Concetta Rafaniello1, Marco Pozzi2, Simone Pisano3, Carmen Ferrajolo1, Silvana Bertella2, Liberata Sportiello1, Carla Carnovale4, Maria Giuseppa Sullo1, Dario Cattaneo4, Marta Gentili4, Renata Rizzo5, Antonio Pascotto3, Elisa Mani2, Laura Villa2, Maria Pia Riccio3, Serena Sperandeo3, Renato Bernardini6, Carmela Bravaccio7, Emilio Clementi2,4, Massimo Molteni2, Francesco Rossi1, Sonia Radice4, Annalisa Capuano1. 1. a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, School of Medicine and Surgery , Second University of Naples , Naples , Italy. 2. b Scientific Institute IRCCS Eugenio Medea , Bosisio Parini, Lecco , Italy. 3. c Department of Mental and Physical Health and Preventive Medicine, Child and Adolescent Psychiatry Division , Second University of Naples , Naples , Italy. 4. d Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco , L. Sacco University Hospital, Università di Milano , Milan , Italy. 5. e Child and Adolescent Neuropsychiatry, Department of Medical and Paediatric Sciences, School of Medicine , University of Catania , Catania , Italy. 6. f Department of Clinical and Molecular Biomedicine, Section of Pharmacology and Biochemistry, School of Medicine , University of Catania , Catania , Italy. 7. g Department of Translational Medical Sciences , University Federico II of Naples , Naples , Italy.
Abstract
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.
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.
Entities:
Keywords:
Adverse drug reactions; aripiprazole; pharmacovigilance; risperidone; second-generation antipsychotics
Authors: C Rafaniello; M Sessa; F F Bernardi; M Pozzi; S Cheli; D Cattaneo; S Baldelli; M Molteni; R Bernardini; F Rossi; E Clementi; C Bravaccio; S Radice; A Capuano Journal: Pharmacogenomics J Date: 2017-07-18 Impact factor: 3.550
Authors: Karin M Egberts; Manfred Gerlach; Christoph U Correll; Paul L Plener; Uwe Malzahn; Peter Heuschmann; Stefan Unterecker; Maike Scherf-Clavel; Hans Rock; Gisela Antony; Wolfgang Briegel; Christian Fleischhaker; Alexander Häge; Tobias Hellenschmidt; Harmut Imgart; Michael Kaess; Andreas Karwautz; Michael Kölch; Karl Reitzle; Tobias Renner; Su-Yin Reuter-Dang; Christian Rexroth; Gerd Schulte-Körne; Frank M Theisen; Susanne Walitza; Christoph Wewetzer; Stefanie Fekete; Regina Taurines; Marcel Romanos Journal: Pharmacopsychiatry Date: 2022-02-07 Impact factor: 2.544
Authors: Giuseppe Cicala; Maria A Barbieri; Vincenza Santoro; Carmela Tata; Pia V Colucci; Francesca Vanadia; Flavia Drago; Carmelita Russo; Paola M Cutroneo; Antonella Gagliano; Edoardo Spina; Eva Germanò Journal: Front Psychiatry Date: 2020-03-24 Impact factor: 4.157