OBJECTIVE: Gap in knowledge on benefit/risk ratio of second generation antipsychotics (SGA) in the paediatric population represents a challenge for the scientific community. This study aims to analyse all suspected adverse drug reactions (ADRs) to SGA observed during the study period; compare the safety profiles of risperidone and aripiprazole; evaluate the effect of switching from risperidone to aripiprazole or to a first generation antipsychotic (FGA). METHODS: Prospective analysis of spontaneously reported ADRs concerning 184 paediatric outpatients between 2012 and 2014.; clinical outcomes of drug switch were evaluated. RESULTS: Out of the 184 patients, 130 experienced at least one ADR; ADRs were usually not serious and more frequently associated with aripiprazole. Switching to aripiprazole was associated with better results than switching to FGAs in the Clinical Global Impression scale- Efficacy (CGI-E) scores (p = 0.018), Disturbed behaviour checklist-parents (DBC-P) self-absorption subscale (p = 0.010); only a trend for difference between changing to aripiprazole vs FGAs in the DBC-P total score (p = 0.054) and social relating subscale (p = 0.053) was observed. CONCLUSIONS: SGAs safety data were consistent with the ones already known; however, there is still a need to improve the knowledge in pharmacovigilance field among clinicians. Switching to aripiprazole may be a valid alternative to risperidone.
Second generation antipsychotics in 'real-life' paediatric patients : adverse drug reactions and clinical outcomes of drug switch / C. Rafaniello, M. Pozzi, S. Pisano, C. Ferrajolo, S. Bertella, L. Sportiello, C. Carnovale, M.G. Sullo, D. Cattaneo, M. Gentili, R. Rizzo, A. Pascotto, E. Mani, L. Villa, M.P. Riccio, S. Sperandeo, R. Bernardini, C. Bravaccio, E. Clementi, M. Molteni, F. Rossi, S. Radice, A. Capuano. - In: EXPERT OPINION ON DRUG SAFETY. - ISSN 1474-0338. - 15:suppl. 2(2016 Dec), pp. 1-8.
|Titolo:||Second generation antipsychotics in 'real-life' paediatric patients : adverse drug reactions and clinical outcomes of drug switch|
POZZI, MARCO (Secondo)
RADICE, SONIA (Penultimo)
|Parole Chiave:||adverse drug reactions; aripiprazole; pharmacovigilance; risperidone; second-generation antipsychotics|
|Settore Scientifico Disciplinare:||Settore BIO/14 - Farmacologia|
|Data di pubblicazione:||dic-2016|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1080/14740338.2016.1229301|
|Appare nelle tipologie:||01 - Articolo su periodico|