Rosuvastatin: A highly potent statin for the prevention and management of coronary artery disease

Expert Review of Cardiovascular Therapy

Volumn 5, Issue 2, 2007, Pages 161-175

  Kapur, Navin K ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Atherosclerosis; Coronary heart disease; Diabetes; High density lipoprotein; HMG CoA reductase inhibitors; Hypertension; Lipoprotein; Low density; Myocardial infarction; Rosuvastatin; Statins

Indexed keywords

ANTACID AGENT; ANTIVITAMIN K; ATORVASTATIN; C REACTIVE PROTEIN; CHOLESTEROL ESTER TRANSFER PROTEIN INHIBITOR; CYCLOSPORIN; CYTOCHROME P450 3A4; ERYTHROMYCIN; EZETIMIBE PLUS SIMVASTATIN; FENOFIBRATE; FIBRIC ACID DERIVATIVE; FLUCONAZOLE; FLUINDOSTATIN; GEMFIBROZIL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; ITRACONAZOLE; KETOCONAZOLE; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; NICOTINIC ACID; PLACEBO; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; TORCETRAPIB; WARFARIN;

ACUTE KIDNEY FAILURE; ATHEROGENESIS; ATHEROMA; ATHEROSCLEROSIS; ATHEROSCLEROTIC PLAQUE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CORONARY ARTERY DISEASE; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; DYSPEPSIA; ETHNIC DIFFERENCE; EVIDENCE BASED MEDICINE; FOOD DRUG INTERACTION; HEART INFARCTION; HUMAN; HYPERCHOLESTEROLEMIA; ISCHEMIC HEART DISEASE; KIDNEY DISEASE; KIDNEY FAILURE; LIVER TOXICITY; META ANALYSIS; MONOTHERAPY; MORTALITY; MYALGIA; MYOPATHY; NAUSEA; PATHOPHYSIOLOGY; PATIENT COMPLIANCE; PHARMACODYNAMICS; PHARYNGITIS; PRACTICE GUIDELINE; PRIMARY PREVENTION; PROTEIN BLOOD LEVEL; PROTEINURIA; REVIEW; RHABDOMYOLYSIS; SINGLE DRUG DOSE; STROKE; SYSTEMATIC REVIEW; THERMODYNAMICS; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

ADOLESCENT; ADULT; AGE FACTORS; CORONARY ARTERIOSCLEROSIS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROBENZENES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERLIPIDEMIA, FAMILIAL COMBINED; HYPERLIPIDEMIAS; MALE; MIDDLE AGED; PRIMARY PREVENTION; PROGNOSIS; PYRIMIDINES; RANDOMIZED CONTROLLED TRIALS; RISK ASSESSMENT; SULFONAMIDES; SURVIVAL ANALYSIS;

EID: 33947694239     PISSN: 14779072     EISSN: 17448344     Source Type: Journal    
DOI: 10.1586/14779072.5.2.161     Document Type: Review

References (93)

