Genetic polymorphisms in cytochrome P450 enzymes: Effect on efficacy and tolerability of HMG-CoA reductase inhibitors

American Journal of Cardiovascular Drugs

Volumn 4, Issue 4, 2004, Pages 247-255

  Vermes, Andras ^a   Vermes, Istvan ^b  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b MEDISCH SPECTRUM TWENTE   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOTRANSFERASE; ATORVASTATIN; CERIVASTATIN; CIMETIDINE; CLARITHROMYCIN; CYCLOSPORIN; CYTOCHROME P450; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; DILTIAZEM; DRUG METABOLIZING ENZYME; ERYTHROMYCIN; FIBRIC ACID DERIVATIVE; FLUINDOSTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; ITRACONAZOLE; LIVER ENZYME; LOW DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN RECEPTOR; MEVINOLIN; MIBEFRADIL; NEFAZODONE; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; TROLEANDOMYCIN; UNINDEXED DRUG;

ABDOMINAL PAIN; ANTICOAGULATION; ARTHRALGIA; CARDIOVASCULAR DISEASE; CEREBROVASCULAR DISEASE; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DISEASE EXACERBATION; DIZZINESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DISPOSITION; DRUG EFFICACY; DRUG ERUPTION; DRUG EXCRETION; DRUG FATALITY; DRUG FECES LEVEL; DRUG HALF LIFE; DRUG METABOLISM; DRUG POTENTIATION; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG URINE LEVEL; FLATULENCE; GENETIC POLYMORPHISM; GENOTYPE; HEADACHE; HUMAN; ISCHEMIC HEART DISEASE; KIDNEY FAILURE; LIVER DYSFUNCTION; LIVER TOXICITY; MUSCLE NECROSIS; MYALGIA; MYOGLOBINURIA; MYOPATHY; PATIENT COMPLIANCE; PERIPHERAL VASCULAR DISEASE; PHARMACOGENETICS; PRIORITY JOURNAL; PROTEIN FAMILY; PROTEIN FUNCTION; PRURITUS; REVIEW; RHABDOMYOLYSIS; STRUCTURE ACTIVITY RELATION; TREATMENT FAILURE;

CYTOCHROME P-450 ENZYME SYSTEM; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERCHOLESTEROLEMIA; ISOENZYMES; POLYMORPHISM, GENETIC;

EID: 4444292394     PISSN: 11753277     EISSN: None     Source Type: Journal    
DOI: 10.2165/00129784-200404040-00005     Document Type: Review

References (98)

1. Goldstein JL, Brown MS. Regulation of the mevalonate pathway. Nature 1990: 343: 425-30
2. Grundy SM. HMG-CoA reductase inhibitors for treatment of hypercholesterolemia. N Engl J Med 1988: 319: 24-33
3. Maron DJ, Fazio S, Linton MF. Current perspectives on statins. Circulation 2000; 101: 207-13
4. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344: 1383-9
5. 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 Airforce/Texas Coronary Artheriosclerosis Prevention Study. JAMA 1998; 279: 1615-22
6. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: 7-22
7. Corti R, Fuster V, Fayad ZA. et al. Lipid lowering by simvastatin induces regression of human atherosclerotic lesions: two years' follow-up by high-resolution noninvasive megnetic resonance imaging. Circulation 2002; 106: 2884-7
8. Bustos C. Hernandez-Presa MA, Ortego M, et al. HMG-CoA reductase inhibition by atorvastatin reduces neointimal inflammation in a rabbit model of atherosclerosis. J Am Coll Cardiol 1998; 32: 2057-64
9. Lefer AM, Scalia R, Lefer DJ. Vascular effects of HMG-CoA reductase inhibitors (statins) unrelated to cholesterol lowering: new concepts for cardiovascular disease. Cardiovasc Res 2001; 49: 281-7
10. Ridker PM, Rifai N, Clearfield M, et al. Measurement of C-reactive protein for the targeting of statin therapy in the primary preventionof acute coronary events. N Engl J Med 2001; 344: 1959-65
