
Maria-Isabel Jimenez-Serrania
Miguel de Cervantes European University (UEMC), SpainTitle: Dementia among early signal detections of mental disorders with statins
Abstract
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.
Biography
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.?