1. Thom T, Haase N, Rosamond W et al. Heart disease and stroke statistics - 2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 113(6), e85-e151 (2006).
2. Khavkin T. Nikolai Nikolaevich Anitschkow. Beitr. Pathol. 156(4), 301-312 (1975).
3. Vance DE, Van den Bosch H. Cholesterol in the year 2000. Biochim. Biophys. Acta 1529(1-3), 1-8 (2000).
4. Soloff LA. Intermediate lipoproteins, atherosclerosis, and Gofman. Circulation 97(7), 708 (1998).
5. Endo A. The origin of the statins. Atheroscler. Suppl. 5(3), 125-130 (2004).
6. Topol EJ. Intensive statin therapy - a sea change in cardiovascular prevention. N. Engl. J. Med. 350, 1562-1564 (2004).
7. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 344(8934), 1383-1389 (1994).
8. 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, 1301-1307 (1995).
9. 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. JAMA 279, 1615-1622 (1998).
10. Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N. Engl. J. Med. 339, 1349-1357 (1998).
11. Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults. Summary of the second report of the National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel II). Arch. Int. Med. 148, 36-69 (1988).
12. 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).
13. MRC/BHF Heart Protection Study of cholesterol-lowering therapy and of antioxidant vitamin supplementation in a wide range of patients at increased risk of coronary heart disease death: early safety and efficacy experience. Eur. Heart J. 20(10), 725-741 (1999).
14. Cannon CP, Braunwald E, McCabe CH et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N. Engl. J. Med. 350(15), 1495-1504 (2004).
15. Grundy SM, Cleeman JI, Metz CN et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. J. Am. Coll. Cardiol. 44(3), 720-732 (2004).
16. Shah PK. Low-density lipoprotein lowering and atherosclerosis progression: does more mean less? Circulation 10606), 2039-2040 (2002).
17. Forrester JS, Makkar R, Shah PK. Increasing high-density lipoprotein cholesterol in dyslipidemia by cholesteryl ester transfer protein inhibition: an update for clinicians. Circulation 111(14), 1847-1854 (2005).
18. LaRosa JC, Grundy SM, Waters DD et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N. Engl. J. Med 352(14), 1425-1435 (2005).
19. Wiviott SW, Cannon CP, Morrow DA et al. Can low-density lipoprotein be too low? The safety and efficacy of achieving very low low-density lipoprotein with intensive statin therapy: a PROVE IT-TIMI 22 substudy. J. Am. Coll. Cardiol. 46, 1411-1416 (2005).
20. Ferdinand KC. Rosuvastatin: a risk-benefit assessment for intensive lipid lowering. Expert Opin. Pharmacother. 6(11), 1897-1910 (2005).
21. McKenney JM. Pharmacologic options for aggressive low-density lipoprotein cholesterol lowering: benefits versus risks. Am. J. Cardiol. 96(4A), 60E-66E (2005).
22. Nezasa K, Higaki K Takeuchi M, Nakano M, Koike M. Uptake of rosuvastatin by isolated rat hepatocytes: comparison with pravastatin. Xenobiotica 33(4), 379-388 (2003).
23. Carbonell T, Freire E. Binding thermodynamics of statins to HMG-CoA reductase. Biochemistry 44, 11741-11748 (2005).
24. Holdgate GA, Ward WH, McTaggert F. Molecular mechanism for inhibition of 3-hydroxy-3-methylglutaryl CoA (HMG-CoA) reductase by rosuvastatin. Biochem. Soc. Trans. 31(Pt 3), 528-531 (2003).
25. Schaefer JR, Schweer H, Ikewaki K et al. Metabolic basis of high density lipoproteins and apolipoprotein A-I increase by HMG-CoA reductase inhibition in healthy subjects and a patient with coronary artery disease. Atherosclerosis 144(1), 177-184 (1999).
26. Martin G, Duez H, Blanquart C et al. Statin-induced inhibition of the Rhosignaling pathway activates PPARα and induces HDL apoA-I. J. Clin. Invest. 107(11), 1423-1432 (2001).
27. Toth PP. High-density lipoprotein as a therapeutic target: clinical evidence and treatment strategies. Am. J. Cardiol. 96(9A), 50K-58K (2005).