11. Lefer DJ. Statins as potent antiinflammatory drugs. Circulation 2002; 106: 2041-2
12. Anderson TJ, Meredith IT, Yeung AC, et al. The effect of cholesterol-lowering and antioxidant therapy on endothelium-dependent coronary vasomotion. N Engl J Med 1995; 332: 488-93
13. Mach F. Statins as immunomodulators. Transpl Immunol 2002; 9: 197-202
14. Indolfi C, Cioppa A, Stabile E, et al. Effects of hydroxymethylglutaryl coenzyme A reductase inhibitor simvastatin on smooth muscle cell proliferation in vitro and neointimal formation in vivo after vascular injury. J Am Coll Cardiol 2000; 35: 214-21
15. Kureishi Y, Luo Z, Shiojima I, et al. The HMG-CoA reductase inhibitor simvastatin activates the protein kinase Akt and promotes angiogenesis in normocholesterolemic animals. Nat Med 2000; 6: 1004-10
16. Walter DH, Ritting K. Bahlmann FH, et al. Satin therapy accelerates reendothelization: a novel effect involving mobilization and incorporation of bone marrow-derived endothelial progenitor cells. Circulation 2002; 105: 3017-24
17. Vasa M, Fichtlscherer S, Adler K, et al. Increase in circulating endothelial progenitor cells by statin therapy in patients with stable coronary artery disease. Circulation 2001: 103: 2885-90
18. Dimmeler S, Aicher A, Vasa M, et al. HMG-CoA reductase inhibitors (statins) increase endothelial progenitor cells via the PI 3-kinase/Akt pathway. J Clin Invest 2001: 108: 391-7
19. Eto M, Kozai T, Cosentino F, et al. Statin prevents tissue factor expression in human endothelial cells: role of Rho/Rho-kinase and Akt pathways. Circulation 2002; 105: 1756-9
20. Bays HE, Dujovne CA. Drug interactions of lipid-altering drugs. Drug Saf 1998: 19: 355-71
21. Chong PH. Lack of therapeutic interchangeability of HMG-CoA reductase inhibitors. Ann Pharmacother 2002; 36: 1907-17
22. Chong PH, Yim BT. Rosuvastatin for the treatment of patients with hypercholesterolemia. Ann Pharmacother 2002; 36: 93-101
23. White CM. A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin Pharmacol 2002; 42: 963-70
24. Weber W. Drug firm withdraws statin from market. Lancet 2001: 358: 568
25. Tobert J. Efficacy and long term adverse effect pattern of lovastatin. Am J Cardiol 1988; 62: J28-34
26. Blum C. Comparison of properties of four inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase. Am J Cardiol 1994; 73: D3-11
27. Pasternak RC, Smith SC, Bairey-Merz CB, et al. ACC/AHA/NHLBI Clinical advisory on the use and safety of statins. Circulation 2002: 106: 1024-8
28. Bradford RH, Shear CL, Chremos AN, et al. Expanded clinical evaluation of lovastatin (EXCEL) study results: 1. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia. Arch Intern Med 1991; 151: 43-9
29. Hunninghake DB. Drug treatment of dyslipoproteinemia. Endocrinol Metab Clin North Am 1990; 19: 345-60
30. Davidson MH. Safety profiles for the HMG-CoA reductase inhibitors: treatment and trust. Drugs 2001; 61: 197-206
31. Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis. N Engl J Med 2002; 346: 539-40
32. Mantel-Teeuwisse AK, Klungel OH, VanPuijenbroek EP, et al. Myopathy due to statin/fibrate use in the Netherlands. Ann Pharmacother 2002; 36: 1957-60
33. Goldman JA, Fishman AB, Lee JE, et al. The role of cholesterol-lowering agents in drug-induced rhabdomyolysis and polymyositis. Arthritis Rheum 1989; 32: 358-9
34. Greur PJ, Vega JM, Mercuri MF, et al. Concomitant use of cytochrome P450 3A4 inhibitors and simvastatin. Am J Cardiol 1999; 84: 811-5
