessed 25 Jul 2013.
64. Chwieduk CM. Sitagliptin/metformin fixed-dose combination: in patients with type 2 diabetes mellitus. Drugs. 2011;71(3):349-61.
65. Yoon KH, Shockey GR, Teng R, et al. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of β-cell function in patients with type 2 diabetes. Int J Clin Pract. 2011;65(2):154-64.
66. Perez-Monteverde A, Seck T, Xu L, et al. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes. Int J Clin Pract. 2011;65(9):930-8.
67. Henry RR, Staels B, Fonseca VA, et al. Efficacy and safety of initial combination treatment with sitagliptin and pioglitazone - a factorial study [abstract no. O-0597]. 21st World Diabetes Congress; 4-8 Dec 2011; Dubai.
68. Charbonnel B, Karasik A, Liu J, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006;29(12):2638-43.
69. Kadowaki T, Tajima N, Odawara M, et al. Addition of sitagliptin to ongoing metformin monotherapy improves glycemic control in Japanese patients with type 2 diabetes over 52 weeks. J Diabetes Investig. 2013;4(2):174-81.
70. Raz I, Chen Y, Wu M, et al. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008;24(2):537-50.
71. Yang W, Guan Y, Shentu Y, et al. The addition of sitagliptin to ongoing metformin therapy significantly improves glycemic control in Chinese patients with type 2 diabetes. J Diabetes. 2012;4(3):227-37.
72. Arechavaleta R, Seck T, Chen Y, et al. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011;13(2):160-8.
73. Aschner P, Chan J, Owens DR, et al. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. Lancet. 2012;379(9833):2262-9.
74. Bergenstal RM, Wysham C, Macconell L, et al. 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):431-9.
75. Nauck MA, Meininger G, Sheng D, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007;9(2):194-205.
76. Pratley RE, Nauck M, Bailey T, et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial [Erratum appears in Lancet. 2010 Jul 24;376(9737):234]. Lancet. 2010;375(9724):1447-56.
77. Scheen AJ, Charpentier G, Ostgren CJ, et al. Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus. Diabetes Metab Res Rev. 2010;26(7):540-9.
78. Scott R, Loeys T, Davies MJ, et al. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008;10(10):959-69.
79. 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):562-76.
80. Best JH, Rubin RR, Peyrot M, et al. 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):314-9.
81. Pratley R, Nauck M, Bailey T, et al. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011;65(4):397-407.
82. Pratley RE, Nauck MA, Bailey T, et al. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial. Diabetes Care. 2012;35(10):1986-93.
83. Dobs AS, Goldstein BJ, Aschner P, et al. Efficacy and safety of sitagliptin added to ongoing metformin and rosiglitazone combination therapy in a randomized placebo-controlled 54-week trial in patients with type 2 diabetes. J Diabetes. 2013;5(1):68-79.
84. Fonseca V, Staels B, Morgan IJD, et al. Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes. J Diabetes Complications. 2013;27(2):177-83.
85. Kashiwagi A, Kadowaki T, Tajima N, et al. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes. J Diabetes Investig. 2011;2(5):381-90.
86. Rosenstock J, Brazg R, Andryuk PJ, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006;28(10):1556-68.
87. Hermansen K, Kipnes M, Luo E, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007;9(5):733-45.
88. Round E, Shentu Y, Golm GT, et al. Safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control [abstract]. 73rd Annual Meeting of the American Diabetes Association; 21-25 June. 2013; Chicago (IL).
89. Tajima N, Kadowaki T, Odawara M, et al. Addition of sitagliptin to ongoing glimepiride therapy in Japanese patients with type 2 diabetes over 52 weeks leads to improved glycemic control. Diabetol Int. 2011;2(1):32-44.
90. Kadowaki T, Tajima N, Odawara M, et al. Addition of sitagliptin, an oral, highly-selective dipeptidyl peptidase-4 inhibitor, improved glycemic control and was well tolerated in Japanese patients with type 2 diabetes on insulin monotherapy. Diabetes. 2011;60:A279-80.
91. Vilsboll T, Rosenstock J, Yki-Jarvinen H, et al. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12(2):167-77.
92. Deacon CF, Holst JJ. Dipeptidyl peptidase-4 inhibitors for the treatment of type 2 diabetes: comparison, efficacy and safety. Expert Opin Pharmacother. 2013;14(15):2047-58.
93. Engel SS, Round E, Golm GT, et al. Safety and tolerability of sitagliptin in type 2 diabetes: pooled analysis of 25 clinical studies (Erratum appears in Diabetes Ther. 2013;4(2):487). Diabetes Ther. 2013;4(1):119-45.
94. Eurich DT, Simpson S, Senthilselvan A, et al. Comparative safety and effectiveness of sitagliptin in patients with type 2 diabetes: retrospective population based cohort study. BMJ. 2013;346:f2267.
95. Engel SS, Williams-Herman DE, Golm GT, et al. Sitagliptin: review of preclinical and clinical data regarding incidence of pancreatitis. Int J Clin Pract. 2010;64(7):984-90.
96. Elashoff M, Matveyenko AV, Gier B, et al. Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies. Gastroenterology. 2011;141(1):150-6.
97. Butler AE, Campbell-Thompson M, Gurlo T, et al. Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors. Diabetes. 2013;62(7):2595-604.
98. 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):1019-27.
99. 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):2349-54.