28. Simonson SG, Martin PD, Mitchell P et al. Pharmacokinetics and pharmacodynamics of rosuvastatin in subjects with hepatic impairment. Eur. J. Clin. Pharm. 58(10), 669-675 (2003).
29. Martin PD, Dane AL, Nwose OM et al. No effect of age or gender on the pharmacokinetics of rosuvastatin: a new HMG-CoA reductase inhibitor. J. Clin. Pharmacol. 42(10), 1116-1121 (2002).
30. Martin PD, Mitchell PD, Schneck DW. Pharmacodynamic effects and pharmacokinetics of a new HMG-CoA reductase inhibitor, rosuvastatin, after morning or evening administration in healthy volunteers. Br. J. Clin. Pharmacol. 54(5), 472-477 (2002).
31. Shitara Y, Sugiama Y. Pharmacokinetic and pharmacodynamic alterations of HMG-CoA reductase inhibitors: Drug-drug interactions and interindividual differences in transporter and metabolic enzyme functions. Pharmacol, Ther. 112(1), 71-105 (2006).
32. McCormick AD, McKillop D, Butters CJ et al. ZD4522 - an HMG-CoA reductase inhibitor free of metabolically mediated drug interactions: metabolic studies in human in vitro systems. J. Clin. Pharmacol. 40, 1055 (2000) (Abstract).
33. Martin PD, Dane AL, Schneck DW et al. Disposition of a new HMG-CoA reductase inhibitor ZD4522 following dosing in healthy subjects. J. Clin. Pharmacol. 40, 1056 (2006) (Abstract).
34. Product information: Crestor®, rosuvastatin calcium tablets. Astra. Zeneca Pharmaceuticals, DE, USA (PI issued 8/2003) reviewed 8/2003.
35. Simonson SG, Martin PD, Mitchell PD et al. Pharmacokinetics and pharmacodynamics of rosuvastatin in subjects with hepatic impairment. Eur. J. Clin. Pharmacol. 58(10), 669-675 (2003).
36. Sekino H, Onishi T. Phase I study of ZD4522 (rosuvastatin), a new HMG-CoA reductase inhibitor - evaluation of tolerance and pharmacokinetics in healthy adult male volunteers after single and repeated oral administration. J. Clin. Ther. Med. 21, 187-203 (2005).
37. Lee E, Ryan S, Birmingham B et al. Rosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environment. Clin. Pharmacol, Ther. 78(4), 330-341 (2005).
38. Cooper KJ, Martin PD, Dane AL et al. Effect of itraconazole on the pharmacokinetics of rosuvastatin. Clin. Pharmacol. Ther. 73(4), 322-329 (2003).
39. Cooper KJ, Martin PD, Dane AL et al. Lack of effect of ketoconazole on the pharmacokinetics of rosuvastatin in healthy subjects. Br. J. Clin. Pharmacol. 55(1), 94-99 (2003).
40. Cooper KJ, Martin PD, Dane AL et al. The effect of erythromycin on the pharmacokinetics of rosuvastatin. Eur. J. Clin. Pharmacol. 59(1), 51-56 (2003).
41. Cooper KJ, Martin PD, Dane AL et al. The effect of fluconazole on the pharmacokinetics of rosuvastatin. Eur. J. Clin. Pharmacol. 58(8), 527-531 (2002).
42. Simonson G, Raza A, Martin PD et al. Rosuvastatin pharmacokinetics in heart transplant recipients administered an antirejection regimen including cyclosporine. Clin. Pharm. Therap. 76(2), 167-177 (2004).
43. Simonson SG, Martin PD, Mitchell PD et al. Effect of rosuvastatin on warfarin pharmacodynamics and pharmacokinetics. J. Clin. Pharm. 45(8), 927-934 (2005).
44. Redman AR. Implications of cytochrome P450 2C9 polymorphism on warfarin metabolism and dosing. Pharmacotherapy 21(2), 235-242 (2001).
45. Sheck A, Ferrill MJ. Statin-fibrate combination therapy. Ann. Pharmacother. 35, 908-917 (2001).
46. Bellosta S. Safety of statins. Circulation 109, 50-57 (2004).
47. Prueksaritanont T, Tang C, Qiu Y et al. Effect of fibrates on metabolism of statins in humans hepatocytes. Drug Metab. Dispos. 30, 1280-1287 (2002).
48. Duell PB, Connor WE, Illingworth DR. Rhabdomyolysis after taking atorvastatin with gemfibrozil. Am. J Cardiol. 81(3), 368-369 (1998).
49. Schneck DW, Birmingham BK, Zalikowski JA et al. The effect of gemfibrozil on the pharmacokinetics of rostivastatin. Clin. Pharmacol. Ther 75(5), 455-463 (2004).
50. McKenney JM. Efficacy and safety of rosuvastatin in treatment of dyslipidemia. Am. J. Health Syst. Pharm. 62(10), 1033-1047 (2005).
51. Martin P, Dane A, Schneck D, Warwick M. An open-label, randomized, three-way crossover trial of the effects of coadministration of rosuvastatin and fenofibrate on the pharmacokinetic properties of rosuvastatin and fenofibric acid in healthy male volunteers. Clin. Therapeut. 25(2), 459-471 (2003).
