Erratum to Safety and tolerability of Sitagliptin in type 2 diabetes: Pooled analysis of 25 clinical studies (Diabetes Ther, (2013), 4, (119-145), 10.1007/s13300-013-0024-0);Safety and tolerability of sitagliptin in type 2 diabetes: Pooled analysis of 25 clinical studies

Diabetes Therapy

Volumn 4, Issue 1, 2013, Pages 119-145

  Engel, Samuel S ^a   Round, Elizabeth ^a   Golm, Gregory T ^a   Kaufman, Keith D ^a   Goldstein, Barry J ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Adverse events; Dipeptidyl peptidase 4 inhibitor; Safety; Sitagliptin; Tolerability; Type 2 diabetes

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CREATININE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; INSULIN; METFORMIN; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SITAGLIPTIN; SULFONYLUREA;

ADULT; ANGIONEUROTIC EDEMA; ARTICLE; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HUMAN; HYPOGLYCEMIA; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MODERATE RENAL IMPAIRMENT; MULTICENTER STUDY; NEOPLASM; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 84885384645     PISSN: 18696953     EISSN: 18696961     Source Type: Journal    
DOI: 10.1007/s13300-013-0031-1     Document Type: Erratum

References (68)

1. Inzucchi SE, Bergenstal RM, Buse JB, American Diabetes Association; European Association for the Study of Diabetes, et al. Management of hyperglycemia in type 2 diabetes: a patientcentered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364-79
2. Nathan DM, Buse JB, Davidson MB, American Diabetes Association; European Association for the Study of Diabetes, et al. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2009;52:17-30
3. Monami M, Dicembrini I, Martelli D, Mannucci E. Safety of dipeptidyl peptidase-4 inhibitors: a metaanalysis of randomized clinical trials. Curr Med Res Opin. 2011;27(Suppl 3):57-64
4. 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;64:984-90
5. Williams-Herman D, Round E, Swern AS, et al. Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis. BMC Endocr Disord. 2008;8:14
6. Williams-Herman D, Engel SS, Round E, et al. Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord. 2010;10:7
7. Arjona Ferreira JC, Marre M, Barzilai N, et al. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-tosevere chronic renal insufficiency. Diabetes Care. 2013;36:1067-73
8. 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;61:579-87
9. 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;10:545-55
10. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4:213-26
11. Breslow NE, Day NE. Statistical methods in cancer research. The design and analysis of cohort studies, vol. II. Lyon: IARC Sci Pub; 1987
12. Engel SS, Golm GT, Shapiro D, Davies MJ, Kaufman KD, Goldstein BJ. Cardiovascular safety of sitagliptin in patients with type 2 diabetes mellitus: a pooled analysis. Cardiovasc Diabetol. 2013;12:3
13. Deacon CF. Dipeptidyl peptidase 4 inhibition with sitagliptin: a new therapy for type 2 diabetes. Expert Opin Investig Drugs. 2007;16:533-45
14. Cobble ME, Frederich R. Saxagliptin for the treatment of type 2 diabetes mellitus: assessing cardiovascular data. Cardiovasc Diabetol. 2012;11:6
15. Schernthaner G, Barnett AH, Emser A, et al. Safety and tolerability of linagliptin: a pooled analysis of data from randomized controlled trials in 3572 patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2012;14:470-8
16. Schweizer A, Dejager S, Foley JE, Kothny W. Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies. Vasc Health Risk Manag. 2011;7:49-57
17. Goossen K, Graber S. Longer term safety of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus: systematic review and meta-analysis. Diabetes Obes Metab. 2012 (Epub ahead of print).
18. Karagiannis T, Paschos P, Paletas K, Matthews DR, Tsapas A. Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and metaanalysis. BMJ. 2012;344:e1369
19. 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;12:167-77
20. Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P. 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;9:733-45
21. Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylureatreated patients with type 2 diabetes. Diabetes Care. 2004;27:2628-35
22. Rosenstock J, Einhorn D, Hershon K, Glazer NB, Yu S. Efficacy and safety of pioglitazone in type 2 diabetes: a randomised, placebo-controlled study in patients receiving stable insulin therapy. Int J Clin Pract. 2002;56:251-7
23. Bain SC, Stephens JW. Exenatide and pancreatitis: an update. Expert Opin Drug Saf. 2008;7:643-4
24. Denker PS, Dimarco PE. Exenatide (exendin-4)- induced pancreatitis: a case report. Diabetes Care. 2006;29:471
25. Januvia prescribing information. 2013. Whitehouse Station, New Jersey, USA, Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc.
26. US Food and Drug Administration. Adverse event reporting system; 2013. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm (Accessed 28 Feb 2013).
27. Elashoff M, Matveyenko AV, Gier B, Elashoff R, Butler PC. Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies. Gastroenterology. 2011;141:150-6
