654
Views
27
CrossRef citations to date
0
Altmetric
Review

Muscle and statins: from toxicity to the nocebo effect

, &
Pages 573-579 | Received 19 Mar 2019, Accepted 01 May 2019, Published online: 09 May 2019

References

  • Goldstein JL, Brown MS. A century of cholesterol and coronaries: from plaques to genes to statins. Cell. 2015;161:161–172.
  • Catapano AL, Graham I, De Backer G, et al. ESC/EAS guidelines for the management of dyslipidaemias: the Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J. 2016;2016(37):2999–3058.
  • Ference BA, Ginsberg HN, Graham I, et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017;38:2459–2472.
  • Brown MS, Goldstein JL. A tribute to Akira Endo, discoverer of a “Penicillin” for cholesterol. Atheroscler Suppl. 2004;5:13–16.
  • Baigent C, Keech A, Kearney PM, et al., 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;366:1267–1278.
  • Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from. 170,000 participants in 26 randomised trials. Lancet. 2010;376:1670–1681.
  • Cholesterol Treatment Trialists’ (CTT) Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from. 27 randomised trials. Lancet. 2012;380:581–590.
  • Yiannakopoulou EC, Papadopulos JS, Cokkinos DV, et al. Adherence to antihypertensive treatment: a critical factor for blood pressure control. Eur J Cardiovasc Prev Rehabil. 2005;12:243–249.
  • Kamal-Bahl SJ, Burke T, Watson D, et al. Discontinuation of lipid modifying drugs among commercially insured United States patients in recent clinical practice. Am J Cardiol. 2007;99:530–534.
  • Zhang H, Plutzky J, Skentzos S, et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med. 2013;158:526–534.
  • Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487–497.
  • McGinnis B, Olson KL, Magid D, et al. Factors related to adherence to statin therapy. Ann Pharmacother. 2007;41:1805–1811.
  • Colantonio LD, Rosenson RS, Deng L, et al. Adherence to statin therapy among US adults between 2007 and 2014. J Am Heart Assoc. 2019;8:e010376.
  • Wei MY, Ito MK, Cohen JD, et al. Predictors of statin adherence, switching and discontinuation in the USAGE survey: understanding the use of statins in America and gaps in patient education. J Clin Lipidol. 2013;7:472–483.
  • Cohen JD, Brinton EA, Ito MK, et al. 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. 2012;6:208–215.
  • Mampuya WM, Frid D, Rocco M, et al. Treatment strategies in patients with statin intolerance: the Cleveland Clinic experience. Am Heart J. 2013;166:597–603.
  • Serban M-C, Colantonio LD, Manthripragada AD, et al. Statin intolerance and risk of coronary heart events and all-cause mortality following myocardial infarction. J Am Coll Cardiol. 2017;69:1386–1395.
  • Graham JH, Sanches RJ, Sassen JJ, et al. Clinical and economic consequences of statin intolerance in the United States: results from an integrated health system. J Clin Lipidol. 2017;11:70–79.
  • Backes JM, Ruisinger JF, Gibson CA, et al. Statin-associated muscle symptoms. Managing the highly intolerant. J Clin Lipidol. 2017;11:24–33.
  • Laufs U, Filipiak KJ, Gouni-Berthold I, et al., SAMS Expert Working Group.Practical aspects in the management of statin-associated muscle symptoms (SAMS). Atheroscler Suppl. 2017;26:45–55.
  • Rosenson RS, Baker S, Banach M, et al. Optimizing cholesterol treatment in patients with muscle complaints. J Am Coll Cardiol. 2017;70:1290–1301.
  • Taylor BA, Thompson PD. Statin-associated muscle disease: advances in diagnosis and management. Neurotherapeutics. 2018;15:1006–1017.
  • Toth PP, Patti AM, Giglio RV, et al. Management of statin intolerance in 2018: still more questions than answers. Am J Cardiovasc Drugs. 2018;18:157–173.
  • Ward NC, Watts GF, Eckel RH. Statin toxicity. Circ Res. 2019;124:328–350.
