| アブストラクト | A significant heterogeneity prevails in antipsychotics (APs) safety monitoring recommendations. Youths are deemed more vulnerable to cardiometabolic side effects. We aimed to assess age-dependent reporting of cardiac and metabolic disorders in youths, relying on the WHO safety database (VigiBase(R)). VigiBase(R) was queried for all reports of cardiac, glucose, lipid and nutritional disorders involving APs. Patients <18 years were classified as pediatric population. Disproportionality analyses relied on the Information Component (IC): the positivity of the lower end of its 95 % confidence interval was required to suspect a signal. We yielded 4,672 pediatric reports. In disproportionality analysis, nutritional disorders were leading in youths (IC 3.9 [3.9-4.0]). Among healthcare professionals' reports, stronger signals were detected in youths than in adults. Children had the greatest signal with nutritional disorders (IC 4.7 [4.6-4.8]). In adolescents, aripiprazole was ascribed to non-alcoholic steatohepatitis (NASH). Our findings, based on real-world data, support the hypothesis of a greater propensity for nutritional disorders in youths, despite limitations of pharmacovigilance studies. We suggest specific safety profiles, such as aripiprazole and NASH. Pending more answers from population-based studies, a careful anamnesis should seek for risk factors before AP initiation. A cautious monitoring is warranted to allow earlier identification of side effects. |
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| 投稿者 | Merino, Diane; Gerard, Alexandre O; Destere, Alexandre; Saidessalam, Haitam; Askenazy, Florence; Montastruc, Francois; Drici, Milou-Daniel; Thummler, Susanne |
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| 組織名 | University Department of Child and Adolescent Psychiatry, Children's Hospitals of;Nice, CHU-Lenval, Nice, France; Department of Pharmacology and Pharmacovigilance;Center of Nice, University Hospital CHU de Nice, Nice, France; Universite Cote;d'Azur, CoBTeK, Nice, France.;Department of Pharmacology and Pharmacovigilance Center of Nice, University;Hospital CHU de Nice, Nice, France; Universite Cote d'Azur, Laboratory of;Molecular Physio Medicine (LP2M), UMR 7370, CNRS, Nice, France.;Hospital CHU de Nice, Nice, France; Universite Cote d'Azur, Inria, CNRS,;Laboratoire J.A. Dieudonne, Maasai team, Nice, France.;Hospital CHU de Nice, Nice, France.;Nice, CHU-Lenval, Nice, France; Universite Cote d'Azur, CoBTeK, Nice, France.;Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and;Pharmacoepidemiology, Faculty of Medicine, Toulouse University Hospital,;Toulouse, France.;Electronic address: susanne.thummler@univ-cotedazur.fr. |
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