3.6) INSTRUMENTOS DE RECOLECCIÓN DE LA INFORMACIÓN

References

1. Fujita Y, Inagaki N. Renal sodium glucose cotransporter 2 inhibitors as a novel therapeutic approach to treatment of type 2 diabetes: Clinical data and mechanism of action. J Diabetes Investig. 2014;5(3):265-275. doi:10.1111/ jdi.12214.

Appendix 9 S171

double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013;1(3):208-219. doi:10.1016/S2213-8587(13)70084-6.

5. Stenlöf K, Cefalu WT, Kim K-A, et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes, Obes Metab. 2013;15(4):372-382. doi:10.1111/ dom.12054.

6. Vasilakou D, Karagiannis T, Athanasiadou E, et al. Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013;159(4):262-274. doi:10.7326/0003-4819-159-4-201308200-00007.

7. Zaccardi F, Webb DR, Htike ZZ, Youssef D, Khunti K, Davies MJ. Efficacy and safety of sodium-glucose co-transporter-2 inhibitors in type 2 diabetes mellitus: systematic review and network meta-analysis. Diabetes, Obes Metab. 2016;18(8):783-794. doi:10.1111/dom.12670.

8. 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(1):43. doi:10.1186/1741-7015-11-43.

9. Häring H-U, Merker L, Seewaldt-Becker E, et al. Empagliflozin as Add-On to Metformin in Patients With Type 2 Diabetes: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Trial. Diabetes Care. 2014;37(6):1650-1659. doi:10.2337/dc13-2105.

10. Nauck MMA, Del Prato S, Meier JJJJJJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin. Diabetes Care. 2011;34(9):2015-2022. doi:10.2337/ dc11-0606.

11. Del Prato S, Nauck M, Durán-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. doi:10.1111/dom.12459.

12. Ridderstråle M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014;2(9):691-700. doi:10.1016/ S2213-8587(14)70120-2.

13. Cefalu WT, Leiter LA, Yoon K-H, et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013;382(9896):941-950. doi:10.1016/ S0140-6736(13)60683-2.

14. Strojek K, Yoon K-H, Hruba V, Sugg J, Langkilde AM, Parikh S. Dapagliflozin Added to Glimepiride in Patients with Type 2 Diabetes Mellitus Sustains Glycemic Control and Weight Loss Over 48 Weeks: A Randomized, Double- Blind, Parallel-Group, Placebo-Controlled Trial. Diabetes Ther. 2014;5(1):267-283. doi:10.1007/s13300-014-0072-0.

15. Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S, Study 05 Group. Dapagliflozin Improves Glycemic Control and Reduces Body Weight as Add-on Therapy to Metformin Plus Sulfonylurea: A 24-Week Randomized, Double-Blind Clinical Trial. Diabetes Care. 2015;38(3):365-372. doi:10.2337/dc14-0666. 16. Haring H-U, Merker L, Seewaldt-Becker E, et al. Empagliflozin as Add-on to

Metformin Plus Sulfonylurea in Patients With Type 2 Diabetes: A 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013;36(11):3396-3404. doi:10.2337/dc12-2673.

17. Haering H-U, Merker L, Christiansen AV, et al. Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes. Diabetes Res Clin Pract. 2015;110(1):82-90. doi:10.1016/j.diabres.2015.05.044.

18. Wilding JPH, 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. doi:10.1111/dom.12187.

19. Rosenstock J, Jelaska A, Zeller C, Kim G, Broedl UC, Woerle HJ. Impact of empagliflozin added on to basal insulin in type 2 diabetes inadequately controlled on basal insulin: a 78-week randomized, double-blind, placebo- controlled trial. Diabetes, Obes Metab. 2015;17(10):936-948. doi:10.1111/ dom.12503.

20. Rosenstock J, Jelaska A, Frappin G, et al. Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections of Insulin in Obese Inadequately Controlled Type 2 Diabetes. Diabetes Care. 2014;37(7):1815-1823. doi:10.2337/ dc13-3055.

21. Neal B, Perkovic V, Matthews DR, et al. Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): A randomized, placebo-controlled trial. Diabetes, Obes Metab. 2017;19(3):387-393. doi:10.1111/dom.12829.

22. Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014;85(4):962-971. doi:10.1038/ki.2013.356.

23. Yale J-F, Bakris G, Cariou B, et al. Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease. Diabetes, Obes Metab. 2013;15(5):463-473. doi:10.1111/dom.12090.

24. Barnett AH, Mithal A, Manassie J, et al. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014;2(5):369-384. doi:10.1016/S2213-8587(13)70208-0. 25. European Medicines Agency. Jardiance : European Public Assessment Report -

Product Information. Updated 07 December 2015. http://www.ema.europa.eu/ docs/en_GB/document_library/EPAR_-_Product_Information/human/002677/ WC500168592.pdf. Accessed February 10, 2016.

26. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT01730534. Accessed February 15, 2016.

27. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117-2128. doi:10.1056/NEJMoa1504720.

28. Neal B, Perkovic V, de Zeeuw D, et al. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—A randomized placebo-controlled trial. Am Heart J. 2013;166(2):217- 223.e11. doi:10.1016/j.ahj.2013.05.007.

29. Lorenzi M, Ploug UJ, Langer J, Skovgaard R, Zoratti M, Jansen J. Liraglutide Versus SGLT-2 Inhibitors in People with Type 2 Diabetes: A Network Meta-Analysis. Diabetes Ther. 2017;8(1):85-99. doi:10.1007/s13300-016-0217-4.

30. Leiter LA, Yoon K-H, Arias P, et al. Canagliflozin Provides Durable Glycemic Improvements and Body Weight Reduction Over 104 Weeks Versus Glimepiride in Patients With Type 2 Diabetes on Metformin: A Randomized, Double-Blind, Phase 3 Study. Diabetes Care. 2015;38(3):355-364. doi:10.2337/dc13-2762. 31. Baker WL, Smyth LR, Riche DM, Bourret EM, Chamberlin KW, White WB. Effects

of sodium-glucose co-transporter 2 inhibitors on blood pressure: A systematic review and meta-analysis. J Am Soc Hypertens. 2014;8(4):262-275. doi:10.1016/j. jash.2014.01.007.

32. Schwartz SS, Ahmed I. Sodium-Glucose Cotransporter-2 Inhibitors: An Evidence- Based Practice Approach to Their Use in the Natural History of Type 2 Diabetes. Curr Med Res Opin. February 2016:1-43. doi:10.1185/03007995.2016.1151774. 33. De Nicola L, Gabbai FB, Liberti ME, Sagliocca A, Conte G, Minutolo R. Sodium/

Glucose Cotransporter 2 Inhibitors and Prevention of Diabetic Nephropathy: Targeting the Renal Tubule in Diabetes. Am J Kidney Dis. 2014;64(1):16-24. doi:10.1053/j.ajkd.2014.02.010.

34. U.S. Food and Drug Administration. Safety Alerts for Human Medical Products - SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections. 35. Rosenstock J, Ferrannini E. Euglycemic Diabetic Ketoacidosis : A Predictable

, Detectable , and Preventable Safety Concern With SGLT2 Inhibitors. Diabetes Care. 2015;38(September):1638-1642. doi:10.2337/dc15-1380.

36. FDA. Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density. 10 September 2015. http://www.fda.gov/Drugs/DrugSafety/ucm461449.htm. Accessed February 21, 2016.

37. Bilezikian JP, Watts NB, Usiskin K, et al. Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin. J Clin Endocrinol Metab. 2016;101(1):44-51. doi:10.1210/jc.2015-1860.

38. FDA Briefing Document NDA 202293. Dapagliflozin Oral Tablets, 5 and 10 mg. Sponsor : Bristol-Myers Squibb Advisory Committee Meeting December 12, 2013. http://www.fda.gov/downloads/ A d v i s o r y C o m m i t t e e s / C o m m i t t e e s M e e t i n g M a t e r i a l s / D r u g s / EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM378076.pdf. Accessed February 20, 2016.

39. European Medicines Agency. Forxiga : European Public Assessment Report - Product Information. Updated 08 May 2015. http://www.ema.europa.eu/ docs/en_GB/document_library/EPAR_-_Product_Information/human/002322/ WC500136026.pdf. Accessed February 10, 2016.

Journal of Endocrinology, Metabolism and Diabetes of South Africa 2017 ; 22(1) S172

40. European Medicines Agency. Invokana : European Public Assessment Report - Product Information. Updated 13 January 2016. http://www.ema.europa.eu/ docs/en_GB/document_library/EPAR_-_Product_Information/human/002649/ WC500156456.pdf. Accessed February 10, 2016.

41. European Medicines Association. EMA Adds Potential for Toe Amputation to SGLT2 Inhibitor Prescribing Info | RAPS. February 2017. http://www.raps.org/ Regulatory-Focus/News/2017/02/24/26961/EMA-Adds-Potential-for-Toe- Amputation-to-SGLT2-Inhibitor-Prescribing-Info/. Accessed February 20, 2017. 42. List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-Glucose Cotransport

Inhibition With Dapagliflozin in Type 2 Diabetes. Diabetes Care. 2009;32(4):650- 657. doi:10.2337/dc08-1863.