28. Singh S, Chang HY, Richards TM, Weiner JP, Clark JM, Segal JB. 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;173:534-9
29. Cai B, Katz L, Alexander CM, Williams-Herman D, Girman CJ. Characteristics of patients prescribed sitagliptin and other oral antihyperglycaemic agents in a large US claims database. Int J Clin Pract. 2010;64:1601-8
30. Dore DD, Seeger JD, Arnold CK. Use of a claimsbased 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;25:1019-27
31. 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;33:2349-54
32. Bethel MA, Green J, Califf M, Holman RR. Rationale and design of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) [abstract]. Diabetologia. 2009;52(Suppl 1):S480
33. Giovannucci E, Michaud D. The role of obesity and related metabolic disturbances in cancers of the colon, prostate, and pancreas. Gastroenterology. 2007;132:2208-25
34. Neumann A, Weill A, Ricordeau P, Fagot JP, Alla F, Allemand H. Pioglitazone and risk of bladder cancer among diabetic patients in France: a populationbased cohort study. Diabetologia. 2012;55:1953-62
35. Burki TK. FDA rejects novel diabetes drug over safety fears. Lancet. 2012;379:507
36. Hofstad B. Colon polyps: prevalence rates, incidence rates, and growth rates. In: Waye JD, Rex DK, Williams CB, editors. Colonoscopy: principles and practice. 2nd ed. New York: Blackwell Publishing Ltd; 2009. p. 358-78
37. Okolo S. Incidence, aetiology and epidemiology of uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2008;22:571-88
38. Rydholm A, Berg NO. Size, site and clinical incidence of lipoma. Factors in the differential diagnosis of lipoma and sarcoma. Acta Orthop Scand. 1983;54:929-34
39. Chrysant SG, Chrysant GS. Clinical implications of cardiovascular preventing pleiotropic effects of dipeptidyl peptidase-4 inhibitors. Am J Cardiol. 2012;109:1681-5
40. Deacon CF, Marx N. Potential cardiovascular effects of incretin-based therapies. Expert Rev Cardiovasc Ther. 2012;10:337-51
41. United States Renal Data System. Annual Data Report (Volume 1): Atlas of Chronic Kidney Disease in the United States. Bethesda: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2010. http://www.usrds.org/2010/view/default.asp.
42. Scott R, Wu M, Sanchez M, Stein P. 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;61:171-80
43. Hanefeld M, Herman GA, Wu M, Mickel C, Sanchez M, Stein PP. Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Curr Med Res Opin. 2007;23:1329-39
44. Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P. 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, placebocontrolled, parallel-group study. Clin Ther. 2006;28:1556-68
45. Charbonnel B, Karasik A, Liu J, Wu M, Meininger G. 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;29:2638-43
46. Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006;29:2632-7
47. Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006;49:2564-71
48. Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP. 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, noninferiority trial. Diabetes Obes Metab. 2007;9:194-205
49. Seck T, Nauck M, Sheng D, Sitagliptin Study 024 Group, 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;64:562-76
50. Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE. 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;30:1979-87
51. 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;25:569-83
52. 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;12:442-51
53. 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;83:106-16
54. 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;27:1049-58
55. Aschner P, Katzeff HL, Guo H, Sitagliptin Study 049 Group, et al. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12:252-61
56. 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 (542). J Diabetes. 2013;5:68-79
57. 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;24:537-50
58. 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 beta-cell function in patients with type 2 diabetes. Int J Clin Pract. 2011;65:154-64
59. Yoon KH, Steinberg H, Teng R, et al. Efficacy and safety of initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes: a 54-week study. Diabetes Obes Metab. 2012;14:745-52
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;14:409-18
61. 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;65:930-8
62. 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;4:227-37
63. 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;13:841-9
64. 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;13:644-52
65. Henry RR, Staels B, Fonseca VB, et al. Efficacy and safety of initial combination treatment with sitagliptin and pioglitazone -a factorial study [abstract]. 2011 International Diabetes Federation, 21st World Diabetes Congress; 2011
66. Fonseca V, Staels B, Morgan JD, 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. 2012;27:177-83
67. Scott R, Loeys T, Davies MJ, Engel SS. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008;10:959-69
68. 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;13:160-8.