Surrogate end-points in clinical practice: Are we providing worse care?

Internal Medicine Journal

Volumn 40, Issue 6, 2010, Pages 395-398

  Martin, J H ^a   Fay, M F ^b  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; DIPEPTIDYL PEPTIDASE IV INHIBITOR; ERYTHROPOIETIN; EZETIMIBE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN; PIOGLITAZONE; ROSIGLITAZONE; SIBUTRAMINE; SIMVASTATIN; TORCETRAPIB;

ARTERY INTIMA PROLIFERATION; ATHEROSCLEROSIS; BLOOD PRESSURE; CARDIOVASCULAR DISEASE; CHRONIC KIDNEY DISEASE; DIABETES CONTROL; DISEASE MARKER; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HEART ARRHYTHMIA; HEART INFARCTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERCHOLESTEROLEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; VIRUS LOAD;

BIOLOGICAL MARKERS; ENDPOINT DETERMINATION; HUMANS; PATIENT CARE; TREATMENT OUTCOME;

EID: 77953831776     PISSN: 14440903     EISSN: 14455994     Source Type: Journal    
DOI: 10.1111/j.1445-5994.2010.02248.x     Document Type: Editorial

References (30)

1. Woodcock J. A Framework for Biomarker and Surrogate Endpoint Use in Drug Development. Biomarkers Definition Working Group, National Institutes for Health. 1998. Available from URL: http://www.fda.gov/ohrms/dockets/ac/04/slides/ 2004-4079S2-03-Woodcock.ppt
2. Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991 324 : 781 788.
3. Pharmaceutical Benefits Advisory Committee. Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (Version 4.3). Department of Health and Ageing, Canberra, Australia, 2008 [cited 2010 May 11]. Available from URL: http://www.health.gov.au/internet/main/publishing.nsf/ Content/pbacguidelines-index
4. Unger EF, Thompson A, Blank M, Temple R. Erythropoiesis-stimulating agents - time for a re-evaluation? N Engl J Med 2010 362 : 189 192.
5. The Diabetes Control and Complications Trial Research Group. The effects of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes. N Engl J Med 1993 329 : 977 986.
6. The 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.
7. Yudkin J, Richter B. Intensive glucose control and cardiovascular outcome. Lancet 2009 374 : 522.
8. Gerstein HC, Miller ME, Byrington RP. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008 358 : 2545 2559.
9. Patel A, MacMahon S, Chalmers J. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008 358 : 2560 2572.
10. Duckworth W, Abaira C, Moritz T. Glucose control and vascular outcomes in veterans with type 2 diabetes. N Engl J Med 2009 360 : 129 139.
11. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular cause. N Engl J Med 2007 356 : 2457 2471.
12. Nissen SE, Wolski K, Topol EJ. Effect of muraglitazaar on death and major adverse cardiovascular events in patients with T2D. Lancet 2005 294 : 2581 2586.
13. Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones RR et al. Glycaemic durability of rosiglitazone, metformin or glyburide monotherapy. N Engl J Med 2006 355 : 2427 2423.
14. Landefeld CS, Steinman MA. The neurontin legacy - marketing through misinformation and manipulation. N Engl J Med 2009 360 : 103 106.
15. Department of Health and Ageing, Canberra, Australia. 2005. Available from URL: http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac- psd-insulin
16. Jonasson J, Ljung R, Talback M, Haglund B, Gudbjornsdottir S, Steineck G. Insulin glargine use and short-term incidence of malignancies - a population-based follow-up study in Sweden. Diabetalogia 2009 52 : 1745 1754.
17. Hemkens LG, Grouven U, Bender R, Gunster C, Gutschmidt S, Selke G et al. Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study. Diabetalogia 2009 52 : 1732 1744.
18. Prospective Studies Collaboration. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet 2009 373 : 1083 1096.
19. Avenell A, Broom J, Brown TJ. Systematic review of the long-term effect and economic consequences of treatments for obesity and implications for health improvement. Health Technol Assess 2004 8 : 1 182.
20. Nisoli E, Carruba M. A risk-benefit assessment of sibutramine in the management of obesity. Drug Saf 2003 26 : 1027 1048.
21. Rader DJ. Molecular regulation of HDL metabolism and function: implications for novel therapies. J Clin Invest 2006 116 : 3090 3100.
22. Kastelein J, van Leuven SI, Burgess L, Evans G. Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia. N Engl J Med 2007 356 : 1620 1630.
23. Kastelein J, Akdim F, Stroes E. Simvastatin with or without ezetimibe in familial hypercholesterolaemia. N Engl J Med 2008 358 : 1431 1443.
24. Haines IE, Olver I. Are guidelines on use of colony-stimulating factors in solid cancers flawed? Intern Med J 2009 39 : 259 262.
25. Smith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol 2006 24 : 3187 3205.
26. Kim ES, Hirsh V, Mok T. Gefitinib vs docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008 372 : 1809 1818.
27. Garattini S, Bertele V. Non-inferiority trials are unethical because they disregard patients' interests. Lancet 2007 370 : 1875 1877.
28. Turner E, Matthews A, Linardatos E, Tell R, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008 358 : 252 260.
29. Landerfeld CS. The neurontin legacy. N Engl J Med 2009 360 : 103 106.
30. Psaty BM, Weiss NS, Furberg CD. Surrogate end points, health outcomes, and the drug approval process for the treatment of risk factors for cardiovascular disease. JAMA 1999 295 : 1704 1706.