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Volumn 13, Issue 1, 2014, Pages

Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)

Author keywords

Blood pressure; Body weight; Empagliflozin; Glycemic control; Macrovascular; Microvascular; SGLT2 inhibitor; Type 2 diabetes

Indexed keywords

EMPAGLIFLOZIN; GLUCOSE; HEMOGLOBIN A1C; INSULIN; PLACEBO; ACETYLSALICYLIC ACID; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; FIBRIC ACID DERIVATIVE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

EID: 84902756416     PISSN: None     EISSN: 14752840     Source Type: Journal    
DOI: 10.1186/1475-2840-13-102     Document Type: Article
Times cited : (219)

References (28)
  • 1
    • 84871995815 scopus 로고    scopus 로고
    • Standards of medical care in diabetes-2013
    • American Diabetes Association
    • American Diabetes Association Standards of medical care in diabetes-2013. Diabetes Care 2013, 36(Suppl 1):S11-S66. American Diabetes Association.
    • (2013) Diabetes Care , vol.36 , Issue.SUPPL. 1
  • 7
    • 0026061942 scopus 로고
    • Resolved and unresolved issues in the prevention and treatment of coronary artery disease: a workshop consensus statement
    • Dzau V, Braunwald E. Resolved and unresolved issues in the prevention and treatment of coronary artery disease: a workshop consensus statement. Am Heart J 1991, 121:1244-1263.
    • (1991) Am Heart J , vol.121 , pp. 1244-1263
    • Dzau, V.1    Braunwald, E.2
  • 8
    • 84890914711 scopus 로고    scopus 로고
    • Incorporating lag time to benefit into prevention decisions for older adults
    • Lee SJ, Leipzig RM. Incorporating lag time to benefit into prevention decisions for older adults. JAMA 2013, 310:2609-2610.
    • (2013) JAMA , vol.310 , pp. 2609-2610
    • Lee, S.J.1    Leipzig, R.M.2
  • 9
    • 72249116214 scopus 로고    scopus 로고
    • (accessed November 15, 2013), Food and Drug Administration (Center for Drug Evaluation and Research)
    • Food and Drug Administration (Center for Drug Evaluation and Research) Guidance for Industry: Diabetes Mellitus - Eevaluating Cardiovascular risk in New Antidiabetic Therapies to Treat Type 2 Diabetes 2008, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf. (accessed November 15, 2013), Food and Drug Administration (Center for Drug Evaluation and Research).
    • (2008) Guidance for Industry: Diabetes Mellitus - Eevaluating Cardiovascular risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
  • 11
    • 80052362968 scopus 로고    scopus 로고
    • Role of sodium-glucose cotransporter 2 (SGLT 2) inhibitors in the treatment of type 2 diabetes
    • Abdul-Ghani MA, Norton L, DeFronzo RA. Role of sodium-glucose cotransporter 2 (SGLT 2) inhibitors in the treatment of type 2 diabetes. Endocr Rev 2011, 32:515-531.
    • (2011) Endocr Rev , vol.32 , pp. 515-531
    • Abdul-Ghani, M.A.1    Norton, L.2    DeFronzo, R.A.3
  • 13
    • 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
    • EMPA-REG METSU Trial Investigators
    • Häring H-U, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Woerle HJ, Broedl UC, . EMPA-REG METSU Trial Investigators 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, 36:3396-3404. EMPA-REG METSU Trial Investigators.
    • (2013) Diabetes Care , vol.36 , pp. 3396-3404
    • Häring, H.-U.1    Merker, L.2    Seewaldt-Becker, E.3    Weimer, M.4    Meinicke, T.5    Woerle, H.J.6    Broedl, U.C.7
  • 14
    • 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
    • EMPA-REG PIO™ Trial Investigators
    • Kovacs CS, Seshiah V, Swallow R, Jones R, Rattunde H, Woerle HJ, Broedl UC, . EMPA-REG PIO™ Trial Investigators 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, 16:147-158. EMPA-REG PIO™ Trial Investigators.
    • (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    Broedl, U.C.7
  • 15
    • 84885954870 scopus 로고    scopus 로고
    • Empagliflozin monotherapy in drug-naïve patients with type 2 diabetes: a randomised, 24-week, double-blind, placebo-controlled, parallel group, trial with sitagliptin as active comparator
    • EMPA-REG MONO Trial Investigators
    • Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC, . EMPA-REG MONO Trial Investigators Empagliflozin monotherapy in drug-naïve 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, 1:208-219. EMPA-REG MONO Trial Investigators.