35. Davidson MH. Does differing metabolism by cytochrome P450 have clinical importance? Curr Atheroscler Rep 2000; 2: 14-9
36. Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis. N Engl J Med 2002; 346: 539-40
37. Gaist D, Garcia-Rodrigez LA, Huerta C, et al. Lipid-lowering drugs and risk of myopathy: a population-based follow-up study. Epidemiology 2001: 12: 565-9
38. Lennernas H, Fager G. Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors: similarities and differences. Clin Pharmacokinet 1997; 32: 403-25
39. Williams D, Feely J. Pharmacokinetic-pharmacodynamic drug interactions with HMG-CoA reducatase inhibitors. Clin Pharmacokinet 2002; 41: 343-70
40. Transon C, Leeman T, Dayer P. In vitro comparitive inhibition profiles of major human drug metabolising cytochrome P450 isozymes (CYP2C9, CYP2D6 and CYP3A4) by HMG-CoA reductase inhibitors. Eur J Clin Pharmacol 1996; 50: 209-15
41. Carswell CI, Plosker GL, Jarvis B. Rosuvastatin. Drugs 2002; 62: 2075-85
42. Bolego C, Poli A, Cignarella A, et al. Novel statins: pharmacological and clinical results. Cardiovasc Drug Ther 2002; 16: 251-7
43. Vyas KP, Kari PH, Wang RW, et al. Biotransformation of lovastatin: III. Effect of cimetidine and famotidine on in vitro metabolism of lovastatin by rat and human liver microsomes. Biochem Pharmacol 1990; 39: 67-73
44. Wang RW, Kari PH, Lu AY, et al. Biotransformation of lovastatin: IV. Identification of cytochrome P450 3A proteins as the major enzymes responsible for the oxidative metabolism of lovastatin by rat and human liver microsomes. Arch Biochem Biophys 1991; 290: 355-61
45. East C, Alivizatos PA, Grundy SM, et al. Rhabdomyolysis in patients receiving lovastatin after cardiac transplantation [letter]. N Engl J Med 1988; 318: 47-8
46. Tobert JA. Rhabdomyolysis in patients receiving lovastatin after cardiac transplantation [letter]. N Engl J Med 1988; 318: 48
47. Gullestad L, Nordal KP, Berg KJ, et al. Interaction between lovastatin and cyclosporine A after heart and kidney transplantation. Transplant Proc 1999; 31: 2163-5
48. Olbricht C, Wanner C, Eisenhauer T, et al. Accumulation of lovastatin, but not pravastatin, in the blood of cyclosporine-treated kidney graft patients after multiple doses. Clin Pharmacol Ther 1997: 62: 311-21
49. Kobashigawa JA, Murphy FL, Stevenson LW. et al. Low-dose lovastatin safety lowers cholesterol after cardiac transplantation. Circulation 1990; 82 (5 Suppl.): IV281-3
50. Traindl O, Reading S, Franz M, et al. Low-dose lovastatin in hyperlipidemic kidney graft recipients with cyclosporine A. Transplant Proc 1992; 24: 2745-7
51. Kandus A, Kovac D, Koselj M. et al. Lovastatin treatment of hyperlipidemia kidney transplant recipients on cyclosporine immunosuppression. Transplant Proc 1994; 26: 2642-3
52. Ayanian JZ, Fuchs CS, Stone RM. Lovastatin and rhabdomyolysis [letter]. Ann Intern Med 1988; 109: 682-3
53. Lees RS, Lees AM. Rhabdomyolysis from the coadministration of lovastatin and the antifungal agent itraconazole [letter]. N Engl J Med 1995; 333: 664-5
54. Horn M. Coadministration of itraconazole with hypolipidaemic agents may induce rhabdomyolysis in healthy individuals [letterl. Arch Dermatol 1996; 132: 1254
55. Grunden JW, Fisher KA. Lovastatin-induced rhabdomyolysis possible associated with clarithromycin and azithromycin. Ann Pharmacother 1997; 31: 859-63
