Original Contribution
An assessment by the Statin Muscle Safety Task Force: 2014 update

https://doi.org/10.1016/j.jacl.2014.03.004Get rights and content

Highlights

  • Differential diagnosis of myalgia occurring during statin therapy.

  • Nosology for statin-associated muscle adverse events that provides definitions with clinical utility.

  • Myalgia clinical index score.

  • Recommendations for neuromuscular testing.

Abstract

The National Lipid Association's Muscle Safety Expert Panel was charged with the duty of examining the definitions for statin-associated muscle adverse events, development of a clinical index to assess myalgia, and the use of diagnostic neuromuscular studies to investigate muscle adverse events. We provide guidance as to when a patient should be considered for referral to neuromuscular specialists and indications for the performance of a skeletal muscle biopsy. Based on this review of evidence, we developed an algorithm for the evaluation and treatment of patients who may be intolerant to statins as the result of adverse muscle events. The panel was composed of clinical cardiologists, clinical lipidologists, an exercise physiologist, and a neuromuscular specialist.

Section snippets

2014 Questions

The panel was asked to answer several specific questions for this report. The following questions were addressed by the current panel with their answers. Each answer is provided with an explanation and statements regarding both the strength and the quality of the evidence.

  • 1.

    Can statin-associated myalgia be reliably differentiated from myalgia associated with a placebo?

ANSWER: Yes.

STRENGTH OF RECOMMENDATION: B (Moderate).

QUALITY OF EVIDENCE: Moderate.

EXPLANATION: Myalgia refers to unexplained

Financial disclosures

The following authors disclose that they have modest relationships with industry that might pose a potential conflict of interest(s): Dr. Rosenson (consulting fees: Aegerion, Amgen, AstraZeneca, Genentech, GSK, Janssen, LipoScience, Novartis, Regeneron, Sanofi, Sticares InterACT; Research grants: Amgen, Astra Zeneca, Genentech, Roche, Sanofi; Royalty: UpToDate, Inc.; Ownership interest: LipoScience, Inc.; Honoraria: Kowa); Dr. Jacobson is a consultant for Amarin, Amgen, Astra Zeneca, Merck,

References (72)

  • J.S. Danik et al.

    Lack of association between SLCO1B1 polymorphisms and clinical myalgia following rosuvastatin therapy

    Am Heart J

    (2013)
  • C.J. Glueck 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

    (2006)
  • J.F. Ruisinger et al.

    Once-a-week rosuvastatin (2.5 to 20 mg) in patients with a previous statin intolerance

    Am J Cardiol

    (2009)
  • M. Gadarla et al.

    Efficacy of rosuvastatin (5 mg and 10 mg) twice a week in patients intolerant to daily statins

    Am J Cardiol

    (2008)
  • W. Ahmed et al.

    Low serum 25 (OH) vitamin D levels (<32 ng/mL) are associated with reversible myositis-myalgia in statin-treated patients

    Transl Res

    (2009)
  • A. Gupta et al.

    The relationship of vitamin D deficiency to statin myopathy

    Atherosclerosis

    (2011)
  • L. Marcoff et al.

    The role of coenzyme Q10 in statin-associated myopathy: a systematic review

    J Am Coll Cardiol

    (2007)
  • B.A. Parker et al.

    A randomized trial of coenzyme Q10 in patients with statin myopathy: rationale and study design

    J Clin Lipidol

    (2013)
  • S.C. Halbert 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

    (2010)
  • T.A. Jacobson

    Toward “pain-free” statin prescribing: clinical algorithm for diagnosis and management of myalgia

    Mayo Clin Proc

    (2008)
  • Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce...
  • G.H. Guyatt et al.

    GRADE: an emerging consensus on rating quality of evidence and strength of recommendations

    BMJ

    (2008)
  • P.A. James 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

    (2014)
  • P.D. Thompson et al.

    An assessment of statin safety by muscle experts

    Am J Cardiol

    (2006)
  • D.J. Graham et al.

    Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs

    JAMA

    (2004)
  • P.S. Phillips et al.

    Statin-associated myopathy with normal creatine kinase levels

    Ann Intern Med

    (2002)
  • P.S. Phillips et al.

    Observations from a statin myopathy clinic

    Arch Intern Med

    (2006)
  • E. Bruckert et al.

    Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients—the PRIMO study

    Cardiovasc Drugs Ther

    (2005)
  • C. Buettner et al.

    Prevalence of musculoskeletal pain and statin use

    J Gen Intern Med

    (2008)
  • K. El-Salem et al.

    Prevalence and risk factors of muscle complications secondary to statins

    Muscle Nerve

    (2011)
  • P.M. Ridker et al.

    Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein

    N Engl J Med

    (2008)
  • Ganga HV, Slim HB, Thompson PD. Systematic review of statin-induced muscle problems in clinical trials. Am Heart J. in...
  • H. Zhang et al.

    Discontinuation of statins in routine care settings: a cohort study

    Ann Intern Med

    (2013)
  • J.A. de Lemos 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)
  • J.C. LaRosa et al.

    Intensive lipid lowering with atorvastatin in patients with stable coronary disease

    N Engl J Med

    (2005)
  • T.R. Pedersen et al.

    High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial

    JAMA

    (2005)
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