The safety of aggressive statin therapy: How much can low-density lipoprotein cholesterol be lowered?

Mayo Clinic Proceedings

Volumn 81, Issue 9, 2006, Pages 1225-1231

  Jacobson, Terry A ^a  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIFUNGAL AGENT; ATORVASTATIN; CYCLOSPORIN; CYTOCHROME P450; CYTOCHROME P450 3A4; DIGOXIN; ERYTHROMYCIN; FENOFIBRATE; FIBRIC ACID DERIVATIVE; FLUINDOSTATIN; GEMFIBROZIL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LIVER ENZYME; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MACROLIDE; MEVINOLIN; PLACEBO; PRAVASTATIN; PROTEINASE INHIBITOR; PYRROLE DERIVATIVE; ROSUVASTATIN; SIMVASTATIN; TRIACYLGLYCEROL; WARFARIN;

AMINOTRANSFERASE BLOOD LEVEL; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; COMORBIDITY; DRUG EFFICACY; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRUG WITHDRAWAL; EARLY DIAGNOSIS; HUMAN; HYPERLIPIDEMIA; LIVER DISEASE; LIVER FAILURE; LIVER TOXICITY; LOW DRUG DOSE; MORBIDITY; MORTALITY; MUSCLE WEAKNESS; MYALGIA; MYOPATHY; PATIENT COMPLIANCE; PROTEINURIA; REVIEW; RHABDOMYOLYSIS; RISK ASSESSMENT; TITRIMETRY;

EID: 33748195617     PISSN: 00256196     EISSN: None     Source Type: Journal    
DOI: 10.4065/81.9.1225     Document Type: Review

References (32)

1. 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) final report. Circulation. 2002;106:3143-3421.
2. Grundy SM, Cleeman JI, Bairey Merz CN, et al, Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110:227-239.
3. De Backer G, Ambrosioni E, Borch-Johnsen K, et al. European guidelines on cardiovascular disease prevention in clinical practice: Third Joint Task Force of European and other Societies on Cardiovascular Disease Pre-vention in Clinical Practice (constituted by representatives of eight societies and by invited experts). Eur J Cardiovasc Prev Rehab. 2003;10:S1-S10.
4. O'Keefe JH Jr, Cordain L, Harris WH, Moe RM, Vogel R. Optimal low-density lipoprotein is 50 to 70 mg/dl: lower is better and physiologically normal. J Am Coll Cardiol. 2004;43:2142-2146.
5. 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.
6. 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 [published correction appears in Lancet. 2005;366:1358]. Lancet. 2005;366:1267-1278.
7. Cheng JWM. Rosuvastatin in the management of hyperlipidemia. Clin Ther. 2004;26:1368-1387.
8. Cannon CP, Braunwald E, McCabe CH, et al, Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes [published correction appears in N Engl J Med. 2006;354:778]. N Engl J Med. 2004;350:1495-1504.
9. de Lemos JA, Blazing MA, Wiviott SD, et al, A to Z Investigators. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA. 2004 Sep 15;292:1307-1316. Epub 2004 Aug 30.
10. LaRosa JC, Grundy SM, Waters DD, et al, Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005 Apr 7;352:1425-1435. Epub 2005 Mar 8.
11. Pedersen TR, Faergeman O, Kastelein JJ, et al, Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial [published correction appears in JAMA. 2005;294:3092]. JAMA. 2005;294:2437-2445.
12. Nissen SE, Nicholls SJ, Sipahi I, et al, ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006 Apr 5;295:1556-1565. Epub 2006 Mar 13.
13. Pasternak RC, Smith SC Jr, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C. ACC/AHA/NHLBI clinical advisory on the use and safety of statins. J Am Coll Cardiol. 2002;40:567-572.
14. Vuppalanchi R, Teal E, Chalasani N. Patients with elevated baseline liver enzymes do not have higher frequency of hepatotoxicity from lovastatin than those with normal baseline liver enzymes. Am J Med Sci. 2005;329:62-65.
15. Chalasani N, Aljadhey H, Kesterson J, Murray MD, Hall SD. Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity. Gastroenterology. 2004;126:1287-1292.
16. Jacobson TA. Combination lipid-lowering therapy with statins: safety issues in the postcerivastatin era. Expert Opin Drug Saf. 2003;2:269-286.
17. Ballantyne CM, Corsini A, Davidson MH, et al. Risk for myopathy with statin therapy in high-risk patients. Arch Intern Med. 2003;163:553-564.
18. Rosenson RS. Current overview of statin-induced myopathy. Am J Med. 2004;116:408-416.
19. Davidson MH. Combination therapy for dyslipidemia: safety and regulatory considerations. Am J Cardiol. 2002;90(suppl 2):50-60.
20. McTaggart F, Buckett L, Davidson R, et al. Preclinical and clinical pharmacology of rosuvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. Am J Cardiol. 2001;87(suppl):28B-32B.
21. Coumadin tablets/Coumadin for injection (warfarin sodium) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Co; April 2005.
22. Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis [letter]. N Engl J Med. 2002;346:539-540.
23. Davidson MH. Rosuvastatin safety: lessons from the FDA review and post-approval surveillance. Expert Opin Drug Saf. 2004;3:547-557.
24. Pedersen TR, Berg K, Cook TJ, et al. Safety and tolerability of cholesterol lowering with simvastatin during 5 years in the Scandinavian Simvastatin Survival Study. Arch Intern Med. 1996;156:2085-2092.
25. Newman CB, Tsai J, Szarek M, Luo D, Gibson E. Comparative safety of atorvastatin 80 mg versus 10 mg derived from analysis of 49 completed trials in 14,236 patients. Am J Cardiol. 2006 Jan 1;97:61-67. Epub 2005 Nov 15.
26. Shepherd J, Hunninghake DB, Stein EA, et al. Safety of rosuvastatin. Am J Cardiol. 2004;94:882-888.
27. Bakker-Arkema RG, Nawrocki JW, Black DM. Safety profile of atorvastatin-treated patients with low LDL-cholesterol levels. Atherosclerosis. 2000;149:123-129.
28. Iso H, Jacobs DR Jr, Wentworth D, Neaton JD, Cohen JD, MRFIT Research Group. Serum cholesterol levels and six-year mortality from stroke in 350,977 men screened for the Multiple Risk Factor Intervention Trial. N Engl J Med. 1989;320:904-910.
29. Department of Health and Human Services, Food and Drug Administration. FDA response to a citizen petition on Crestor. Available at: www.fda.gov/cder/drug/infopage/rosuvastatin/crestor_CP.pdf. Accessed August 2, 2006.
30. Wiviott SD, Cannon CP, Morrow DA, Ray KK, Pfeffer MA, Braunwald E, PROVE IT-TIMI 22 Investigators. 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 [published correction appears in J Am Coll Cardiol. 2006;47:472]. J Am Coll Cardiol. 2005;46:1411-1416.
31. Brewer HB Jr. Benefit-risk assessment of rosuvastatin 10 to 40 milligrams. Am J Cardiol. 2003;92(suppl):23K-29K.
32. Schuster H. Improving lipid management-to titrate, combine or switch. Int J Clin Pract. 2004;58:689-694.