56. Azie NE, Brater DD, Becker PA, et al. The interaction of diltiazem with lovastatin and pravastatin. Clin Pharmacol Ther 1998; 64: 369-77
57. Jacobson W, Kirchner G, Hallensleben K, et al. Comparison of cytochrome P-450-dependent metabolism and drug interactions of the 3-hydroxy-3-methylglutaryl-CoA reductase inhibitors lovastatin and pravastatin in the liver. Drug Metab Dispos 1999; 27: 173-9
58. Regazzi MB, Iacona I, Camparra C, et al. Altered disposition of pravastatin following concomitant drug therapy with cyclosporin A in transplant recipients. Transplant Proc 1993; 25: 2732-4
59. Yoshimura N, Oka T, Okamoto M, et al. The effects of pravastatin oh hyperlipidaemia in renal transplant recipients. Transplantation 1992; 53: 94-9
60. Neuvonen PJ, Kantola T, Kivisto KT. Simvastatin but not pravastatin is very susceptible to interaction with the CYP3A4 inhibitor itraconazole. Clin Pharmacol Ther 1998; 63: 332-41
61. Oo C, Akbari B, Lee S, et al. Effects of orlistat, a novel anti-obesity agent, on the pharmacokinetics and pharmacodynamics of pravastatin in patients with mild hypercholesterolaemia. Clin Drug Invest 1999; 17: 217-33
62. Alderman CP. Possible interaction between nefazodone and pravastatin [letter]. Ann Pharmacother 1999; 33: 871
63. Arnadottir M, Eriksson LO, Thysell H, et al. Plasma concentration profiles of simvastatin 3-hydroxy-3-methylglutaryl-co-enzyme A reductase inhibitory activity in kidney transplant recipients with and without cyclosporin. Nephron 1993; 65: 410-3
64. Weise WJ, Possidente CJ. Fatal rhabdomyolysis associated with simvastatin in a renal transplant patient [letter]. Am J Med 2000; 108: 351-2
65. Kantola T, Kivisto KT, Neuvonen PJ. Erythromycin and verapamil considerably increase serum simvastatin and simvastatin acid concentrations. Clin Pharmacol Ther 1998; 64: 177-82
66. Yeo KR, Yeo WW, Wallis EJ, et al. Enhanced cholesterol reduction by simvastatin in diltiazem-treated patients. Br J Clin Pharmacol 1999; 48: 610-5
67. Jacobson RH, Wang P, Glueck CJ. Myositis and rhabdomyolysis associated with concurrent use of of simvastatin and nefazodone [letter]. JAMA 1997; 277: 296-7
68. Schmassmann-Suhijar D, Bullingham R, Gasser R. et al. Rhabdomyolysis due to interaction of simvastatin with mibefradil [letterl. Lancet 1998; 351: 1929-30
69. Gilad R, Lampl Y. Rhabdomyolysis induced by simvastatin and ketoconazole treatment. Clin Neuropharmacol 1999; 22: 295-7
70. Mogyorosi A, Bradley B, Schubert M. Rhabdomyolysis attributed to HMG-CoA-reductase inhibitor-warfarin interaction [abstract]. Am J Kidney Dis 1999; 33: A36
71. Mogyorosi A, Bradley B, Showalter A, et al. Rhabdomyolysis and acute renal failure due to combination therapy with simvastatin and warfarin. J Intern Med 1999; 246: 599-602
72. Kantola T, Kivisto KT, Neuvonen PJ. Effect of itraconazole on the pharmacokinetics of atorvastatin. Clin Pharmacol Ther 1998; 64: 58-65
73. Maltz HC, Balog DL, Cheigh JS. Rhabdomyolysis associated with concomitant use of atorvastatin and cyclosporine. Ann Pharmacother 1999; 33: 1176-9
74. Wenisch C, Krause R, Fladerer P, et al. Acute rhabdomyolysis after atorvastatin and fusidic acid therapy [letter]. Am J Med 2000; 109: 78
75. Transon C, Leeman T, Vogt N. et al. In vivo inhibition profile of cytochrome P450TB (CYP2C9) by (±)-fluvastatin. Clin Pharmacol Ther 1995; 58: 412-7
76. Kivisti KT, Kantola T, Neuvonen PJ. Different effects of itraconazole on the pharmacokinetics of fluvastatin and lovastatin. Br J Clin Pharmacol 1998; 46: 49-53
