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Volumn 98, Issue 2, 2012, Pages 271-284

A meta-analysis of serious adverse events reported with exenatide and liraglutide: Acute pancreatitis and cancer

Author keywords

Cancer; GLP 1 agonists; Meta analysis; Pancreatitis

Indexed keywords

ANTIDIABETIC AGENT; EXENDIN 4; GLIBENCLAMIDE; GLIMEPIRIDE; GLITAZONE DERIVATIVE; INSULIN ASPART; INSULIN GLARGINE; LIRAGLUTIDE; METFORMIN; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SITAGLIPTIN; SULFONYLUREA DERIVATIVE;

EID: 84870508803     PISSN: 01688227     EISSN: 18728227     Source Type: Journal    
DOI: 10.1016/j.diabres.2012.09.008     Document Type: Article
Times cited : (133)

References (39)
  • 1
    • 60449089649 scopus 로고    scopus 로고
    • 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
    • Nathan D.M., Buse J.B., Davidson M.B., Ferrannini E., Holman R.R., Sherwin R., 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, 32:193-203.
    • (2009) Diabetes Care , vol.32 , pp. 193-203
    • Nathan, D.M.1    Buse, J.B.2    Davidson, M.B.3    Ferrannini, E.4    Holman, R.R.5    Sherwin, R.6
  • 2
    • 53249142132 scopus 로고    scopus 로고
    • Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study
    • Drucker D.J., Buse J.B., Taylor K., Kendall D.M., Trautmann M., Zhuang D., et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 2008, 372:1240-1250.
    • (2008) Lancet , vol.372 , pp. 1240-1250
    • Drucker, D.J.1    Buse, J.B.2    Taylor, K.3    Kendall, D.M.4    Trautmann, M.5    Zhuang, D.6
  • 3
    • 2542451393 scopus 로고    scopus 로고
    • NN2211-1310 International Study Group Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN221): a 12-week, double-blind, randomized, controlled trial
    • Madsbad S., Schmitz O., Ranstam J., Jakobsen G., Matthews D.R. NN2211-1310 International Study Group Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN221): a 12-week, double-blind, randomized, controlled trial. Diabetes Care 2004, 27:1334-1342.
    • (2004) Diabetes Care , vol.27 , pp. 1334-1342
    • Madsbad, S.1    Schmitz, O.2    Ranstam, J.3    Jakobsen, G.4    Matthews, D.R.5
  • 4
    • 84870541973 scopus 로고    scopus 로고
    • Byetta drug approval package. FDA/Centre for Drug Evaluation and Research, available at: ; 2005 [access2nd edn3.05.12]
    • Byetta drug approval package. FDA/Centre for Drug Evaluation and Research, available at: ; 2005 [access2nd edn3.05.12]. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_ByettaTOC.cfm.
  • 5
    • 84870523797 scopus 로고    scopus 로고
    • European public assessment report (EPAR) for Byetta. EMA/Committee for Medicinal Products for Human Use, available at: ; 2006 [access2nd edn3.05.12].
    • European public assessment report (EPAR) for Byetta. EMA/Committee for Medicinal Products for Human Use, available at: ; 2006 [access2nd edn3.05.12]. http://www.ema.europa.eu/ema/index.jsp%3Fcurl=pages/medicines/human/medicines/000698/human_med_000682.jsp%26mid=WC0b01ac058001d124.
  • 6
    • 84870483891 scopus 로고    scopus 로고
    • Bydureon label and approval history. FDA/Centre for Drug Evaluation and Research, 2012 [access2nd edn3.05.12].
    • Bydureon label and approval history. FDA/Centre for Drug Evaluation and Research, available at: ; 2012 [access2nd edn3.05.12]. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm%3Ffuseaction=Search.Label_ApprovalHistory%23apphist.
  • 7
    • 84870524407 scopus 로고    scopus 로고
    • European public assessment report (EPAR) for Bydureon. EMA/Committee for Medicinal Products for Human Use, available at: ; 2011 [accessed 23.05.12].
    • European public assessment report (EPAR) for Bydureon. EMA/Committee for Medicinal Products for Human Use, available at: ; 2011 [accessed 23.05.12]. http://www.ema.europa.eu/ema/index.jsp%3Fcurl=pages/medicines/human/medicines/002000/human_med_001457.jsp%26mid=WC0b01ac058001d124.
  • 8
