Statin-related neurocognitive disorder: a real-world pharmacovigilance study based on the FDA adverse event reporting system

References

• Sirtori CR. The pharmacology of statins. Pharmacol Res. 2014;88:3–11. doi: 10.1016/j.phrs.2014.03.002
   PubMed Web of Science ®Google Scholar
• Stone NJ, Robinson JG, Lichtenstein AH, et al. ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2013;63(25):2889–2934. doi: 10.1016/j.jacc.2013.11.002
   PubMed Web of Science ®Google Scholar
• Gu Q, Paulose-Ram R, Burt VL, et al. Prescription cholesterol-lowering medication use in adults aged 40 and over: United States, 2003–2012. NCHS Data Brief. 2014;177:1–8.
   Google Scholar
• Pharnexcloud. Top 100 national pharmaceutical sales in 2022 (online) Jun 14, 2023. [cited 2023 Aug 14]. Available from: https://www.pharnexcloud.com/zixun/sd_6604
   Google Scholar
• Armitage J. The safety of statins in clinical practice. Lancet. 2007;370(9601):1781–1790. doi: 10.1016/S0140-6736(07)60716-8
   PubMed Web of Science ®Google Scholar
• Galatti L, Polimeni G, Salvo F, et al. Short-term memory loss associated with rosuvastatin. Pharmacotherapy. 2006;26(8):1190–1192. doi: 10.1592/phco.26.8.1190
   PubMed Web of Science ®Google Scholar
• Wagstaff LR, Mitton MW, Arvik BM, et al. Statin-associated memory loss: analysis of 60 case reports and review of the literature. Pharmacotherapy. 2003;23(7):871–880. doi: 10.1592/phco.23.7.871.32720
   PubMed Web of Science ®Google Scholar
• Orsi A, Sherman O, Woldeselassie Z. Simvastatin-associated memory loss. Pharmacotherapy. 2001;21(6):767–769. doi: 10.1592/phco.21.7.767.34577
   PubMed Web of Science ®Google Scholar
• King DS, Wilburn AJ, Wofford MR, et al. Cognitive impairment associated with atorvastatin and simvastatin. Pharmacotherapy. 2003;23(12):1663–1667. doi: 10.1592/phco.23.15.1663.31953
   PubMed Web of Science ®Google Scholar
• Muldoon MF, Ryan CM, Sereika SM, et al. Randomized trial of the effects of simvastatin on cognitive functioning in hypercholesterolemic adults. Am J Med. 2004;117(11):823–829. doi: 10.1016/j.amjmed.2004.07.041
   PubMed Web of Science ®Google Scholar
• Redelmeier DA, Thiruchelvam D, Daneman N. Delirium after elective surgery among elderly patients taking statins. CMAJ. 2008;179(7):645–652. doi: 10.1503/cmaj.080443
   PubMed Web of Science ®Google Scholar
• Odden MC, Pletcher MJ, Coxson PG, et al. Cost-effectiveness and population impact of statins for primary prevention in adults aged 75 years or older in the United States. Ann Intern Med. 2015;162(8):533–541. doi: 10.7326/M14-1430
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. FDA Drug Safety Communication: important Safety label changes to cholesterol-lowering statin drugs (online). 2023 [cited 2018 Aug 14]. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm293101.html
   Google Scholar
• Glasser SP, Wadley V, Judd S, et al. The association of statin use and statin type and cognitive performance: analysis of the reasons for geographic and racial differences in stroke (REGARDS) study. Clin Cardiol. 2010;33(5):280–288. doi: 10.1002/clc.20758
   PubMed Web of Science ®Google Scholar
• Murphy C, Dyer AH, Lawlor B, et al. What is the impact of ongoing statin use on cognitive decline and dementia progression in older adults with mild-moderate alzheimer disease? PloS One. 2023;18(5):e0285529. doi: 10.1371/journal.pone.0285529
   PubMed Web of Science ®Google Scholar
• Power MC, Weuve J, Sharrett AR, et al. Statins, cognition, and dementia—systematic review and methodological commentary. Nat Rev Neurol. 2015;11(4):220–229. doi: 10.1038/nrneurol.2015.35
   PubMed Web of Science ®Google Scholar
• Ott BR, Daiello LA, Dahabreh IJ, et al. Do statins impair cognition? A systematic review and meta-analysis of randomized controlled trials. J Gen Intern Med. 2015;30(3):348–358. doi: 10.1007/s11606-014-3115-3
   PubMed Web of Science ®Google Scholar
• Trompet S, van Vliet P, de Craen AJ, et al. Pravastatin and cognitive function in the elderly. Results of the PROSPER study. J Neurol. 2010;257(1):85–90. doi: 10.1007/s00415-009-5271-7
   PubMed Web of Science ®Google Scholar
• Heart Protection Study Collaborative Group. MRC/BHF heart protection study of antioxidant vitamin supplementation in 20 536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002;360(9326):23–33. doi: 10.1016/S0140-6736(02)09328-5
   PubMed Web of Science ®Google Scholar
• Bath PM, Scutt P, Blackburn DJ, et al. Intensive versus guideline blood pressure and lipid lowering in patients with previous stroke: main results from the pilot ‘prevention of decline in cognition after stroke trial’ (PODCAST) randomised controlled trial. PloS One. 2017;12(1):e0164608. doi: 10.1371/journal.pone.0164608
   PubMed Web of Science ®Google Scholar