52. Brewer HB. Benefit-risk assessment of rosuvastatin 10 to 40 milligrams. Am. J. Cardiol. 92(4B), 23K-29K (2003).
53. Olsson AG, Istad H, Luurila O et al. Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia. Am. Heart J. 144(6), 1044-1051(2002).
54. Schneck DW, Knopp RH, Ballantyne CM et al. Comparative effects of rosuvastatin and atorvastatin across their dose ranges in patients with hypercholesterolemia and without active arterial disease. Am. J. Cardiol. 91(1), 33-41 (2003).
55. Schuster H. The GALAXY program: an update on studies investigating efficacy and tolerability of rosuvastatin for reducing cardiovascular risk. Expert Rev. Cardiovasc. Ther. 5(2), 177-193 (2006).
56. Jones PH, Davidson MH, Stein EA et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). Am. J. Cardiol 92(2), 152-160 (2003).
57. Brown WV, Bays HE, Hassman DR et al. Efficacy and safety of rosuvastatin compared with pravastatin and simvastatin in patients with hypercholesterolemia: a randomized, double-blind, 52-week trial. Am. Heart J. 144(6),1036-1043 (2002).
58. Tuomilehto J, Leiter LA, Kallend D. A review of the efficacy of rosuvastatin in patients with Type 2 diabetes. Int. J. Clin. Pract. Suppl. 143, 30-40 (2004).
59. Krum H, Tonkin A et al. The rosuvastatin impact on ventricular remodelling cytokines and neurohormones (UNIVERSE) study. J. Am. Coll. Cardiol. 26(47), 61P-62A (2006) (Abstract).
60. Raina A, Pickering T, Shimbo D. Statin use in heart failure - a cause for concern? Am. Heart J. 152(1), 39-49 (2006).
61. Ferdinand KC, Clark LT, Watson KE et al. Comparison of efficacy and safety of rosuvastatin versus atorvastatin in African-American patients in a six-week trial. Am. J. Cardiol. 97(2), 229-235 (2006).
62. Llorett R, Haffner S, Ycas J, Stein M et al. for the STARSHIP Study Group. Lipid-lowering results from the first large-scale trial of statin therap in Hispanic-American patients with hypercholesterolemia: STARSHIP.J. Am. Coll. Cardiol. 26(47), 349A-350A (2006) (Abstract).
63. Deedwania P, Gupta M, Stein M et al. First large randomized trial of a statin therapy in South Asian patients at risk for coronary heart disease: the IRIS trial. Atheroscler. Suppl, 206(7), 161 (2006).
64. Smilde TJ, van Wissen S, Wallersheim H et al. Effect of aggressive versus conventional lipid lowering on atherosclerosis progression in familial hypercholesterolaemia (ASAP): a prospective, randomised, double-blind trial. Lancet 357(9256), 577-581 (2001).
65. Taylor AJ, Kent SM, Flaherty PJ et al. ARBITER: Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol: a randomized trial comparing the effects of atorvastatin and pravastatin on carotid intima medial thickness. Circulation 106(16), 2055-2060 (2002).
66. Crouse JR, Grobbee DE, O'leary DH et al. Measuring effects on intima media thickness: an evaluation of rosuvastatin in subclinical atherosclerosis - the rationale and methodology of the METEOR study. Cardiovasc. Drugs Ther. 18(3), 231-238 (2004).
67. Hatsukami T, Zhao XQ, Kraiss LW et al. Assessment of rosuvastatin treatment on carotid atherosclerosis in moderate hypercholesterolemic subjects using magnetic resonance imaging. Eur. Heart J. 26, 626 (2005).
68. Nissen SE, Tuzcu EM, Schoenhagen P et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA 291(9), 1071-1080 (2004).
69. Nissen SE, Nicholls SJ, Sipahi I et al. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA 295(13), 1556-1565 (2006).
70. Blumenthal RS, Kapur NK. Can a potent statin actually regress coronary atherosclerosis? JAMA 295(13), 1583-1584 (2006).
71. 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).
72. Fellstrom. B, Zannad F, Schmieder R et al. Effect of rosuvastatin on outcomes in chronic haemodialysis patients - design and rationale of the AURORA study. Curr. Control Trials Cardiovasc. Med. 6(1), 9 (2005).