    • 84870477532 scopus 로고    scopus 로고
    • Victoza approval package. FDA/Centre for Drug Evaluation and Research, 2010 [accessed 23.05.12].
    • Victoza approval package. FDA/Centre for Drug Evaluation and Research, available at: ; 2010 [accessed 23.05.12]. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022341s000TOC.cfm.
  • 9
    • 84870529754 scopus 로고    scopus 로고
    • European public assessment report (EPAR) for Victoza. EMA/Committee for Medicinal Products for Human Use, available at: ; 2009 [accessed 23.05.12].
    • European public assessment report (EPAR) for Victoza. EMA/Committee for Medicinal Products for Human Use, available at: ; 2009 [accessed 23.05.12]. http://www.ema.europa.eu/ema/index.jsp%3Fcurl=pages/medicines/human/medicines/001026/human_med_001137.jsp%26mid=WC0b01ac058001d124.
  • 10
  • 11
    • 84870525365 scopus 로고    scopus 로고
    • FDA alert: information for healthcare professionals: exenatide (marketed as Byetta). FDA/Postmarket Drug Safety Information for Patients and Providers, available at: ; 2007 [accessed 23.05.12].
    • FDA alert: information for healthcare professionals: exenatide (marketed as Byetta). FDA/Postmarket Drug Safety Information for Patients and Providers, available at: ; 2007 [accessed 23.05.12]. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124713.htm.
  • 12
    • 79959559653 scopus 로고    scopus 로고
    • Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies
    • Elashoff M., Matveyenko A.V., Gier B., Elashoff R., Butler P.C. Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies. Gastroenterology 2011, 141:150-156.
    • (2011) Gastroenterology , vol.141 , pp. 150-156
    • Elashoff, M.1    Matveyenko, A.V.2    Gier, B.3    Elashoff, R.4    Butler, P.C.5
  • 13
    • 84884903039 scopus 로고    scopus 로고
    • The association of pancreatitis with antidiabetic drug use: gaining insight through the FDA pharmacovigilance database
    • [published online 19 October; 10.1007/s00592-011-0340-7]
    • Raschi E., Piccinni C., Poluzzi E., Marchesini G., De Ponti F. The association of pancreatitis with antidiabetic drug use: gaining insight through the FDA pharmacovigilance database. Acta Diabetol 2011, [published online 19 October; http://dx.doi.org/10.1007/s00592-011-0340-7].
    • (2011) Acta Diabetol
    • Raschi, E.1    Piccinni, C.2    Poluzzi, E.3    Marchesini, G.4    De Ponti, F.5
  • 14
    • 67649304917 scopus 로고    scopus 로고
    • 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
    • Dore D.D., Seeger J.D., Chan K.A. 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, 25:1019-1027.
    • (2009) Curr Med Res Opin , vol.25 , pp. 1019-1027
    • Dore, D.D.1    Seeger, J.D.2    Chan, K.A.3
  • 15
    • 79951704452 scopus 로고    scopus 로고
    • Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis
    • 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, 33:2349-2354.
    • (2010) Diabetes Care , vol.33 , pp. 2349-2354
    • Garg, R.1    Chen, W.2    Pendergrass, M.3
  • 17
    • 84870490066 scopus 로고    scopus 로고
    • Byetta (exenatide) injection-detailed view: safety labelling changes approved by FDA Centre for Drug Evaluation and Research. FDA/MedWatch the FDA Safety Information and Adverse Event Reporting Program, available at: ; 2009 [accessed 23.05.12].
    • Byetta (exenatide) injection-detailed view: safety labelling changes approved by FDA Centre for Drug Evaluation and Research. FDA/MedWatch the FDA Safety Information and Adverse Event Reporting Program, available at: ; 2009 [accessed 23.05.12]. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm190571.htm.
  • 18
    • 77649294607 scopus 로고    scopus 로고
    • Weighting risks and benefits of liraglutide - the FDA's review of a new antidiabetic therapy
    • Parks M., Rosenbraugh C. Weighting risks and benefits of liraglutide - the FDA's review of a new antidiabetic therapy. N Engl J Med 2010, 362:774-777.