  • Banach M, Rizzo M, Toth PP, et al. Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Expert Opin Drug Saf. 2015;14:935–955.
  • Thompson PD, Panza G, Zaleski A, et al. Statin-associated side effects. J Am Coll Cardiol. 2016;67:2395–2410.
  • Mancini GB, Baker S, Bergeron J, et al. Diagnosis, prevention, and management of statin adverse effects and intolerance: Canadian Consensus Working Group Update (2016). Can J Cardiol. 2016;32(7Suppl):S35–S65.
  • Stroes ES, Thompson PD, Corsini A, et al., European Atherosclerosis Society Consensus Panel. Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society consensus panel statement on assessment, aetiology and management. Eur Heart J. 2015;36:1012–1022.
  • Alfirevic A, Neely D, Armitage J, et al. Phenotype standardization for statin-induced myotoxicity. Clin Pharmacol Ther. 2014;96:470–476.
  • Rosenson RS, Baker SK, Jacobson TA, et al., The National Lipid Association’s Muscle Safety Expert Panel. An assessment by the Statin Muscle Safety Task Force: 2014 update.. J Clin Lipidol. 2014;8(3 Suppl):S58–S71.
  • Pedro-Botet J, Millán Núñez-Cortés J, Chillarón JJ, et al. Severity of statin-induced adverse effects on muscle and associated conditions: data from the DAMA study. Expert Opin Drug Saf. 2016;15:1583–1587.
  • Lakey WC, Greyshock NG, Kelley CE, et al. Statin intolerance in a referral lipid clinic. J Clin Lipidol. 2016;10:870–879.
  • Hovingh GK, Gandra SR, McKendrick J, et al. Identification and management of patients with statin-associated symptoms in clinical practice: a clinician survey. Atherosclerosis. 2016;245:111–117.
  • Keen HI, Krishnarajah J, Bates TR, et al. Statin myopathy: the fly in the ointment for the prevention of cardiovascular disease in the 21st century? Expert Opin Drug Saf. 2014;13:1227–1239.
  • Algharably EA, Filler I, Rosenfeld S, et al. Statin intolerance – a question of definition. Expert Opin Drug Saf. 2017;16:55–63.
  • Christopher-Stine L, Basharat P. Statin-associated immune-mediated myopathy: biology and clinical implications. Curr Opin Lipidol. 2017;28:186–192.
  • Reiner Z. Resistance and intolerance to statins. Nutr Metab Cardiovasc Dis. 2014;24:1057–1066.
  • Rosenson RS, Miller K, Bayliss M, et al. The statin-associated muscle symptom clinical index (SAMS-CI): revision for clinical use, content validation, and inter-rater reliability. Cardiovasc Drugs Ther. 2017;31:179–186.
  • Bruckert E, Hayem G, Dejager S, et al. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients–the PRIMO study. Cardiovasc Drugs Ther. 2005;19:403–414.
  • Buettner C, Davis RB, Leveille SG, et al. Prevalence of musculoskeletal pain and statin use. J Gen Intern Med. 2008;23:1182–1186.
  • Rosenbaum D, Dallongeville J, Sabouret P, et al. Discontinuation of statin therapy due to muscular side effects: a survey in real life. Nutr Metab Cardiovasc Dis. 2013;23:871–875.
  • Newman CB, Tobert JA. Statin intolerance: reconciling clinical trials and clinical experience. Jama. 2015;313:1011–1012.
  • Peto R, Collins R. Trust the blinded randomized evidence that statin therapy rarely causes symptomatic side effects. Circulation. 2018;138:1499–1501.
  • Kashani A, Phillips CO, Foody JM, et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation. 2006;114:2788–2797.
  • Ganga HV, Slim HB, Thompson PD. A systematic review of statin-induced muscle problems in clinical trials. Am Heart J. 2014;168:6–15.
  • Collins R, Reith C, Emberson J, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet. 2016;388:2532–2561.
  • Riaz H, Khan AR, Khan MS, et al. Meta-analysis of placebo-controlled randomized controlled trials on the prevalence of statin intolerance. Am J Cardiol. 2017;120:774–781.
