Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease

Nutrition Reviews

Volumn 66, Issue 2, 2008, Pages 76-81

  Rasnake, Crystal M ^a,b   Trumbo, Paula R ^b   Heinonen, Therese M ^c  

^a HFS 830 ^*  (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c MONTREAL HEART INSTITUTE   (Canada)

Author keywords

Biomarkers; Cardiovascular disease; Health claims; Surrogate endpoint

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; BILE ACID SEQUESTRANT; BIOLOGICAL MARKER; CHOLESTEROL; EZETIMIBE; FIBRIC ACID DERIVATIVE; HIGH DENSITY LIPOPROTEIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN; NICOTINIC ACID;

BLOOD PRESSURE; CARDIOVASCULAR DISEASE; CHOLESTEROL BLOOD LEVEL; DIASTOLIC BLOOD PRESSURE; DRUG EFFECT; FOOD AND DRUG ADMINISTRATION; FOOD SAFETY; HUMAN; MORTALITY; NONHUMAN; OXIDATIVE STRESS; PATHOPHYSIOLOGY; REVIEW; RISK REDUCTION; SYSTOLIC BLOOD PRESSURE; BLOOD; FOOD PACKAGING; GOVERNMENT; HEALTH FOOD; PHYSIOLOGY; RISK ASSESSMENT; RISK FACTOR; STANDARD; UNITED STATES;

BIOLOGICAL MARKERS; BLOOD PRESSURE; CARDIOVASCULAR DISEASES; CHOLESTEROL; FOOD LABELING; HEALTH FOOD; HUMANS; LIPOPROTEINS, LDL; RISK ASSESSMENT; RISK FACTORS; UNITED STATES; UNITED STATES DEPARTMENT OF AGRICULTURE;

EID: 42949143199     PISSN: 00296643     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1753-4887.2007.00010.x     Document Type: Review

References (70)

