메뉴 건너뛰기




Volumn 36, Issue SUPPL.2, 2013, Pages

Cardiovascular outcome studies with novel antidiabetes agents: Scientific and operational considerations

Author keywords

[No Author keywords available]

Indexed keywords

ALEGLITAZAR; ALOGLIPTIN; ANTIDIABETIC AGENT; CANAGLIFLOZIN; EXENDIN 4; FENOFIBRATE; GLIMEPIRIDE; HEMOGLOBIN A1C; INSULIN GLARGINE; LINAGLIPTIN; LIRAGLUTIDE; PLACEBO; SAXAGLIPTIN; SITAGLIPTIN;

EID: 84891760955     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dcS13-2041     Document Type: Article
Times cited : (44)

References (33)
  • 1
    • 0027370108 scopus 로고
    • The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus
    • The Diabetes Control and Complications Trial Research Group.
    • The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329: 977-986
    • (1993) N Engl J Med , vol.329 , pp. 977-986
  • 2
    • 0032511583 scopus 로고    scopus 로고
    • Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)
    • UK Prospective Diabetes Study (UKPDS) Group.
    • UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352: 837-853
    • (1998) Lancet , vol.352 , pp. 837-853
  • 3
    • 77954654472 scopus 로고    scopus 로고
    • Effects of medical therapies on retinopathy progression in type 2 diabetes
    • ACCORD Study Group; ACCORD Eye Study Group.
    • Chew EY, Ambrosius WT, Davis MD, et al.; ACCORD Study Group; ACCORD Eye Study Group. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med 2010;363: 233-244
    • (2010) N Engl J Med , vol.363 , pp. 233-244
    • Chew, E.Y.1    Ambrosius, W.T.2    Davis, M.D.3
  • 4
    • 75149180515 scopus 로고    scopus 로고
    • Standards of medical care in diabetesd2010
    • American Diabetes Association.
    • American Diabetes Association. Standards of medical care in diabetesd2010. Diabetes Care 2010;33(Suppl. 1):S11-S61
    • (2010) Diabetes Care , vol.33 , Issue.SUPPL. 1
  • 6
    • 45149131667 scopus 로고    scopus 로고
    • Effects of intensive glucose lowering in type 2 diabetes
    • Action to Control Cardiovascular Risk in Diabetes Study Group.
    • Gerstein HC, Miller ME, Byington RP, et al.; Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-2559
    • (2008) N Engl J Med , vol.358 , pp. 2545-2559
    • Gerstein, H.C.1    Miller, M.E.2    Byington, R.P.3
  • 7
    • 45149133036 scopus 로고    scopus 로고
    • Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes
    • ADVANCE Collaborative Group.
    • Patel A, MacMahon S, Chalmers J, et al.; ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560-2572
    • (2008) N Engl J Med , vol.358 , pp. 2560-2572
    • Patel, A.1    Macmahon, S.2    Chalmers, J.3
  • 8
    • 81255201441 scopus 로고    scopus 로고
    • The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study
    • Scirica BM, Bhatt DL, Braunwald E, et al. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J 2011;162:818.e6-825.e6
    • (2011) Am Heart J , vol.162
    • Scirica, B.M.1    Bhatt, D.L.2    Braunwald, E.3
  • 9
    • 84864270406 scopus 로고    scopus 로고
    • Basal insulin and cardiovascular and other outcomes in dysglycemia
    • ORIGIN Trial Investigators.
    • Gerstein HC, Bosch J, Dagenais GR, et al.; ORIGIN Trial Investigators. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012;367: 319-328
    • (2012) N Engl J Med , vol.367 , pp. 319-328
    • Gerstein, H.C.1    Bosch, J.2    Dagenais, G.R.3
  • 10
    • 68449088664 scopus 로고    scopus 로고
    • Does diabetes therapy influence the risk of cancer?
    • Smith U, Gale EA. Does diabetes therapy influence the risk of cancer? Diabetologia 2009;52:1699-1708
    • (2009) Diabetologia , vol.52 , pp. 1699-1708
    • Smith, U.1    Gale, E.A.2
  • 12
    • 79959796830 scopus 로고    scopus 로고
    • Impact of the US Food and Drug Administration cardiovascular assessment requirements on the development of novel antidiabetes drugs
    • Hirshberg B, Raz I. Impact of the U.S. Food and Drug Administration cardiovascular assessment requirements on the development of novel antidiabetes drugs. Diabetes Care 2011;34(Suppl. 2):S101-S106
    • (2011) Diabetes Care , vol.34 , Issue.SUPPL. 2
    • Hirshberg, B.1    Raz, I.2
  • 13
    • 84857374142 scopus 로고    scopus 로고
    • Rationale and design of the CAROLINA Trial: An active comparator CARdiOvascular outcome study of the DPP-4 inhibitor LINAgliptin in patients with type 2 diabetes at high cardiovascular risk (Abstract)
    • Rosenstock J, Marx N, Kahn SE, Zinman B, Kastelein JJ, Lachin J, Bluhmki E, Schlosser A, Neubacher D, Patel S, Johansen OE, Woerle H. Rationale and design of the CAROLINA Trial: An active comparator CARdiOvascular outcome study of the DPP-4 inhibitor LINAgliptin in patients with type 2 diabetes at high cardiovascular risk (Abstract). Diabetes 2011;60 (Suppl. 1):A303
    • (2011) Diabetes , vol.60 , Issue.SUPPL. 1
    • Rosenstock, J.1    Marx, N.2    Kahn, S.E.3    Zinman, B.4    Kastelein, J.J.5    Lachin, J.6    Bluhmki, E.7    Schlosser, A.8    Neubacher, D.9    Patel, S.10    Johansen, O.E.11    Woerle, H.12
