Effects of simvastatin 40 mg daily on muscle and liver adverse effects in a 5-year randomized placebo-controlled trial in 20,536 high-risk people

BMC Clinical Pharmacology

Volumn 9, Issue , 2009, Pages

  Bowman, Louise ^a   Armitage, Jane ^b   Collins, Rory ^b   Parish, Sarah ^b   Tobert, Jonathan ^b   Meade, T ^b   Sleight, P ^b   Peto, R ^b   Youngman, L ^b   Buxton, M ^b   de Bono, D ^b   George, C ^b   Fuller, J ^b   Keech, A ^b   Mansfield, A ^b   Pentecost, B ^b   Simpson, D ^b   Warlow, C ^b   McNamara, J ^b   O'Toole, L ^b   Doll, R ^b   Wilhelmsen, L ^b   Fox, K M ^b   Hill, C ^b   Sandercock, P ^b   more..

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; SIMVASTATIN; ANTIDIABETIC AGENT; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; HYPOCHOLESTEROLEMIC AGENT;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BILIRUBIN BLOOD LEVEL; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEPATITIS; HEPATOBILIARY DISEASE; HIGH RISK PATIENT; HUMAN; INCIDENCE; KIDNEY FAILURE; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MORBIDITY; MORTALITY; MUSCLE WEAKNESS; MYALGIA; MYOPATHY; NEUROLOGIC DISEASE; PATIENT COMPLIANCE; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS; SIDE EFFECT; TREATMENT DURATION; UNITED KINGDOM; VASCULAR DISEASE; CHEMICALLY INDUCED DISORDER; DRUG EFFECT; FOLLOW UP; LIVER; METABOLISM; MIDDLE AGED; MUSCLE; MUSCLE DISEASE; RISK FACTOR; TREATMENT OUTCOME;

AGED; ANTICHOLESTEREMIC AGENTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPOGLYCEMIC AGENTS; INCIDENCE; LIVER; MIDDLE AGED; MUSCLES; MUSCULAR DISEASES; PATIENT COMPLIANCE; PLACEBOS; RISK FACTORS; SIMVASTATIN; TREATMENT OUTCOME;

EID: 65749097599     PISSN: None     EISSN: 14726904     Source Type: Journal    
DOI: 10.1186/1472-6904-9-6     Document Type: Article

References (25)

