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Dapagliflozin

A Review of its Use in Type 2 Diabetes Mellitus

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Abstract

Dapagliflozin (Forxiga®) is the first in a novel class of glucose-lowering agents known as sodium-glucose co-transporter-2 (SGLT2) inhibitors and is used in the treatment of patients with type 2 diabetes. By inhibiting the transporter protein SGLT2 in the kidneys, dapagliflozin reduces renal glucose reabsorption, leading to urinary glucose excretion and a reduction in blood glucose levels. Unlike oral antidiabetic drugs from several other classes, the efficacy of dapagliflozin is independent of insulin secretion and action. Therefore, when used in combination with other antidiabetic drugs, dapagliflozin provides complementary therapy via its unique mechanism of action.

A consistent finding across phase III, randomized, double-blind trials in patients with inadequately controlled type 2 diabetes was that dapagliflozin 5 or 10 mg/day for 24 weeks as monotherapy in previously untreated patients, or as add-on combination therapy with metformin, glimepiride, pioglitazone or insulin-based therapy, significantly reduced both glycosylated haemoglobin values (primary endpoint) and fasting plasma glucose levels compared with placebo. Various randomized trials have also shown improvements in postprandial blood glucose with dapagliflozin monotherapy and combination therapy compared with placebo. In addition, dapagliflozin was noninferior to glipizide, in terms of glycaemic control after 52 weeks, when used as add-on therapy in patients with type 2 diabetes that was inadequately controlled with metformin. In most clinical trials, dapagliflozin was associated with reductions in body weight that were statistically superior to placebo or active comparators. Longer-term extension studies indicate that the efficacy of dapagliflozin is maintained for up to ≈2 years.

Dapagliflozin was generally well tolerated in clinical trials of 24 or 52 weeks duration and in extension studies of up to ≈2 years. Events suggestive of genital infections and urinary tract infections occurred more frequently among dapagliflozin than placebo recipients. These adverse events are of special interest because they appear to be related to the mechanism of action of dapagliflozin. Dapagliflozin has a low propensity to cause hypoglycaemia, especially when used alone or in combination with metformin, although the incidence of hypoglycaemic events reported with dapagliflozin in clinical trials varied depending on the background therapy. Longer-term tolerability/safety data with dapagliflozin are awaited with interest.

In conclusion, dapagliflozin, with its unique and complementary mechanism of action, appears to be an important addition to the therapeutic options for the management of type 2 diabetes, particularly when used as add-on therapy.

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References

  1. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012 Jun; 35(6): 1364–79

    Article  PubMed  CAS  Google Scholar 

  2. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2012; 35 Suppl 1: S64–71

    Article  Google Scholar 

  3. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2012; 35 Suppl. 1: S11–63

    Google Scholar 

  4. International Diabetes Federation. Global diabetes plan 2011–2021 [online]. Available from URL: www.idf.org/sites/default/files/Global_Diabetes_Plan_Final.pdf [Accessed 2012 Jul 13]

  5. Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract 2010 Jan; 87(1): 4–14

    Article  PubMed  CAS  Google Scholar 

  6. Roglic G, Unwin N. Mortality attributable to diabetes: estimates for the year 2010. Diabetes Res Clin Pract 2010 Jan; 87(1): 15–9

    Article  PubMed  Google Scholar 

  7. U.K. Prospective Diabetes Study 16. Overview of 6 years’ therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes 1995 Nov; 44(11): 1249–58

    Article  Google Scholar 

  8. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000 Aug 12; 321(7258): 405–12

    Article  PubMed  CAS  Google Scholar 

  9. Moss SE, Klein R, Klein BE, et al. The association of glycemia and cause-specific mortality in a diabetic population. Arch Intern Med 1994 Nov 14; 154(21): 2473–9

    Article  PubMed  CAS  Google Scholar 

  10. Turner RC, Cull CA, Frighi V, et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA 1999 Jun 2; 281(21): 2005–12

    Article  PubMed  CAS  Google Scholar 

  11. Resnick HE, Foster GL, Bardsley J, et al. Achievement of American Diabetes Association clinical practice recommendations among U.S. adults with diabetes, 1999–2002: the National Health and Nutrition Examination Survey. Diabetes Care 2006 Mar; 29(3): 531–7

    Article  PubMed  Google Scholar 

  12. Ong KL, Cheung BM, Wong LY, et al. Prevalence, treatment, and control of diagnosed diabetes in the U.S. National Health and Nutrition Examination Survey 1999–2004. Ann Epidemiol 2008 Mar; 18(3): 222–9