  • 14
    • 59749094860 scopus 로고    scopus 로고
    • Clinical review 2: The metabolic memory is more than just tight glucose control necessary to prevent diabetic complications?
    • Ceriello A, Ihnat MA, Thorpe JE. Clinical review 2: The "metabolic memory": is more than just tight glucose control necessary to prevent diabetic complications? J Clin Endocrinol Metab 2009;94:410-415
    • (2009) J Clin Endocrinol Metab , vol.94 , pp. 410-415
    • Ceriello, A.1    Ihnat, M.A.2    Thorpe, J.E.3
  • 16
    • 84891753324 scopus 로고    scopus 로고
    • Summary review: Linagliptin
    • Accessed 1 November 2012
    • Parks M. Summary review: linagliptin. CDER 201280 Orig1s000, 2011. Available from http://www. accessdata. fda.gov/drugsatfda- docs/nda/2011/ 201280Orig1s000SumR. pdf. Accessed 1 November 2012
    • (2011) CDER 201280 Orig1s000
    • Parks, M.1
  • 17
    • 84867183673 scopus 로고    scopus 로고
    • The prevention and treatment of missing data in clinical trials
    • Little RJ, D'Agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012; 367:1355-1360
    • (2012) N Engl J Med , vol.367 , pp. 1355-1360
    • Little, R.J.1    D'Agostino, R.2    Cohen, M.L.3
  • 18
    • 28044452217 scopus 로고    scopus 로고
    • Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): Randomised controlled trial
    • FIELD study investigators.
    • Keech A, Simes RJ, Barter P, et al.; FIELD study investigators. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet 2005;366:1849-1861
    • (2005) Lancet , vol.366 , pp. 1849-1861
    • Keech, A.1    Simes, R.J.2    Barter, P.3
  • 19
    • 67149146438 scopus 로고    scopus 로고
    • Rosiglita-zone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): A multicentre randomised open-label trial
    • RECORD Study Team.
    • Home PD, Pocock SJ, Beck-Nielsen H, et al.; RECORD Study Team. Rosiglita-zone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009;373:2125-2135
    • (2009) Lancet , vol.373 , pp. 2125-2135
    • Home, P.D.1    Pocock, S.J.2    Beck-Nielsen, H.3
  • 20
    • 84862907587 scopus 로고    scopus 로고
    • Ri-varoxaban in patients with a recent acute coronary syndrome
    • ATLAS ACS 2-TIMI 51 Investigators
    • Mega JL, Braunwald E, Wiviott SD, et al.; ATLAS ACS 2-TIMI 51 Investigators. Ri-varoxaban in patients with a recent acute coronary syndrome. N Engl J Med 2012; 366:9-19
    • (2012) N Engl J Med , vol.366 , pp. 9-19
    • Mega, J.L.1    Braunwald, E.2    Wiviott, S.D.3
  • 22
    • 84857231864 scopus 로고    scopus 로고
    • The prevention and treatment of missing data in clinical trials: An FDA perspective on the importance of dealing with it
    • O'Neill RT, Temple R. The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it. Clin Pharmacol Ther 2012;91:550-554
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 550-554
    • O'Neill, R.T.1    Temple, R.2
  • 25
    • 85066456886 scopus 로고    scopus 로고
    • Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies
    • Expert Consultation WHO; WHO Expert Consultation.
    • Expert Consultation WHO; WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet 2004;363:157-163
    • (2004) Lancet , vol.363 , pp. 157-163
  • 26
    • 79959936188 scopus 로고    scopus 로고
    • National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: Systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2z7 million participants
    • Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose).
    • Danaei G, Finucane MM, Lu Y, et al.; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose). National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2z7 million participants. Lancet 2011;378:31-40
    • (2011) Lancet , vol.378 , pp. 31-40
    • Danaei, G.1    Finucane, M.M.2    Lu, Y.3
  • 28
    • 84866268783 scopus 로고    scopus 로고
    • Management of hyper-glycemia 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)
    • American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD).
    • Inzucchi SE, Bergenstal RM, Buse JB, et al.; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyper-glycemia 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;35:1364-1379
    • (2012) Diabetes Care , vol.35 , pp. 1364-1379
    • Inzucchi, S.E.1    Bergenstal, R.M.2    Buse, J.B.3
  • 31
    • 77649294607 scopus 로고    scopus 로고
    • Weighing risks and benefits of liraglutidedthe FDA's review of a new antidiabetic therapy
    • Parks M, Rosebraugh C. Weighing risks and benefits of liraglutidedthe FDA's review of a new antidiabetic therapy. N Engl J Med 2010;362:774-777
    • (2010) N Engl J Med , vol.362 , pp. 774-777
    • Parks, M.1    Rosebraugh, C.2
  • 33
    • 33846670732 scopus 로고    scopus 로고
    • Finding new treatments for diabetesdhow many how fast⋯ how good?
    • Nathan DM. Finding new treatments for diabetesdhow many, how fast⋯ how good? N Engl J Med 2007;356:437-440
    • (2007) N Engl J Med , vol.356 , pp. 437-440
    • Nathan, D.M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.