An assessment by the statin muscle safety task force: 2014 update

Journal of Clinical Lipidology

Volumn 8, Issue 3 SUPPL, 2014, Pages

  Rosenson, Robert S ^a   Baker, Steven K ^b   Jacobson, Terry A ^c   Kopecky, Stephen L ^d   Parker, Beth A ^e  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b MCMASTER UNIVERSITY   (Canada)

^c EMORY UNIVERSITY   (United States)

^d MAYO CLINIC   (United States)

^e HARTFORD HOSPITAL   (United States)

Author keywords

Muscle adverse events; Myalgia; Myopathy; Neuromuscular testing; Rhabdomyolysis; Statin intolerance; Statins

Indexed keywords

ATORVASTATIN; CERIVASTATIN; CHOLESTIN; COLESEVELAM; FLUINDOSTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; NUTRACEUTICAL; PITAVASTATIN; PLACEBO; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; TIROFIBAN; UBIDECARENONE; CREATINE KINASE; VITAMIN D;

ARTICLE; CHOLESTEROL BLOOD LEVEL; CREATINE KINASE BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG SAFETY; DRUG WITHDRAWAL; HUMAN; HYPERCHOLESTEROLEMIA; MUSCLE BIOPSY; MUSCLE EXAMINATION; MUSCLE NECROSIS; MYALGIA; MYOPATHY; MYOSITIS; NEUROMUSCULAR SYSTEM; NONHUMAN; PARKINSON DISEASE; PATIENT REFERRAL; PRACTICE GUIDELINE; PRIORITY JOURNAL; RHABDOMYOLYSIS; SUPPLEMENTATION; SYMPTOMATOLOGY; VITAMIN D DEFICIENCY; BLOOD; CARDIOVASCULAR DISEASES; COMPLICATION; EVIDENCE BASED MEDICINE; FAMILIAL HYPERCHOLESTEROLEMIA; METABOLISM; MUSCULAR DISEASES; PATHOLOGY; SKELETAL MUSCLE;

CARDIOVASCULAR DISEASES; CREATINE KINASE; EVIDENCE-BASED MEDICINE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERLIPOPROTEINEMIA TYPE II; MUSCLE, SKELETAL; MUSCULAR DISEASES; MYALGIA; VITAMIN D;

EID: 84899893293     PISSN: 19332874     EISSN: 18764789     Source Type: Journal    
DOI: 10.1016/j.jacl.2014.03.004     Document Type: Article

References (72)

1. Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol, in press.
2. G.H. Guyatt, A.D. Oxman, G.E. Vist Group Grade Working Group GRADE: an emerging consensus on rating quality of evidence and strength of recommendations BMJ 336 2008 924 926
3. P.A. James, S. Oparil, and B.L. Carter et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) JAMA 311 2014 507 520
4. P.D. Thompson, P.M. Clarkson, R.S. Rosenson National Lipid Association Statin Safety Task Force Muscle Safety Expert Panel An assessment of statin safety by muscle experts Am J Cardiol 97 2006 69C 76C
5. R.C. Pasternak, S.C. Smith Jr., C.N. Bairey-Merz American College of Cardiology, American Heart Association, National Heart, Lung, and Blood Institute ACC/AHA/NHLBI clinical advisory on the use and safety of statins J Am Coll Cardiol 40 2002 567 572
6. G.B. Mancini, S. Baker, and J. Bergeron et al. Diagnosis, prevention, and management of statin adverse effects and intolerance: proceedings of a Canadian Working Group Consensus Conference Can J Cardiol 27 2011 635 662
7. D.J. Graham, J.A. Staffa, and D. Shatin et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs JAMA 292 2004 2585 2590
8. P.S. Phillips, R.H. Haas, S. Bannykh Scripps Mercy Clinical Research Center Statin-associated myopathy with normal creatine kinase levels Ann Intern Med 137 2002 581 585
9. P.S. Phillips, and R.H. Haas Observations from a statin myopathy clinic Arch Intern Med 166 2006 1232 1233 author reply 1233
10. E. Bruckert, G. Hayem, S. Dejager, C. Yau, and B. Begaud Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients - the PRIMO study Cardiovasc Drugs Ther 19 2005 403 414
11. C. Buettner, R.B. Davis, S.G. Leveille, M.A. Mittleman, and K.J. Mukamal Prevalence of musculoskeletal pain and statin use J Gen Intern Med 23 2008 1182 1186
12. K. El-Salem, B. Ababneh, and S. Rudnicki et al. Prevalence and risk factors of muscle complications secondary to statins Muscle Nerve 44 2011 877 881
13. J.D. Cohen, E.A. Brinton, M.K. Ito, and T.A. Jacobson Understanding Statin Use in America and Gaps in Patient Education (USAGE): an internet-based survey of 10,138 current and former statin users J Clin Lipidol 6 2012 208 215
14. P.M. Ridker, E. Danielson, and F.A. Fonseca et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein N Engl J Med 359 2008 2195 2207
15. Ganga HV, Slim HB, Thompson PD. Systematic review of statin-induced muscle problems in clinical trials. Am Heart J. in press.
16. R.C. Neal, K.C. Ferdinand, J. Ycas, and E. Miller Relationship of ethnic origin, gender, and age to blood creatine kinase levels Am J Med 122 2009 73 78
17. H. Zhang, J. Plutzky, and S. Skentzos et al. Discontinuation of statins in routine care settings: a cohort study Ann Intern Med 158 2013 526 534
18. W.M. Mampuya, D. Frid, and M. Rocco et al. Treatment strategies in patients with statin intolerance: the Cleveland Clinic experience Am Heart J 166 2013 597 603
19. J.A. de Lemos, M.A. Blazing, and S.D. Wiviott 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 292 2004 1307 1316
20. J.C. LaRosa, S.M. Grundy, D.D. Waters Treating to New Targets Investigators Intensive lipid lowering with atorvastatin in patients with stable coronary disease N Engl J Med 352 2005 1425 1435
21. T.R. Pedersen, O. Faergeman, J.J. Kastelein Incremental Decrease in End Points Through Aggressive Lipid Lowering Study Group High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial JAMA 294 2005 2437 2445
22. Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) Collaborative Group J. Armitage, L. Bowman, and K. Wallendszus et al. Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial Lancet 376 2010 1658 1669
23. B.A. Parker, J.A. Capizzi, and A.S. Grimaldi et al. Effect of statins on skeletal muscle function Circulation 127 2013 96 103
24. C.S. Cleeland, and K.M. Ryan Pain assessment: global use of the Brief Pain Inventory Ann Acad Med Singapore 23 1994 129 138
25. R. Melzack The short-form McGill Pain Questionnaire Pain 30 1987 191 197
