Atorvastatin: safety and tolerability

Bibliography

• Grundy SM. HMG-CoA reductase inhibitors for treatment of hypercholesterolemia. N Engl J Med 1988;319:24-33
   PubMed Web of Science ®Google Scholar
• Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005;366:1267-78
   PubMed Web of Science ®Google Scholar
• Pedersen TR, Tobert JA. Benefits and risks of HMG-CoA reductase inhibitors in the prevention of coronary heart disease: a reappraisal. Drug Saf 1996;14:11-24
   PubMed Web of Science ®Google Scholar
• Armitage J. The safety of statins in clinical practice. Lancet 2007;370:1781-90
   PubMed Web of Science ®Google Scholar
• Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 2003;326:1423-9
   PubMed Web of Science ®Google Scholar
• Arca M. Atorvastatin. A safety and tolerability profile. Drugs 2007;67(Suppl 1):63-9
   PubMedGoogle Scholar
• Sever PS, Dahlof B, Poulter NR, ; ASCOT investigators. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet 2003;361:1149-58
   PubMed Web of Science ®Google Scholar
• Colhoun HM, Betteridge DJ, Durrington PN, ; on behalf of the CARDS investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004;364:685-96
   PubMed Web of Science ®Google Scholar
• Schwartz GG, Olsson AG, Ezekowitz MD, ; Myocardial ischemia reduction with aggressive cholesterol lowering (MIRACL) Study Investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA 2001;285:1711-8
   PubMed Web of Science ®Google Scholar
• Cannon CP, Braunwald E, McCabe CH, ; Pravastatin or atorvastatin evaluation and infection therapy-thrombolysis in myocardial infarction 22 investigators. 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
• LaRosa JC, Grundy SM, Waters DD, ; for the Treating to New Targets (INT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352:1425-35
   PubMed Web of Science ®Google Scholar
• The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med 2006;355:549-59
   PubMed Web of Science ®Google Scholar
• Athyros VG, Kakafika AI, Tziomalos K, Pleiotropic effects of statins – clinical evidence. Curr Pharm Des 2009;15:479-89
   PubMed Web of Science ®Google Scholar
• Feely WD J. Pharmacokinetic-pharmacodynamic drug interactions with HMG-CoA reductase inhibitors. Clin Pharmacokinet 2002;41:343-70
   PubMed Web of Science ®Google Scholar
• Law MR, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006;97(Suppl):52C-60C
   PubMedGoogle 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
• Jacobson TA. Comparative pharmacokinetic interaction profiles of pravastatin, simvastatin, and atorvastatin when co-administered with cytochrome P450 inhibitors. Am J Cardiol 2004;94:1140-6
   PubMed Web of Science ®Google Scholar
• Mitsios JV, Papathanasiou AI, Rodis FI, Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation 2004;109:1335-8
   PubMed Web of Science ®Google Scholar
• Lotfi A, Schweiger MJ, Giugliano GR, ; TIMI 22 Investigators. High-dose atorvastatin does not negatively influence clinical outcomes among clopidogrel treated acute coronary syndrome patients – a pravastatin or atorvastatin evaluation and infection therapy-thrombolysis in myocardial infarction 22 (PROVE IT-TIMI 22) analysis. Am Heart J 2008;155:954-8
   PubMed Web of Science ®Google Scholar
• Farid NA, Small DS, Payne CD, Effect of atorvastatin on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel in healthy subjects. Pharmacotherapy 2008;28:1483-94
   PubMed Web of Science ®Google Scholar
• Ahmed W, Khan N, Glueck CJ, Low serum 25 (OH) vitamin D levels (<32 ng/mL) are associated with reversible myositis-myalgia in statin-treated patients. Transl Res 2009;153:11-6