73. Kjekshus J, Dunselman P, Blideskog M et al. A statin in the treatment of heart failure? Controlled rosuvastatin multinational study in heart failure (CORONA): study design and baseline characteristics. Eur. J. Heart Fail. 7(6), 1059-1069 (2005).
74. Vidt DG, Harris S, McTaggart F et al. Effect of short-term rosuvastatin treatment on estimated glomerular filtration rate. Am. J. Cardiol 97(11), 1602-1166 (2006).
75. McAfee AT, Ming EE, Seeger JD et al. The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapy. Pharmacoepidemiol. Drug Saf. 15, 444-453 (2006).
76. Grundy SM. The issue of statin safety: where do we stand? Circulation 111(23), 3016-3019 (2005).
77. Goettsch WG, Heintjes EM, Kastelein JJ et al. Results from a rosuvastatin historical cohort study in more than 45 000 Dutch statin users, a PHARMO study. Pharmacoepidemiol. Drug Saf. 15(7), 435-443 (2006).
78. Alsheikh-Ali AA, Ambrose MS, Kuvin JT et al. The safety of rosuvastatin as used in common clinical practice: a postmarketing analysis. Circulation 111(23), 3051-3057 (2005).
79. Gordon DJ, Probstfield JL, Garrison RJ et al. High-density lipoprotein cholesterol and cardiovascular disease. Four prospective American studies. Circulation 79(1), 8-15 (1989).
80. Castelli WP, Anderson K, Wilson PW et al. Lipids and risk of coronary heart disease. The Framingham Study. Ann. Epidemiol. 2(1-2), 23-28 (1992).
81. Multiple Risk Factor Intervention Trial. Risk factor changes and mortality results. Multiple Risk Factor Intervention Trial Research Group. 1982. JAMA 277(7), 582-594 (1997).
82. Jones P. 2006 International Symposium on Atherosclerosis. June 18-22, Rome, Italy 2006.
83. Brousseau ME, Schaefer EJ, Wolfe ML et al. Effects of an inhibitor of cholesteryl ester transfer protein on HDL cholesterol. N. Engl. J. Med. 350(15), 1505-1515 (2004).
84. Stelenhoef AG, Ballantyne CM, Sarti C et al. A comparative study with rosuvastatin in subjects with metabolic syndrome: results ofthe COMETS study. Eur. Heart J. 26(24), 2664-2672 (2005).
85. Strandberg TE, Feely J, Sigurdsson EL. Twelve-week, Multicenter, randomized, open-label comparison of the effects of rosuvastatin 10 mg/d and atorvastatin 10 mg/d in high-risk adults: a DISCOVERY study. Clin. Ther. 26(11), 1821-1833 (2004).
86. Faergeman O, Sosef F, Duffield E. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in high-risk patients: results from the ECLIPSE Study. Atheroscler. Suppl. 7, 580 (2006).
87. Pitt B, Loscalzo J, Ycas J, Raichlen J. Acute coronary syndromes do not lower lipid levels. J. Am. Coll. Cardiol. 47(Suppl. 1), 323A (2006).
88. Schuster H, Barter PJ, Stender S et al. Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY (MERCURY I) study. Am. Heart J. 147, 705-712 (2004).
89. Ballantyne CM, Bertolami M, Hernandez Garcia HR et al. Achieving LDL cholesterol, non-HDL cholesterol, and apolipoprotein B target levels in high-risk patients: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY (MERCURY) II. Am. Heart J. 151, 975.el-e9 (2006).
90. Willich S, Müller-Nordhorn J, Sonntag F. Effects of a twelve months rosuvastatin treatment plus additional care (drug intake adherence and lifestyle enhancing initiatives) compared to rosuvastatin treatment alone on long-term disease-related costs in patients with an indication for statin treatment according to the joint European guidelines. Am. Heart J. 148(6), 1060-1067 (2004).
91. Leiter LA, Palmer M, Kallend D. Rosuvastatin 40 mg versus atorvastatin 80 mg in high-risk patients with hypercholesterolaemia: early results of the POLARIS study. Atheroscler. Suppl. 6, 113 (2005).
92. Clearfield M, Kallend D, Palmer M. Efficacy and safety of rosuvastatin 10 mg versus atorvastatin 20 mg: results of the PULSAR study. Atheroscler. Suppl. 6, 104 (2005).
93. Berne C, Siewert-Delle A, and URANUS study investigators. Comparison of rosuvastatin and atorvastatin far lipid lowering in patients with Type 2 diabetes mellitus: results from the URANUS study. Cardiovasc. Diabetol. 5, 4-7 (2005).