Maria-Isabel Jimenez-SerraniaMiguel de Cervantes European University (UEMC), Spain
Title: Dementia among early signal detections of mental disorders with statins
Statins are widely prescribed to treat dyslipidemias. It is well known adverse reaction of these active ingredients related to rhabdomyolysis and myalgia, but there are other signals to be aware of, such as mental disorders. Pharmacovigilance tools help to trace known risks and detect early other unknown effects that appear over time. Data of all reported suspected adverse drug reactions for statins from the international World Health Organization repository (WHO) Vigibase were analyzed with an adaptation of data mining Bayesian methodology to search for positive signals; threshold of false discovery rate (FDR)<0.05 and listed candidates for priority clinical investigation. Among positive mental signals observed, some were currently stated as adverse reactions in technical factsheets as insomnia, depression, dementia, and nightmares; but others have not reached this condition as bipolar, psychotic, and emotional disorders or symptoms, and suicide. Worrying positive signals proposed as candidates to further investigation are insomnia for pitavastatin, pravastatin, and simvastatin; dementia for atorvastatin and rosuvastatin; and suicide and psychotic disorders for atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin. Inside dementia signals, it would be interesting to clarify if stated for atorvastatin and rosuvastatin is a dementia Alzheimer’s type, a vascular dementia, or a memory impairment; and if it could be confounded with amnesia for atorvastatin.
Maria-Isabel Jimenez-Serrania is a pharmacist, biochemist, and a Ph.D. graduated magna cum laude with European Mention from the University of Salamanca (Spain, 2012). She is an Associate Professor at the Miguel de Cervantes European University (UEMC, Valladolid, Spain) since 2016 in the subjects of Physiology, Pharmacology, and Biochemistry. She also is a member of the Center for Studies on Drug Safety (CESME, Valladolid; formerly Regional Pharmacovigilance Center), and founder member of the research group Assessment in Drug Vigilance and Supplementation in Exercise ADViSE (UEMC, Valladolid). She has made stays in national and international organizations, participating in basic and applied research projects with extensive experience in drug databases and data mining. Her investigations have been awarded by the University of Salamanca, the Regional Academy of Pharmacy of Castilla-Leon, and the Spanish Royal National Academy of Pharmacy, among others. She is the author of relevant publications in pharmacoepidemiology, pharmacovigilance, and pharmacogenetics; and the editor of several technical reports on the rational use of medicines.?