Generic placeholder image

Current Drug Safety

Editor-in-Chief

ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Research Article

Statin Associated Muscular Adverse Effects

Author(s): Rania Kammoun, Ons Charfi*, Ghozlane Lakhoua, Ahmed Zaiem, Riadh Daghfous, Sarrah Kastalli, Imen Aouinti and Sihem El Aidli

Volume 19, Issue 1, 2024

Published on: 05 April, 2023

Page: [114 - 116] Pages: 3

DOI: 10.2174/1574886318666230227143627

Price: $65

Abstract

Background: Statins are widely used in the treatment of hyperlipidemia and in the prevention of cardiovascular diseases. However, they may induce muscular adverse effects that range from asymptomatic elevation of creatine kinase to life threatening rhabdomyolysis.

Objective: The aim of the study was to describe epidemiological and clinical characteristics of patients with muscular adverse effects.

Methods: We conducted a retrospective and descriptive study over a ten-year period from January 2010 to December 2019. We included all cases of statin associated muscular adverse effects notified to the Tunisian National Centre of Pharmacovigilance during this period.

Results: The study involved 22 muscular adverse effects related to statins (28% of all adverse events reported with statins during this period). Patient’s mean age was 58.7 years and the sex ratio was 1.6. There were 12 cases of isolated creatine kinase elevation, 5 cases of myalgia, 3 cases of myopathy, one case of myositis and one case of rhabdomyolysis. Muscular adverse effects occurred 7 days to 15 years after starting this drug. In all cases, the statin was withdrawn after muscular adverse effects and resolution of symptoms was observed within 10 days to 18 months. In seven cases, creatine kinase persisted elevated for 18 months. Involved statins were atorvastatin, simvastatin, rosuvastatin and fluvastatin.

Conclusion: Early recognition of muscle symptoms is required to prevent rhabdomyolysis. Further researchare needed to completely elucidate the pathophysiology of statin-induced muscular adverse effects.

Keywords: Statin, adverse drug reaction, creatine kinase, myotoxicity, atorvastatin, rhabdomyolysis.

Graphical Abstract
[1]
Bouitbir J, Sanvee GM, Panajatovic MV, Singh F, Krähenbühl S. Mechanisms of statin-associated skeletal muscle-associated symptoms. Pharmacol Res 2020; 154: 104201.
[http://dx.doi.org/10.1016/j.phrs.2019.03.010] [PMID: 30877064]
[2]
Thompson PD, Panza G, Zaleski A, Taylor B. Statin-associated side effects. J Am Coll Cardiol 2016; 67(20): 2395-410.
[http://dx.doi.org/10.1016/j.jacc.2016.02.071] [PMID: 27199064]
[3]
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30(2): 239-45.
[http://dx.doi.org/10.1038/clpt.1981.154] [PMID: 7249508]
[4]
Stroes ES, Thompson PD, Corsini A, et al. Statin-associated muscle symptoms: Impact on statin therapy-European atherosclerosis society consensus panel statement on assessment, aetiology and management. Eur Heart J 2015; 36(17): 1012-22.
[http://dx.doi.org/10.1093/eurheartj/ehv043] [PMID: 25694464]
[5]
Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis. N Engl J Med 2002; 346(7): 539-40.
[http://dx.doi.org/10.1056/NEJM200202143460721] [PMID: 11844864]
[6]
Cohen JD, Brinton EA, Ito MK, Jacobson TA. 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(3): 208-15.
[http://dx.doi.org/10.1016/j.jacl.2012.03.003] [PMID: 22658145]
[7]
Auer J, Sinzinger H, Franklin B, Berent R. Muscle- and skeletal-related side-effects of statins: Tip of the iceberg? Eur J Prev Cardiol 2016; 23(1): 88-110.
[http://dx.doi.org/10.1177/2047487314550804] [PMID: 25230981]
[8]
Danielak D, Karaźniewicz-Łada M, Główka F. Assessment of the risk of rhabdomyolysis and myopathy during concomitant treatment with ticagrelor and statins. Drugs 2018; 78(11): 1105-12.
[http://dx.doi.org/10.1007/s40265-018-0947-x] [PMID: 30003466]
[9]
Bruckert E, Hayem G, Dejager S, Yau C, Bégaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients: The PRIMO study. Cardiovasc Drugs Ther 2005; 19(6): 403-14.
[http://dx.doi.org/10.1007/s10557-005-5686-z] [PMID: 16453090]
[10]
Farmer JA. The effect of statins on skeletal muscle function: The STOMP trial. Curr Atheroscler Rep 2013; 15(8): 347.
[http://dx.doi.org/10.1007/s11883-013-0347-3] [PMID: 23843151]
[11]
Thompson PD. My approach to managing statin associated muscle symptoms. Trends Cardiovasc Med 2017; 27(2): 160-1.
[http://dx.doi.org/10.1016/j.tcm.2016.09.007] [PMID: 28107840]
[12]
Echaniz-Laguna A, Mohr M, Tranchant C. Neuromuscular symptoms and elevated creatine kinase after statin withdrawal. N Engl J Med 2010; 362(6): 564-5.
[http://dx.doi.org/10.1056/NEJMc0908215] [PMID: 20147729]
[13]
El-Salem K, Ababneh B, Rudnicki S, et al. Prevalence and risk factors of muscle complications secondary to statins. Muscle Nerve 2011; 44(6): 877-81.
[http://dx.doi.org/10.1002/mus.22205] [PMID: 22102457]
[14]
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(3): 567-72.
[http://dx.doi.org/10.1016/S0735-1097(02)02030-2] [PMID: 12142128]
[15]
Azemawah V, Movahed MR, Centuori P, et al. State of the art comprehensive review of individual statins, their differences, pharmacology, and clinical implications. Cardiovasc Drugs Ther 2019; 33(5): 625-39.
[http://dx.doi.org/10.1007/s10557-019-06904-x] [PMID: 31773344]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy