메뉴 건너뛰기




Volumn 14, Issue 1, 2015, Pages

Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naïve patients with type 2 diabetes: A double-blind extension of a Phase III randomized controlled trial

Author keywords

Blood pressure; Empagliflozin; Safety; SGLT2 inhibitor; Type 2 diabetes

Indexed keywords

EMPAGLIFLOZIN; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; SITAGLIPTIN; TRIACYLGLYCEROL; URIC ACID; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; BIOLOGICAL MARKER; GLUCOSE BLOOD LEVEL; GLUCOSIDE; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN;

EID: 84952990032     PISSN: None     EISSN: 14752840     Source Type: Journal    
DOI: 10.1186/s12933-015-0314-0     Document Type: Article
Times cited : (103)

References (34)
  • 1
    • 83655193529 scopus 로고    scopus 로고
    • The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia
    • 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;14:5-14.
    • (2012) Diabetes Obes Metab , vol.14 , pp. 5-14
    • DeFronzo, R.A.1    Davidson, J.A.2    Prato, S.3
  • 2
    • 84923527667 scopus 로고    scopus 로고
    • Probing SGLT2 as a therapeutic target for diabetes: basic physiology and consequences
    • Gallo LA, Wright EM, Vallon V. Probing SGLT2 as a therapeutic target for diabetes: basic physiology and consequences. Diab Vasc Dis Res. 2015;12:78-89.
    • (2015) Diab Vasc Dis Res , vol.12 , pp. 78-89
    • Gallo, L.A.1    Wright, E.M.2    Vallon, V.3
  • 3
    • 84948716657 scopus 로고    scopus 로고
    • Efficacy and safety of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes: a meta-analysis of randomized controlled trials for 1 to 2 years
    • Liu XY, Zhang N, Chen R, Zhao JG, Yu P. Efficacy and safety of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes: a meta-analysis of randomized controlled trials for 1 to 2 years. J Diabetes Complicat. 2015;29:1295-303.
    • (2015) J Diabetes Complicat , vol.29 , pp. 1295-1303
    • Liu, X.Y.1    Zhang, N.2    Chen, R.3    Zhao, J.G.4    Yu, P.5
  • 4
    • 84937525356 scopus 로고    scopus 로고
    • A comprehensive review of the pharmacodynamics of the SGLT2 inhibitor empagliflozin in animals and humans
    • Michel MC, Mayoux E, Vallon V. A comprehensive review of the pharmacodynamics of the SGLT2 inhibitor empagliflozin in animals and humans. Naunyn Schmiedebergs Arch Pharmacol. 2015;388:801-16.
    • (2015) Naunyn Schmiedebergs Arch Pharmacol , vol.388 , pp. 801-816
    • Michel, M.C.1    Mayoux, E.2    Vallon, V.3
  • 5
    • 84898854471 scopus 로고    scopus 로고
    • Effects of sodium-glucose co-transporter 2 inhibitors on blood pressure: a systematic review and meta-analysis
    • 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(262-75):e9.
    • (2014) J Am Soc Hypertens , vol.8 , pp. 262-275
    • Baker, W.L.1    Smyth, L.R.2    Riche, D.M.3    Bourret, E.M.4    Chamberlin, K.W.5    White, W.B.6
  • 6
    • 84930205413 scopus 로고    scopus 로고
    • The role of empagliflozin in the management of type 2 diabetes by patient profile
    • Hedrington MS, Davis SN. The role of empagliflozin in the management of type 2 diabetes by patient profile. Ther Clin Risk Manag. 2015;11:739-49.
    • (2015) Ther Clin Risk Manag , vol.11 , pp. 739-749
    • Hedrington, M.S.1    Davis, S.N.2
  • 7
    • 83655184724 scopus 로고    scopus 로고
    • Empagliflozin, a novel selective sodium glucose cotransporter-2 (SGLT-2) inhibitor: characterisation and comparison with other SGLT-2 inhibitors
    • Grempler R, Thomas L, Eckhardt M, Himmelsbach F, Sauer A, Sharp DE, et al. Empagliflozin, a novel selective sodium glucose cotransporter-2 (SGLT-2) inhibitor: characterisation and comparison with other SGLT-2 inhibitors. Diabetes Obes Metab. 2012;14:83-90.
    • (2012) Diabetes Obes Metab , vol.14 , pp. 83-90
