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- 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
- 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
- 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
Byetta drug approval package. FDA/Centre for Drug Evaluation and Research, available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_ByettaTOC.cfm; 2005 [access2nd edn3.05.12].
European public assessment report (EPAR) for Byetta. EMA/Committee for Medicinal Products for Human Use, available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000698/human_med_000682.jsp&mid=WC0b01ac058001d124; 2006 [access2nd edn3.05.12].
Bydureon label and approval history. FDA/Centre for Drug Evaluation and Research, available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist; 2012 [access2nd edn3.05.12].
European public assessment report (EPAR) for Bydureon. EMA/Committee for Medicinal Products for Human Use, available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002000/human_med_001457.jsp&mid=WC0b01ac058001d124; 2011 [accessed 23.05.12].
Victoza approval package. FDA/Centre for Drug Evaluation and Research, available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022341s000TOC.cfm; 2010 [accessed 23.05.12].
European public assessment report (EPAR) for Victoza. EMA/Committee for Medicinal Products for Human Use, available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001026/human_med_001137.jsp&mid=WC0b01ac058001d124; 2009 [accessed 23.05.12].
- Increatin-based therapies for the treatment of type 2 diabetes: evaluation of the risks and benefits.Diabetes Care. 2010; 33: 428-433
FDA alert: information for healthcare professionals: exenatide (marketed as Byetta). FDA/Postmarket Drug Safety Information for Patients and Providers, available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124713.htm; 2007 [accessed 23.05.12].
- Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies.Gastroenterology. 2011; 141: 150-156
- 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])
- 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
- Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis.Diabetes Care. 2010; 33: 2349-2354
- A cohort study of acute pancreatitis in relation to exenatide use.Diabetes Obes Metab. 2011; 13: 559-566
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: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm190571.htm; 2009 [accessed 23.05.12].
- Weighting risks and benefits of liraglutide – the FDA's review of a new antidiabetic therapy.N Engl J Med. 2010; 362: 774-777
- Glucagon-like peptide-1 receptor agonists active rodent thyroid C-cells causing calcitonin release and C-cell proliferation.Endocrinology. 2010; 151: 1473-1486
MSSO medical dictionary for regulatory activities. MedDRA v14.0, available at: http://www.meddramsso.com/index.asp [accessed 23.04.12].
- 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
- Meta-analysis in clinical trials.Control Clin Trials. 1986; 7: 177-188
- Measuring inconsistency in meta-analysis.BMJ. 2003; 327: 557-560
- Introduction to meta-analysis.John Wiley & Sons, Chichester, England2009
- Bias in meta-analysis detected by a simple, graphical test.BMJ. 1997; 315: 629-634
- Drug-induced pancreatitis: incidence, management, and prevention.Drug Saf. 2008; 31: 823-837
- Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes.Diabetes Care. 2009; 32: 834-838
- Association of pancreatitis with glucagon-like peptide-1 agonist use.Ann Pharmacother. 2010; 44: 904-909
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: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258826.htm, 2011 [accessed 23.05.12].
- GLP-1-based therapy for diabetes: what you do not know can hurt you.Diabetes Care. 2010; 33: 453-455
- Pancreatic duct replication is increased with obesity and type 2 diabetes in humans.Diabetologia. 2010; 53: 21-26
- 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
- Biochemical and histological effects of exendin-4 (exenatide) on the rat pancreas.Diabetologia. 2010; 53: 153-159
- The effects of 13 weeks 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])
- The hazards of scoring the quality of clinical trials for meta-analysis.JAMA. 1999; 282: 1054-1060
Parola T. Victoza® (liraglutide injection): human relevance of rodent thyroid C-cell tumors. FDA/Endocrinologic and Metabolic Drugs Advisory Committee Meeting, available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM151129.pdf; 2009 [accessed 23.05.12].
- 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: 1092-1100
- 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
- Effects of exenatide (Exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes.Diabetes Care. 2004; 27: 2628-2635
