Primary prevention of vascular events in patients with high levels of C-reactive protein: The JUPITER study

Expert Review of Cardiovascular Therapy

Volumn 7, Issue 9, 2009, Pages 1041-1056

  Fonseca, Francisco A H ^a   Izar, Maria Cristina O ^a  

^a FEDERAL UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

High sensitivity C reactive protein; Primary prevention; Rosuvastatin; Total mortality; Venous thromboembolism

Indexed keywords

ACETYLSALICYLIC ACID; ATORVASTATIN; C REACTIVE PROTEIN; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INTERLEUKIN 6; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; OXIDIZED LOW DENSITY LIPOPROTEIN RECEPTOR 1; PLACEBO; PRAVASTATIN; ROSUVASTATIN; TRIACYLGLYCEROL; TUMOR NECROSIS FACTOR ALPHA;

ANTIINFLAMMATORY ACTIVITY; ATHEROSCLEROSIS; BLEEDING; BODY MASS; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; DEEP VEIN THROMBOSIS; DIABETES MELLITUS; FRACTURE; GASTROINTESTINAL DISEASE; GLOMERULUS FILTRATION RATE; HEART INFARCTION; HUMAN; INFLAMMATION; ISCHEMIC HEART DISEASE; KIDNEY DISEASE; LIVER DISEASE; LUNG EMBOLISM; MALIGNANT NEOPLASTIC DISEASE; MUSCLE STIFFNESS; MUSCLE WEAKNESS; MYALGIA; MYOPATHY; PATHOPHYSIOLOGY; PLEIOTROPY; PRIMARY PREVENTION; REVIEW; RHABDOMYOLYSIS; SECONDARY PREVENTION; SIDE EFFECT; STROKE; UNSTABLE ANGINA PECTORIS; VENOUS THROMBOEMBOLISM; WAIST CIRCUMFERENCE;

AGED; C-REACTIVE PROTEIN; CARDIOVASCULAR DISEASES; CHOLESTEROL, LDL; FEMALE; FLUOROBENZENES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PRIMARY PREVENTION; PYRIMIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STROKE; SULFONAMIDES;

EID: 70450195567     PISSN: 14779072     EISSN: 17448344     Source Type: Journal    
DOI: 10.1586/erc.09.93     Document Type: Review

References (72)