1. US Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements. Guidance for Industry Evidence-Based Review System for the Scientific Evaluation of Health Claims. Available at: http://www.cfsan.fda.gov/∼dms/hclmgui5.html. Accessed 9 July 2007.
2. Spilker B. Guide to Clinical Studies. New York : Raven Press 1991 : 608 609.
3. The American Heritage Medical Dictionary. New York : Houghton Mifflin Company 2007 : 719.
4. US Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Special Nutritionals. Guidance for Industry Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. Available at: http://www.cfsan.fda.gov/∼dms/ssaguide. html. Accessed 20 April 2007.
5. US Food and Drug Administration. Food labeling: general requirements for health claims for food. Fed Regist 1993 58 : 2478 2536.
6. Mayo Clinic. High Blood Pressure Dangers: Hypertension's Effects on Your Body. Available at: http://www.mayoclinic.com/health/high-blood-pressure/ HI00062. Accessed 23 April 2007.
7. Neaton JD, Wentworth D. Serum cholesterol, blood pressure, cigarette smoking, and death from coronary heart disease. Overall findings and differences by age for 316,099 white men. Multiple Risk Factor Intervention Group. Arch Intern Med 1992 152 : 56 64.
8. Stamler J, Stamler R, Neaton JD. Blood pressure, systolic and diastolic and cardiovascular risk. U.S. population data. Arch Intern Med 1993 153 : 598 615.
9. van den Hoogen PC, Feskens EJ, Nagelkerke NJ, Menotti A, Nissinen A, Kromhout D. The relation between blood pressure and mortality due to coronary heart disease among men in different parts of the world. Seven Countries Study Research Group. N Engl J Med 2000 342 : 1 8.
10. Vasan RS, Larson MG, Leip EP, et al. Impact of high-normal blood pressure on the risk of cardiovascular disease. N Engl J Med 2001 345 : 1291 1297.
11. Stamler R. Implications of the INTERSALT study. Hypertension 1991 17 : 116 120.
12. Desai M, Stockbridge N, Temple R. Blood pressure as an example of a biomarker that functions as a surrogate. AAPS Journal 2006 8 : E146 E152.
13. US Food and Drug Administration. Food Labeling: Health Claims and Label Statements; Sodium and Hypertension, Final Rule. Fed Register 1993 58 : 2802.
14. US Food and Drug Administration. Center for Food Safety and Applied Nutrition. Office of Nutritional Products, Labeling and Dietary Supplements. Qualified Health Claims: Letter of Enforcement Discretion - Calcium and Hypertension; Pregnancy-Induced Hypertension; and Preeclampsia. Available at: http://www.cfsan.fda.gov/∼dms/qhcca3.html. Accessed 3 July 2007.
15. Gould AL, Rossouw JE, Santanello NC, Heyse JF, Furberg CD. Cholesterol reduction yields clinical benefit: impact of statin trials. Circulation 1998 97 : 946 952.
16. National Cholesterol Education Program. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III). Final Report. Rockville, MD: National Heart, Lung and Blood Institute; 2002.
17. World Health Organization. WHO cooperative trial on primary prevention of ischaemic heart disease using clofibrate to lower serum cholesterol; mortality follow-up. Report of the Committee of Principal Investigators. Lancet 1980 2 : 379 385.
18. Multiple Risk Factor Intervention Trial Research Group. Multiple risk factor intervention trial. Risk factor changes and mortality results. JAMA 1982 248 : 1465 1477.
19. WHO. Multifactorial trial in the prevention of coronary heart disease. 3. Incidence and mortality results. Eur Heart J 1983 4 : 141 147.
20. Lipids Research Clinics Program. The Lipids Research Clinics Coronary Primary Prevention Trial results. I. Reduction in the incidence of coronary heart disease. JAMA 1984 251 : 351 364.
21. Lipid Research Clinics Program. The Lipids Research Clinics Coronary Primary Prevention Trial results. II. The relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA 1984 251 : 365 374.
22. Frick MH, Elo MO, Haapa K, et al. Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. Safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med 1987 317 : 1237 1245.
23. Frantz ID, Dawson EA, Ashman PL, et al. Test of effect of lipid lowering by diet on cardiovascular risk. The Minnesota Coronary Survey. Arteriosclerosis. 1989 9 : 129 135.
24. Kannel WB, Castelli WP, Gordon T, McNamara PM. Serum cholesterol, lipoproteins, and risk of coronary heart disease. Ann Intern Med 1971 74 : 1 12.
