Drug safety evaluation of rosuvastatin

Bibliography

• 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 2001;285:2486-97
   PubMed Web of Science ®Google Scholar
• Liao JK, Laufs U. Pleiotropic effects of statins. Annu Rev Pharmacol Toxicol 2005;45:89-118
   PubMed Web of Science ®Google Scholar
• Downs JR, Clearfield M, Weis S, 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 1998;279:1615-22
   PubMed Web of Science ®Google Scholar
• Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-9
   PubMed Web of Science ®Google Scholar
• Cannon CP, Braunwald E, McCabe CH, Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004;350:1495-504
   PubMed Web of Science ®Google Scholar
• Ballantyne CM, Raichlen JS, Nicholls SJ, Effect of rosuvastatin therapy on coronary artery stenoses assessed by quantitative coronary angiography: a study to evaluate the effect of rosuvastatin on intravascular ultrasound-derived coronary atheroma burden. Circulation 2008;117:2458-66
   PubMed Web of Science ®Google Scholar
• McTaggart F, Buckett L, Davidson R, Preclinical and clinical pharmacology of Rosuvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. Am J Cardiol 2001;87:28B-32B
   PubMed Web of Science ®Google Scholar
• Istvan ES, Deisenhofer J. Structural mechanism for statin inhibition of HMG-CoA reductase. Science 2001;292:1160-4
   PubMed Web of Science ®Google Scholar
• White CM. A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin Pharmacol 2002;42:963-70
   PubMed Web of Science ®Google Scholar
• Smith G DR, Bloor S. Pharmacological properties of ZD4522: a new HMG-CoA reductase inhibitor [abstract]. Atherosclerosis 2000;151:39
   Google Scholar
• Crestor Prescribing Information Sheet Rev 2011 1291406. Available from: http://www1.astrazeneca-us.com/pi/crestor.pdf [Last accessed 09 July 2011]
   Google Scholar
• Jones PH, Davidson MH, Stein EA, Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). Am J Cardiol 2003;92:152-60
   PubMed Web of Science ®Google Scholar
• Ridker PM, Danielson E, Fonseca FA, Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet 2009;373:1175-82
   PubMed Web of Science ®Google Scholar
• Crouse JR III, Raichlen JS, Riley WA, Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA 2007;297:1344-53
   PubMed Web of Science ®Google Scholar
• Nissen SE, Nicholls SJ, Sipahi I, Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA 2006;295:1556-65
   PubMed Web of Science ®Google Scholar
• Ose L. Pitavastatin: a distinctive lipid-lowering drug. Clin Lipidol 2010;5:309-23
   Web of Science ®Google Scholar
• Shitara Y, Sugiyama Y. Pharmacokinetic and pharmacodynamic alterations of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors: drug-drug interactions and interindividual differences in transporter and metabolic enzyme functions. Pharmacol Ther 2006;112:71-105
   PubMed Web of Science ®Google Scholar
• Martin PD, Warwick MJ, Dane AL, Metabolism, excretion, and pharmacokinetics of rosuvastatin in healthy adult male volunteers. Clin Ther 2003;25:2822-35
   PubMed Web of Science ®Google Scholar
• Neuvonen PJ. Drug interactions with HMG-CoA reductase inhibitors (statins): the importance of CYP enzymes, transporters and pharmacogenetics. Curr Opin Investig Drugs 2010;11:323-3
   PubMed Web of Science ®Google Scholar
• Hagenbuch B, Gui C. Xenobiotic transporters of the human organic anion transporting polypeptides (OATP) family. Xenobiotica 2008;38:778-801
   PubMed Web of Science ®Google Scholar
• Niemi M. Transporter pharmacogenetics and statin toxicity. Clin Pharmacol Ther 2010;87:130-3
   PubMed Web of Science ®Google Scholar
• Rodrigues AC. Efflux and uptake transporters as determinants of statin response. Expert Opin Drug Metab Toxicol 2010;6:621-32
   PubMed Web of Science ®Google Scholar
• Kitamura S, Maeda K, Wang Y, Sugiyama Y. Involvement of multiple transporters in the hepatobiliary transport of rosuvastatin. Drug Metab Dispos 2008;36:2014-23
   PubMed Web of Science ®Google Scholar
• Keskitalo JE, Zolk O, Fromm MF, ABCG2 polymorphism markedly affects the pharmacokinetics of atorvastatin and rosuvastatin. Clin Pharmacol Ther 2009;86:197-203
   PubMed Web of Science ®Google Scholar
