Early Signal Detection: Data Mining 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 the reported suspected adverse drug reactions for statins from the international World Health Organization (WHO) repository 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. Other diverse central positive signals that can be confounded with mental conditions obtained and not stated were senses impairment, such as blindness, deafness, balance disorder, and events related to 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.