    • (2010) N Engl J Med , vol.362 , pp. 774-777
    • Parks, M.1    Rosenbraugh, C.2
  • 19
    • 77950228684 scopus 로고    scopus 로고
    • Glucagon-like peptide-1 receptor agonists active rodent thyroid C-cells causing calcitonin release and C-cell proliferation
    • Bjerre Knudsen L., Madsen L.W., Andersen S., Almholt K., de Boer A.S., Drucker D.J., et al. Glucagon-like peptide-1 receptor agonists active rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Endocrinology 2010, 151:1473-1486.
    • (2010) Endocrinology , vol.151 , pp. 1473-1486
    • Bjerre Knudsen, L.1    Madsen, L.W.2    Andersen, S.3    Almholt, K.4    de Boer, A.S.5    Drucker, D.J.6
  • 20
    • 84870557644 scopus 로고    scopus 로고
    • MSSO medical dictionary for regulatory activities. MedDRA v14.0, available at: [accessed 23.04.12].
    • MSSO medical dictionary for regulatory activities. MedDRA v14.0, available at: [accessed 23.04.12]. http://www.meddramsso.com/index.asp.
  • 21
    • 0031754739 scopus 로고    scopus 로고
    • The feasibility of creating a checklist for assessment of the methodological quality of both the randomised and nonrandomised studies of health care interventions
    • Downs S.H., Black N. The feasibility of creating a checklist for assessment of the methodological quality of both the randomised and nonrandomised studies of health care interventions. J Epidemiol Community Health 1998, 52:377-384.
    • (1998) J Epidemiol Community Health , vol.52 , pp. 377-384
    • Downs, S.H.1    Black, N.2
  • 25
    • 0030922816 scopus 로고    scopus 로고
    • Bias in meta-analysis detected by a simple, graphical test
    • Egger M., Davey Smith G., Schneider M., Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997, 315:629-634.
    • (1997) BMJ , vol.315 , pp. 629-634
    • Egger, M.1    Davey Smith, G.2    Schneider, M.3    Minder, C.4
  • 26
    • 50649112783 scopus 로고    scopus 로고
    • Drug-induced pancreatitis: incidence, management, and prevention
    • Balani A.R., Grendell J.H. Drug-induced pancreatitis: incidence, management, and prevention. Drug Saf 2008, 31:823-837.
    • (2008) Drug Saf , vol.31 , pp. 823-837
    • Balani, A.R.1    Grendell, J.H.2
  • 27
    • 65949111736 scopus 로고    scopus 로고
    • Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes
    • Noel R.A., Braun D.K., Patterson R.E., Bloomgren G.L. Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes. Diabetes Care 2009, 32:834-838.
    • (2009) Diabetes Care , vol.32 , pp. 834-838
    • Noel, R.A.1    Braun, D.K.2    Patterson, R.E.3    Bloomgren, G.L.4
  • 28
    • 77951523535 scopus 로고    scopus 로고
    • Association of pancreatitis with glucagon-like peptide-1 agonist use
    • Anderson S.L., Trujillo M.J. Association of pancreatitis with glucagon-like peptide-1 agonist use. Ann Pharmacother 2010, 44(5):904-909.
    • (2010) Ann Pharmacother , vol.44 , Issue.5 , pp. 904-909
    • Anderson, S.L.1    Trujillo, M.J.2
  • 29
    • 84870485354 scopus 로고    scopus 로고
    • MedWatch. Victoza (liraglutide [rDNA origin]) Injection: REMS - risk of thyroid C-cell tumors, Acute Pancreatitis. FDA/MedWatch the FDA Safety Information and Adverse Event Reporting Program, available at: , 2011 [accessed 23.05.12].
    • MedWatch. Victoza (liraglutide [rDNA origin]) Injection: REMS - risk of thyroid C-cell tumors, Acute Pancreatitis. FDA/MedWatch the FDA Safety Information and Adverse Event Reporting Program, available at: , 2011 [accessed 23.05.12]. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258826.htm.
  • 30
    • 75149182370 scopus 로고    scopus 로고
    • GLP-1-based therapy for diabetes: what you do not know can hurt you
    • Butler P.C., Dry S., Elashoff R. GLP-1-based therapy for diabetes: what you do not know can hurt you. Diabetes Care 2010, 33:453-455.
    • (2010) Diabetes Care , vol.33 , pp. 453-455
    • Butler, P.C.1    Dry, S.2    Elashoff, R.3
  • 32