    Article  PubMed  Google Scholar 

  13. Neumiller JJ, White JR, Campbell RK. Sodium glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Drugs 2010; 70: 377–85

    Article  PubMed  CAS  Google Scholar 

  14. Nair S, Wilding JP. Sodium glucose cotransporter 2 inhibitors as a new treatment for diabetes mellitus. J Clin Endocrinol Metab 2010 Jan; 95(1): 34–42

    Article  PubMed  CAS  Google Scholar 

  15. Dapagliflozin (Forxiga): EU summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/emc/medicine/27188/SPC/Forxiga+5 mg++%26+10+mg+film+coated+tablets/[Accessed 2012 Nov 19]

  16. AstraZeneca. Forxiga (dapagliflozin) now approved in European Union for treatment of type 2 diabetes [media release]. 2012 Nov 14 [online]. Available from URL: http://www.astrazeneca.com/Media/Press-releases/Article/20121114-forxiga-eu-approval-type-2-diabetes [Accessed 2012 Nov 19]

  17. Wright EM, Loo DD, Hirayama BA, et al. Surprising versatility of Na+-glucose cotransporters: SLC5. Physiology (Bethesda) 2004 Dec; 19: 370–6

    Article  CAS  Google Scholar 

  18. Meng W, Ellsworth BA, Nirschl AA, et al. Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes. J Med Chem 2008 13 Mar; 51(5): 1145–9

    Article  PubMed  CAS  Google Scholar 

  19. Kanai Y, Lee WS, You G, et al. The human kidney low affinity Na+/glucose cotransporter SGLT2. Delineation of the major renal reabsorptive mechanism for D-glucose. J Clin Invest 1994 Jan; 93(1): 397–404

    Article  PubMed  CAS  Google Scholar 

  20. Idris I, Donnelly R. Sodium-glucose co-transporter-2 inhibitors: an emerging new class of oral antidiabetic drug. Diabetes Obes Metab 2009 Feb; 11(2): 79–88

    Article  PubMed  CAS  Google Scholar 

  21. Bakris GL, Fonseca VA, Sharma K, et al. Renal sodium-glucose transport: role in diabetes mellitus and potential clinical implications. Kidney Int 2009 Jun; 75(12): 1272–7

    Article  PubMed  CAS  Google Scholar 

  22. Scheepers A, Joost HG, Schurmann A. The glucose transporter families SGLT and GLUT: molecular basis of normal and aberrant function. J Parenter Enteral Nutr 2004 Sep–Oct; 28(5): 364–71

    Article  CAS  Google Scholar 

  23. Bellamine A, Uveges A, Thompson C, et al. Dapagliflozin selectively inhibits human SGLT2 versus SGLT1, SMIT, SGLT4 and SGLT6 [abstract no. 987-P]. Diabetes 2011; 60: A271

    Google Scholar 

  24. Komoroski B, Vachharajani N, Boulton D, et al. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther 2009 May; 85(5): 520–6

    Article  PubMed  CAS  Google Scholar 

  25. Komoroski B, Vachharajani N, Feng Y, et al. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther 2009 May; 85(5): 513–9

    Article  PubMed  CAS  Google Scholar 

  26. List JF, Woo V, Morales E, et al. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care 2009 April; 32(4): 650–7

    Article  PubMed  CAS  Google Scholar 

  27. DeFronza RA, Hompesch M, Kasichayanula S, et al. Dapagliflozin reduces renal threshold for glucose excretion in type 2 diabetes [abstract no. 747]. Diabetologia 2012; 55 Suppl. 1: S306

    Google Scholar 

  28. Obermeier MT, Yao M, Khanna A, et al. In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Drug Metab Dispos 2010 March; 38(3): 405–14

    Article  PubMed  CAS  Google Scholar 

  29. Kasichayanula S, Liu X, Zhang W, et al. Effect of a high-fat meal on the pharmacokinetics of dapagliflozin, a selective SGLT2 inhibitor, in healthy subjects. Diabetes Obes Metab 2011 August; 13(8): 770–3

    Article  PubMed  CAS  Google Scholar 

  30. Kasichayanula S, Liu X, Zhang W, et al. Influence of hepatic impairment on the pharmacokinetics and safety profile of dapagliflozin: an open-label, parallel-group, single-dose study. Clin Ther 2011 Nov; 33(11): 1798–808

    Article  PubMed  CAS  Google Scholar 

  31. Kasichayanula S, Chang M, Hasegawa M, et al. Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium-glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus. Diabetes Obes Metab 2011 April; 13(4): 357–65

