American Journal of Cardiology
Volume 97, Issue 8, Supplement 1 , Pages S69-S76 , 17 April 2006

An Assessment of Statin Safety by Muscle Experts

  • Paul D. Thompson, MD

      Affiliations

    • Division of Cardiology, Hartford Hospital, Hartford, Connecticut, USA.
    • Corresponding Author InformationAddress for reprints: Paul D. Thompson, MD, Division of Cardiology, Hartford Hospital, 80 Seymour Street, Hartford, Connecticut 06102.
    • ,
  • Priscilla M. Clarkson, PhD

      Affiliations

    • University of Massachusetts at Amherst, Amherst, Massachusetts, USA
    • ,
  • Robert S. Rosenson, MD

      Affiliations

    • Northwestern University, Chicago, Illinois, USA.

References 

  1. Thompson PD , Clarkson P , Karas RH . Statin-associated myopathy . JAMA . 2003;289:1681–1690
  2. Pasternak RC , Smith SC , 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
  3. Pierce LR , Wysowski DK , Gross TP . Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy . JAMA . 1990;264:71–75
  4. Ballantyne CM, Corsini A, Davidson MH, Holdaas H, Jacobson TA, Leitersdorf E, et al. Risk for myopathy with statin therapy in high-risk patients . Arch Intern Med . 2003;163:553–564
  5. de Lemos JA, Blazing MA, Wiviott SD, Lewis EF, Fox KA, White HD, et al  Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes (phase Z of the A to Z trial) . JAMA . 2004;292:1307–1316
  6. Clarkson PM , Hubal MJ . Exercise-induced muscle damage in humans . Am J Phys Med Rehabil . 2002;81:S52–S69
  7. Sayers SP , Clarkson PM , Rouzier PA , Kamen G . Adverse events associated with eccentric exercise protocols (six case studies) . Med Sci Sports Exerc . 1999;31:1697–1702
  8. Clarkson PM, Kearns AK, Rouzier P, Rubin R, Thompson PD. Serum creatine kinase levels and renal function measures in exertional muscle damage. Med Sci Sports Exerc. In press.
  9. Black HR , Quallich H , Gareleck CB . Racial differences in serum creatine kinase levels . Am J Med . 1986;81:479–487
  10. Fuhrmans V . Bayer discloses higher death toll from Baycol . Wall Street Journal . 2002;21:A10; January
  11. Gharavi AG , Diamond JA , Smith DA , Phillips RA . Niacin-induced myopathy . Am J Cardiol . 1994;74:841–842
  12. Langer T , Levy R . Acute muscular syndrome associated with administration of clofibrate . N Engl J Med . 1968;279:856–858
  13. Graham DJ, Staffa JA, Shatin D, Andrade SE, Schech SD, La Grenade L, et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs . JAMA . 2004;292:2585–2590
  14. Gaist D , Rodriguez LA , Huerta C , Hallas J , Sindrup SH . Lipid-lowering drugs and risk of myopathy (a population-based follow-up study) . Epidemiology . 2001;12:565–569
  15. Fux R , Morike K , Gundel UF , Hartmann R , Gleiter CH . Ezetimibe and statin-associated myopathy . Ann Intern Med . 2004;140:671–672
  16. East C , Alivizatos PA , Grundy SM , Jones PH , Farmer JA . Rhabdomyolysis in patients receiving lovastatin after cardiac transplantation . N Engl J Med . 1988;318:47–48
  17. Davidson MH, Stein EA, Dujovne CA, Hunninghake DB, Weiss SR, Knopp RH, et al  The efficacy and six-week tolerability of simvastatin 80 and 160 mg/day . Am J Cardiol . 1997;79:38–42
  18. Rosenson RS , Bays HE . Results of two clinical trials on the safety and efficacy of pravastatin 80 and 160 mg per day . Am J Cardiol . 2003;91:878–881
  19. The statin wars (why AstraZeneca must retreat [editorial]) . Lancet . 2003;362:1341
  20. Hsiang B, Zhu Y, Wang Z, Wu Y, Sasseville V, Yang WP, et al. A novel human hepatic organic anion transporting polypeptide (OATP2) (identification of a liver-specific human organic anion transporting polypeptide and identification of rat and human hydroxymethylglutaryl-CoA reductase inhibitor transporters) . J Biol Chem . 1999;274:37161–37168
  21. Thompson PD , Nugent AM , Herbert PN . Increases in creatine kinase after exercise in patients treated with HMG Co-A reductase inhibitors [letter] . JAMA . 1990;264:2992