    • 70349120958 scopus 로고    scopus 로고
    • Glucagon-like peptide-1 receptor activation modulates pancreatitis-associated gene expression but does not modify the susceptibility to experimental pancreatitis in mice
    • Koehler J.A., Baggio L.L., Lamont B.J., Ali S., Drucker D.J. Glucagon-like peptide-1 receptor activation modulates pancreatitis-associated gene expression but does not modify the susceptibility to experimental pancreatitis in mice. Diabetes 2009, 58:2148-2161.
    • (2009) Diabetes , vol.58 , pp. 2148-2161
    • Koehler, J.A.1    Baggio, L.L.2    Lamont, B.J.3    Ali, S.4    Drucker, D.J.5
  • 34
    • 84863950236 scopus 로고    scopus 로고
    • The effects of 13weeks of liraglutide treatment on endocrine and exocrine pancreas in male and female ZDF-rats: no evidence of drug induced pancreatitis
    • [published online 15 May, 00182.2012]
    • Vrang N., Jelsing J., Simonsen L., Jensen A.E., Thorup I., Søeborg H., et al. The effects of 13weeks of liraglutide treatment on endocrine and exocrine pancreas in male and female ZDF-rats: no evidence of drug induced pancreatitis. Am J Physiol Endocrinol Metab 2012, [published online 15 May, http://dx.doi.org/10.1152/ajpendo.00182.2012].
    • (2012) Am J Physiol Endocrinol Metab
    • Vrang, N.1    Jelsing, J.2    Simonsen, L.3    Jensen, A.E.4    Thorup, I.5    Søeborg, H.6
  • 35
    • 0345583669 scopus 로고    scopus 로고
    • The hazards of scoring the quality of clinical trials for meta-analysis
    • Jüni P., Witschi A., Bloch R., Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA 1999, 282:1054-1060.
    • (1999) JAMA , vol.282 , pp. 1054-1060
    • Jüni, P.1    Witschi, A.2    Bloch, R.3    Egger, M.4
  • 36
    • 84870537730 scopus 로고    scopus 로고
    • Victoza® (liraglutide injection): human relevance of rodent thyroid C-cell tumors. FDA/Endocrinologic and Metabolic Drugs Advisory Committee Meeting, available at: ; 2009 [accessed 23.05.12].
    • Parola T. Victoza® (liraglutide injection): human relevance of rodent thyroid C-cell tumors. FDA/Endocrinologic and Metabolic Drugs Advisory Committee Meeting, available at: ; 2009 [accessed 23.05.12]. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM151129.pdf.
    • Parola, T.1
  • 37
    • 18144401971 scopus 로고    scopus 로고
    • Effects of exenatide (Exendin-4) on glycemic control and weight over 30weeks in metformin-treated patients with type 2 diabetes
    • DeFronzo R.A., Ratner R.E., Han J., Kim D.D., Fineman M.S., Baron A.D. Effects of exenatide (Exendin-4) on glycemic control and weight over 30weeks in metformin-treated patients with type 2 diabetes. Diabetes Care 2005, 28:1092-1100.
    • (2005) Diabetes Care , vol.28 , pp. 1092-1100
    • DeFronzo, R.A.1    Ratner, R.E.2    Han, J.3    Kim, D.D.4    Fineman, M.S.5    Baron, A.D.6
  • 38
    • 17144371646 scopus 로고    scopus 로고
    • Effects of exenatide (Exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and sulfonylurea
    • Kendall D.M., Riddle M.C., Rosenstock J., Zhuang D., Kim D.D., Fineman M.S., et al. Effects of exenatide (Exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and sulfonylurea. Diabetes Care 2005, 28:1083-1091.
    • (2005) Diabetes Care , vol.28 , pp. 1083-1091
    • Kendall, D.M.1    Riddle, M.C.2    Rosenstock, J.3    Zhuang, D.4    Kim, D.D.5    Fineman, M.S.6
  • 39
    • 7444228521 scopus 로고    scopus 로고
    • Effects of exenatide (Exendin-4) on glycemic control over 30weeks in sulfonylurea-treated patients with type 2 diabetes
    • Buse J.B., Henry R.R., Han J., Kim D.D., Fineman M.S., Baron A., et al. Effects of exenatide (Exendin-4) on glycemic control over 30weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care 2004, 27:2628-2635.
    • (2004) Diabetes Care , vol.27 , pp. 2628-2635
    • Buse, J.B.1    Henry, R.R.2    Han, J.3    Kim, D.D.4    Fineman, M.S.5    Baron, A.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.