Forxiga® dapagliflozine
Forxiga is een sterk selectieve SGLT2-remmer bij type 2 diabetes, met 4 jaar aan veiligheids- en werkzaamheidsgegevens. Forxiga verwijdert glucose en de bijbehorende calorieën via de nieren.1
Referenties
- FORXIGA. Samenvatting van de productkenmerken, meest recente versie
- XIGDUO. Samenvatting van de productkenmerken, meest recente versie.
- IMS Health-database MIDAS, Mei 2017
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- Yavin Y, Mansfield TA, Ptaszynska A, Johnsson K, Parikh S, Johnsson E. Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Diabetes Ther. 2016;7(1):125-137.
- FORXIGA®. Europees openbaar beoordelingsrapport (EPAR), 2012. 2016.
- Gegevens uit dossier: Atlas Approval ID: 980,306.011. 2016.
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- ClinicalTrials.gov. Indentificatienummer: NCT01730534. https://clinicaltrials gov/ct2/show/NCT01730534?term=NCT01730534&rank=1 Laatst geraadpleegd augustus 2016.
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- Cefalu WT, et al. Gepresenteerd tijdens de 75ste Scientific Sessions van de American Diabetes Association, VS. 5–9 juni 2015. Uittreksel 2611. American Diabetes Association. 2016.
- IMS Health Total Patient Tracker, mei 2017
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- Rosenstock J, Hansen L, Zee P, et al. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care. 2015;38(3):376-383.
- Frias J, et al. Lancet 2016. E-publicatie voorafgaand aan druk http://dx.doi.org/10.1016/S2213-8587(16)30267-4. 2016.
- EMDAC background document. https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicand-metabolicdrugsadvisorycommittee/ucm378079.pdf. Laatst geraadpleegd in juli 2015.
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- Nauck MA, Del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011;34(9):2015-2022.
- Nauck MA. Nauck MA, et al. Diabetes Care 2011;34:2015–22 (Aanvullende gegevens). Aanvullende gegevens. 2016.
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- Jabbour SA, Hardy E, Sugg J, Parikh S. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740-750.
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- Weber MA, Mansfield TA, Cain VA, Iqbal N, Parikh S, Ptaszynska A. Blood pressure and glycaemic effects of dapagliflozin versus placebo in patients with type 2 diabetes on combination antihypertensive therapy: a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Diabetes Endocrinol. 2016;4(3):211-220.
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NS ID BE-1256-RD07/2017-WEB Local code 809