Use of dipeptidyl peptidase-4 inhibitors and the reporting of infections: A disproportionality analysis in the World Health Organization VigiBase

Diabetes Care

Volumn 34, Issue 2, 2011, Pages 369-374

  Willemen, Marjolein J ^a,b   Mantel Teeuwisse, Aukje K ^a,b   Straus, Sabine M ^b,c   Meyboom, Ron H ^a,d   Egberts, Toine C ^a,e   Leufkens, Hubert G ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

^d WORLD HEALTH ORGANIZATION   (Switzerland)

^e UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; BIGUANIDE DERIVATIVE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; INSULIN; ORAL ANTIDIABETIC AGENT; SULFONYLUREA DERIVATIVE;

ADULT; ARTICLE; BRONCHITIS; CASE CONTROL STUDY; CLINICAL ASSESSMENT; COHORT ANALYSIS; CONTROLLED STUDY; CYSTITIS; DIABETES MELLITUS; FEMALE; HUMAN; INSULIN TREATMENT; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; PNEUMONIA; PYELONEPHRITIS; RHINOPHARYNGITIS; SINUSITIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; WORLD HEALTH ORGANIZATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; CASE-CONTROL STUDIES; DATABASES, FACTUAL; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL PEPTIDASE 4; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INFECTION; MALE; MIDDLE AGED; RISK FACTORS; WORLD HEALTH ORGANIZATION;

EID: 79951701438     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc10-1771     Document Type: Article

References (25)

1. Committee for Medicinal Products for Human Use. European Public Assessment Report (EPAR) for Januvia. London, UK, CHMP, 2009
2. Committee for Medicinal Products for Human Use. European Public Assessment Report (EPAR) for Galvus. London, UK, CHMP, 2007
3. Committee for Medicinal Products for Human Use. European Public Assessment Report (EPAR) for Onglyza. London, UK, CHMP, 2010
4. Reinhold D, Biton A, Goihl A, et al. Dual inhibition of dipeptidyl peptidase IV and aminopeptidase N suppresses inflammatory immune responses. Ann N Y Acad Sci 2007;1110:402-409 (Pubitemid 350043029)
5. Ansorge S, Bank U, Heimburg A, et al. Recent insights into the role of dipeptidyl aminopeptidase IV (DPIV) and aminopeptidase N (APN) families in immune functions. Clin Chem Lab Med 2009;47:253-261
6. Thompson MA, Ohnuma K, Abe M, Morimoto C, Dang NH. CD26/dipeptidyl peptidase IV as a novel therapeutic target for cancer and immune disorders. Mini Rev Med Chem 2007;7:253-273 (Pubitemid 46488249)
7. 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
8. Ligueros-Saylan M, Foley JE, Schweizer A, Couturier A, Kothny W. An assessment of adverse effects of vildagliptin versus comparators on the liver, the pancreas, the immune system, the skin and in patients with impaired renal function from a large pooled database of Phase II and III clinical trials. Diabetes Obes Metab 2010;12:495-509
9. European Union Volume 9A of the rules governing medicinal products in the European Union: guideline on pharmacovigilance for medicinal products for human use. European Commission, 2010. Available from http://ec.europa.eu/health/ files/eudralex/vol-9/pdf/vol9a-09-2008-en.pdf
10. Duncan BB, Schmidt MI. The epidemiology of low-grade chronic systemic inflammation and type 2 diabetes. Diabetes Technol Ther 2006;8:7-17
11. Alexandraki K, Piperi C, Kalofoutis C, Singh J, Alaveras A, Kalofoutis A. Inflammatory process in type 2 diabetes: the role of cytokines. Ann N Y Acad Sci 2006;1084:89-117 (Pubitemid 47091972)
12. Muller LM, Gorter KJ, Hak E, et al. Increased risk of common infections in patients with type 1 and type 2 diabetes mellitus. Clin Infect Dis 2005;41:281-288 (Pubitemid 41022101)
13. Bertoni AG, Saydah S, Brancati FL. Diabetes and the risk of infection-related mortality in the U.S. Diabetes Care 2001;24:1044-1049 (Pubitemid 33716374)
14. Boyko EJ, Fihn SD, Scholes D, Chen CL, Normand EH, Yarbro P. Diabetes and the risk of acute urinary tract infection among postmenopausal women. Diabetes Care 2002;25:1778-1783 (Pubitemid 41071086)
15. Shah BR, Hux JE. Quantifying the risk of infectious diseases for people with diabetes. Diabetes Care 2003;26:510-513 (Pubitemid 36929083)
16. Joshi N, Caputo GM, Weitekamp MR, Karchmer AW. Infections in patients with diabetes mellitus. N Engl J Med 1999;341:1906-1912
17. Rayfield EJ, Ault MJ, Keusch GT, Brothers MJ, Nechemias C, Smith H. Infection and diabetes: the case for glucose control. Am J Med 1982;72:439-450 (Pubitemid 12188680)
18. Edwards IR, Olsson S. The WHO International Drug Monitoring Program. Amsterdam, Elsevier Science, 2003
19. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001;345:1098-1104
20. Hamilton CD. Infectious complications of treatment with biologic agents. Curr Opin Rheumatol 2004;16:393-398 (Pubitemid 38803140)
21. Weber JCP. Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs. New York, Raven Press, 1984
22. Boyko EJ, Fihn SD, Scholes D, Abraham L, Monsey B. Risk of urinary tract infection and asymptomatic bacteriuria among diabetic and nondiabetic postmenopausal women. Am J Epidemiol 2005;161:557-564 (Pubitemid 40349911)
23. National Institute for Health and Clinical Excellence. Type 2 diabetes - newer agents (update). London, National Institute for Health and Clinical Excellence, 2008. Available from http://www.nice.org.uk/nicemedia/live/12165/ 44320/44320.pdf
24. 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;15:540-559
25. Turner RC, Cull CA, Frighi V, Holman RR; UK Prospective Diabetes Study (UKPDS) Group. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA 1999;281:2005-2012 (Pubitemid 29254858)