  22. Thompson PD , Gadaleta PA , Yurgalevitch S , Cullinane E , Herbert PN . Effects of exercise and lovastatin on serum creatine kinase activity . Metabolism . 1991;40:1333–1336
  23. Thompson PD , Zmuda JM , Domalik LJ , Zimet RJ , Staggers J , Guyton JR . Lovastatin increases exercise-induced skeletal muscle injury . Metabolism . 1997;46:1206–1210
  24. Rosenberg AD , Neuwirth MG , Kagen LJ , Singh K , Fischer HD , Bernstein RL . Intraoperative rhabdomyolysis in a patient receiving pravastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor . Anesth Analg . 1995;81:1089–1091
  25. Phillips PS, Haas RH, Bannykh S, Hathaway S, Gray NL, Kimura BJ, et al. Statin-associated myopathy with normal creatine kinase levels . Ann Intern Med . 2002;137:581–585
  26. Shek A , Ferrill MJ . Statin-fibrate combination therapy . Ann Pharmacother . 2001;35:908–917
  27. Prueksaritanont T, Zhao JJ, Ma B, Roadcap BA, Tang C, Qiu Y, et al. Mechanistic studies on metabolic interactions between gemfibrozil and statins . J Pharmacol Exp Ther . 2002;301:1042–1051
  28. Prueksaritanont T , Tang C , Qiu Y , Mu L , Subramanian R , Lin JH . Effects of fibrates on metabolism of statins in human hepatocytes . Drug Metab Dispos . 2002;30:1280–1287
  29. Hill MD , Bilbao JM . Case of the month (February 1999—54 year old man with severe muscle weakness) . Brain Pathol . 1999;9:607–608
  30. Reaven P , Witztum JL . Lovastatin, nicotinic acid, and rhabdomyolysis . Ann Intern Med . 1988;109:597–598
  31. 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) . Arch Intern Med . 2003;163:688–692
  32. Smith DJ , Olive KE . Chinese red rice-induced myopathy . South Med J . 2003;96:1265–1267
  33. Dahan A , Altman H . Food-drug interaction (grapefruit juice augments drug bioavailability—mechanism, extent and relevance) . Eur J Clin Nutr . 2004;58:1–9
  34. Flint OP , Masters BA , Gregg RE , Durham SK . Inhibition of cholesterol synthesis by squalene synthase inhibitors does not induce myotoxicity in vitro . Toxicol Appl Pharmacol . 1997;145:91–98
  35. Ghirlanda G, Oradei A, Manto A, Lippa S, Uccioli L, Caputo S, et al. Evidence of plasma CoQ10-lowering effect by HMG-CoA reductase inhibitors (a double-blind, placebo-controlled study) . J Clin Pharmacol . 1993;33:226–229
  36. Laaksonen R , Riihimaki A , Laitila J , Martensson K , Tikkanen MJ , Himberg JJ . Serum and muscle tissue ubiquinone levels in healthy subjects . J Lab Clin Med . 1995;125:517–521
  37. Laaksonen R, Jokelainen K, Laakso J, Sahi T, Harkonen M, Tikkanen MJ, et al. The effect of simvastatin treatment on natural antioxidants in low-density lipoproteins and high-energy phosphates and ubiquinone in skeletal muscle . Am J Cardiol . 1996;77:851–854
  38. Laaksonen R , Ojala JP , Tikkanen MJ , Himberg JJ . Serum ubiquinone concentrations after short- and long-term treatment with HMG-CoA reductase inhibitors . Eur J Clin Pharmacol . 1994;46:313–317
  39. Laaksonen R , Jokelainen K , Sahi T , Tikkanen MJ , Himberg JJ . Decreases in serum ubiquinone concentrations do not result in reduced levels in muscle tissue during short-term simvastatin treatment in humans . Clin Pharmacol Ther . 1995;57:62–66
  40. Paiva H, Thelen KM, Van Coster R, Smet J, De Paepe B, Mattila KM, et al. High-dose statins and skeletal muscle metabolism in humans (a randomized, controlled trial) . Clin Pharmacol Ther . 2005;78:60–68
  41. Schaefer WH, Lawrence JW, Loughlin AF, Stoffregen DA, Mixson LA, Dean DC, et al. Evaluation of ubiquinone concentration and mitochondrial function relative to cerivastatin-induced skeletal myopathy in rats . Toxicol Appl Pharmacol . 2004;194:10–23
  42. Kelly P , Vasu S , Getato M , McNurlan M , Lawson WE . Coenzyme Q10 improves myopathic pain in statin treated patients . [abstract] J Am Coll Cardiol . 2005;45:3A

PII: S0002-9149(05)02146-6

doi: 10.1016/j.amjcard.2005.12.013

American Journal of Cardiology
Volume 97, Issue 8, Supplement 1 , Pages S69-S76 , 17 April 2006

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