FORXIGA® (dapagliflozin)

FORXIGA® (dapagliflozin) is a highly selective SGLT2 inhibitor for type 2 diabetes mellitus, with 4-year safety and efficacy data, that removes glucose and its associated calories via the kidney.1

References

  1. Forxiga 10 mg film coated tablets. Summary of Product Characteristics. October 2017. https://www.medicines.org.uk/emc/product/7607/smpc
  2. Astrazeneca DOF/031/Sept 2017
  3. Rosenstock J 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. doi: 10.2337/dc 14-1142
  4. Shatskov A et al. Efficacy and safety of dapagliflozin in patients with type 2 diabetes: outcomes by Body Mass Index. Poster presented at the American Diabetes Association 76th Scientific Sessions; 10-14 June, 2016; New Orleans, LA, USA. Poster 1141 -P.
  5. Bailey CJ et al. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC medicine. 2013;11(1):43. doi: 10.1186/1741-7015-11-43.
  6. Bailey CJ et al. 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):2223-33. doi: 10.1016/S0140-6736(10)60407-2.
  7. Nauck MA 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. doi: 10.2337/dc11-0606.
  8. Yang W et al. Efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes after metformin failure: a randomized controlled trial. J diabetes. 2016;8(6):796-808. doi: 10.1111/1753-0407.12357.
  9. Müller-Wieland D et al. Presented at the Annual Scientific Conference of the German Diabetes Association. 2017
  10. Frías JP et al. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2016;4(12):1004-1016. doi: 10.1016/S2213-8587(16)30267-4.
  11. Del Prato 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):581-90. doi: 10.1111/dom.12459.
  12. Weber MA et al. 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. doi: 10.1016/S2213-8587(15)00417-9.
  13. Data on File: FOR/040/July2018 
  14. Frias JP et al. DURATION-8 52 week Ext Poster Presentation 141 LB presented at ADA 2017
  15. Wilding J et al. Dapagliflozin therapy for type 2 diabetes in primary care: Changes in HbA1c, weight and blood pressure over 2 years follow-up. Prim care diabetes. 2017;11(5):437-44. doi: 10.1016/j.pcd.2017.04.004
  16. Wilding J et al. Dapagliflozin therapy for type 2 diabetes in primary care: Changes in HbA1c, weight and blood pressure over 2 years follow-up. Prim Care Diabetes 2017. DOI http://dx.doi.org/10.1016/j.pcd.2017.04.004: Appendix A. Supplementary data.
  17. Grandy S et al. Changes in weight loss‐related quality of life among type 2 diabetes mellitus patients treated with dapagliflozin. Diabetes Obes Metab. 2014; 16(7):645-50. doi: 10.1111/dom.12263.
  18. Hardy E et al. Dapagliflozin decreases both HbA1c and body weight in the majority of patients with type 2 diabetes. Poster presented at the American Diabetes Association 72nd Scientific Sessions; 8-12 June 2012; Philadelphia, PA, USA. Poster 987-P
  19. Whaley JM et al. Targeting the kidney and glucose excretion with dapagliflozin: preclinical and clinical evidence for SGLT2 inhibition as a new option for treatment of type 2 diabetes mellitus. Diabetes Metab Syndr Obes. 2012;5:135-148. doi: 10.2147/DMSO.S22503.
  20. Geerlings SE. Urinary tract infections in patients with diabetes mellitus: epidemiology, pathogenesis and treatment. Int J of Antimicrob Agents. 2008;31:S54-S57.
  21. Endocrinologic and Metabolic Drugs Advisory Committee Meeting (EMDAC). Dapagliflozin BMS-512148. December 2013.
  22. Invokana (Canagliflozin) 100 mg and 300 mg film-coated tablets. Summary of Product Characteristics. September 2017. https://www.medicines.org.uk/emc/product/8855
  23. Jardiance (Empagliflozin) 25 mg film-coated tablets. Summary of Product Characteristics. January 2018. https://www.medicines.org.uk/emc/product/7703
  24. Ptaszynska A et al. Effect of dapagliflozin on renal function. Poster presented at American Diabetes Association 72nd Scientific Sessions, 8-12 June 2012; Philadelphia, PA, USA. Poster 1098-P.
  25. Sonesson C et al. Cardiovascular effects of dapagliflozin in patients with type 2 diabetes and different risk categories: a meta-analysis. Cardiovasc diabetol. 2016;15(1):37. doi: 10.1186/s12933-016-0356-y.
  26. List J et al. No increased risk of early or late adjudicated cardiovascular events with dapagliflozin [abstract]. Circulation. 2014; 130: A 16682.
  27. Medicines and Healthcare products Regulatory Agency. Welcome to Clinical Practice Research Datalink. Available from: https://www.cprd.com/home/ [Accessed May 2018] 
  28. Chen J et al. Quantitative PCR tissue expression profiling of the human SGLT2 gene and related family members. Diabetes Ther. 2010;1(2), 57-92. doi: 10.1007/s13300-010-0006-4.
  29. Idris I and Donnelly R. Sodium–glucose co‐transporter‐2 inhibitors: an emerging new class of oral antidiabetic drug. Diabetes Obes Metab. 2009;11(2):79-88. doi: 10.1111/j.1463-1326.2008.00982.x.
  30. Rosenstock et al. Composite endpoint analysis of dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin. Poster presented at the 14th Annual World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC), 1-3 December 2016; Los Angeles, CA, USA. Poster 99.
  31. Onglyza 2.5 mg and 5 mg film-coated tablets. Summary of Product Characteristics. June 2017. https://www.medicines.org.uk/emc/product/6675
  32. Wilding JP et al. 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. doi: 10.1111/dom.12187.
  33. Ljunggren O, et al. Diab Obes Metab 2012; 14: 990–999
  34. Jabbour S et al . Diabetes Obes Metab. 2017: 1-9
  35. Mills L, et al. J Diab Nurs 2014; 18: 8–12.
  36. Wilding JP, et al. Ann Intern Med 2012; 156: 405–415.

GB-11655 Date of preparation: August 2018