SGLT2: new approaches to combination therapy of type 2 diabetes mellitus
https://doi.org/10.21518/2079-701X-2016-3-10-17
Abstract
About the Authors
I. V. KononenkoRussian Federation
O. M. Smirnova
Russian Federation
References
1. Inzucchi SE, BergenstaL RM, Buse JB, Diamant M et aL. Management of hyperglycemia in type 2 diabetes, 2015: A patient-centered approach: Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care, 2015, 38, 1: 140-149.
2. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. Под редакцией И.И. Дедова, М.В. Шестаковой. М., 2015. Вып. 7.
3. Michael D Feher, Ma'en AL-Mrayat. ToLerabiLity of ProLonged-ReLease Metformin (GLucophage) in individuals intoLerant to standard metformin-resuLts from four UK centres. British J Diabetes and Vascular Diseade, 2007, 7(5): 225-228.
4. Turner RC et aL. GLycemic controL with diet, suL-fonyLurea, metformin, or insuLin in patients with type 2 diabetes meLLitus. Progression requirement for muLtipLe therapies (UKPDS 49). Jama, 1999, June 2, 281, 21: 2005-2012.
5. DeFronzo RA, Davidson JA, DeL Prato S. The roLe of the kidneys in gLucose homeostasis: a new path towards normaLizing gLycaemia. Diabetes Obes. Metab., 2012, 14(1): 5-14.
6. Мкртумян А.М., Егшатян Л.В. Новый неинсулинзависимый подход к терапии сахарного диабета 2 типа. Дапаглифлозин: результаты клинических исследований. Эффективная фармакотерапия, 2015, 11: 17-24.
7. Forxiga.EMA.http//www.ema.europa.eu/ema/ index.jsp?curL=pages/medicines/human/ mеdicines/002322/human_med_001546. jsp&mid.
8. FDA approves Farxiga to treat type 2 diabetes. U.S. Food and Drug Administration. http://www. fda.gov/newsevents/newsroom/pressannounce-ments/ucm380829.htm.
9. BoLinder J et aL. DapagLifLozin maintains gLy-caemic controL whiLe reducing weight andbody fat mass over 2 years in patients with type 2 diabetes meLLitus inadequateLy controLLed on metformin. Diabetes Obes Metab, 2014, 16: 15969. doi: 10.1111/dom.12189/.
10. Инструкция по медицинскому применению лекарственного препарата Форсига® (таблетки, покрытые пленочной оболочкой, 5 мг). Регистрационное удостоверение ЛП-002596 от 21/08/2014.
11. Henry RR, Murray AV, MarmoLejo MH et aL. DapagLifLozin, metformin-XR, or both: initial pharmacotherapy for type 2 diabetes, a randomized controLLed triaL. Int. J. Clin. Pract., 2012, 66: 446-456.
12. Ferrannini E, Ramos SJ, SaLsaLi A, Tang W, List JF. 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, 33(10): 2217-24.
13. 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): 2223-33.
14. BaiLey CJ, Gross JL, Hennicken D, IqbaL N, MansfieLd TA, List J. DapagLifLozin add-on to metformin in type 2 diabetes inadequateLy controLLed with metformin: a randomized, doubLe-bLind, pLacebo-controLLed 102-week triaL. BMCMedicine, 2013, 11: 43.
15. Henry RR, Murray AV, MarmoLejo MH, Hennicken D, Ptaszynska A, List JF. DapagLifL ozin, metformin XR, or both: initiaL pharmacotherapy for type 2 diabetes, a randomised controLLed triaL. Int. J. Clin. Pract., 2012, 66(5): 446-56.
16. Nauck MA, DeL Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, ELze M, Parikh SJ. 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 non-inferiority triaL. Diabetes Care, 2011, 34(9): 2015-22.
17. Nauck MA, DeL Prato S, Duran-Garcia S, Rohwedder K, LangkiLde AM, Sugg J, Parikh SJ. DurabiLity of gLycaemic efficacy over 2 years with dapagLifLozin versus gLipizide as add-on therapies in patients whose type 2 diabetes meLLitus is inadequateLy controLLed with met-formin. Diabetes Obes. Metab., 2014, 16(11): 1111-20.
18. DeL Prato S, Nauck M, Duran-Garcia S, Maffei L, Rohwedder K, Theuerkauf A, Parikh S. 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 Jun, 17(6): 581-90. doi: 10.1111/ dom.12459. Epub 2015 Apr 6.
19. Serge A. Jabbour, ELise Hardy, Jennifer Sugg, Shamik Parikh. 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: 740-50.