    • Grempler, R.1    Thomas, L.2    Eckhardt, M.3    Himmelsbach, F.4    Sauer, A.5    Sharp, D.E.6
  • 8
    • 84885952950 scopus 로고    scopus 로고
    • Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial
    • Haering H-U, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Woerle HJ, 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;36:3396-404.
    • (2013) Diabetes Care , vol.36 , pp. 3396-3404
    • Haering, H.-U.1    Merker, L.2    Seewaldt-Becker, E.3    Weimer, M.4    Meinicke, T.5    Woerle, H.J.6
  • 9
    • 84885954870 scopus 로고    scopus 로고
    • Empagliflozin monotherapy in drug-naive patients with type 2 diabetes: a randomised, 24-week, double-blind, placebo-controlled, parallel group, trial with sitagliptin as active comparator
    • Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, et al. Empagliflozin monotherapy in drug-naive patients with type 2 diabetes: a randomised, 24-week, double-blind, placebo-controlled, parallel group, trial with sitagliptin as active comparator. Lancet Diabetes Endocrinol. 2013;1:208-19.
    • (2013) Lancet Diabetes Endocrinol , vol.1 , pp. 208-219
    • Roden, M.1    Weng, J.2    Eilbracht, J.3    Delafont, B.4    Kim, G.5    Woerle, H.J.6
  • 10
    • 84892477577 scopus 로고    scopus 로고
    • Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24-week, randomized, placebo-controlled trial
    • Kovacs CS, Seshiah V, Swallow R, Jones R, Rattunde H, Woerle HJ, et al. Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24-week, randomized, placebo-controlled trial. Diabetes Obes Metab. 2014;16:147-58.
    • (2014) Diabetes Obes Metab , vol.16 , pp. 147-158
    • Kovacs, C.S.1    Seshiah, V.2    Swallow, R.3    Jones, R.4    Rattunde, H.5    Woerle, H.J.6
  • 11
    • 84901455931 scopus 로고    scopus 로고
    • Empagliflozin as add-on to metformin in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial
    • Haering H-U, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Broedl UC, 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;37:1650-9.
    • (2014) Diabetes Care , vol.37 , pp. 1650-1659
    • Haering, H.-U.1    Merker, L.2    Seewaldt-Becker, E.3    Weimer, M.4    Meinicke, T.5    Broedl, U.C.6
  • 12
    • 84899961819 scopus 로고    scopus 로고
    • 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
    • Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, 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;2:369-84.
    • (2014) Lancet Diabetes Endocrinol , vol.2 , pp. 369-384
    • Barnett, A.H.1    Mithal, A.2    Manassie, J.3    Jones, R.4    Rattunde, H.5    Woerle, H.J.6
  • 13
    • 84908332537 scopus 로고    scopus 로고
    • 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
    • Ridderstrale M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC, et al. 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;2:691-700.
    • (2014) Lancet Diabetes Endocrinol , vol.2 , pp. 691-700
    • Ridderstrale, M.1    Andersen, K.R.2    Zeller, C.3    Kim, G.4    Woerle, H.J.5    Broedl, U.C.6
  • 14
    • 84903511385 scopus 로고    scopus 로고
    • 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
    • Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, 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;37:1815-23.
    • (2014) Diabetes Care , vol.37 , pp. 1815-1823
    • Rosenstock, J.1    Jelaska, A.2    Frappin, G.3    Salsali, A.4    Kim, G.5    Woerle, H.J.6
  • 15
    • 84928196614 scopus 로고    scopus 로고
    • Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension
    • Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, et al. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care. 2015;38:420-8.
    • (2015) Diabetes Care , vol.38 , pp. 420-428
    • Tikkanen, I.1    Narko, K.2    Zeller, C.3    Green, A.4    Salsali, A.5    Broedl, U.C.6