77. Olsson AG, McTaggart F, Raza A. Rosuvastatin: a highly effective new HMG-CoA reductase inhibitor. Cardiovasc Drug Rev 2002; 20: 303-28
78. Cooper KJ, Martin PD, Dane AL, et al. The effect of fluconazole on the pharmacokinetics of rosuvastatin. Eur J Clin Pharmacol 2002; 58: 7-31
79. Meyer UA. Genotype or phenotype: the definition of a pharmacogenetic polymorphism. Pharmacogenetics 1991: 1: 66-7
80. Meyer UA, Zanger UM. Molecular mechanisms of genetic polymorphisms of drug metabolism. Ann Rev Pharmacol Toxicol 1997; 37: 269-96
81. Nakagawa K, Ishizaki T. Therapeutic relevance of pharmacogenetic factors in cardiovascular medicine. Pharmacol Ther 2000; 86: I-28
82. Nebert DW, Russel DW. Clinical importance of the cytochromes P450. Lancet 2002; 360: I155-62
83. Mauro VF. Clinical pharmacokinetics and practical applications of simvastatin. Clin Pharmacokinet 1993; 24: 195-202
84. Wolf CR, Smith G. Pharmacogenetics. Br Med Bull 1999; 55: 366-86
85. Sachse C, Brockmöller J. Bauer S, et al. Cytochrome p450 2D6 variants in a Caucasian polulation: allele frequencies and phenotypic consequences. Am J Hum Genet 1997; 60: 285-95
86. Johansson I, Lundqvist E, Bertilsson L, et al. Inherited amplification of an active gene in the cytochrome P450 CYP2D locus as a cause of ultrarapid metabolism of debrisoquine. Proc Natl Acad Sci U S A 1993; 90: 11825-9
87. Marez D, Legrand M, Sabbagh N, et al. Polymorphism of the cytochrome P450 CYP2D6 gene in a European population: characterization of 48 mutations and 53 alleles, their frequencies and evolution. Pharmacogenetics 1997; 7: 193-202
88. Kalow W, Bertilsson L. Interethnic factors affecting drug response. Adv Drug Res 1994; 25: 1-53
89. Agúndez JA, Ledesma MC, Ladero JM, et al. Prevalence of CYP2D6 duplication and its repercussion on the oxidative phenotype in a white population. Clin Pharmacol Ther 1995; 57: 265-9
90. Dahl ML, Johansson I, Bertilsson L, et al. Ultrarapid hydroxylation of debrisoqoline in a Swedish population: analysis of the molecular genetic basis. J Pharmacol Exp Ther 1995; 274: 516-20
91. Nordin C, Dahl ML, Eriksson M, et al. Is the cholesterol-lowering effect of simvastatin influenced by CYP2D6 polymorphism? Lancet 1997; 350: 29-30
92. Mulder AB, van Lijf HJ, Bon MAM, et al. Association of polymorphism in the cytochrome CYP2D6 and the efficacy and tolerability of simvastatin. Clin Pharmacol Ther 2001; 70: 546-51
93. De Leon J, Barnhill J, Rogers T, et al. Pilot study of the cytochrome P450-2D6 genotype in a psychiatric state hospital. Am J Psychiatry 1998; 155: 1278-80
94. Steimer W, Potter JM. Pharmacogenetic screening and therapeutic drugs. Clin Chim Acta 2002; 315: 137-55
95. Kirchheiner J, Kudlicz D, Meisel C, et al. Influence of CYP 2C9 polymorphisms on the pharmacokinetics and cholesterol-lowering activity of (-)-3S,5R-fluvastatin and (+)-3R.5S-fluvastatin in healthy volunteers. Clin Pharmacol Ther 2003; 74: 186-94
96. Sabia H, Prasad P, Smith HT, et al. Safety, tolerability, and pharmacokinetics of an extended-release formulation of fluvasatin administered once daily to patients with primary hypercholesterolemia. J Cardiovasc Pharmacol 2001; 37: 502-11
97. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200-5
98. Linder MW, Prough RA, Valdes R. Pharmacogenetics: a laboratory tool for optimizing therapeutic efficiency. Clin Chem 1997; 43: 254-66