25. Martin MJ, Hulley SB, Browner WS, Kuller LH, Wentworth D. Serum cholesterol, blood pressure, and mortality: implications from a cohort of 361,662 men. Lancet 1986 2 : 933 936.
26. US Food and Drug Administration. Food labeling: health claims and label statements; dietary saturated fat and cholesterol and coronary heart disease, final rule. Fed Regist 1993 58 : 2739.
27. US Food and Drug Administration. Food labeling: health claims and label statements; dietary fiber and cardiovascular disease, final rule. Fed Regist 1993 58 : 2552.
28. US Food and Drug Administration. Food labeling: health claims; oat and coronary heart disease, final rule. Fed Regist 1997 62 : 3583.
29. US Food and Drug Administration. Food labeling: health claims; soy protein nd coronary heart disease, final rule. Fed Regist 1999 64 : 57699.
30. US Food and Drug Administration. Food labeling: health claims; plant sterol/stanol esters and coronary heart disease; interim final rule. Fed Regist 2000 65 : 54685.
31. US Food and Drug Administration. Center for Food Safety and Applied Nutrition, Office of Nutritional Products Labeling and Dietary Supplements. Qualified Health Claims: Letter of Enforcement Discretion - Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease. Available at http://www.cfsan.fda.gov/∼dms/qhccanol.html. Accessed 3 July 2007.
32. US Food and Drug Administration. Center for Food Safety and Applied Nutrition. Office of Nutritional Products Labeling and Dietary Supplements. Letter Responding to Health Claim Petition dated August 28, 2003: Monounsaturated Fatty Acids from Olive Oil and Coronary Heart Disease. Available at: http://www.cfsan.fda.gov/∼dms/qhcolive.html. Accessed 3 July 2007.
33. US Food and Drug Administration. Center for Food Safety and Applied Nutrition. Office of Nutritional Products Labeling and Dietary Supplements. Qualified Health Claims: Letter of Enforcement Discretion - Corn Oil and Corn Oil-Containing Products and a Reduced Risk of Heart Disease. Available at http://www.cfsan.fda.gov/∼dms/qhccorno.html. Accessed 3 July 2007.
34. Grundy SM. Role of low-density lipoproteins in atherogenesis and development of coronary heart disease. Clin Chem 1995 41 : 139 146.
35. Kannel WB, Castelli WP, Gordon T. Cholesterol in the prediction of atherosclerotic disease: new perspectives based on the Framingham Study. Ann Intern Med 1979 90 : 85 91.
36. US Food and Drug Administration. Center for Food Safety and Applied Nutrition. Office of Nutritional Products Labeling and Dietary Supplements. Letter Responding to Health Claim Petition dated November 3, 2003 (Martek Petition): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease. Available at http://www.cfsan.fda.gov/∼dms/ds-ltr37.html. Accessed 5 July 2007.
37. Brewer HB, Remaley AT, Neufeld EB, Basso F, Joyce C. Regulation of plasma high-density lipoprotein levels by the ABCA1 transporter and the emerging role of high-density lipoprotein in the treatment of cardiovascular disease. Arterioscler Thromb Vasc Biol 2004 24 : 1755 1760.
38. Navab M, Anantharamaiah GM, Reddy ST, Lenten B, Ansell B, Fogelman AM. Mechanisms of disease: proatherogenic HDL - an evolving field. Nat Clin Pract Endocrinol Metab 2006 2 : 504 511.
39. Shao B, Oda M, Oram JF, Heinecke JW. Myeloperoxidase: an inflammatory enzyme for generating dysfunctional high density lipoprotein. Curr Opion Cardiol 2006 21 : 322 328.
40. Brewer HB. Focus on high-density lipoproteins in reducing cardiovascular risk. Am Heart J. 2004 148 (Suppl 14 18.
41. Choi BG, Vilahur G, Viles-Gonzalez JF, Badimon JJ. The role of high-density lipoprotein cholesterol in atherothrombosis. Mt Sinai J Med 2006 73 : 690 701.
42. Badimon JJ, Badimon L, Fuster V. Regression of atherosclerotic lesions by high density lipoprotein plasma fraction in the cholesterol-fed rabbit. J Clin Invest 1990 85 : 1234 1241.
43. Chiesa G, Monteggia E, Marchesi M, et al. Recombinant apoliportoein A-1(Milano) infusion into rabbit carotid artery rapidly removes lipid from fatty streaks. Cir Res 2002 90 : 974 980.
44. Kaul S, Rukshin V, Santos R, et al. Intramural delivery of recombinant apoplipoprotein A-IMilano/phospholipid complex (ETC-216) inhibits in-stent stenosis in porcine coronary arteries. Circulation. 2003 107 : 2551 2554.
45. Gofman JW, Young W, Tandy R. Ischemic heart disease, atherosclerosis and longevity. Circulation 1966 34 : 679 697.
46. Wiklund O, Wihelmsen L, Elmfeldt D, Wedel H, Valek J, Gustafson A. Alpha-lipoprotein cholesterol concentration in relation to subsequent myocardial infarction in hypercholesterolemic men. Atherosclerosis 1980 37 : 47 53.
47. Miller GJ, Miller NE. Plasma-high-density-lipoprotein concentration and development of ischaemic heart disease. Lancet 1975 1 : 16 19.
48. Gordon T, Castelli WP, Hjortland MC, Kannel WB, Dawber TR. High density lipoprotein as protective factor against coronary heart disease: the Framingham Study. Am J Med 1977 62 : 707 714.
49. Gordon DJ, Rifkind BM. High-density lipoprotein: the clinical implications of recent studies. N Engl J Med 1989 321 : 1311 1316.
50. Clark RW, Sutfin TA, Ruggeri RB, et al. Raising high-density lipoprotein in humans through inhibition of cholesteryl ester transfer protein: an initial multidose study of torcetrapib. Arterioscler Thromb Vasc Biol 2004 24 : 490 497.
51. Davidson MH, Maki K, Umporowicz D, Wheeler A, Rittershaus C, Ryan U. The safety and immunogenicity of a CETP vaccine in healthy adults. Athersclerosis 2003 169 : 113 120.
52. Bisoendial RJ, Hovingh GK, Levels J, et al. Restoration of endothelial function by increasing high-density lipoportein in subjects with isolated low high-density lipoprotein. Circulation 2003 107 : 2944 2948.
53. Tall AR, Yvan-Charvet L, Wang N. The failure of torcetrapib: was it the molecule or the mechansim? Arterioscler Thromb Vasc Biol 2007 27 : 257 260.
54. Armstrong EJ, Morrow DA, Sabatine MS. Inflammatory biomarkers in acute coronary syndromes. Part II: acute-phase reactants and biomarkers of endothelial cell activation. Circulation 2006 113 : e152 e155.
55. Verma S, Szmitko PE, Ridker PM. C-reactive protein comes of age. Nat Clin Pract Cardiovasc Med 2005 2 : 29 36.
56. Albert MA, Ridker PM. C-reactive protein as a risk predictor. Do race/ethnicity and gender make a difference? Circulation 2006 114 : e67 e74.
57. Danesh J, Wheeler JG, Hirschfield GM, et al. C-reactive protein and other circulating markers of inflammation in the prediction of coronary heart disease. N Engl J Med 2004 350 : 1387 1397.
58. Pai JK, Pischon T, Ma J, et al. Inflammatory markers and the risk of coronary heart disease in men and women. N Engl J Med 2004 351 : 2599 2610.
59. Ridker PM, Rifai N, Cook NR, Bradwin G, Buring JE. Non-HDL cholesterol, apolipoproteins A-1 and B100, standard lipid measures, lipid ratios, and CRP as risk factors for cardiovascular disease in women. JAMA 2005 294 : 326 333.
60. Shlipak MG, Fried LF, Cushman M, et al. Cardiovascular mortality risk in chronic kidney disease: comparison of traditional and novel risk factors. JAMA 2005 293 : 1737 1745.
61. Wilson PW, Nam BH, Pencia M, D'Agostino RB, Benjamin EJ, O'Donnell CJ. C-reactive protein and risk of cardiovascular disease in men and women from the Framingham Heart Study. Arch Intern Med 2005 165 : 2473 2478.
62. Ridker PM, Cook N. Clinical usefulness of very high and very low levels of C-reactive protein across the full range of Framingham Risk Scores. Circulation 2004 109 : 1955 1999.
63. Pearson TA, Mensah GA, Alexander RW, et al. Markers of inflammation and cardiovascular disease: application to clinical and public health practice. A statement for healthcare professionals for the Center for Disease Control and Prevention and the American Heart Association. Circulation 2003 107 : 499 511.
64. Cook NR, Buring JE, Ridker PM. The effect of including C-reactive protein in cardiovascular risks prediction models for women. Ann Intern Med 2006 145 : 21 29.
65. Lloyd-Jones DM, Liu K, Tian L, Greenland P. Narrative review: assessment of C-reactive protein in risk prediction for cardiovascular disease. Ann Intern Med 2006 145 : 35 42.
66. Tsimikas S. Oxidative biomarkers in the diagnosis and prognosis of cardiovascular disease. Am J Cardiol 2006 98 : 9P 17P.
67. Fu X, Kassim SY, Parks WC, Heinecke JW. Hypochlorous acid oxygenates the cysteine switch domain of pro-matrilysin (MMP-7). J Biol Chem 2001 276 : 41279 41287.
68. Vita JA, Brennan ML, Gokce N, et al. Serum myeloperoxidase levels independently predict endothelial dysfunction in humans. Circulation 2004 110 : 1134 1113.
69. Zhang R, Brennan ML, Fu X, et al. Association between myleoperoxidase levels and risk of coronary artery disease. JAMA 2001 286 : 2136 2142.
70. Brennan M, Penn MS, Van Lente G, et al. Prognostic values of myeloperoxidase in patients with chest pain. N Engl J Med 2003 349 : 1595 1604.