  • 16
    • 84942294658 scopus 로고    scopus 로고
    • 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
    • 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;17:936-48.
    • (2015) Diabetes Obes Metab , vol.17 , pp. 936-948
    • Rosenstock, J.1    Jelaska, A.2    Zeller, C.3    Kim, G.4    Broedl, U.C.5    Woerle, H.J.6
  • 17
    • 84924328996 scopus 로고    scopus 로고
    • Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study
    • Nishimura R, Tanaka Y, Koiwai K, Inoue K, Hach T, Salsali A, Lund SS, Broedl UC. Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study. Cardiovasc Diabetol. 2015;14:11.
    • (2015) Cardiovasc Diabetol , vol.14 , pp. 11
    • Nishimura, R.1    Tanaka, Y.2    Koiwai, K.3    Inoue, K.4    Hach, T.5    Salsali, A.6    Lund, S.S.7    Broedl, U.C.8
  • 18
    • 84919999219 scopus 로고    scopus 로고
    • Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)
    • Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2015;38:140-9.
    • (2015) Diabetes Care , vol.38 , pp. 140-149
    • Inzucchi, S.E.1    Bergenstal, R.M.2    Buse, J.B.3    Diamant, M.4    Ferrannini, E.5    Nauck, M.6
  • 19
    • 84861109293 scopus 로고    scopus 로고
    • Worry vs. knowledge about treatment-associated hypoglycaemia and weight gain in type 2 diabetic patients on metformin and/or sulphonylurea
    • Lund A, Knop FK. Worry vs. knowledge about treatment-associated hypoglycaemia and weight gain in type 2 diabetic patients on metformin and/or sulphonylurea. Curr Med Res Opin. 2012;28:731-6.
    • (2012) Curr Med Res Opin , vol.28 , pp. 731-736
    • Lund, A.1    Knop, F.K.2
  • 20
    • 64249145623 scopus 로고    scopus 로고
    • Treatment preferences and medication adherence of people with type 2 diabetes using oral glucose-lowering agents
    • Hauber AB, Mohamed AF, Johnson FR, Falvey H. Treatment preferences and medication adherence of people with type 2 diabetes using oral glucose-lowering agents. Diabet Med. 2009;26:416-24.
    • (2009) Diabet Med , vol.26 , pp. 416-424
    • Hauber, A.B.1    Mohamed, A.F.2    Johnson, F.R.3    Falvey, H.4
  • 22
    • 84891851923 scopus 로고    scopus 로고
    • Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes
    • Ferrannini E, Berk A, Hantel S, Pinnetti S, Hach T, Woerle HJ, et al. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care. 2013;36:4015-21.
    • (2013) Diabetes Care , vol.36 , pp. 4015-4021
    • Ferrannini, E.1    Berk, A.2    Hantel, S.3    Pinnetti, S.4    Hach, T.5    Woerle, H.J.6
  • 23
    • 33845472504 scopus 로고    scopus 로고
    • Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes
    • Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE, et al. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006;29:2632-7.
    • (2006) Diabetes Care , vol.29 , pp. 2632-2637
    • Aschner, P.1    Kipnes, M.S.2    Lunceford, J.K.3    Sanchez, M.4    Mickel, C.5    Williams-Herman, D.E.6
  • 24
    • 33845489598 scopus 로고    scopus 로고
    • Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus
    • Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006;49:2564-71.
    • (2006) Diabetologia , vol.49 , pp. 2564-2571
    • Raz, I.1    Hanefeld, M.2    Xu, L.3    Caria, C.4    Williams-Herman, D.5    Khatami, H.6
  • 25
    • 75649128008 scopus 로고    scopus 로고
    • Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes
    • Aschner P, Katzeff HL, Guo H, Sunga S, Williams-Herman D, Kaufman KD, et al. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12:252-61.
    • (2010) Diabetes Obes Metab , vol.12 , pp. 252-261
    • Aschner, P.1    Katzeff, H.L.2    Guo, H.3    Sunga, S.4    Williams-Herman, D.5    Kaufman, K.D.6
  • 26
    • 84902756416 scopus 로고    scopus 로고
    • Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)