1. Vasan RS. Commentary: C-reactive protein and risk prediction-moving beyond associations to assessing predictive utility and clinical usefulness. Intern. J. Epidemiol. 38(1), 231-234 (2009).
2. Greenland P, Knoll MD, Stamler J et al. Major risk factors as antecedents of fatal and nonfatal coronary heart disease events. JAMA 290(7), 891-897 (2003). (Pubitemid 37430460)
3. Libby P. The molecular mechanisms of the thrombotic complications of atherosclerosis. J. Intern. Med. 263(5), 517-527 (2008).
4. Thim T, Hagensen MK, Bentzon JF, Falk E. From vulnerable plaque to atherothrombosis. J. Intern. Med. 263(5), 506-516 (2008).
5. Shah T, Casas JP, Cooper JA et al. Critical appraisal of CRP measurement for the prediction of coronary heart disease events: new data and systematic review of 31 prospective cohorts. Intern. J. Epidemiol. 38(1), 217-231 (2009).
6. Haverkate F, Thompson SG, Pyke SD, Gallimore JR, Pepys MB; European Concerted Action on Thrombosis and Disabilities Angina Pectoris Study Group. Production of C-reactive protein and risk of coronary events in stable and unstable angina. Lancet I349(9050), 462-466 (1997).
7. Ridker PM, Cushman M, Stampfer MJ, Tracy RP, Hennekens CH. Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men. N. Engl. J. Med. 336(14), 973-979 (1997). (Pubitemid 27152782)
8. Ridker PM, Rifai N, Rose L, Buring JE, Cook NR. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. N. Engl. J. Med. 347(20), 1557-1565 (2002). (Pubitemid 35315836)
9. Ridker PM, Buring JE, Shih J, Matias M, Hennekens CH. Prospective study of C-reactive protein and the risk of future cardiovascular events among apparently healthy women. Circulation 98(8), 731-733 (1998). (Pubitemid 28391836)
10. Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N. Engl. J. Med. 342(12), 836-843 (2000). (Pubitemid 30165206)
11. Pradhan AD, Manson JE, Rossouw JE et al. Inflammatory biomarkers, hormone replacement therapy, and incident coronary heart disease: prospective analysis from the Women's Health Initiative observational study. JAMA 288(8), 980-987 (2002).
12. 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. 351(25), 2599-2610 (2004). (Pubitemid 39628581)
13. Koenig W, Löwel H, Baumert J, Meisinger C. C-reactive protein modulates risk prediction based on the Framingham Score: implications for future risk assessment: results from a large cohort study in southern Germany. Circulation 109(11), 1349-1353 (2004). (Pubitemid 38387819)
14. Ballantyne CM, Hoogeveen RC, Bang H et al. Lipoprotein-associated phospholipase A2, high-sensitivity C-reactive protein, and risk for incident ischemic stroke in middle-aged men and women in the Atherosclerosis Risk in Communities (ARIC) study. Arch. Intern. Med. 165(21), 2479-2484 (2005). (Pubitemid 41720009)
15. Strandberg TE, Tilvis RS. C-reactive protein, cardiovascular risk factors, and mortality in a prospective study in the elderly. Arterioscler. Thromb. Vasc. Biol. 20(4), 1057-1060 (2000).
16. Woodward M, Welsh P, Rumley A, Tunstall-Pedoe H, Lowe GD. Do inflammatory biomarkers add to the discrimination of cardiovascular disease after allowing for social deprivation? Results from a 10 year cohort study in Glasgow, Scotland. Eur. Heart. J. DOI: 10.1093/eurheartj/ehp115 (2009) (Epub ahead of print).
17. 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. 350(14), 1387-1397 (2004). (Pubitemid 38419992)
18. Folsom AR, Chambless LE, Ballantyne CM et al. An assessment of incremental coronary risk prediction using C-reactive protein and other novel risk markers: the atherosclerosis risk in communities study. Arch. Intern. Med. 166(13), 1368-1373 (2006).
19. Ridker PM, Rifai N, Pfeffer MA, Sacks F, Braunwald E; The Cholesterol and Recurrent Events (CARE) Investigators. Long-term effects of pravastatin on plasma concentration of C-reactive protein. Circulation 100(3), 230-235 (1999).
20. Ridker PM, Rifai N, Clearfield M et al. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N. Engl. J. Med. 344(26), 1959-1965 (2001).
21. Nissen SE. Effect of intensive lipid lowering on progression of coronary atherosclerosis: evidence for an early benefit from the Reversal of Atherosclerosis with Aggressive Lipid Lowering (REVERSAL) trial. Am. J. Cardiol. 96(5A), 61F-68F (2005).
22. Nissen SE, Tuzcu EM, Schoenhagen P et al. Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease. N. Engl. J. Med. 352(1), 29-38 (2005). (Pubitemid 40075678)
23. Ridker PM, Cannon CP, Morrow D et al. C-reactive protein levels and outcomes after statin therapy. N. Engl. J. Med. 352(1), 20-28 (2005). (Pubitemid 40075677)
24. Ray KK, Cannon CP, Cairns R, Morrow DA, Ridker PM, Braunwald E. Prognostic utility of apoB/AI, total cholesterol/HDL, non-HDL cholesterol, or hs-CRP as predictors of clinical risk in patients receiving statin therapy after acute coronary syndromes: results from PROVE IT-TIMI 22. Arterioscler. Thromb. Vasc. Biol. 29(3), 424-430 (2009).
