BYDUREON® (exenatide)
Bydureon® (exenatide suspensie met verlengde afgifte voor injectie in voorafgevulde pen) is een eenmaal per week te injecteren receptoragonist van glucagonachtig peptide-1 (GLP-1), beschikbaar als pen met één dosis, geïndiceerd ter verbetering van de glykemische controle bij volwassenen met diabetes type 2. Beschikbaar als 2 mg poeder en oplosmiddel voor suspensie met verlengde afgifte voor injectie.
Referenties
- Henry RR, Klein EJ, Han J, Iqbal N. Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study. Diabetes Technol Ther. 2016;18(11):677-686.
- Diamant M, Van GL, Guerci B, et al. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014;2(6):464-473.
- Bydureon Pen, Samenvatting van de productkenmerken, meest recente versie
- Gearchiveerde gegevens, AstraZeneca Pharmaceuticals LP, 3211825. 2016.
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- Wysham CH, MacConell LA, Maggs DG, Zhou M, Griffin PS, Trautmann ME. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015;90(3):356-365.
- Buse JB, Drucker DJ, Taylor KL, et al. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010;33(6):1255-1261.
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- Diamant M, Van GL, Stranks S, et al. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010;375(9733):2234-2243.
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- DeYoung MB, Macconell L, Sarin V, Trautmann M, Herbert P. Encapsulation of exenatide in poly-(D,L-lactide-co-glycolide) microspheres produced an investigational long-acting once-weekly formulation for type 2 diabetes. Diabetes Technol Ther. 2011;13(11):1145-1154.
- Blevins T, Pullman J, Malloy J, et al. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011;96(5):1301-1310.
- Buse JB, Nauck M, Forst T, et al. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013;381(9861):117-124.
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- Wysham CH, et al. Poster 1041-P. Presented at the American Diabetes Association’s 76th Scientific Sessions (ADA 2016), New Orleans, LA, June 40-14, 2016
- Klein EJ. Klein EJ, Henry RR, Malloy J, et al. DURATION-1 extension: efficacy and tolerability of exenatide once weekly over 6 years in patients with type 2 diabetes mellitus. Poster gepresenteerd tijdens: 50e Jaarlijks Congres van de Europese Associatie voor Diabetesonderzoek; 15-19 augustus, 2014; Wenen, Oostenrijk. Poster. 2016.
- Johnston SS, Nguyen H, Felber E, et al. Retrospective study of adherence to glucagon-like peptide-1 receptor agonist therapy in patients with type 2 diabetes mellitus in the United States. Adv Ther. 2014;31(11):1119-1133.
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- Giugliano D, Maiorino MI, Bellastella G, Chiodini P, Ceriello A, Esposito K. Efficacy of insulin analogs in achieving the hemoglobin A1c target of <7% in type 2 diabetes: meta-analysis of randomized controlled trials. Diabetes Care. 2011;34(2):510-517.
- Vaag A, Lund SS. Insulin initiation in patients with type 2 diabetes mellitus: treatment guidelines, clinical evidence and patterns of use of basal vs premixed insulin analogues. Eur J Endocrinol. 2012;166(2):159-170.
- 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):431-439.
- Diamant et al. Extra bijlage bij: Diamant M, Van Gaal L, Guerci B, et al. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014;2(6):1-12. Extra bijlage. 2016.
- 3024913. Gearchiveerde gegevens, AstraZeneca Pharmaceuticals LP, 3024913. 2016
- Gegevens uit dossier. AstraZeneca Pharmaceuticals LP, 3123823. 2016.
NS ID BE-1052-RD05/2017-WEB Local code 660