Final Conclusions and Recommendations of the National Lipid Association Statin Safety Assessment Task Force

https://doi.org/10.1016/j.amjcard.2006.02.030Get rights and content

This article summarizes the final conclusions of the National Lipid Association (NLA) Statin Safety Task Force, based on a review and independent research of New Drug Application (NDA) information, US Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) data, cohort and clinical trial results, and analysis of administrative claims database information and the assessment of its 4 Expert Panels, which focused on issues of statin safety with regard to liver, muscle, renal, and neurologic systems. Practical guidance in the form of recommendations to health professionals who manage the coronary artery disease risk of patients with statin therapy is provided.

Section snippets

Final conclusions

Asymptomatic elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver enzymes >3 times the upper limit of normal (ULN) are seen with all 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins. 1 According to data from New Drug Applications (NDAs) and the prescribing information for each marketed statin, elevations of this magnitude are seen in <1% of patients receiving initial and intermediate doses and in 2%–3% of patients receiving 80

Final conclusions

Muscle symptoms (ie, pain, soreness, weakness, and/or cramps) or signs (creatine kinase [CK] elevations) are arguably the most prevalent and important adverse effect associated with statin therapy. The occurrence of serious muscle toxicity with currently marketed statins fortunately is rare. 6 According to findings from 21 clinical trials providing 180,000 person-years of follow-up in patients treated with statin or placebo, myopathy (defined as muscle symptoms plus CK >10 times the ULN) occurs

Final conclusions

In the absence of rhabdomyolysis, acute renal failure or insufficiency does not appear to be caused by statin therapy. 7 Although case reports of renal failure have been reported in patients receiving statin therapy, they are encountered as frequently in patients receiving statins as in patients not receiving statins. 2 In the 3 pravastatin clinical trials (Cholesterol and Recurrent Events [CARE] trial, Long-Term Intervention with Pravastatin in Ischaemic Disease [LIPID] study, and West of

Final conclusions

The occurrence of peripheral neuropathy in patients taking a statin is very rare. 9 A causal relation is not supported by the Heart Protection Study (HPS), a randomized, placebo-controlled clinical trial in >20,000 individuals in which peripheral neuropathy was recorded in 11 patients who received simvastatin and in 8 patients who received placebo. 2 Another large randomized, placebo-controlled trial in elderly patients, the Pravastatin in Elderly Individuals at Risk of Vascular Disease

Acknowledgments

The authors are grateful for the generous expert advice we received from Neil J. Stone, MD, Professor of Medicine, Northwestern University School of Medicine and Harold Bays, MD, President, Louisville Metabolic and Atherosclerosis Research Center.

References (9)

  • D.E. Cohen et al.

    An assessment of statin safety by hepatologists

    Am J Cardiol

    (2006)
  • H. Bays

    Statin safetyan overview and assessment of the data—2005

    Am J Cardiol

    (2006)
  • T.A. Jacobson

    Statin safetylessons from New Drug Applications for marketed statins

    Am J Cardiol

    (2006)
  • M. Law et al.

    Statin safetyevidence from the published literature

    Am J Cardiol

    (2006)
There are more references available in the full text version of this article.

Cited by (0)

View full text