Second generation antipsychotics in ‘real-life’ paediatric patients. Adverse drug reactions and clinical outcomes of drug switch

Rafaniello, Concetta; Pozzi, Marco; Pisano, Simone; Ferrajolo, Carmen; Bertella, Silvana; Sportiello, Liberata; Carnovale, Carla; Sullo, Maria Giuseppa; Cattaneo, Dario; Gentili, Marta; Rizzo, Renata; Pascotto, Antonio; Mani, Elisa; Villa, Laura; Riccio, Maria Pia; Sperandeo, Serena; Bernardini, Renato; Bravaccio, Carmela; Clementi, Emilio; Molteni, Massimo; Rossi, Francesco; Radice, Sonia; Capuano, Annalisa

doi:10.1080/14740338.2016.1229301

Cited by 22 publications

(13 citation statements)

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“…This study aims to provide a comprehensive overview of all ICSRs spontaneously reported to EV (one of the largest pharmacovigilance databases) in the pediatric population with a huge variety of psychiatric disorders treated with risperidone and aripiprazole, contributing to define their safety profiles in real-world settings. In line with recent pharmacoepidemiological studies evaluating the safety profile of SGAs in the young population, we found that the largest proportion of ICSRs was reported for boys, and the most frequently reported suspected antipsychotic drug was risperidone (19,20). These findings are consistent with previous evidence showing that male adolescents are more likely than females to be prescribed atypical antipsychotics and that risperidone is the SGA most commonly prescribed to the young population due to a wider spectrum of indicated uses (21).…”

Section: Discussionsupporting

confidence: 91%

We Really Need Clear Guidelines and Recommendations for Safer and Proper Use of Aripiprazole and Risperidone in a Pediatric Population: Real-World Analysis of EudraVigilance Database

et al. 2020

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Background: Although aripiprazole and risperidone are used widespread in pediatrics, there are still limited pieces of evidence on their actual safety profile. By using the EudraVigilance database, we carried out an analysis to perform a comprehensive overview of reported adverse events among children and adolescents treated with aripiprazole and risperidone.Methods: Descriptive analysis was performed of all individual case safety reports (ISCRs) submitted to EudraVigilance associated with aripiprazole and risperidone and related to the pediatric population from 2016 to 2018.Results: A total of 855 and 2,242 ISCRs for aripiprazole and risperidone, respectively, were recorded for a total of 11,042 suspected adverse drug reactions (2,993 for aripiprazole and 8,049 for risperidone). Most ISCRs were related to male patients (65.0 and 86.3% for aripiprazole and risperidone, respectively) and were serious (81.0 and 94.1% for aripiprazole and risperidone, respectively). Schizophrenia spectrum and other psychotic disorders, such as disruptive, impulse-control, and conduct disorders, and autism spectrum disorder were the top three clinical indications for aripiprazole (19.0, 16.1, and 11.6%, respectively). For risperidone, attention-deficit/hyperactivity disorder (25.4%), disruptive, impulse-control, and conduct disorders (17.1%), and bipolar and related disorders (14.2%) were more commonly reported as clinical indications. Data also showed a high proportion of use for clinical conditions not authorized in children. Psychiatric disorders were the main related adverse events for aripiprazole (20.2%), and among these, suicidal behavior was one of the most reported (14.9%). Reproductive system and breast disorders were the main related adverse events for risperidone (19.8%), and gynecomastia was the most reported event; metabolism and nutrition disorders, mainly reported as weight gain disorders, were more reported in children (3–11 years) than in adolescents (12–17 years).Conclusions: Our results demonstrate that spontaneously reported adverse events associated with aripiprazole and risperidone reflect what is already known in terms of safety profile, although with about 90% of them being serious. This analysis stresses the need for further studies and effective training and information activities to better define the actual benefit/risk ratio of these drugs in pediatric patients.

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Section: Discussionsupporting

confidence: 91%

We Really Need Clear Guidelines and Recommendations for Safer and Proper Use of Aripiprazole and Risperidone in a Pediatric Population: Real-World Analysis of EudraVigilance Database

et al. 2020

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“…Indeed, to date, the safety of these medications for long-term treatments in pediatric patients remains a subject of debate, and several important safety concerns previously highlighted in literature are still not yet resolved (13,15,(21)(22)(23). Therefore, it is clear that close and long-term monitoring of pediatric patients treated with APs in a real-world setting could be useful to clinicians in the process of tailoring the therapies for the single patient and for the identification and treatment of therapy-related conditions (e.g., metabolic dysregulation) as previously stated by other authors (24). In addition to that, such monitoring could be helpful for a better definition of the safety and tolerability profiles of these drugs especially in the long term, as highlighted by previous studies based in a realworld setting (25).…”

Section: Introductionmentioning

confidence: 94%

Safety and Tolerability of Antipsychotic Drugs in Pediatric Patients: Data From a 1-Year Naturalistic Study