• McCormick AD MD, Butters CJ, ZD4422- an HMG-CoA reductase inhibitor free of metabolically mediated drug interactions: metabolic studies in human in vitro systems [abstract 46]. J Clin Pharmacol 2000;40:1055
   Google Scholar
• Cooper KJ, Martin PD, Dane AL, The effect of fluconazole on the pharmacokinetics of rosuvastatin. Eur J Clin Pharmacol 2002;58:527-31
   PubMed Web of Science ®Google Scholar
• Toth PP, Harper C, Jacobson T. Clinical characterization and molecular mechanisms of statin myopathy. Expert Rev Cardiovasc Ther 2008;6:955-69
   PubMedGoogle Scholar
• Knauer MJ, Urquhart BL, Meyer zu Schwabedissen HE, Human skeletal muscle drug transporters determine local exposure and toxicity of statins. Circ Res 2010;106:297-306
   PubMed Web of Science ®Google Scholar
• Shepherd J, Vidt DG, Miller E, Safety of rosuvastatin: update on 16,876 rosuvastatin-treated patients in a multinational clinical trial program. Cardiology 2007;107:433-43
   PubMed Web of Science ®Google Scholar
• Prueksaritanont T, Zhao JJ, Ma B, Mechanistic studies on metabolic interactions between gemfibrozil and statins. J Pharmacol Exp Ther 2002;301:1042-51
   PubMed Web of Science ®Google Scholar
• Neuvonen PJ, Niemi M, Backman JT. Drug interactions with lipid-lowering drugs: mechanisms and clinical relevance. Clin Pharmacol Ther 2006;80:565-81
   PubMed Web of Science ®Google Scholar
• Tan AT, Low LP, Lim CH, Tan CE. Effects of rosuvastatin on low-density lipoprotein cholesterol and plasma lipids in Asian patients with hypercholesterolemia. J Atheroscler Thromb 2009;16:509-16
   PubMed Web of Science ®Google Scholar
• Deedwania PC, Gupta M, Stein M, Comparison of rosuvastatin versus atorvastatin in South-Asian patients at risk of coronary heart disease (from the IRIS Trial). Am J Cardiol 2007;99:1538-43
   PubMed Web of Science ®Google Scholar
• Takayama T, Hiro T, Yamagishi M, Effect of rosuvastatin on coronary atheroma in stable coronary artery disease: multicenter coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Circ J 2009;73:2110-17
   PubMed Web of Science ®Google Scholar
• Lee E, Ryan S, Birmingham B, Rosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environment. Clin Pharmacol Ther 2005;78:330-41
   PubMed Web of Science ®Google Scholar
• Choi JH, Lee MG, Cho JY, Influence of OATP1B1 genotype on the pharmacokinetics of rosuvastatin in Koreans. Clin Pharmacol Ther 2008;83:251-7
   PubMed Web of Science ®Google Scholar
• Martin PD, Dane AL, Nwose OM, No effect of age or gender on the pharmacokinetics of rosuvastatin: a new HMG-CoA reductase inhibitor. J Clin Pharmacol 2002;42:1116-21
   PubMed Web of Science ®Google Scholar
• Li Y, Jiang X, Lan K, Pharmacokinetic properties of rosuvastatin after single-dose, oral administration in Chinese volunteers: a randomized, open-label, three-way crossover study. Clin Ther 2007;29:2194-203
   PubMed Web of Science ®Google Scholar
• Samman A, Imai C, Straatman L, Safety and efficacy of rosuvastatin therapy for the prevention of hyperlipidemia in adult cardiac transplant recipients. J Heart Lung Transplant 2005;24:1008-13
   PubMed Web of Science ®Google Scholar
• Simonson SG, Raza A, Martin PD, Rosuvastatin pharmacokinetics in heart transplant recipients administered an antirejection regimen including cyclosporine. Clin Pharmacol Ther 2004;76:167-77
   PubMed Web of Science ®Google Scholar
• Kiser JJ, Gerber JG, Predhomme JA, Drug/Drug interaction between lopinavir/ritonavir and rosuvastatin in healthy volunteers. J Acquir Immune Defic Syndr 2008;47:570
   PubMed Web of Science ®Google Scholar
• van der Lee M SR, Schipplers E, Pharkmacokinetics and pharmacodynamics of combined use of lopinavir/ritonavir and rosuvastatin in HIV-infected patients. Antivir Ther 2007;12:1127-32
   PubMed Web of Science ®Google Scholar
• Cohen DE, Anania FA, Chalasani N. An assessment of statin safety by hepatologists. Am J Cardiol 2006;97:77C-81C
   PubMed Web of Science ®Google Scholar
• Kjekshus J, Apetrei E, Barrios V, Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007;357:2248-61
   PubMed Web of Science ®Google Scholar
• Shepherd J, Hunninghake DB, Stein EA, Safety of rosuvastatin. Am J Cardiol 2004;94:882-8
   PubMed Web of Science ®Google Scholar
