Table 1.

Evidence Supporting Cognitive Impairment

Study	Study Type	Statin	Participants	Findings/Relevance
FDA, 2012, [6]	Safety Literature Review	All	N/A	Statin labels should include cognitive impairment however the cardiovascular risks outweigh the small cognitive impairment risk.
Posvar EL, et al., 1996, [12]	Rising single-dose, partially blinded, three period study	Ator	22	Tolerance study that resulted in one participant experiencing cognitive side effects at the 120-mg solution dose. The participant experienced mild, transient restlessness, euphoria, and mental confusion that were considered to be dose-limiting side effects.
Wagstaff LR, et al., 2003, [13]	Review of case reports	Ator(23), Prava(1), Sim (36)	60	Case reports raise the possibility that statins may be associated with cognitive impairment in rare cases.
Muldoon MF, et al., 2000, [14]	Double-blind investigational	lova	209	Lovastatin treatment resulted in small performance decrements on neuropsychological tests of attention and psychomotor speed, the clinical importance of which is uncertain.
Muldoon MF, et al., 2004, [15]	Randomized trial	Sim	308	Patients given placebos performance improved more than statin patients on cognition tests given at day 0 and 6 months.
Evans MA, et al., 2009, [16]	Patient survey-based analysis	All	171	There is a characterizable association between statins and cognitive impairment. 128 patients experienced cogitive adrs determined to be probably or definitely related to statin therapy. Of 143 patients who reported stopping statin therapy, 128 reported improvement in cognitive problems, sometimes within days of statin discontinuation.
M Sahebzamani, 2014, [18]	FDA AERs database analysis	All	4867	Lipophilic statins (especially atorvastatin and simvastatin) have significantly more reports of Cog. Dys. than hydrophilic statins. Estimated Cog Dys reporting with atorvastatin and simvastatin is truly 3,00–30,000 reports/year.

ator atorvastatin, flu fluvastatin, lova lovastatin, prav pravastatin, rosu rosuvastatin, sim simvastatin