26. S. Cham, M.A. Evans, J.O. Denenberg, and B.A. Golomb Statin-associated muscle-related adverse effects: a case series of 354 patients Pharmacotherapy 30 2010 541 553
27. H. Sinzinger, and J. O'Grady Professional athletes suffering from familial hypercholesterolaemia rarely tolerate statin treatment because of muscular problems Br J Clin Pharmacol 57 2004 525 528
28. P.D. Thompson, J.M. Zmuda, L.J. Domalik, R.J. Zimet, J. Staggers, and J.R. Guyton Lovastatin increases exercise-induced skeletal muscle injury Metabolism 46 1997 1206 1210
29. B.A. Parker, A.L. Augeri, and J.A. Capizzi et al. Effect of statins on creatine kinase levels before and after a marathon run Am J Cardiol 109 2012 282 287
30. B.M. Meador, and K.A. Huey Statin-associated changes in skeletal muscle function and stress response after novel or accustomed exercise Muscle Nerve 44 2011 882 889
31. B.A. Parker, and P.D. Thompson Effect of statins on skeletal muscle: exercise, myopathy, and muscle outcomes Exerc Sport Sci Rev 40 2012 188 194
32. Medical Research Council (Great Britain), University of Edinburgh. Department of Surgery Aids to the examination of the peripheral nervous system 1976 Her Majesty's Stationery Office London
33. P.D. Thompson, B.A. Parker, and P.M. Clarkson et al. A randomized clinical trial to assess the effect of statins on skeletal muscle function and performance: rationale and study design Prev Cardiol 13 2010 104 111
34. J.S. Wu, C. Buettner, H. Smithline, L.H. Ngo, and R.L. Greenman Evaluation of skeletal muscle during calf exercise by 31-phosphorus magnetic resonance spectroscopy in patients on statin medications Muscle Nerve 43 2011 76 81
35. B. Grassi, S. Porcelli, and M. Marzorati et al. Metabolic myopathies: functional evaluation by analysis of oxygen uptake kinetics Med Sci Sports Exerc 41 2009 2120 2127
36. S.K. Baker, G.D. Vladutiu, W.L. Peltier, P.J. Isackson, and M.A. Tarnopolsky Metabolic myopathies discovered during investigations of statin myopathy Can J Neurol Sci 35 2008 94 97
37. S.C. Group, E. Link, and S. Parish et al. SLCO1B1 variants and statin-induced myopathy - a genomewide study N Engl J Med 359 2008 789 799
38. P.J. Isackson, H.M. Ochs-Balcom, and C. Ma et al. Association of common variants in the human eyes shut ortholog (EYS) with statin-induced myopathy: evidence for additional functions of EYS Muscle Nerve 44 2011 531 538
39. M.J. Hubal, J.M. Devaney, and E.P. Hoffman et al. CCL2 and CCR2 polymorphisms are associated with markers of exercise-induced skeletal muscle damage J Appl Physiol (1985) 108 2010 1651 1658
40. A. Ghatak, O. Faheem, and P.D. Thompson The genetics of statin-induced myopathy Atherosclerosis 210 2010 337 343
41. G.D. Vladutiu, Z. Simmons, and P.J. Isackson et al. Genetic risk factors associated with lipid-lowering drug-induced myopathies Muscle Nerve 34 2006 153 162
42. A. Echaniz-Laguna, M. Mohr, and C. Tranchant Neuromuscular symptoms and elevated creatine kinase after statin withdrawal N Engl J Med 362 2010 564 565
43. R. Armour, and L. Zhou Outcomes of statin myopathy after statin withdrawal J Clin Neuromuscul Dis 14 2013 103 109
44. N.J. Silvestri, and G.I. Wolfe Asymptomatic/pauci-symptomatic creatine kinase elevations (hyperckemia) Muscle Nerve 47 2013 805 815
45. B.B. Murinson, N.J. Haughey, and N.J. Maragakis Selected statins produce rapid spinal motor neuron loss in vitro BMC Musculoskelet Disord 13 2012 100
46. K. Iwamoto, Y. Yoshii, and K. Ikeda Atorvastatin treatment attenuates motor neuron degeneration in wobbler mice Amyotroph Lateral Scler 10 2009 405 409
47. N. Simsek Ozek, I.B. Bal, Y. Sara, R. Onur, and F. Severcan Structural and functional characterization of simvastatin-induced myotoxicity in different skeletal muscles Biochim Biophys Acta 1840 2014 406 415
48. F.R. Westwood, A. Bigley, K. Randall, A.M. Marsden, and R.C. Scott Statin-induced muscle necrosis in the rat: distribution, development, and fibre selectivity Toxicol Pathol 33 2005 246 257
49. T. Kyriakides, C. Angelini, and J. Schaefer et al. EFNS review on the role of muscle biopsy in the investigation of myalgia Eur J Neurol 20 2013 997 1005