    Article  PubMed  CAS  Google Scholar 

  32. Kasichayanula S, Liu X, Hesney M, et al. Meta analysis of dapagliflozin pharmacokinetics and dose/exposure-urinary glucose pharmacodynamic relationships [abstract no. PIII-99]. Clin Pharmacol Ther 2012; 91: S131–S2

    Google Scholar 

  33. Hong Y, Roy A, Boulton D, et al. Population pharmacokinetic analysis of dapagliflozin in patients with type 2 diabetes mellitus [abstract]. Clin Pharmacol Ther 2012; 91: S43

    Google Scholar 

  34. Kasichayanula S, Liu X, Shyu WC, et al. Lack of pharmacokinetic interaction between dapagliflozin, a novel sodium-glucose transporter 2 inhibitor, and metformin, pioglitazone, glimepiride or sitagliptin in healthy subjects. Diabetes Obes Metab 2011 Jan; 13(1): 47–54

    Article  PubMed  CAS  Google Scholar 

  35. Kasichayanula S, Liu X, Griffen SC, et al. Effects of rifampin and mefenamic acid on the pharmacokinetics and pharmacodynamics of dapagliflozin. Diabetes Obes Metab. Epub 2012 Oct 15

  36. Kasichayanula S, Chang M, Liu X, et al. Lack of pharmacokinetic interactions between dapagliflozin and simvastatin, valsartan, warfarin, or digoxin. Adv Ther 2012 Feb; 29(2): 163–77

    Article  PubMed  CAS  Google Scholar 

  37. Ferrannini E, Ramos SJ, Salsali A, et al. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 2010 Oct; 33(10): 2217–24

    Article  PubMed  Google Scholar 

  38. Bailey CJ, Gross JL, Pieters A, 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

    Article  PubMed  CAS  Google Scholar 

  39. Rosenstock J, Vico M, Wei L, et al. Effects of dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, on hemoglobin A1c, body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care 2012 July; 35(7): 1473–8

    Article  PubMed  CAS  Google Scholar 

  40. Strojek K, Yoon KH, Hruba V, et al. 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 Oct; 13(10): 928–38

    Article  PubMed  CAS  Google Scholar 

  41. Wilding JPH, 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 Mar 20; 156(6): 405–15

    PubMed  Google Scholar 

  42. 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 Sep; 34(9): 2015–22

    Article  PubMed  CAS  Google Scholar 

  43. Wilding JPH, Norwood P, T’Joen C, et al. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment. Diabetes Care 2009 Sep; 32(9): 1656–62

    Article  PubMed  CAS  Google Scholar 

  44. Henry RR, Murray AV, Marmolejo MH, et al. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract 2012 May; 66(5): 446–56

    Article  PubMed  CAS  Google Scholar 

  45. Zhang L, Feng Y, List J, et al. Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight. Diabetes Obes Metab 2010 Jun; 12(6): 510–6

    Article  PubMed  CAS  Google Scholar 

  46. 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 Endocrinol Metab 2012 Mar; 97(3): 1020–31

    Article  PubMed  CAS  Google Scholar 

  47. Bailey CJ, Iqbal N, T’Joen C, et al. Dapagliflozin monotherapy in drug-naive patients with diabetes: a randomized-controlled trial of low-dose range. Diabetes Obes Metab 2012 Oct; 14(10): 951–9

    Article  PubMed  CAS  Google Scholar 

  48. Hardy E, Salsali A, Wessman C, et al. Exploration of the relationship of reduction in HbA1c and body weight by dapagliflozin in patients with T2DM: pooled analysis of 5 clinical trials [abstract no. 987-P]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  49. White JR, Bastien A, Parikh S, et al. Dapagliflozin monotherapy and combination therapy reduces hyperglycemia in patients with type 2 diabetes [abstract no. 96E]. Pharmacotherapy 2011; 31(10): 337e

    Google Scholar 

  50. Langkilde AM, Sugg J, Johannson P, et al. A meta-analysis of cardiovascular outcomes in clinical trials of dapagliflozin [abstract no. A8947]. Circulation 2011 Nov; 124 (21 Suppl. 1)

    Google Scholar 

  51. Hardy E, Salsali A, Hruba V, et al. Efficacy increases with increasing baseline HbA1c category with dapagliflozin therapy [abstract no. 82-OR]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  52. Hardy E, Rohwedder K, Hruba V, et al. Dapagliflozin, a selective SGLT2 inhibitor, reduces serum levels of uric acid in patients with type 2 diabetes [abstract no. 843]. Diabetologia 2011; 54: S344–S5