25. Expert panel on detection, evaluation, and treatment of high blood cholesterol in adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III). JAMA 285(19), 2486-2497 (2001).
26. Downs JR, Clearfield M, Weis S et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 279(20), 1615-1622 (1998).
27. Shepherd J, Cobbe SM, Ford I et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl. J. Med. 333(20), 1301-1307 (1995).
28. Ridker PM; JUPITER Study Group. Rosuvastatin in the primary prevention of cardiovascular disease among patients with low levels of low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: rationale and design of the JUPITER trial. Circulation 108(19), 2292-2297 (2003).
29. Ray KK, Cannon CP, Cairns R et al. Relationship between uncontrolled risk factors and C-reactive protein levels in patients receiving standard or intensive statin therapy for acute coronary syndromes in the PROVE IT-TIMI 22 trial. J. Am. Coll. Cardiol. 46(8), 1417-1424 (2005). (Pubitemid 41446175)
30. Ridker PM, Fonseca FA, Genest J et al. Baseline characteristics of participants in the JUPITER trial, a randomized placebo-controlled primary prevention trial of statin therapy among individuals with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein. Am. J. Cardiol. 100(11), 1659-1664 (2007). (Pubitemid 350122337)
31. Altman DG, Andersen PK. Calculating the number needed to treat for trials where the outcome is time to event. BMJ 319(7223), 1492-1495 (1999).
32. Ridker PM, Danielson E, Fonseca FA et al.; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N. Engl. J. Med. 359, 2195-2207 (2008).
33. Ridker PM, Danielson E, Fonseca FA et al. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet 373(9670), 1175-1182 (2009).
34. Morrow DA, de Lemos JA, Sabatine MS et al. Clinical relevance of C-reactive protein during follow-up of patients with acute coronary syndromes in the Aggrastat-to-Zocor trial. Circulation 114(4), 281-288 (2006).
35. Kinlay S. Low-density lipoprotein-dependent and -independent effects of cholesterol-lowering therapies on C-reactive protein: a meta-analysis. J. Am. Coll. Cardiol. 49(20), 2003-2009 (2007). (Pubitemid 46734641)
36. Grundy SM, Cleeman JI, Daniels SR et al. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation 112(17), 2735-2752 (2005).
37. Glynn RJ, Danielson E, Fonseca FA et al. A randomized trial of rosuvastatin in the prevention of venous thromboembolism. N. Engl. J. Med. 360(18), 1851-1861 (2009).
38. Undas A, Brummel-Ziedins KE, Mann KG. Statins and blood coagulation. Arterioscler. Thromb. Vasc .Biol. 25(2), 287-294 (2005).
39. Kaba NK, Francis CW, Moss AJ et al. Effects of lipids and lipid-lowering therapy on hemostatic factors in patients with myocardial infarction. J. Thromb. Haemost. 2(5), 718-725 (2004).
40. Albert MA, Danielson E, Rifai N, Ridker PM; the PRINCE Investigators. Effect of statin therapy on C-reactive protein levels: the Pravastatin Inflammation/CRP Evaluation (PRINCE): a randomized trial and cohort study. JAMA 286(1), 64-70 (2001). (Pubitemid 32606333)
41. Eto M, Luscher TF. Modulation of coagulation and fibrinolytic pathways by statins. Endothelium 10(1), 35-41 (2003). (Pubitemid 36355981)
42. Grady D, Wenger NK, Herrington D et al. Postmenopausal hormone therapy increases risk for venous thromboembolic disease. The Heart and Estrogen/progestin Replacement Study. Ann. Intern. Med. 132(9), 689-696 (2000). (Pubitemid 30244167)
43. Ray JG, Mamdani M, Tsuyuki RT, Anderson DR, Yeo EL, Laupacis A. Use of statins and the subsequent development of deep vein thrombosis. Arch. Intern. Med. 161(11), 1405-1410 (2001). (Pubitemid 32681161)
44. Doggen CJ, Lemaitre RN, Smith NL, Heckbert SR, Psaty BM. HMG CoA reductase inhibitors and the risk of venous thrombosis among postmenopausal women. J. Thromb. Haemost. 2(5), 700-701 (2004).
45. Lacut K, Oger E, Le Gal G et al. Statins but not fibrates are associated with a reduced risk of venous thromboembolism: a hospital-based case-control study. Fundam. Clin. Pharmacol. 18(4), 477-482 (2004). (Pubitemid 39215361)
46. Ramcharan AS, Van Stralen KJ, Snoep JD, Mantel-Teeuwisse AK, Rosendaal FR, Doggen CJ. HMG-CoA reductase inhibitors, other lipid-lowering medication, antiplatelet therapy, and the risk of venous thrombosis. J. Thromb. Haemost. 7(4), 514-520 (2009).
47. Ridker PM. The JUPITER trial results, controversies, and implications for prevention. Circ. Cardiovasc. Qual. Outcomes 2, 279-285 (2009).
48. Apple FS, Smith SW, Pearce LA, Murakami MM. Assessment of the multiple-biomarker approach for diagnosis of myocardial infarction in patients presenting with symptoms suggestive of acute coronary syndrome. Clin. Chem. 55(1), 93-100 (2009).
49. Ridker PM, Friedewald VE, Davidson MH, Willerson JT, Roberts WC. The editor's roundtable: the JUPITER trial - initial results and clinical implications. Am. J. Cardiol. 103(10), 1417-1425 (2009).