  • Thompson PD, Zmuda JM, Domalik LJ, et al. Lovastatin increases exercise-induced skeletal muscle injury. Metabolism. 1997;46:1206–1210.
  • Parker BA, Capizzi JA, Grimaldi AS, et al. Effect of statins on skeletal muscle function. Circulation. 2013;127:96–103.
  • Taylor BA, Lorson L, White CM, et al. A randomized trial of coenzyme Q10 in patients with confirmed statin myopathy. Atherosclerosis. 2015;238:329–335.
  • Moriarty PM, Thompson PD, Cannon CP, et al.; ODYSSEY ALTERNATIVE Investigators. Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: the ODYSSEY ALTERNATIVE randomized trial. J Clin Lipidol. 2015;9:758–769.
  • Nissen SE, Stroes E, Dent-Acosta RE, et al. Efficacy and tolerability of evolocumab versus ezetimibe in patients with muscle-related statin intolerance: the GAUSS-3 randomized clinical trial. Jama. 2016;315:1580–1590.
  • Joy TR, Monjed A, Zou GY, et al. N-of-1 (single-patient) trials for statin-related myalgia. Ann Intern Med. 2014;160:301–310.
  • Tobert JA, Newman CB. The nocebo effect in the context of statin intolerance. J Clin Lipidol. 2016;10:739–747.
  • Kennedy WP. The nocebo reaction. Med World. 1961;95:203–205.
  • Olshansky B. Placebo and nocebo in cardiovascular health: implications for healthcare, research, and the doctor-patient relationship. J Am Coll Cardiol. 2007;49:415–421.
  • Cocco G. Erectile dysfunction after therapy with metoprolol: the Hawthorne effect. Cardiology. 2009;112:174–177.
  • Matthews A, Herrett E, Gasparrini A, et al. Impact of statin-related media coverage on use of statins: interrupted time series analysis with UK primary care data. Bmj. 2016;353:i3283.
  • Nielsen SF, Nordestgaard BG. Negative statin-related news stories decrease statin persistence and increase myocardial infarction and cardiovascular mortality: a nationwide prospective cohort study. Eur Heart J. 2016;37:908–916.
  • Webster RK, Weinman J, Rubin GJ. A systematic review of factors that contribute to nocebo effects. Health Psychol. 2016;35:1334–1355.
  • Gupta A, Thompson D, Whitehouse A, et al., ASCOT Investigators. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet.. 2017;389:2473–2481.
  • Penson PE, Mancini GBJ, Toth PP, et al., Lipid and Blood Pressure Meta-Analysis Collaboration (LBPMC) Group & International Lipid Expert Panel (ILEP).Introducing the ‘Drucebo’ effect in statin therapy: a systematic review of studies comparing reported rates of statin-associated muscle symptoms, under blinded and open-label conditions. J Cachexia Sarcopenia Muscle. 2018;9:1023–1033.
  • Rojas-Mirquez JC, Rodriguez-Zuniga MJ, Bonilla-Escobar FJ, et al. Nocebo effect in randomized clinical trials of antidepressants in children and adolescents: systematic review and meta-analysis. Front Behav Neurosci. 2014;8:375.
  • Herrett E, Williamson E, Beaumont D, et al. Study protocol for statin web-based investigation of side effects (StatinWISE): a series of randomised controlled N-of-1 trials comparing atorvastatin and placebo in UK primary care. BMJ Open. 2017;7(12):e016604.
  • Pedro-Botet J, Rubiés-Prat J. Statin-associated muscle symptoms: beware of the nocebo effect. Lancet. 2017;389:2445–2446.
  • Newman CB, Preiss D, Tobert JA, et al., American Heart Association Clinical Lipidology, Lipoprotein, Metabolism and Thrombosis Committee, a Joint Committee of the Council on Atherosclerosis, Thrombosis and Vascular Biology and Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Stroke Council. Statin safety and associated adverse events: a scientific statement from the American Heart Association. Arterioscler Thromb Vasc Biol. 2019; 39:e38–e81.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.