alexa Examination of the FDA Warning for Statins and Cognitive Dysfunction
ISSN: 2329-6887

Journal of Pharmacovigilance
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Research Article

Examination of the FDA Warning for Statins and Cognitive Dysfunction

Frances M Sahebzamani1*, Cindy L Munro1, Oscar C Marroquin2, David M Diamond3,4, Erin Keller5 and Kevin E Kip1
1University of South Florida, College of Nursing, Tampa FL, USA
2University of Pittsburgh Medical Center, Division of Provider Analytics, Pittsburgh, PA, USA
3Research and Development Service, VA Hospital, Tampa, FL, USA
4Departments of Psychology and Molecular Pharmacology and Physiology, Center for Preclinical and Clinical Research on PTSD, University of South Florida, Tampa, FL, USA
5Denison University, Granville OH, USA
Corresponding Author : Frances M. Sahebzamani, Ph.D
Moffitt, University of South Florida
College of Nursing, 12901 Bruce B. Downs Blvd. MDN
Room 2010, Tampa, FL 33612-4476, USA
Tel: (813) 974-2702
Fax: (813) 974-7903
E-mail: [email protected]
Received June 18, 2014; Accepted August 26, 2014; Published September 02, 2014
Citation: Sahebzamani FM, Munro CL, Marroquin OC, Diamond DM, Keller E, et al. (2014) Examination of the FDA Warning for Statins and Cognitive Dysfunction. J Pharmacovigilance 2:141. doi: 10.4172/2329-6887.1000141
Copyright: © 2014 Sahebzamani FM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Abstract

Background: The ACC/AHA released new guidelines in December of 2013 for treatment of high blood cholesterol to simplify identification and treatment of patients most likely to benefit from statins. These guidelines may result in more patients receiving statin therapy, and at younger ages. In 2012, the U.S. Food and Drug Administration (FDA) mandated warnings for all statin drugs for possible adverse effects on cognitive performance. Statins can be classified as having greater lipophilic or hydrophilic solubility properties with lipophilic statins more readily crossing the blood brain barrier, and possibly differentially inducing detrimental cognitive effects.
Objective: We sought to analyze generalizability of the FDA statin class warning.
Methods: De-identified publicly-available data were analyzed from the FDA Adverse Event Reporting System (AERS) in relation to reports of cognitive dysfunction (primary outcome), and by type of statin (lipophilic, hydrophilic) versus “control” drugs used in the general population.
Results: Significantly higher proportional reporting ratios (PRRs) were observed for lipophilic statins, which more readily cross the blood-brain barrier, (range: 1.47-3.51) compared to hydrophilic statins (range: 0.69-1.64). However, fluvastatin, lovastatin, and pitavastatin (lipophilic) had relatively few adverse reports. The signal of higher risk of cognitive dysfunction was observed for the lipophilic statin atorvastatin (PRR = 2.59, 95% confidence interval: 2.44-2.75) followed by simvastatin (PRR = 2.22, 95% confidence interval: 2.04-2.31). Hydrophilic statins (rosuvastatin, pravastatin) showed essentially no evidence suggestive of heightened risk of cognitive dysfunction. Fluvastatin, lovastatin, and pitavastatin had relatively few adverse reports, and no evidence of a higher proportion of cognitive dysfunction reports compared to the control drugs in aggregate (PRR range: 0.22 to 1.48).
Conclusions: Inconsistent with the FDA class warning, highly lipophilic statins with specific pharmacokinetic properties (atorvastatin, simvastatin) appear to confer a significantly greater risk of adverse cognitive effects compared to other lipophilic statins and those with hydrophilic solubility properties.

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