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.

Early signals of motor disorders and pleiotropic effects of statins

“…In this database, it is plausible to approach the frequency of suspected ADR using the data mining methodology developed and is used by de UMC as the WHO Collaborating Centre for International Drug Monitoring that is Bayesian Confidence Propagation Neural Network (BCPNN) [8], extensions [9][10][11][12][13] and adaptations with a correct interpretation of the signals [14][15][16][17][18].…”

“…In this case, the chemical subgroup C10AA "HMG CoA reductase inhibitors" [15] was considered in the analysis. This adaptation was previously applied and approved robustness and consistency with other specific groups of drugs [16][17][18].…”