Cicala

Santoro

Tata³

et al. 2020

Front. Psychiatry

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Background: Antipsychotic drugs (APs) are increasingly used to treat a variety of psychiatric disorders in children and adolescents. However, their safety and tolerability profiles, when used in a developmental age context, show different characteristics from the ones observed in adult patients. Treatment with APs in pediatric patients is often long-term. However, the tolerability data regarding these patients mostly derive from short-term studies.Methods: Starting from April 2017, for a 1-year period, patients between 4 and 18 years of age followed by five units of developmental age neuropsychiatry, who initiated a treatment with at least an AP (ATC class N05A) were included into the study. Patient-related data have been collected at baseline and regularly thereafter, as allowed by the clinical routine. Changes to continuous variables over time have been analyzed using a linear mixed model in subsamples of our population treated with risperidone or aripiprazole.Results: During the observation period, 158 patients were initially enrolled, but only 116 completed 12 months of therapy with an AP. Risperidone was the most used AP (n = 52) followed by aripiprazole (n = 44) and olanzapine (n = 7). For both the aripiprazole and risperidone groups, the mean body mass index (BMI) (P < 0.001 for both groups) and heart rate (P = 0.026 for aripiprazole group and P < 0.001 for the risperidone one) values significantly increased over time. The mean prolactin concentration value significantly increased over time only in the risperidone group (P = 0.04). Eighty-six patients experienced at least one adverse drug reaction (ADR), accounting for a total of 238 specific reactions, with the most frequent being weight gain (n = 34), increased serum prolactin levels (n = 21), hyperphagia (n = 20), and hypercholesterolemia (n = 14). Among these, only 24 ADRs were classifiable as serious.Cicala et al. Antipsychotic Drugs in Pediatric PatientsConclusions: The results of this study confirm that risperidone and aripiprazole are relatively well-tolerated therapeutic options for the treatment of a variety of psychiatric disorders in pediatric patients. However, in findings such as statistically significant increments of BMI and heart rate mean values, the variations over time in prolactin levels observed with risperidone and the differences between the two drugs remark the necessity of systematic monitoring.

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“…Moreover, in the last thirty years several targeted therapies were approved for the treatment of cancer and autoimmune diseases, but their long-term safety profile have not yet been completely defined. Since clinical evidence derived from pivotal studies could fail to address key safety questions, real world data (RWD; Ruggiero et al, 2012 ; Iolascon et al, 2013 ; Cammarota et al, 2014 ; Ferrajolo et al, 2014 ; Parretta et al, 2014 ; Woo, 2014 ; Menditto et al, 2015 ; Donati et al, 2016 ; Giardini et al, 2016 ; Rafaniello et al, 2016b ) should be considered complementary to those obtained from traditional RCTs.…”

Section: Introductionmentioning

confidence: 99%

Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study

et al. 2017

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Objectives: To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs.Design: A prospective observational study.Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units in Campania Region (Italy).Participants: 775 patients (53.81% female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% confidence interval 3.13–3.84).Main outcome measures: We collected all AEs associated to biotech drugs, including serious infections and malignancies. Serious AEs were defined according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, clinical safety data management: definitions and standards for expedited reporting E2A guideline.Results: The majority of the study population was enrolled in Onco-hematology and Rheumatology Units and the most common diagnosis were hematological malignancies, followed by rheumatoid arthritis, colorectal cancer, breast cancer, and psoriatic arthritis. The most commonly prescribed biotech drugs were rituximab, bevacizumab, infliximab, trastuzumab, adalimumab, and cetuximab. Out of 775 patients, 320 experienced at least one AE. Most of patients experienced AEs to cetuximab therapy, rituximab and trastuzumab. Comparing female and male population, our findings highlighted a statistically significant difference in terms of AEs for adalimumab (35.90% vs. 7.41%, p < 0.001) and etanercept (27.59% vs. 10.00%, p = 0.023). Considering all biotech drugs, we observed a peak for all AEs occurrence at follow-up 91–180 days category. Bevacizumab, brentuximab, rituximab, trastuzumab and cetuximab were more commonly associated to serious adverse events; most of these were possibly related to biotech drugs, according to causality assessment. Three cases of serious infections occurred.Conclusions: The results of our study demonstrated that the majority of AEs were not serious and expected. Few cases of serious infections occurred, while no case of malignancy did. Overall, the safety profile of biotech drugs used in our population was similar to those observed in pivotal trials. Notwithstanding the positive results of our study, some safety concerns still remain unresolved. In order to collect more effectiveness and safety data on biotech drugs, the collection and analysis of real world data should be endorsed as well as the management of post-authorization studies.

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Second generation antipsychotics in ‘real-life’ paediatric patients. Adverse drug reactions and clinical outcomes of drug switch

Abstract: 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.

Cited by 22 publications

References 44 publications

We Really Need Clear Guidelines and Recommendations for Safer and Proper Use of Aripiprazole and Risperidone in a Pediatric Population: Real-World Analysis of EudraVigilance Database

We Really Need Clear Guidelines and Recommendations for Safer and Proper Use of Aripiprazole and Risperidone in a Pediatric Population: Real-World Analysis of EudraVigilance Database

Safety and Tolerability of Antipsychotic Drugs in Pediatric Patients: Data From a 1-Year Naturalistic Study

Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study

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