50. Shih HH, Zhang S, Cao W, Hahn A et al. CRP is a novel ligand for the oxidized LDL receptor LOX-1. Am. J. Physiol. Heart Circ. Physiol. 296(5), H1643-H1650 (2009).
51. Paul A, Ko KW, Li L et al. C-reactive protein accelerates the progression of atherosclerosis in apolipoprotein E-deficient mice. Circulation 109(5), 647-655 (2004). (Pubitemid 38198873)
52. Full LE, Ruisanchez C, Monaco C. The inextricable link between atherosclerosis and prototypical inflammatory diseases rheumatoid arthritis and systemic lupus erythematosus. Arthritis. Res. Ther. 11(2), 217 (2009).
53. Haque S, Mirjafari H, Bruce IN. Atherosclerosis in rheumatoid arthritis and systemic lupus erythematosus. Curr. Opin. Lipidol. 19(4), 338-343 (2008).
54. Zhou Q, Liao JK. Statins and cardiovascular diseases: from cholesterol lowering to pleiotropy. Curr. Pharm. Des. 15(5), 467-478 (2009).
55. Rawlings R, Nohria A, Liu PY et al. Comparison of effects of rosuvastatin (10 mg) versus atorvastatin (40 mg) on rho kinase activity in Caucasian men with a previous atherosclerotic event. Am. J. Cardiol. 103(4), 437-441 (2009).
56. Wang CY, Liu PY, Liao JK. Pleiotropic effects of statin therapy: molecular mechanisms and clinical results. Trends Mol. Med. 14, 37-44 (2008).
57. Liu PY, Liu YW, Lin LJ, Chen JH, Liao JK. Evidence for statin pleiotropy in humans: differential effects of statins and ezetimibe on rho-associated coiled-coil containing protein kinase activity, endothelial function, and inflammation. Circulation 119(1), 131-138 (2009).
58. Fonseca FA, Ruiz A, Cardona-Muñoz EG, Silva JM, Fuenmayor N, Marotti M; DISCOVERY PENTA Investigators. The DISCOVERY PENTA study: a direct statin comparison of LDL-C value - an evaluation of rosuvastatin therapy compared with atorvastatin. Curr. Med. Res. Opin. 21(8), 1307-1315 (2005). (Pubitemid 41140735)
59. Jones PH, Hunninghake DB, Ferdinand KC et al. Statin therapies for elevated lipid levels compared across doses to rosuvastatin study group. Effects of rosuvastatin versus atorvastatin, simvastatin, and pravastatin on non-high-density lipoprotein cholesterol, apolipoproteins, and lipid ratios in patients with hypercholesterolemia: additional results from the STELLAR trial. Clin. Ther. 26(9), 1388-1399 (2004).
60. Wlodarczyk J, Sullivan D, Smith M. Comparison of benefits and risks of rosuvastatin versus atorvastatin from a meta-analysis of head-to-head randomized controlled trials. Am. J. Cardiol. 102(12), 1654-1662 (2008).
61. Asher J, Houston M. Statins and C-reactive protein levels. J. Clin. Hypertens. (Greenwich) 9(8), 622-628 (2007).
62. Glynn RJ, MacFadyen JG, Ridker PM. Tracking of high-sensitivity C-reactive protein after an initially elevated concentration: the JUPITER study. Clin. Chem. 55(2), 305-312 (2009).
63. Robinson JG. Models for describing relations among the various statin drugs, low-density lipoprotein cholesterol lowering, pleiotropic effects, and cardiovascular risk. Am. J. Cardiol. 101(7), 1009-1015 (2008).
64. Zacho J, Tybjaerq-Hansen A, Jensen JS, Grande P, Sillesen H, Nordestgaard BG. Genetically elevated C-reactive protein and ischemic vascular disease. N. Engl. J. Med. 359(18), 1897-1908 (2008).
65. Pirro M, Schillaci G, Romagno PF et al. Influence of short-term rosuvastatin therapy on endothelial progenitor cells and endothelial function. J. Cardiovasc. Pharmacol. Ther. 14(1), 14-21 (2009).
66. Leone AM, Rutella S, Giannico MB et al. Effect of intensive vs standard statin therapy on endothelial progenitor cells and left ventricular function in patients with acute myocardial infarction: Statins for Regeneration After Acute Myocardial Infarction and PCI (STRAP) trial. Int .J. Cardiol. 130(3), 457-462 (2008).
67. Tousoulis D, Andreou I, Antoniades C, Tentolouris C, Stefanadis C. Role of inflammation and oxidative stress in endothelial progenitor cell function and mobilization: therapeutic implications for cardiovascular diseases. Atherosclerosis 201(2), 236-247 (2008).
68. Kruithof EK. Regulation of plasminogen activator inhibitor type 1 gene expression by inflammatory mediators and statins. Thromb. Haemost. 100(6), 969-975 (2008).
69. Nakakuki T, Ito M, Iwasaki H et al. Rho/Rho-kinase pathway contributes to C-reactive protein-induced plasminogen activator inhibitor-1 expression in endothelial cells. Arterioscler. Thromb. Vasc. Biol. 25, 2088-2093 (2005). (Pubitemid 41416305)
70. Sato Y, Dong J, Imagawa S et al. Impact of statins on modulation by insulin of expression of plasminogen activator inhibitor type-1. Coron. Artery Dis. 19(5), 355-361 (2008).
71. Michos ED, Blumenthal RS. Prevalence of low low-density lipoprotein cholesterol with elevated high sensitivity C-reactive protein in the US. J. Am. Coll. Cardiol. 53(11), 931-935 (2009).
72. Reynolds Risk Score www.reynoldsriskscore.org