• Guthrie RM, Martin DR. The safety of rosuvastatin: effects on renal and hepatic function. Expert Opin Drug Saf 2007;6:573-81
   PubMed Web of Science ®Google Scholar
• Pasternak RC, Smith SC Jr, Bairey-Merz CN, ACC/AHA/NHLBI clinical advisory on the use and safety of statins. J Am Coll Cardiol 2002;40:567-72
   PubMed Web of Science ®Google Scholar
• Brewer H. Benefit–risk assessment of rosuvastatin 10 – 40 milligrams. Am J Cardiol 2003;92(Suppl):K23-K9
   Google Scholar
• Garcia-Rodriguez LA, Masso-Gonzalez EL, Wallander MA, Johansson S. The safety of rosuvastatin in comparison with other statins in over 100,000 statin users in UK primary care. Pharmacoepidemiol Drug Saf 2008;17:943-52
   PubMed Web of Science ®Google Scholar
• Dujovne CA. Side effects of statins: hepatitis versus "transaminitis"-myositis versus "CPKitis". Am J Cardiol 2002;89:1411-13
   PubMed Web of Science ®Google Scholar
• Puri P, Sanyal AJ. Why do lipid-lowering agents affect serum transaminase levels, are these drugs toxic to the liver, and can they precipitate liver failure? In: Toth PP, Sica DA, editors. Clinical Challenges in Lipid Disorders. Atlas Publishing; Oxford, UK: 2008. p. 189-201
   Google Scholar
• Ridker PM. The JUPITER trial: results, controversies, and implications for prevention. Circ Cardiovasc Qual Outcomes 2009;2:279-85
   PubMed Web of Science ®Google Scholar
• Rajpathak SN, Kumbhani DJ, Crandall J, Statin therapy and risk of developing type 2 diabetes: a meta-analysis. Diabetes Care 2009;32:1924-9
   PubMed Web of Science ®Google Scholar
• Sattar N, Preiss D, Murray HM, Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010;375:735-42
   PubMed Web of Science ®Google Scholar
• Preiss D, Seshasai SRK, Welsh P, Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy. JAMA 2011;305:2556-64
   PubMed Web of Science ®Google Scholar
• Thongtang N, Ai M, Otokozawa S, Effects of maximal atorvastatin and rosuvastatin treatment on markers of glucose homeostasis and inflammation. Am J Cardiol 2011;107:387-9
   PubMed Web of Science ®Google Scholar
• Vidt DG. Statins and proteinuria. Curr Atheroscler Rep 2005;7:351-7
   PubMedGoogle Scholar
• US Food and Drug Administration.FDA Rejection of Public Citizen Petition. Cited March 11, 2005. Docket No. 2004P-01131CP1
   Google Scholar
• Vidt DG, Ridker PM, Monyak JT, Longitudinal assessment of estimated glomerular filtration rate in apparently healthy adults: a post hoc analysis from the JUPITER Study (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). Clin Ther 2011;33:717-25
   PubMed Web of Science ®Google Scholar
• PLANET 1. Available from: http://www.astrazenecaclinicaltrials.com/_mshost800325/content/clinical-trials/resources/pdf/D3569C00007
   Google Scholar
• PLANET 2. Available from: http://www.astrazenecaclinicaltrials.com/_mshost800325/content/clinical-trials/resources/pdf/D3569C00011
   Google Scholar
• Ridker PM, Danielson E, Fonseca FA, Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359:2195-207
   PubMed Web of Science ®Google Scholar
• Avis HJ, Hutten BA, Gagne C, Efficacy and safety of rosuvastatin therapy for children with familial hypercholesterolemia. J Am Coll Cardiol 2010;55:1121-6
   PubMed Web of Science ®Google Scholar
• Ferdinand KC, Clark LT, Watson KE, Comparison of efficacy and safety of rosuvastatin versus atorvastatin in African-American patients in a six-week trial. Am J Cardiol 2006;97:229-35
   PubMed Web of Science ®Google Scholar
• Lloret R, Ycas J, Stein M, Haffner S. Comparison of rosuvastatin versus atorvastatin in Hispanic-Americans with hypercholesterolemia (from the STARSHIP trial). Am J Cardiol 2006;98:768-73
   PubMed Web of Science ®Google Scholar
• Lablanche JM, Leone A, Merkely B, Comparison of the efficacy of rosuvastatin versus atorvastatin in reducing apolipoprotein B/apolipoprotein A-1 ratio in patients with acute coronary syndrome: results of the CENTAURUS study. Arch Cardiovasc Dis 2010;103:160-9
   PubMed Web of Science ®Google Scholar
• LUNAR trial. Available from: http://www.astrazenecaclinicaltrials.com/_mshost800325/content/clinical-trials/resources/pdf/D3560L00021study.synopsis
   Google Scholar