100. Monami M, Dicembrini I, Martelli D, et al. Safety of dipeptidyl peptidase-4 inhibitors: a meta-analysis of randomized clinical trials. Curr Med Res Opin. 2011;27 Suppl 3:57-64.
101. Singh S, Chang H-Y, Richards TM, et al. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med. 2013;173(7):534-9.
102. Brodovicz KG, Engel SS, Thornberry NA. Glucagon-like peptide 1-based drugs and pancreatic safety [letter]. JAMA Intern Med. 2013;173(19):1842-3.
103. Scheen A. Gliptins (dipeptidyl peptidase-4 inhibitors) and risk of acute pancreatitis. Expert Opin Drug Saf. 2013;12(4):545-57.
104. Pollack A. European regulator finds little risk in diabetes drugs. 2013. http://www.nytimes.com/2013/07/27/business/european-regulator-finds-little-risk- in-diabetes-drugs.html?-r=1. Accessed 11 Sept 2013.
105. Engel SS, Golm GT, Shapiro D, et al. Cardiovascular safety of sitagliptin in patients with type 2 diabetes mellitus: a pooled analysis. Cardiovasc Diabetol. 2013;12(1):3.
106. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317-26.
107. White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369(14):1327-35.
108. Scheen AJ. Cardiovascular effects of dipeptidyl peptidase-4 inhibitors: from risk factors to clinical outcomes. Postgrad Med. 2013;125(3):7-20.
109. Bloomfield DM, Krishna R, Hreniuk D, et al. A thorough QTc study to assess the effect of sitagliptin, a DPP4 inhibitor, on ventricular repolarization in healthy subjects. J Clin Pharmacol. 2009;49(8):937-46.
110. Pendergrass M, Fenton C, Haffner SM, et al. 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.
111. Glactiv (sitagliptin phosphate hydrate tablets): Japanese prescribing information. Osaka: Ono Pharmaceutical Co., Ltd. 2013.
112. Plosker GL. Dapagliflozin: a review of its use in type 2 diabetes mellitus. Drugs. 2012;72(17):2289-312.
113. Deeks ED. Linagliptin: a review of its use in the management of type 2 diabetes mellitus. Drugs. 2012;72(13):1793-824.
114. Tahrani AA, Bailey CJ, Del Prato S, et al. Management of type 2 diabetes: new and future developments in treatment. Lancet. 2011;378(9786):182-97.
115. Barnett AH. New treatments in type 2 diabetes: a focus on the incretin-based therapies. Clin Endocrinol (Oxf). 2009;70(3):343-53.
116. Burgmaier M, Heinrich C, Marx N. Cardiovascular effects of GLP-1 and GLP-1-based therapies: implications for the cardiovascular continuum in diabetes? Diabet Med. 2013;30(3):289-99.
117. Peters AL. Patient and treatment perspectives: revisiting the link between type 2 diabetes, weight gain, and cardiovascular risk. Cleve Clin J Med. 2009;76 Suppl 5:S20-7.
118. Schwarz B, Gouveia M, Chen J, et al. Cost-effectiveness of sitagliptin-based treatment regimens in European patients with type 2 diabetes and haemoglobin A1c above target on metformin monotherapy. Diabetes Obes Metab. 2008;10 Suppl 1:43-55.
119. Lage MJ, Fabunmi R, Boye KS. Comparison of costs among patients with type 2 diabetes treated with exenatide or sitagliptin therapy. Adv Ther. 2009;26:217-29.
120. Langer J, Hunt B, Valentine WJ. Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States. J Manag Care Pharm. 2013;19:237-46.
121. Kaltenboeck A, Ivanova J, Thomas N, et al. Health care resource use and costs in patients with type 2 diabetes mellitus after treatment initiation with saxagliptin or sitagliptin [abstract no. PDB31]. Value Health. 2013;16(3):A161.
122. Hutchings A, Tolley K, Achana F, et al. Cost-effectiveness of saxagliptin compared to sitagliptin for the treatment of patients with type 2 diabetes mellitus (T2DM) [abstract no. PDB39]. Value Health. 2011;14(7):A478.
123. Romero M, Marrugo R, Sanchez O, et al. Cost-effectiveness analysis of using hypoglycemic agents (linagliptin, saxagliptin, sitagliptin, vildagliptin, glimepiride and glibenclamide) with metformin in diabetes in Colombia [abstract no. PDB44]. Value Health. 2013;16(3):A163.
124. Wilson BP, Beaudet A, Caputo J, et al. Projected long-term clinical and economic outcomes of exenatide once weekly versus sitagliptin for the treatment of Type 2 diabetes in the UK [abstract no. P371]. Diabet Med. 2012;29 Suppl 1:142.
125. Schlander M, Mentrup S, Lund N. Addition of incretin-therapy to metformin in type-2-diabetes mellitus (T2DM): cost-effectiveness of liraglutide versus sitagliptin from the perspective of the German statutory health insurance (SHI) [abstract no. PDB38]. Value Health. 2010;13(7):A290.
126. Aledort Gaebler J, Samyshkin Y, Guillermin ALG, et al. Long-term cost-consequence analysis of exenatide once weekly versus sitagliptin or pioglitazone in type 2 diabetes patients in the United States [abstract no. PDB36]. Value Health. 2010;13 (7):A290.
127. Lee WC, Samyshkin Y, Langer J, et al. Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis. J Med Econ. 2012;15 Suppl 2:28-37.