   PubMed Web of Science ®Google Scholar
• Schwartz JB. Effects of vitamin D supplementation in atorvastatin-treated patients: a new drug interaction with an unexpected consequence. Clin Pharmacol Ther 2009;85:198-203
   PubMed Web of Science ®Google Scholar
• Adams JS, Hewison M. Update in vitamin D. J Clin Endocrinol Metab 2010;95:471-8
   PubMed Web of Science ®Google Scholar
• Croom KF, Plosker GL. Atorvastatin. A review of its use in the primary prevention of cardiovascular events in patients with type 2 diabetes mellitus. Drugs 2005;65:137-52
   PubMed Web of Science ®Google Scholar
• Armitage J. The safety of statins in clinical practice. Lancet 2007;370:1781-90
   PubMed Web of Science ®Google Scholar
• Chatzizisis YS, Koskinas KC, Misirli G, Risk factors and drug interactions predisposing to statin-induced myopathy: implications for risk assessment, prevention and treatment. Drug Saf 2010;33:171-87
   PubMed Web of Science ®Google Scholar
• Arora R, Liebo M, Maldonado F. Statin-induced myopathy: the two faces of Janus. J Cardiovasc Pharmacol Ther 2006;11:105-12
   PubMed Web of Science ®Google Scholar
• Tiwari A, Bansal V, Chugh A, Mookhtiar K. Statins and myotoxicity: a therapeutic limitation. Expert Opin Drug Saf 2006;5:651-66
   PubMed Web of Science ®Google Scholar
• Athyros VG, Mikhailidis DP, Didangelos TP, Effect of multifactorial treatment on non-alcoholic fatty liver disease in metabolic syndrome: a randomised study. Curr Med Res Opin 2006;22:873-83
   PubMed Web of Science ®Google Scholar
• Anfossi G, Massucco P, Bonomo K, Trovati M. Prescription of statins to dyslipidemic patients affected by liver diseases: a subtle balance between risks and benefits. Nutr Metab Cardiovasc Dis 2004;14:215-24
   PubMed Web of Science ®Google Scholar
• Owczarek J, Jasinska M, Orszulak-Michalak D. Drug-induced myopathies. An overview of the possible mechanisms. Pharmacol Rep 2005;57:23-34
   PubMed Web of Science ®Google Scholar
• LaRosa JC, Grundy SM, Kastelein JJ, ; Treating to New Targets (TNT) Steering Committee and Investigators. Safety and efficacy of atorvastatin-induced very low-density lipoprotein cholesterol levels in patients with coronary heart disease (a post hoc analysis of the treating to new targets [TNT] study). Am J Cardiol 2007;100:747-52
   PubMed Web of Science ®Google Scholar
• Escobar C, Echarri R, Barrios V. Relative safety profiles of high dose statin regimens. Vasc Health Risk Manag 2008;4:525-33
   PubMedGoogle Scholar
• Pedersen TR, Faergeman O, Kastelein JJP, High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA 2005;294:2437-45
   PubMed Web of Science ®Google Scholar
• Athyros VG, Tziomalos K, Florentin M, Statin loading in patients undergoing percutaneous coronary intervention for acute coronary syndromes: a new pleiotropic effect? Curr Med Res Opin 2010;26:839-42
   PubMed Web of Science ®Google Scholar
• Newman CB, Palmer G, Silbershatz H, Szarek M. Safety of atorvastatin derived from analysis of 44 completed trials in 9,416 patients. Am J Cardiol 2003;92:670-6
   PubMed Web of Science ®Google Scholar
• Newman C, Tsai J, Szarek M, Comparative safety of atorvastatin 80 mg versus 10 mg derived from analysis of 49 completed trials in 14,236 patients. Am J Cardiol 2006;97:61-7
   PubMed Web of Science ®Google Scholar
• Athyros VG, Papageorgiou AA, Mercouris BR, Treatment with atorvastatin: the National Cholesterol Educational Program goal versus ‘usual’ care in secondary coronary heart disease prevention. The GREek Atorvastatin and Coronary heart disease Evaluation (GREACE) study. Curr Med Res Opin 2002;18:220-8