50. A.L. Mammen, T. Chung, and L. Christopher-Stine et al. Autoantibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase in patients with statin-associated autoimmune myopathy Arthritis Rheum 63 2011 713 721
51. K.D. Marciante, J.P. Durda, and S.R. Heckbert et al. Cerivastatin, genetic variants, and the risk of rhabdomyolysis Pharmacogenet Genomics 21 2011 280 288
52. J.S. Danik, D.I. Chasman, J.G. MacFadyen, F. Nyberg, B.J. Barratt, and P.M. Ridker Lack of association between SLCO1B1 polymorphisms and clinical myalgia following rosuvastatin therapy Am Heart J 165 2013 1008 1014
53. L.R. Brunham, P.J. Lansberg, and L. Zhang et al. Differential effect of the rs4149056 variant in SLCO1B1 on myopathy associated with simvastatin and atorvastatin Pharmacogenomics J 12 2012 233 237
54. B.A. Schick, R. Laaksonen, and J.J. Frohlich et al. Decreased skeletal muscle mitochondrial DNA in patients treated with high-dose simvastatin Clin Pharmacol Ther 81 2007 650 653
55. Cholesterol Treatment Trialists (CTT) Collaboration C. Baigent, L. Blackwell, and J. Emberson et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials Lancet 376 2010 1670 1681
56. C. Piamsomboon, P. Laothavorn, and S. Saguanwong et al. Efficacy and safety of atorvastatin 10 mg every other day in hypercholesterolemia J Med Assoc Thai 85 2002 297 300
57. M.A. Juszczyk, R.L. Seip, and P.D. Thompson Decreasing LDL cholesterol and medication cost with every-other-day statin therapy Prev Cardiol 8 2005 197 199
58. J.M. Backes, C.V. Venero, and C.A. Gibson et al. Effectiveness and tolerability of every-other-day rosuvastatin dosing in patients with prior statin intolerance Ann Pharmacother 42 2008 341 346
59. C.J. Glueck, D. Aregawi, and M. Agloria et al. Rosuvastatin 5 and 10 mg/d: a pilot study of the effects in hypercholesterolemic adults unable to tolerate other statins and reach LDL cholesterol goals with nonstatin lipid-lowering therapies Clin Ther 28 2006 933 942
60. J.F. Ruisinger, J.M. Backes, C.A. Gibson, and P.M. Moriarty Once-a-week rosuvastatin (2.5 to 20 mg) in patients with a previous statin intolerance Am J Cardiol 103 2009 393 394
61. M. Gadarla, A.K. Kearns, and P.D. Thompson Efficacy of rosuvastatin (5 mg and 10 mg) twice a week in patients intolerant to daily statins Am J Cardiol 101 2008 1747 1748
62. C.M. Ballantyne, J. Houri, and A. Notarbartolo et al. Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial Circulation 107 2003 2409 2415
63. M.H. Davidson, J.M. Donovan, S. Misir, and M.R. Jones A 50-week extension study on the safety and efficacy of colesevelam in adults with primary hypercholesterolemia Am J Cardiovasc Drugs 10 2010 305 314
64. W. Ahmed, N. Khan, and C.J. Glueck et al. Low serum 25 (OH) vitamin D levels (<32 ng/mL) are associated with reversible myositis-myalgia in statin-treated patients Transl Res 153 2009 11 16
65. A. Gupta, and P.D. Thompson The relationship of vitamin D deficiency to statin myopathy Atherosclerosis 215 2011 23 29
66. L. Marcoff, and P.D. Thompson The role of coenzyme Q10 in statin-associated myopathy: a systematic review J Am Coll Cardiol 49 2007 2231 2237
67. J. Fedacko, D. Pella, and P. Fedackova et al. Coenzyme Q(10) and selenium in statin-associated myopathy treatment Can J Physiol Pharmacol 91 2013 165 170
68. M.P. Bogsrud, G. Langslet, and L. Ose et al. No effect of combined coenzyme Q10 and selenium supplementation on atorvastatin-induced myopathy Scand Cardiovasc J 47 2013 80 87
69. B.A. Parker, S.M. Gregory, L. Lorson, D. Polk, C.M. White, and P.D. Thompson A randomized trial of coenzyme Q10 in patients with statin myopathy: rationale and study design J Clin Lipidol 7 2013 187 193
70. S.C. Halbert, B. French, and R.Y. Gordon et al. Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance Am J Cardiol 105 2010 198 204
71. T.A. Jacobson Toward "pain-free" statin prescribing: clinical algorithm for diagnosis and management of myalgia Mayo Clin Proc 83 2008 687 700
72. T.T. Abd, and T.A. Jacobson Statin-induced myopathy: a review and update Expert Opin Drug Saf 10 2011 373 387