    • (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    Broedl, U.C.7
  • 16
    • 84892658063 scopus 로고    scopus 로고
    • Empagliflozin improves blood pressure in patients with type 2 diabetes (T2DM) and hypertension
    • Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, Woerle HJ. Empagliflozin improves blood pressure in patients with type 2 diabetes (T2DM) and hypertension. Diabetologia 2013, 56(suppl 1):S377 [942].
    • (2013) Diabetologia , vol.56 , Issue.SUPPL. 1
    • Tikkanen, I.1    Narko, K.2    Zeller, C.3    Green, A.4    Salsali, A.5    Broedl, U.C.6    Woerle, H.J.7
  • 17
    • 84899961819 scopus 로고    scopus 로고
    • Efficacy and safety of empagliflozin added to existing anti-diabetes therapy in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial
    • EMPA-REG RENAL Trial Investigators
    • Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC, . EMPA-REG RENAL Trial Investigators Efficacy and safety of empagliflozin added to existing anti-diabetes therapy in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol 2014, 2:369-384. EMPA-REG RENAL Trial Investigators.
    • (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    Broedl, U.C.7
  • 20
    • 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 T, Johansson L, Wilding J, Langkilde AM, Sjöström CD, Sugg J, Parikh S. 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, 16:159-169.
    • (2014) Diabetes Obes Metab , vol.16 , pp. 159-169
    • Bolinder, J.1    Ljunggren, T.2    Johansson, L.3    Wilding, J.4    Langkilde, A.M.5    Sjöström, C.D.6    Sugg, J.7    Parikh, S.8
  • 21
    • 84884167643 scopus 로고    scopus 로고
    • 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
    • Cefalu WT, Leiter LA, Yoon KH, Arias P, Niskanen L, Xie J, Balis DA, Canovatchel W, Meininger G. 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, 382:941-950.
    • (2013) Lancet , vol.382 , pp. 941-950
    • Cefalu, W.T.1    Leiter, L.A.2    Yoon, K.H.3    Arias, P.4    Niskanen, L.5    Xie, J.6    Balis, D.A.7    Canovatchel, W.8    Meininger, G.9
  • 23
    • 43649105816 scopus 로고    scopus 로고
    • Maintaining confidentiality of interim data to enhance trial integrity and credibility
    • Fleming T, Sharples K, McCall J, Moore A, Rodgers A, Stewart R. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clinical Trials 2008, 5:157-167.
    • (2008) Clinical Trials , vol.5 , pp. 157-167
    • Fleming, T.1    Sharples, K.2    McCall, J.3    Moore, A.4    Rodgers, A.5    Stewart, R.6
  • 26
    • 84892588641 scopus 로고    scopus 로고
    • SGLT2 inhibitor empagliflozin reduces renal growth and albuminuria in proportion to hyperglycemia and prevents glomerular hyperfiltration in diabetic Akita mice
    • Vallon V, Gerasimova M, Rose MA, Masuda T, Satriano J, Mayoux E, Koepsell H, Thomson SC, Rieg T. SGLT2 inhibitor empagliflozin reduces renal growth and albuminuria in proportion to hyperglycemia and prevents glomerular hyperfiltration in diabetic Akita mice. Am J Physiol Renal Physiol 2014, 306:F194-F204.
    • (2014) Am J Physiol Renal Physiol , vol.306
    • Vallon, V.1    Gerasimova, M.2    Rose, M.A.3    Masuda, T.4    Satriano, J.5    Mayoux, E.6    Koepsell, H.7    Thomson, S.C.8    Rieg, T.9
  • 27
    • 84899941589 scopus 로고    scopus 로고
    • Empagliflozin improves glycemic parameters and cardiovascular risk factors in patients with type 2 diabetes (T2DM): pooled data from four pivotal Phase III trials
    • Hach T, Gerich J, Salsali A, Kim G, Hantel S, Woerle HJ, Broedl UC. Empagliflozin improves glycemic parameters and cardiovascular risk factors in patients with type 2 diabetes (T2DM): pooled data from four pivotal Phase III trials. Diabetes 2013, 62(suppl 1A):LB19 [69-LB].
    • (2013) Diabetes , vol.62 , Issue.SUPPL. 1A
    • Hach, T.1    Gerich, J.2    Salsali, A.3    Kim, G.4    Hantel, S.5    Woerle, H.J.6    Broedl, U.C.7
  • 28
    • 84908503059 scopus 로고    scopus 로고
    • Sodium-glucose linked transporter-2 inhibitors: potential for renoprotection beyond blood glucose lowering?
    • doi:10.1038/ki.2013.451 [Epub ahead of print]
    • Gilbert RE. Sodium-glucose linked transporter-2 inhibitors: potential for renoprotection beyond blood glucose lowering?. Kidney Int 2013, doi:10.1038/ki.2013.451 [Epub ahead of print].
    • (2013) Kidney Int
    • Gilbert, R.E.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.