An overview of statin-induced myopathy and perspectives for the future

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<p class="first" id="d5178064e162">Introduction: Statins remain the most commonly prescribed lipid-lowering drug class for the treatment of atherosclerotic cardiovascular disease. Their well-recognized side effects are known as statin-associated muscle symptom (SAMS). Some advances in this field have been made in recent years, but the understanding of the mechanisms has lagged. Investigating the specific role of the anti-HMGCR autoantibody, pharmacokinetic genetic variants, characterization of the known phenotypes of statin toxicity, in relation to clinical markers of disease, is of high importance.Areas covered: We summarized currently available findings (on PubMed) related to SAMS and discussed the therapeutic approaches, risk factors, drug interactions, potential novel systems, algorithms and biomarkers for SAMS detection. CoQ10 supplementation has been suggested as a complementary approach to manage SAMS, while vitamin D levels may be useful for both the diagnosis and management.Expert Opinion/Commentary: Further studies might help to understand the easiest way to diagnose SAMS, suitable prevention and an effective non-statin therapy. This review sheds new light on the future directions in both research and clinical practice, which will help with rapid risk assessment, identification of the SAMS risk factors in order to decrease the incidence of statins' adverse effects, and the most effective therapy. </p>

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Intensive versus moderate lipid lowering with statins after acute coronary syndromes.

Christopher Cannon, Eugene Braunwald, Carolyn McCabe … (2004)

Lipid-lowering therapy with statins reduces the risk of cardiovascular events, but the optimal level of low-density lipoprotein (LDL) cholesterol is unclear. We enrolled 4162 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and compared 40 mg of pravastatin daily (standard therapy) with 80 mg of atorvastatin daily (intensive therapy). The primary end point was a composite of death from any cause, myocardial infarction, documented unstable angina requiring rehospitalization, revascularization (performed at least 30 days after randomization), and stroke. The study was designed to establish the noninferiority of pravastatin as compared with atorvastatin with respect to the time to an end-point event. Follow-up lasted 18 to 36 months (mean, 24). The median LDL cholesterol level achieved during treatment was 95 mg per deciliter (2.46 mmol per liter) in the standard-dose pravastatin group and 62 mg per deciliter (1.60 mmol per liter) in the high-dose atorvastatin group (P<0.001). Kaplan-Meier estimates of the rates of the primary end point at two years were 26.3 percent in the pravastatin group and 22.4 percent in the atorvastatin group, reflecting a 16 percent reduction in the hazard ratio in favor of atorvastatin (P=0.005; 95 percent confidence interval, 5 to 26 percent). The study did not meet the prespecified criterion for equivalence but did identify the superiority of the more intensive regimen. Among patients who have recently had an acute coronary syndrome, an intensive lipid-lowering statin regimen provides greater protection against death or major cardiovascular events than does a standard regimen. These findings indicate that such patients benefit from early and continued lowering of LDL cholesterol to levels substantially below current target levels. Copyright 2004 Massachusetts Medical Society

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Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management

Erik Stroes, Paul Thompson, Alberto Corsini … (2015)

Statin-associated muscle symptoms (SAMS) are one of the principal reasons for statin non-adherence and/or discontinuation, contributing to adverse cardiovascular outcomes. This European Atherosclerosis Society (EAS) Consensus Panel overviews current understanding of the pathophysiology of statin-associated myopathy, and provides guidance for diagnosis and management of SAMS. Statin-associated myopathy, with significant elevation of serum creatine kinase (CK), is a rare but serious side effect of statins, affecting 1 per 1000 to 1 per 10 000 people on standard statin doses. Statin-associated muscle symptoms cover a broader range of clinical presentations, usually with normal or minimally elevated CK levels, with a prevalence of 7–29% in registries and observational studies. Preclinical studies show that statins decrease mitochondrial function, attenuate energy production, and alter muscle protein degradation, thereby providing a potential link between statins and muscle symptoms; controlled mechanistic and genetic studies in humans are necessary to further understanding. The Panel proposes to identify SAMS by symptoms typical of statin myalgia (i.e. muscle pain or aching) and their temporal association with discontinuation and response to repetitive statin re-challenge. In people with SAMS, the Panel recommends the use of a maximally tolerated statin dose combined with non-statin lipid-lowering therapies to attain recommended low-density lipoprotein cholesterol targets. The Panel recommends a structured work-up to identify individuals with clinically relevant SAMS generally to at least three different statins, so that they can be offered therapeutic regimens to satisfactorily address their cardiovascular risk. Further research into the underlying pathophysiological mechanisms may offer future therapeutic potential.

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The safety of statins in clinical practice.

Jane Armitage (2007)

Statins are effective cholesterol-lowering drugs that reduce the risk of cardiovascular disease events (heart attacks, strokes, and the need for arterial revascularisation). Adverse effects from some statins on muscle, such as myopathy and rhabdomyolysis, are rare at standard doses, and on the liver, in increasing levels of transaminases, are unusual. Myopathy--muscle pain or weakness with blood creatine kinase levels more than ten times the upper limit of the normal range--typically occurs in fewer than one in 10,000 patients on standard statin doses. However, this risk varies between statins, and increases with use of higher doses and interacting drugs. Rhabdomyolysis is a rarer and more severe form of myopathy, with myoglobin release into the circulation and risk of renal failure. Stopping statin use reverses these side-effects, usually leading to a full recovery. Asymptomatic increases in concentrations of liver transaminases are recorded with all statins, but are not clearly associated with an increased risk of liver disease. For most people, statins are safe and well-tolerated, and their widespread use has the potential to have a major effect on the global burden of cardiovascular disease.

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Camelia Cristina Diaconu: (View ORCID Profile)

Giuseppe Montalto: (View ORCID Profile)

Manfredi Rizzo: (View ORCID Profile)

Journal

Title: Expert Opinion on Drug Safety

Abbreviated Title: Expert Opinion on Drug Safety

Publisher: Informa UK Limited

ISSN (Print): 1474-0338

ISSN (Electronic): 1744-764X

Publication date Created: May 03 2020

Publication date (Electronic): April 13 2020

Publication date (Print): May 03 2020

Volume: 19

Issue: 5

Pages: 601-615

Affiliations

[1 ]Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, Palermo, Italy

[2 ]BELSS, Euro-Mediterranean Institute of Science and Technology (IEMEST), Palermo, Italy

[3 ]Department of Hypertension, Medical University of Lodz, Lodz, Poland

[4 ]Department of Diabetes, Nutrition and Metabolic Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania

[5 ]Department of Internal Medicine, Clinical Emergency Hospital of Bucharest, Bucharest, Romania

[6 ]Department of Internal Medicine, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania

Article

DOI: 10.1080/14740338.2020.1747431

PubMed ID: 32233708

SO-VID: b9d6099f-3e4a-46b2-94e2-6200d9940d75

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An overview of statin-induced myopathy and perspectives for the future

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Most cited references 115

Intensive versus moderate lipid lowering with statins after acute coronary syndromes.

Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management

The safety of statins in clinical practice.

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