1. Pedersen TR Tobert JA Simvastatin: A review Expert Opin Pharmacother 2004, 5:2583-96 10.1517/14656566.5.12.2583 15571475
2. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S) Lancet 1994, 344:1383-9 7968073
3. 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 10.1016/S0140-6736(02)09327-3 12114036
4. Heart Protection Study Collaborative Group MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: A randomised placebo-controlled trial Lancet 2003, 361:2005-16 10.1016/S0140-6736(03)13636-7 12814710
5. Heart Protection Study Collaborative Group Effects of cholesterol-lowering with simvastatin on stroke and other major vascular events in 20536 people with cerebrovascular disease or other high-risk conditions Lancet 2004, 363:757-67 10.1016/S0140-6736(04)15690-0 15016485
6. Heart Protection Study Collaborative Group Randomized trial of the effects of cholesterol-lowering with simvastatin on peripheral vascular and other major vascular outcomes in 20,536 people with peripheral arterial disease and other high-risk conditions Journal of Vascular Surgery 2007, 45:645-654 10.1016/j.jvs.2006.12.054 17398372
7. 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 10.1016/S0140-6736(05)67394-1 16214597
8. Heart Protection Study Collaborative Group 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 European Heart Journal 1999, 20:725-41 10.1053/euhj.1998.1350 10329064
9. Heart Protection Study Collaborative Group The effects of cholesterol lowering with simvastatin on cause-specific mortality and on cancer incidence in 20,536 high-risk people: A randomised placebo-controlled trial BMC Med 2005, 3:6 1079844 15771782 10.1186/1741-7015-3-6
10. Heart Protection Study Collaborative Group N-terminal Pro-B-type natriuretic peptide, vascular disease risk, and cholesterol reduction among 20,536 patients in the MRC/BHF heart protection study Journal of the American College of Cardiology 2007, 49:311-9 10.1016/ j.jacc.2006.08.052 17239712
11. Ballantyne CM Corsini A Davidson MH Holdaas H Jacobson TA Leitersdorf E Marz W Reckless JP Stein EA Risk for myopathy with statin therapy in high-risk patients Archives of Internal Medicine 2003, 163:553-64 10.1001/archinte.163.5.553 12622602
12. Thompson PD Clarkson P Karas RH Statin-associated myopathy JAMA 2003, 289:1681-90 10.1001/jama.289.13.1681 12672737
13. Law M Rudnicka AR Statin safety: A systematic review American Journal of Cardiology 2006, 97:52C-60C 10.1016/j.amjcard.2005.12.010 16581329
14. Tobert JA Efficacy and long-term adverse effect pattern of lovastatin American Journal of Cardiology 1988, 62:28J-34J 10.1016/ 0002-9149(88)90004-5 3055921
15. Tobert JA Lovastatin and beyond: The history of the HMG-CoA reductase inhibitors Nat Rev Drug Discov 2003, 2:517-26 10.1038/nrd1112 12815379
16. Tolman KG The liver and lovastatin American Journal of Cardiology 2002, 89:1374-80 10.1016/S0002-9149(02)02355-X 12062731
17. Bays H Statin safety: An overview and assessment of the data - 2005 American Journal of Cardiology 2006, 97:6C-26C 10.1016/ j.amjcard.2005.12.006 16581330
18. Smith CC Bernstein LI Davis RB Rind DM Shmerling RH Screening for statin-related toxicity: The yield of transaminase and creatine kinase measurements in a primary care setting Archives of Internal Medicine 2003, 163:688-92 10.1001/archinte.163.6.688 12639201
19. Heart Protection Study Collaborative Group MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20,536 high-risk individuals: A randomised placebo-controlled trial Lancet 2002, 360:23-33 10.1016/S0140-6736(02)09328-5 12114037
20. Maddrey WC Drug-induced hepatotoxicity: 2005 Journal of Clinical Gastroenterology 2005, 39:S83-9 10.1097/01.mcg.0000155548.91524.6e 15758665
21. Lang JM Buring JE Rosner B Cook N Hennekens CH Estimating the effect of the run-in on the power of the Physicians' Health Study Statistics in Medicine 1991, 10:1585-93 10.1002/sim.4780101010 1947514
22. Link E Parish S Armitage J Bowman L Heath S Matsuda F Gut I Lathrop M Collins R SLCO1B1 variants and statin-induced myopathy - a genomewide study New England Journal of Medicine 2008, 359:789-99 10.1056/ NEJMoa0801936 18650507
23. Pedersen TR Berg K Cook TJ Faergeman O Haghfelt T Kjekshus J Miettinen T Musliner TA Olsson AG Pyorala K Thorgeirsson G Tobert JA Wedel H Wilhelmsen L Safety and tolerability of cholesterol lowering with simvastatin during 5 years in the Scandinavian Simvastatin Survival Study Archives of Internal Medicine 1996, 156:2085-92 10.1001/ archinte.156.18.2085 8862101
24. Amacher DE Serum transaminase elevations as indicators of hepatic injury following the administration of drugs Regul Toxicol Pharmacol 1998, 27(2):119-30 10.1006/rtph.1998.1201 9671567
25. Bowman L Armitage J Bulbulia R Parish S Collins R Study of the effectiveness of additional reductions in cholesterol and homocysteine (SEARCH): Characteristics of a randomized trial among 12064 myocardial infarction survivors American Heart Journal 2007, 154:815-23 10.1016/ j.ahj.2007.06.034 17967584