    • Zinman B, Inzucchi SE, Lachin JM, Wanner C, Ferrari R, Fitchett D, et al. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™). Cardiovasc Diabetol. 2014;13:102.
    • (2014) Cardiovasc Diabetol , vol.13 , pp. 102
    • Zinman, B.1    Inzucchi, S.E.2    Lachin, J.M.3    Wanner, C.4    Ferrari, R.5    Fitchett, D.6
  • 27
    • 84893214045 scopus 로고    scopus 로고
    • Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus
    • Cherney DZ, Perkins BA, Soleymanlou N, Maione M, Lai V, Lee A, et al. Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus. Circulation. 2014;129:587-97.
    • (2014) Circulation , vol.129 , pp. 587-597
    • Cherney, D.Z.1    Perkins, B.A.2    Soleymanlou, N.3    Maione, M.4    Lai, V.5    Lee, A.6
  • 28
    • 84945455839 scopus 로고    scopus 로고
    • Effects of empagliflozin on blood pressure and markers of arterial stiffness and vascular resistance in patients with type 2 diabetes
    • Chilton R, Tikkanen I, Cannon CP, Crowe S, Woerle HJ, Broedl UC, Johansen OE. Effects of empagliflozin on blood pressure and markers of arterial stiffness and vascular resistance in patients with type 2 diabetes. Diabetes Obes Metab. 2015;17:1180-93.
    • (2015) Diabetes Obes Metab , vol.17 , pp. 1180-1193
    • Chilton, R.1    Tikkanen, I.2    Cannon, C.P.3    Crowe, S.4    Woerle, H.J.5    Broedl, U.C.6    Johansen, O.E.7
  • 29
    • 84964696031 scopus 로고    scopus 로고
    • Glycemic control with empagliflozin, a novel selective SGLT2 inhibitor, ameliorates cardiovascular injury and cognitive dysfunction in obese and type 2 diabetic mice
    • Lin B, Koibuchi N, Hasegawa Y, Sueta D, Toyama K, Uekawa K, et al. Glycemic control with empagliflozin, a novel selective SGLT2 inhibitor, ameliorates cardiovascular injury and cognitive dysfunction in obese and type 2 diabetic mice. Cardiovasc Diabetol. 2014;13:148.
    • (2014) Cardiovasc Diabetol , vol.13 , pp. 148
    • Lin, B.1    Koibuchi, N.2    Hasegawa, Y.3    Sueta, D.4    Toyama, K.5    Uekawa, K.6
  • 30
    • 84893872877 scopus 로고    scopus 로고
    • Metabolic response to sodium-glucose cotransporter 2 inhibition in type 2 diabetic patients
    • Ferrannini E, Muscelli E, Frascerra S, Baldi S, Mari A, Heise T, et al. Metabolic response to sodium-glucose cotransporter 2 inhibition in type 2 diabetic patients. J Clin Invest. 2014;124:499-508.
    • (2014) J Clin Invest , vol.124 , pp. 499-508
    • Ferrannini, E.1    Muscelli, E.2    Frascerra, S.3    Baldi, S.4    Mari, A.5    Heise, T.6
  • 32
    • 84873960885 scopus 로고    scopus 로고
    • Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial
    • 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.
    • (2013) BMC Med , vol.11 , pp. 43
    • Bailey, C.J.1    Gross, J.L.2    Hennicken, D.3    Iqbal, N.4    Mansfield, T.A.5    List, J.F.6
  • 33
    • 84892479365 scopus 로고    scopus 로고
    • 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
    • Bolinder J, Ljunggren Ö, Johansson L, Wilding J, Langkilde AM, Sjöström CD, 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;16:159-69.
    • (2014) Diabetes Obes Metab , vol.16 , pp. 159-169
    • Bolinder, J.1    Ljunggren, Ö.2    Johansson, L.3    Wilding, J.4    Langkilde, A.M.5    Sjöström, C.D.6
  • 34
    • 84893299467 scopus 로고    scopus 로고
    • Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise: findings from the 52-week CANTATA-M study
    • Stenlöf K, Cefalu WT, Kim KA, Jodar E, Alba M, Edwards R, et al. Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise: findings from the 52-week CANTATA-M study. Curr Med Res Opin. 2014;30:163-75.
    • (2014) Curr Med Res Opin , vol.30 , pp. 163-175
    • Stenlöf, K.1    Cefalu, W.T.2    Kim, K.A.3    Jodar, E.4    Alba, M.5    Edwards, R.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.