FORXIGA® Dapagliflozine

Forxiga est un inhibiteur hautement sélectif du SGLT2 pour le diabète de type 2, présentant 4 années de données de sécurité d’emploi et d’efficacité, qui élimine le glucose et ses calories associées par le rein.1

Références

  1. FORXIGA. Résumé des caractéristiques du produit, version la plus récente
  2. XIGDUO. Résumé des caractéristiques du produit, version la plus récente
  3. Base de données IMS Health, MIDAS mai 2017
  4. Sonesson C, Johansson PA, Johnsson E, Gause-Nilsson I. Cardiovascular effects of dapagliflozin in patients with type 2 diabetes and different risk categories: a meta-analysis. Cardiovasc Diabetol. 2016;15:37.
  5. Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016;29(3):391-400.
  6. 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.
  7. FORXIGA®. Rapport d’évaluation européen public (EPAR) 2012. 2016.
  8. Données consignées : Identifiant d’approbation Atlas : 980,306.011. 2016.
  9. List J. List J, et al. Circulation 2014;15:37. Circulation 2014. 2016.
  10. ClinicalTrials.gov. Identifiant : NCT01730534.  Dernière consultation août 2016. 
  11. Del Prato S, Nauck M, Duran-Garcia S, et al. Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. Diabetes Obes Metab. 2015;17(6):581-590.
  12. Bolinder J, Ljunggren O, Johansson L, et al. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014;16(2):159-169.
  13. Cefalu WT, et al. Présenté aux 75e sessions scientifiques de l’ADA, Boston, États-Unis. 5 - 9 juin 2015. Résumé 2611. American Diabetes Association. 2016.
  14. IMS Health Total Patient Tracker, mai 2017
  15. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9733):2223-2233.
  16. Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013;11:43.
  17. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2015;58(3):429-442.
  18. McAdam-Marx C, Bellows BK, Unni S, et al. Determinants of glycaemic control in a practice setting: the role of weight loss and treatment adherence (The DELTA Study). Int J Clin Pract. 2014;68(11):1309-1317.
  19. Look AHEAD Research Group. Diabetes Care 2007;30:1374-83. 2016.
  20. 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.
  21. Frias J, et al. Lancet 2016. Publication électronique avant l’impression. 2016.
  22. Document de référence EMDAC.  Dernière consultation juillet 2015.
  23. Clinical Trials Gov. ClinicalTrials.gov. Identifiant : NCT01730534. ClinicalTrials gov Dernière consultation juillet 2015. 
  24. DOF. (Données stratégiques Cegedim, Bases de données longitudinales Patients, janvier 2015). 2016.
  25. DOF. (Dynamiques de marché NPA IMS, janvier à décembre 2014). 2016.
  26. Bolinder J, Ljunggren O, Kullberg J, et al. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrin Metab. 2012;97(3):1020-1031.
  27. 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.
  28. Nauck MA. Nauck MA, et al. Diabetes Care 2011;34:2015-22 (données supplémentaires). Données supplémentaires. 2016.
  29. Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011;13(10):928-938.
  30. FORXIGA. Informations de prescription, 2014. 2016.
  31. 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.
  32. Matthaei. Matthaei S, et al. Poster présenté au 937th Annual Meeting of the European Association for the Study of Diabetes (EASD), 23-27 septembre 2013, Barcelone, Espagne. Poster. 2016.
  33. Wilding JP, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012;156(6):405-415.
  34. Wilding JP, Woo V, Rohwedder K, Sugg J, Parikh S. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab. 2014;16(2):124-136.
  35. Weber MA, Mansfield TA, Alessi F, Iqbal N, Parikh S, Ptaszynska A. Effects of dapagliflozin on blood pressure in hypertensive diabetic patients on renin-angiotensin system blockade. Blood Press. 2016;25(2):93-103.
  36. 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.
  37. Rosenstock J. et al. Poster presented at the 14th Annual World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC), Los Angeles, CA, USA; Supported by: December 1–3, 2016

NS ID BE-1256-RD07/2017-WEB Local code 809