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