20. Mathieu C et aL. Diabetes Care, 2015 Aug 5.
21. Zachary T. BLoomgarden and Yehuda HandeLsman. SGLT-2 inhibition added to GLP-1 agonist therapy for type 2 diabetes: What is the benefit? Endocrine Practice, 2015 December, 21, 12: 1442-1444.
22. 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 Oct, 13(10): 928-38. doi: 10.1111/j.1463-1326.2011.01434.x.
23. Hemmingsen B, Christensen LL, WettersLev J et aL. Comparison of metformin and insuLin versus insuLin aLone for type 2 diabetes: systematic review of randomised cLinicaL triaLs with meta-anaLyses and triaL sequentiaL anaLyses. BMJ, 2012: 344.
24. WiLding JPH, Woo V, Rohwedder K, Sugg J & Parikh S for the DapagLifLozin 006 Study Group. DapagLifLozin in patients with type 2 diabetes receiving high doses of insuLin: efficacy and safety over 2 years. Diabetes, Obesity and Metabolism, 2014, 16: 124-136.
25. BenfieLd T, Jensen JS, Nordestgaard BG. InfLuence of diabetes and hypergLycaemia on infectious disease hospitaLization and outcome. Diabetologia, 2007, 50, 3: 549-554.
26. De Leon EM, Jacober SJ, SobeL JD, Foxman B. PrevaLence and risk factors for vaginaL Candida coLonization in women with type 1 and type 2 diabetes. BMC Infect. Dis., 2002, 2, 1.
27. GeerLings S, Fonseca V, Castro-Diaz D et aL. GenitaL and urinary tract infections in diabetes: impact of pharmacoLogicaLLy-induced gLucosuria. Diabetes Res. Clin. Pract., 2014, 103, 3: 373-381.
28. Johnsson KM, Ptaszynska A, Schmitz B et aL. Urinary tract infections in patients with diabetes treated with dapagLifLozin. J. Diabetes Complications, 2013, 27, 5: 473-478.
29. Ptaszynska A, Johnsson KM, Parikh SJ, de Bruin TWA et aL. Safety profiLe of dapagLifLozin for type 2 diabetes: PooLed AnaLysis of CLinicaL Studies for OveraLL Safety and Rare Events. Drug Saf., 2014, 37: 815-29.
30. Johnsson KM, Ptaszynska A, Schmitz B et aL. Vulvovaginitis and baLanitis in patients with diabetes treated with dapagLifLozin. J. Diabetes Complications, 2013, 27, 5: 479-484.
31. NicoLLe LE, Capuano G, Ways K, Usiskin K. Effect of canagLifLozin, a sodium gLucose co-transporter 2 (SGLT2)inhibitor, on bacteriuria and urinary tract infection in subjects with type 2 diabetes enroLLed in a 12-week, phase 2 study. Curr Med Res Opin, 2012, 28(7): 1167-71.
32. Nyirjesy P, Zhao Y, Ways K, Usiskin K. EvaLuation of vuLvovaginaL symptoms and Candida coLonization in women with type 2 diabetes meLLitus treated with canagLifLozin, a sodium gLucose co-transporter 2 inhibitor. Curr Med Res Opin, 2012, 28(7): 1173-8.
33. Ferrannini E, Seman L, SeewaLdt-Becker E, HanteL S, Pinnetti S, WoerLe HJ. A Phase lib, randomized, pLacebocontroLLed study of the SGLT2 inhibitor empagLifLozin in patients with type 2 diabetes. Diabetes Obes Metab, 2013.
34. Rosenstock J, Seman LJ, JeLaska A, HanteL S, Pinnetti S, Hach T, et aL. Efficacy and safety of empagLifLozin, a sodium gLucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with miLd hypergLycaemia. Diabetes Obes Metab, 2013, 15(12): 1154-60.
35. https://cLinicaLtriaLs.gov/ct2/show/study/ NCT01730534?term=DECLARE.
36. DeL Prato S, et aL. Diabetes Obes Metab. 2015 Jun, 17(6): 581-90.
37. Algorithms of specialized medical care to patients with diabetes. Edited by II Dedov, M.V. Shestakova. М., 2015. Vol. 7.
38. Mkrtumian A.M., Egshatyan L.V. A new non-insulin dependent approach to the treatment of type 2 diabetes. Dapagliflozin: results of clinical trials. Effektivnaya Farmakoterapiya, 2015, 11: 17-24
39. Instruction for medical use of Forxiga® 5 mg & 10 mg film coated tablets. Registration Certificate LP-002596 of 21.08.2014.
Review
For citations:
Kononenko IV, Smirnova OM. SGLT2: new approaches to combination therapy of type 2 diabetes mellitus. Meditsinskiy sovet = Medical Council. 2016;(3):10-17. (In Russ.) https://doi.org/10.21518/2079-701X-2016-3-10-17