    Google Scholar 

  53. Wilding JP, Woo VC, Rohwedder K, et al. Long-term effectiveness of dapagliflozin over 104 weeks in patients with type 2 diabetes poorly controlled with insulin [abstract no. 1042-P]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  54. Salsali A, Rohwedder K, Mansfield TA, et al. Durability of dapagliflozin treatment response in patients with T2DM: 2-year results [abstract no. 1030-P]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  55. Woo V, Tang W, Salsali A. Long-term efficacy of dapagliflozin monotherapy in patients with type 2 diabetes mellitus [abstract no. D-0991]. 21st World Diabetes Congress; 2011 Dec 4–8; Dubai

  56. Langkilde AM, Sugg J, Parikh S. Dapagliflozin, a novel antihyperglycemic agent that promotes urinary glucose excretion, reduces systolic blood pressure in patients with type 2 diabetes mellitus [abstract no. 9520]. 84th Annual Scientific Sessions of the American Heart Association; 2011 Nov 12–16; Orlando (FL)

  57. Bailey CJ, Gross JL, Yadav M, et al. Long-term efficacy of dapagliflozin as add-on to metformin (MET) in T2DM inadequately controlled with MET alone [abstract no. 988-P]. Diabetes 2011; 60: A271

    Google Scholar 

  58. Bailey CJ, Gross JL, Yadav M, et al. Sustained efficacy of dapagliflozin when added to metformin in type 2 diabetes inadequately controlled by metformin monotherapy [abstract no. 146]. Diabetologia 2011; 54: S67

    Google Scholar 

  59. Del Prato S, Nauck MA, Rohwedder K, et al. Long-term efficacy and safety of add-on dapagliflozin vs add-on glipizide in patients with type 2 diabetes mellitus inadequately controlled with metformin: 2-year results [abstract no. 852]. Diabetologia 2011; 54: S348

    Google Scholar 

  60. Langkilde A, Rhwedder K, Iqbal N, et al. Measures of beta-cell function and insulin sensitivity over time in patients with type 2 diabetes receiving dapagliflozin versus glifizide as add-on therapy to metformin [abstract no. 750]. European Association for the Study of Diabetes; 2012 Oct 1–5; Berlin

  61. Jabbour S, Hardy E, Sugg J, et al. Dapagliflozin as add-on therapy to sitagliptin with or without metformin: a randomized, double-blind, placebo-controlled study [abstract no. 1071-P]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  62. Leiter LA, Cefalu WT, Debruin TW, et al. Efficacy and safety of dapagliflozin for type 2 diabetes mellitus patients with a history of cardiovascular disease [abstract no. 1114-P]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  63. Cefalu WT, Leiter LA, Debruin TW, et al. Dapagliflozin treatment for type 2 diabetes mellitus patients with co-morbid cardiovascular disease and hypertension [abstract no. 1056-P]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  64. Kaku K, Inoue S, Matsuoka O, et al. Efficacy and safety of dapagliflozin as monotherapy for type 2 diabetes mellitus in Japanese patients [abstract no. 1014-P]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  65. Salsali A, Wei L, Wessman C, et al. Dapagliflozin improves glycemic control and reduces body weight in patients with T2DM across the treatment continuum [abstract no. 2353-PO]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  66. Wygant GD, Chalamandaris A-G, Iloeje UH, et al. Dapagliflozin is more effective than glipizide in achieving the composite outcome of glycemic control, weight reduction, and lack of hypoglycemia [abstract no. 2397-PO]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  67. Grandy S, Langkilde A, Ingelgard A, et al. Quality of life (EQ-5D) among type 2 diabetes mellitus patients treated with dapagliflozin for 24 weeks [abstract no. 2382-PO]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  68. Bolinder J, Ljunggren O, Johansson L, et al. Dapagliflozin produces long-term reductions in body weight, waist circumference and total fat mass in patients with type 2 diabetes inadequately controlled on metformin [abstract no. 751]. European Association for the Study of Diabetes; 2012 Oct 1–5; Berlin

  69. Bailey CJ, Wilding J, Nauck MA. Sustained reductions in weight and HbA1c with dapagliflozin: long-term results from phase III clinical studies in type 2 diabetes [abstract no. 721]. European Association for the Study of Diabetes; 2012 Oct 1–5; Berlin

  70. 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 Endocrinol Metab 2012 Mar; 97(3): 1020–31

    Article  PubMed  CAS  Google Scholar 

  71. Johnsson K, Ptaszynska A, Apanovitch A, et al. Safety of dapagliflozin in clinical trials for type 2 diabetes mellitus [abstract no. 743 plus poster]. European Association for the Study of Diabetes; 2012 Oct 1–5; Berlin