• Agostini JV, Tinetti MR, Han L, et al. Effects of statin use on muscle strength, cognition, and depressive symptoms in older adults. J Am Geriatr Soc. 2007;55(3):420–425. doi: 10.1111/j.1532-5415.2007.01071.x
   PubMed Web of Science ®Google Scholar
• Rockwood K, Kirkland S, Hogan DB, et al. Use of lipid-lowering agents, indication bias, and the risk of dementia in community-dwelling elderly people. Arch Neurol. 2002;59(2):223–227. doi: 10.1001/archneur.59.2.223
   PubMed Web of Science ®Google Scholar
• Bettermann K, Arnold AM, Williamson J, et al. Statins, risk of dementia, and cognitive function: secondary analysis of the ginkgo evaluation of memory study. J Stroke Cerebrovasc Dis. 2012;21(6):436–444. doi: 10.1016/j.jstrokecerebrovasdis.2010.11.002
   PubMed Web of Science ®Google Scholar
• Wei C, Liu Y, Jiang A, et al. A pharmacovigilance study of the association between tetracyclines and hepatotoxicity based on food and drug administration adverse event reporting system data. Int J Clin Pharm. 2022;44(3):709–716. doi: 10.1007/s11096-022-01397-5
   PubMed Web of Science ®Google Scholar
• Wu B, Shen P, Yin X, et al. Analysis of adverse event of interstitial lung disease in men with prostate cancer receiving hormone therapy using the food and drug administration adverse event reporting system. Br J Clin Pharmacol. 2023;89(2):440–448. doi: 10.1111/bcp.15336
   PubMed Web of Science ®Google Scholar
• Ni X, Wu F, Song J, et al. Chinese expert consensus on assessment of cognitive impairment in the elderly. Aging Med (Milton). 2022;5(3):154–166. doi: 10.1002/agm2.12222
   PubMedGoogle Scholar
• Jongsiriyanyong S, Limpawattana P. Mild Cognitive Impairment in Clinical Practice: a Review Article. Am J Alzheimers Dis Other Demen. 2018;33(8):500–507. doi: 10.1177/1533317518791401
   PubMed Web of Science ®Google Scholar
• Ma L, Zhang L, Zhang Y, et al. Cognitive frailty in China: results from China comprehensive geriatric assessment study. Front Med. 2017;4:174. doi: 10.3389/fmed.2017.00174
   Web of Science ®Google Scholar
• Fotso Soh J, Almadani A, Beaulieu S, et al. The effect of atorvastatin on cognition and mood in bipolar disorder and unipolar depression patients: a secondary analysis of a randomized controlled trial. J Affect Disord. 2020;262:149–154. doi: 10.1016/j.jad.2019.11.013
   PubMed Web of Science ®Google Scholar
• Arvanitakis Z, Schneider JA, Wilson RS, et al. Statins, incident alzheimer disease, change in cognitive function, and neuropathology. Neurology. 2008;70(19_part_2):1795–1802. doi: 10.1212/01.wnl.0000288181.00826.63
   PubMed Web of Science ®Google Scholar
• Sparks DL, Sabbagh MN, Connor DJ, et al. Atorvastatin for the treatment of mild to moderate alzheimer disease: preliminary results. Arch Neurol. 2005;62(5):753–757. doi: 10.1001/archneur.62.5.753
   PubMedGoogle Scholar
• Samaras K, Makkar SR, Crawford JD, et al. Effects of statins on memory, cognition, and brain volume in the elderly. J Am Coll Cardiol. 2019;74(21):2554–2568. doi: 10.1016/j.jacc.2019.09.041
   PubMed Web of Science ®Google Scholar
• Montastruc JL. Rhabdomyolysis and statins: a pharmacovigilance comparative study between statins [published online ahead of print, 2023 Apr 27]. Br J Clin Pharmacol. 2023. doi: 10.1111/bcp.15757
   Web of Science ®Google Scholar
• Muldoon MF, Barger SD, Ryan CM, et al. Effects of lovastatin on cognitive function and psychological well-being. Am J Med. 2000;108(7):538–546. doi: 10.1016/S0002-9343(00)00353-3
   PubMed Web of Science ®Google Scholar
• Saher G, Simons M. Cholesterol and myelin biogenesis. Subcell Biochem. 2010;51:489–508.
   PubMedGoogle Scholar
• Rojas-Fernandez CH, Goldstein LB, Levey AI, et al. An assessment by the statin cognitive safety task force: 2014 update. J Clin Lipidol. 2014;8(3):S5–S16. doi: 10.1016/j.jacl.2014.02.013
   PubMed Web of Science ®Google Scholar
• Nezasa K, Higaki K, Matsumura T, et al. Liver-specific distribution of rosuvastatin in rats: comparison with pravastatin and simvastatin. Drug Metab Dispos. 2002;30(11):1158–1163. doi: 10.1124/dmd.30.11.1158
   PubMed Web of Science ®Google Scholar
• Rost NS, Meschia JF, Gottesman R, et al. Cognitive impairment and dementia after stroke: design and rationale for the DISCOVERY study. Stroke. 2021;52(8):e499–e516. doi: 10.1161/STROKEAHA.120.031611
   PubMed Web of Science ®Google Scholar
• Gottesman RF, Albert MS, Alonso A, et al. Associations between midlife vascular risk factors and 25-year incident dementia in the atherosclerosis risk in communities (ARIC) cohort. JAMA Neurol. 2017;74(10):1246–1254. doi: 10.1001/jamaneurol.2017.1658
   PubMed Web of Science ®Google Scholar
• Alsubaie N, Al-Kuraishy HM, Al-Gareeb AI, et al. Statins use in alzheimer disease: bane or boon from frantic search and narrative review. Brain Sci. 2022;12(10):1290. doi: 10.3390/brainsci12101290
   PubMed Web of Science ®Google Scholar