ABSTRACT
Severe mental disorders have been reported to be associated with an increased cardiovascular risk. To measure the potential risk excess as compared, not with the baseline cardiovascular risk for the general population, but with the cardiovascular risk associated with drug iatrogenia. 197 reported cases of cardiovascular adverse reaction to antipsychotic drugs as compared to the reported cases of this type of adverse reactions to drugs other than antipsychotics entered in the Spanish Pharmacovigilance System database (FEDRA) (1995-2018) in an observational case/non-case study. Risk estimates of association were reporting odds ratio (ROR), and, chi-square test (χ2). Overall disproportionality for the whole drug class was found [ROR 2.3 (95% CI 2.0-2.7)], χ2â¯=â¯127.07]. When the two types of antipsychotics (typical and atypical) were analysed separately, we also found statistically significant disproportionality, and this disproportionality is similar between both groups, with disproportionality measures around 2.30, with the confidence intervals not including the 1. The disproportionality observed suggests a risk excess that might be greater than expected, which holds particularly true for torsade de pointes, sudden death and cardiac arrhythmias in patients treated with any of the two types of antipsychotics. There was no significant risk for ischaemic heart disease.
Subject(s)
Antipsychotic Agents/therapeutic use , Cardiovascular Diseases/epidemiology , Mental Disorders/drug therapy , Adolescent , Adult , Adverse Drug Reaction Reporting Systems , Aged , Aged, 80 and over , Arrhythmias, Cardiac/epidemiology , Breast Feeding , Case-Control Studies , Child , Child, Preschool , Databases, Factual , Death, Sudden/epidemiology , Dietary Exposure , Female , Humans , Infant , Male , Middle Aged , Myocardial Ischemia/epidemiology , Odds Ratio , Pharmacovigilance , Risk Factors , Spain/epidemiology , Stroke/epidemiology , Torsades de Pointes/epidemiology , Young AdultABSTRACT
OBJECTIVE: To learn the evolution of antidepressant and lithium use in Castilla y León (Central Spain) and its relationship with suicide rates. METHODS: A search in the ECOM (Especialidades Consumo de Medicamentos) database of the Spanish Ministry of Health for antidepressants and lithium was carried out for the period 1992-2005. Defined daily doses (DDD) per 1000 inhabitants per day were obtained as consumption data. Population and suicide rates data come from the Spanish National Statistics Institute. RESULTS: Antidepressant consumption increased 7-fold, from 6.9 DDD per 1000 inhabitants per day in 1992 to 47.3 in 2005; the corresponding increase in cost was more than 10-fold. Selective serotonin reuptake inhibitors (SSRIs) comprised 77% of the total consumption. Venlafaxine consumption multiplied by 2.2. The consumption of monoamine oxidase inhibitors (MAOIs) decreased after venlafaxine and mirtazapine were marketed. Lithium consumption increased by 76% during the period studied, but it plateaued in 2000. CONCLUSIONS: The consumption of antidepressants in Castilla y León has increased remarkably and the pattern has changed; there is an increase in the consumption of the new and more expensive antidepressants such as venlafaxine and escitalopram. No association was observed between suicide rates and antidepressant consumption.