  72. Basile J, Ptasynska A, Ying L, et al. The effects of dapagliflozin on cardiovascular risk factors in patients with type 2 diabetes mellitus [abstract no. A59]. Circ Cardiovasc Qual Outcomes 2012 Jul; 5(1003)

    Google Scholar 

  73. Carlson GF, Tou CKP, Parikh S, et al. Evaluation of the effect of dapagliflozin on cardiac repolarization: a thorough QT/QTc study. Diabetes Therapy 2011 Sep; 2(3): 123–32

    Article  PubMed  CAS  Google Scholar 

  74. Ptaszynska A, Chalamandaris A-G, Sugg J, et al. Dapagliflozin does not impact renal function in patients with type 2 diabetes [abstract no. 242]. European Association for the Study of Diabetes; 2012 Oct 1–5; Berlin

  75. Kohan D, Fioretto P, List J, et al. Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment [abstract no. TH-PO524]. J Am Soc Nephrol 2011; 22: 232A

    Article  Google Scholar 

  76. Ljunggren O, Bolinder J, Johansson L, et al. Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin. Diabetes Obes Metab 2012 May 31; 14(11): 990–9

    Article  PubMed  CAS  Google Scholar 

  77. Ljunggren O, Bolinder J, Johansson L, et al. Dapagliflozin has no long-term effect on markers of bone turnover or bone mineral density in patients with inadequately controlled type 2 diabetes on metformin [abstract no. 748]. European Association for the Study of Diabetes; 2012 Oct 1–5; Berlin

  78. Ptaszynska A, Johnsson KM, Apanovitch AM, et al. Safety of dapagliflozin in clinical trials for T2DM [abstract no. 1011-P]. 72nd Annual Meeting of the American Diabetes Association; 2012 Jun 8–12; Philadelphia (PA)

  79. European Medicines Agency. European Medicines Agency recommends authorisation of novel treatment for type 2 diabetes: SGLT2 transporter protein inhibitor improves glycaemic control in adult patients with type 2 diabetes mellitus [media release]. 2012 Apr 20 [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/04/WC500125707.pdf [Accessed 2012 Jun 7]

  80. European Medicines Agency. Summary of opinion (initial authorisation): Forxiga (dapagliflozin) [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002322/WC500125684.pdf [Accessed 2012 Jun 7]

  81. European Medicines Agency. Human medicines: Forxiga [online]. Available from URL: http://www.ema.europa.eu/ema/[Accessed 2012 Jun 7]

  82. Tahrani AA, Bailey CJ, Del Prato S, et al. Management of type 2 diabetes: new and future developments in treatment. Lancet 2011 Jul 9; 378: 182–97

    Article  PubMed  CAS  Google Scholar 

  83. AstraZeneca Global. AstraZeneca and Bristol-Myers Squibb receive complete response letter from US Food and Drug Administration for dapagliflozin [media release]. 2012 Jan 19 [online]. Available from URL: http://www.astrazeneca.com/Media/Press-releases/Article/19012012-AstraZeneca-Bristol-Myers-Squibb-receive-CRL-for-dapag liflozin/ [Accessed 2012 August 16]

  84. SGLT2 inhibitors under spotlight at US diabetes meeting [media release]. 2012 Jun 12 [online]. Available from URL: http://www.pharmatimes.com/article/12-06-12/SGLT2_inhibitors_under_spotlight_at_US_diabetes_meeting.aspx [Accessed 2012 August 16]

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Correspondence to Greg L. Plosker.

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Various sections of the manuscript reviewed by: B.M. Cheung, Department of Medicine, University of Hong Kong, Hong Kong; D. Cucinotta, Dipartimento di Medicina Interna, Policlinico Universitario, Messina, Italy; P.M. Nilsson, Section of Medicine, Department of Clinical Sciences, University Hospital, Malmö, Sweden; A. Penfornis, Endocrinology-Metabolism and Diabetology-Nutrition, University of Franche-Comté, Besançon, France; A.J. Scheen, Department of Medicine, University of Liège, Liège, Belgium.

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘dapagliflozin’ was identified by searching databases (including MEDLINE and EMBASE) for articles published since 1996, bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug.

Search strategy: MEDLINE and EMBASE search terms were ‘dapagliflozin’ and (‘diabetes mellitus, type 2’ or ‘type 2 diabetes mellitus’ or ‘non insulin dependent diabetes mellitus’). Searches were last updated 19 November 2012.

Selection: Studies in patients with type 2 diabetes mellitus who received dapagliflozin. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Dapagliflozin, type 2 diabetes mellitus, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.

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Plosker, G.L. Dapagliflozin. Drugs 72, 2289–2312 (2012). https://doi.org/10.2165/11209910-000000000-00000

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