Final conclusions and recommendations of the National Lipid Association Statin Safety Assessment Task Force.
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.
McKenney
James M
JM
National Clinical Research, Virginia Commonwealth University, Richmond, Virginia 23294, USA. jmckenney@ncrinc.net
Davidson
Michael H
MH
Jacobson
Terry A
TA
Guyton
John R
JR
D016907:Adverse Drug Reaction Reporting Systems; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D003071:Cognition / Q000502:physiology; D003402:Creatine Kinase / Q000097:blood; D016208:Databases, Factual; D003704:Dementia / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects*; D017093:Liver Failure / Q000139:chemically induced / Q000175:diagnosis; D009135:Muscular Diseases / Q000139:chemically induced; D010523:Peripheral Nervous System Diseases / Q000453:epidemiology; D011507:Proteinuria / Q000453:epidemiology; D051437:Renal Insufficiency / Q000453:epidemiology
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D003402:Creatine Kinase