• Stalenhoef AFH, Ballantyne CM, Sarti C, A COmparative study with rosuvastatin in subjects with METabolic Syndrome: results of the COMETS study. Eur Heart J 2005;26:2664-72
   PubMed Web of Science ®Google Scholar
• Betteridge DJ, Gibson JM. Effects of rosuvastatin on lipids, lipoproteins and apolipoproteins in the dyslipidaemia of diabetes. Diabetes Med 2007;24:541-9
   PubMed Web of Science ®Google Scholar
• Wolffenbuttel BH, Franken AA, Vincent HH. Cholesterol-lowering effects of rosuvastatin compared with atorvastatin in patients with type 2 diabetes – CORALL study. J Intern Med 2005;257:531-9
   PubMed Web of Science ®Google Scholar
• Schuster H, Barter PJ, Stender S, Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin Therapy (MERCURY I) study. Am Heart J 2004;147:705-13
   PubMed Web of Science ®Google Scholar
• Ballantyne CM, Bertolami M, Hernandez Garcia HR, 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 2006;151:975- e1-9
   PubMed Web of Science ®Google Scholar
• Insull W Jr, Ghali JK, Hassman DR, Achieving low-density lipoprotein cholesterol goals in high-risk patients in managed care: comparison of rosuvastatin, atorvastatin, and simvastatin in the SOLAR trial. Mayo Clin Proc 2007;82:543-50
   PubMed Web of Science ®Google Scholar
• Faergeman O, Hill L, Windler E, Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia: results from the ECLIPSE study. Cardiology 2008;111:219-28
   PubMed Web of Science ®Google Scholar
• Ruisinger JF, Backes JM, Gibson CA, Moriarty PM. Once-a-week rosuvastatin (2.5 to 20 mg) in patients with a previous statin intolerance. Am J Cardiol 2009;103:393-4
   PubMed Web of Science ®Google Scholar
• Backes JM, Venero CV, Gibson CA, Effectiveness and tolerability of every-other-day rosuvastatin dosing in patients with prior statin intolerance. Ann Pharmacother 2008;42:341-6
   PubMed Web of Science ®Google Scholar
• Buckett L, BP, Davidson R, Davidson C, Selectivity of ZD4522 for inhibition of cholesterol synthesis in hepatic versus non-hepatic cells. Atherosclerosis 2000;151(1):41
   Google Scholar
• Kostapanos MS, Milionis HJ, Elisaf MS. Rosuvastatin-associated adverse effects and drug-drug interactions in the clinical setting of dyslipidemia. Am J Cardiovasc Drugs 2010;10:11-28
   PubMed Web of Science ®Google Scholar
• Warwick MJ DA, Schneck DW, Single- and multiple-dose pharmacokinetics and safety of the new HMG-CoA reductase inhibitor ZD4522 [poster]. Presented at: International Symposium on Atherosclerosis; June 25 – 29, 2000; Stockholm, Sweden
   Google Scholar
• Chan KL, Teo K, Dumesnil JG, Effect of Lipid lowering with rosuvastatin on progression of aortic stenosis: results of the aortic stenosis progression observation: measuring effects of rosuvastatin (ASTRONOMER) trial. Circulation 2010;121:306-14
   PubMed Web of Science ®Google Scholar
• Fellstrom BC, Jardine AG, Schmieder RE, Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med 2009;360:1395-407
   PubMed Web of Science ®Google Scholar
• 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 2004;26:1821-33
   PubMed Web of Science ®Google Scholar
• Ballantyne CM, Weiss R, Moccetti T, Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study). Am J Cardiol 2007;99:673-80
   PubMed Web of Science ®Google Scholar
• Underhill HR, Yuan C, Zhao XQ, Effect of rosuvastatin therapy on carotid plaque morphology and composition in moderately hypercholesterolemic patients: a high-resolution magnetic resonance imaging trial. Am Heart J 2008;155:584- e1-8
   PubMed Web of Science ®Google Scholar
• Leiter LA, Rosenson RS, Stein E, Efficacy and safety of rosuvastatin 40 mg versus atorvastatin 80 mg in high-risk patients with hypercholesterolemia: results of the POLARIS study. Atherosclerosis 2007;194:e154-64
   PubMed Web of Science ®Google Scholar
• Clearfield MB, Amerena J, Bassand JP, Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia–Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR). Trials 2006;7:35
   PubMed Web of Science ®Google Scholar
• Nicholls SJ, Borgman M, Nissen SE, Impact of statins on progression of atherosclerosis: rationale and design of SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: effect of Rosuvastatin versus AtorvastatiN). Curr Med Res Opin 2011;27:1119-29
   PubMed Web of Science ®Google Scholar