An assessment by the Statin Cognitive Safety Task Force: 2014 update

►Spontaneous reports of adverse cognitive effects such as amnesia, concentration difficulties, confusion, and other complaints have been attributed to statins.►Such spontaneous reports from the FDA's Adverse Event Reporting System form the basis for the FDA statin label change request. These data do not allow for appropriate causality assessment.►To date, the weight of the evidence (albeit of low to moderate quality) does not support the contention that statins have a clear propensity to meaningfully or commonly contribute to adverse cognitive effects.►If patients report adverse cognitive effects that they attribute to initiation of statin therapy, clinicians should not dismiss these reports. A thorough assessment should be conducted to rule out other potential causes.►Baseline assessment of cognition before initiating a statin drug is not recommended.

The National Lipid Association's Safety Task Force convened a consensus conference of experts to develop a position statement on cognitive function to revise and update that published originally by the Association in the 2006 assessment of statin safety by a panel of neurologists. The current expert panel was charged with addressing the specific issue of potential adverse cognitive effects attributable to statins. Search strategies recently used in systematic reviews were used to identify relevant evidence using keywords and topics via Medline searches from 1966 to December 2013. Manual searches of bibliographies were also conducted. Panel members were asked to use the evidence to formulate answers to a series of questions of relevance to the subject matter. The strength of recommendations and quality of evidence were graded using accepted contemporary definitions and procedures. Recommendations to patients, health professionals, and researchers were put forth by the panel to aid in daily clinical decision making, and in future research endeavors.