   PubMed Web of Science ®Google Scholar
• Koren MJ, Hunninghake DB. Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the ALLIANCE study. J Am Coll Cardiol 2004;44:1772-9
   PubMed Web of Science ®Google Scholar
• Alsheikh-Ali AA, Karas RH. Safety of lovastatin/extended re lease niacin therapeutic dosages compared with lovastatin alone, atorvastatin alone, pravastatin alone, and simvastatin alone (from the United States Food and Drug Administration adverse event reporting system). Am J Cardiol 2007;99:379-81
   PubMed Web of Science ®Google Scholar
• Alsheikh-Ali AA, Ambrose MS, Kuvin JT, The safety of rosuvastatin as used in common clinical practice: a postmarketing analysis. Circulation 2005;111:3051-7
   PubMed Web of Science ®Google Scholar
• Bruckert E, Hayem G, Dejager S, Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients – the PRIMO study. Cardiovasc Drugs Ther 2005;19:403-14
   PubMed Web of Science ®Google Scholar
• Davidson MH. Combination therapy for dyslipidemia: safety and regulatory considerations. Am J Cardiol 2002;90:50K-60K
   PubMed Web of Science ®Google Scholar
• The US Food and Drug Administration. Medical product safety information. Available from: http://www.fda.gov/medwatch/safety. [Accessed 4 April 2010]
   Google Scholar
• Chang JT, Staffa JA, Parks M, Green L. Rhabdomyolysis with HMGCoA reductase inhibitors and gemfibrozil combination therapy. Pharmacoepidemiol Drug Saf 2004;13:417-26
   PubMed Web of Science ®Google Scholar
• Graham DJ, Staffa JA, Shatin D, Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA 2004;292:2585-90
   PubMed Web of Science ®Google Scholar
• Black C, Jick H. Etiology and frequency of rhabdomyolysis. Pharmacotherapy 2002;22:1524-6
   PubMed Web of Science ®Google Scholar
• Evans M, Rees A. Effects of HMG-CoA reductase inhibitors on skeletal muscle. Drug Saf 2002;25:649-63
   PubMed Web of Science ®Google Scholar
• Chang JT, Staffa JA, Parks M, Rhabdomyolysis with HMG-CoA reductase inhibitors and gemfibrozil combination. Pharmacoepidemiol Drug Saf 2004;13:417-26
   PubMed Web of Science ®Google Scholar
• SEARCH Collaborative Group, Link E, Parish S, Armitage J, SLCO1B1 variants and statin-induced myopathy – a genomewide study. N Eng J Med 2008;359:789-99
   PubMed Web of Science ®Google Scholar
• Voora D, Shah SH, Spasojevic I, The SLCO1B1*5 genetic variant is associated with statin-induced side effects. J Am Coll Cardiol 2009;54:1609-16
   PubMed Web of Science ®Google Scholar
• Backes JM, Howard PA, Ruisinger JF, Moriarty PM. Does simvastatin cause more myotoxicity compared with other statins?. Ann Pharmacother 2009;43:2012-20
   PubMed Web of Science ®Google Scholar
• Waters DD. Safety of high-dose atorvastatin therapy. Am J Cardiol 2005;96(Suppl):69F-75F
   PubMedGoogle Scholar
• US Food and Drug Administration, Center for Drug Evaluation and Research. Statins and hepatotoxicity. [US Food and Drug Administration Web site] Available from: http://www. fda.gov/ Drugs/GuidanceCompliance RegulatoryInformation/ Surveillance/ucm090385.htm. [Accessed 4 April 2010]
   Google Scholar
• Tolman KG. The liver and lovastatin. Am J Cardiol 2002;89:1374-80
   PubMed Web of Science ®Google Scholar
• Athyros VG, Papageorgiou AA, Symeonidis AN, ; GREACE Study Collaborative Group. Early benefit from structured care with atorvastatin in patients with coronary heart disease and diabetes mellitus. Angiology 2003;54:679-90
   PubMed Web of Science ®Google Scholar
• Knopp RH, D'Emden M, Smilde JG, Pocock SJ; the ASPEN Study Group. Efficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN). Diabetes Care 2006;29:1478-85
   PubMed Web of Science ®Google Scholar
• Gazi IF, Mikhailidis DP. Efficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN): response to Knopp. Diabetes Care 2006;29:2561
   PubMed Web of Science ®Google Scholar
• Patel SS, Kimmel PL, Singh A. New clinical practice guidelines for chronic kidney disease: a framework for K/DOQI. Semin Nephrol 2002;22:449-58
   PubMed Web of Science ®Google Scholar
• Athyros VG, Mikhailidis DP, Papageorgiou AA, The effect of statins versus untreated dyslipidaemia on renal function in patients with coronary heart disease. A subgroup analysis of the Greek atorvastatin and coronary heart disease evaluation (GREACE) study. J Clin Pathol 2004;57:728-34
   PubMed Web of Science ®Google Scholar
• Shepherd J, Kastelein JJ, Bittner V, Intensive lipid lowering with atorvastatin in patients with coronary heart disease and chronic kidney disease: the TNT (Treating to New Targets) study. J Am Coll Cardiol 2008;51:1448-54
   PubMed Web of Science ®Google Scholar
• Athyros VG, Karagiannis A, Kakafika A, Statins and renal function. Is the compound and dose making a difference? Nephrol Dial Transplant 2007;22:963-4
   PubMed Web of Science ®Google Scholar
• Athyros VG, Papageorgiou AA, Elisaf M, Mikhailidis DP; GREACE Study Collaborative Group. Statins and renal function in patients with diabetes mellitus. Curr Med Res Opin 2003;19:615-7
   PubMed Web of Science ®Google Scholar
• Wanner C, Krane V, Marz W, ; German Diabetes and Dialysis Study Investigators. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005;353:238-48
   PubMed Web of Science ®Google Scholar
• Schech S, Graham D, Staffa J, Risk factors for statin associated rhabdomyolysis. Pharmacoepidemiol Drug Saf 2007;16:352-8
   PubMed Web of Science ®Google Scholar
• Hey-Hadavi JH, Kuntze E, Luo D, Tolerability of atorvastatin in a population aged ≥65 years: a retrospective pooled analysis of results from fifty randomized clinical trials. Am J Geriatr Pharmacother 2006;4:112-22
   PubMedGoogle Scholar
• Neil HAW, Demicco DA, Luo D, Analysis of efficacy and safety in patients aged 65–75 years at randomization Collaborative Atorvastatin Diabetes Study (CARDS). Diabetes Care 2006;29:2378-84
   PubMed Web of Science ®Google Scholar
• Wenger NK, Lewis SJ, Herrington DM, Outcomes of using high- or low-dose atorvastatin in patients 65 years of age or older with stable coronary heart disease. Ann Inter Med 2007;147:1-7
   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
• Koh KK, Quon MJ, Han SH, Atorvastatin causes insulin resistance and increases ambient glycemia in hypercholesterolemic patients. J Am Coll Cardiol 2010;55:1209-16
   PubMed Web of Science ®Google Scholar
• Athyros VG, Papageorgiou AA, Athyrou VV, Atorvastatin and micronized fenofibrate alone and in combination in type 2 diabetes with combined hyperlipidemia. Diabetes Care 2002;25:1198-202
   PubMed Web of Science ®Google Scholar
• Athyros VG, Mikhailidis DP, Papageorgiou AA, Targeting vascular risk in patients with metabolic syndrome but without diabetes. Metabolism 2005;54:1065-74
   PubMed Web of Science ®Google Scholar
• McKenney JM, Jones PH, Bays HE, Comparative effects on lipid levels of combination therapy with a statin and extended-release niacin or ezetimibe versus a statin alone (the COMPELL study). Atherosclerosis 2007;192:432-7
   PubMed Web of Science ®Google Scholar