Absence of Change in Corrected QT Interval in Children and Adolescents Receiving Antipsychotic Treatment: A 12 Month Study

Alda, José A; Muñoz-Samons, Daniel; Tor, Jordina; Merchán-Naranjo, Jessica; Tapia-Casellas, Cecilia; Baeza, Inmaculada; Escalona, Rosa Calvo; Castro‐Fornieles, Josefina; Martínez-Cantarero, Carmen; Andrés-Nestares, Patricia; Fernández-Avilés, Francisco; Arango, Celso

doi:10.1089/cap.2015.0151

Cited by 6 publications

(4 citation statements)

References 53 publications

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“…Concerning ECG evaluation, our study showed that the treatment with aripiprazole and risperidone was related with a mostly unmodified mean QTc. This study underlines the relative cardiac safety of aripiprazole and risperidone in children and adolescents, even after 1 year of therapy, as reported in previous investigations (41,42). However, two of the enrolled patients treated with risperidone had a QTc exceeding 450 ms that led to the discontinuation of therapy before 12 months.…”

Section: Monitoring Of Parameters Over Timesupporting

confidence: 77%

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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Section: Monitoring Of Parameters Over Timesupporting

confidence: 77%

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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“…Our findings are also consistent with the meta-analysis done by Jensen et al (2015) that also showed no statistically significant change in QTc with risperidone-treated children compared to placebo. Alda et al (2016) evaluated the effects of atypical antipsychotics (risperidone, olanzapine, or quetiapine) on QTc in an open-label study of 211 youth with various psychiatric disorders treated for 3-12 months. Of the 118 risperidone-treated subjects with ECG data at baseline, complete 1-year data were available on 34 subjects.…”

Section: Discussionmentioning

confidence: 99%

No Apparent Cardiac Conduction Effects of Acute Treatment with Risperidone in Children with Autism Spectrum Disorder

Snyder

McCracken

et al. 2016

Journal of Child and Adolescent Psychopharmacology

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Objectives: Risperidone is approved for the treatment of serious behavioral problems in children with autism spectrum disorder (ASD). This study examined the effects of risperidone on cardiac conduction in children with ASD. Methods: Data were collected from an 8-week, five-site trial conducted by the Research Units on Pediatric Psychopharmacology Autism Network. Children (age 5-17 years) were randomly assigned to risperidone (n = 49) or placebo (n = 52) under double-blind conditions. Risperidone was superior to placebo in reducing serious behavioral problems. A standard 12-lead, electrocardiogram (ECG) was obtained in most subjects at screening and week 8. A pediatric electrophysiologist blind to treatment assignment reviewed all available ECGs for readability, abnormalities, and cardiac conduction parameters, including QTc. The electrophysiologist measurements were compared to machine readings. A second blinded electrophysiologist examined all available ECGs for abnormalities and a 20% random sample for QTc. Results: Of the 101 randomized subjects in the trial, complete pretreatment and week 8 data were available on 65 subjects (placebo n = 30; risperidone n = 35). The electrophysiologist did not identify any cardiac conduction adverse effects of risperidone and there was no difference in mean change on the QTc compared to placebo. The Bland-Altman plot showed a systematic bias in QTc measurements by the electrophysiologist and machine. Machine readings produced higher values than the electrophysiologist for shorter QTc intervals and machine scoring was lower than electrophysiologist readings for longer QTc values ( p = 0.001). Two electrophysiologists had overall percent agreements of 82.9% (95% CI: 76.3 to 89.6) on qualitative assessment and 88.6% (95% CI: 79.3 to 98.0) on QTc interval. Conclusion: Using conventional doses during acute treatment in children with ASD and serious behavioral problems, there was no difference in the mean change in QTc between risperidone and placebo. Compared to the electrophysiologist, the machine readings may miss elevated QTc measurements.

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“…Clinical research assessing the effect of antipsychotics on QTc prolongation in youth (children and adolescents) have recently been performed in response to the increasing use of these drugs in this age group and have produced mounting evidence for a low risk of drug-induced QTc prolongation associated with antipsychotics use in this age group (Correll et al . 2011; Alda et al . 2016; Palanca-Maresca et al .…”

Section: Introductionmentioning

confidence: 99%

QT prolongation is over-estimated by Bazett compared to Friderica in Japanese child and adolescent inpatients

Saito

Kuge

Nagasawa

et al. 2021

International Clinical Psychopharmacology

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Recent researches suggested that the risk of druginduced QTc prolongation is low in child and adolescent psychiatry setting. However, these cohorts enrolled mainly of Caucasian background. We aimed to assess the prevalence of QTc prolongation and its association with antipsychotic use in Japanese youth. The medical records of inpatients were reviewed. Two different definitions of QT prolongation, Bazett's corrected QT interval (QTcB) >450 msec and Fridericia's corrected QT interval (QTcF) >450 msec, were adopted. In 220 participants [age: 13.4 ± 2.3 years, antipsychotics according to the chlorpromazine equivalence: 50 (25th-75th percentiles; 0-150) mg/day], the prevalence of QTcB and QTcF prolongation was 13.6 and 2.3%, respectively. Patients with QTcB >450 msec had a significantly higher heart rate than those with QTcB ≤450 msec (91.2 ± 20.6 bpm vs. 76.1 ± 15.2 bpm; P < 0.001). The other variables, except potassium level (4.1 ± 0.4 mEq/L vs. 4.2 ± 0.3 mEq/L; P = 0.030), showed no significant difference. Clinically meaningful QTc prolongation was rare even in this Japanese cohort. This study also suggested that if QTcB is used, clinicians should be aware of possible overdiagnosis of QTc prolongation due to accelerated heart rate.

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Absence of Change in Corrected QT Interval in Children and Adolescents Receiving Antipsychotic Treatment: A 12 Month Study

Abstract: In this sample, SGA seem to have a safe heart side effect profile in the child and adolescent population. There was no observed mean increase in QTc or in heart rate.

Cited by 6 publications

References 53 publications

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

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

No Apparent Cardiac Conduction Effects of Acute Treatment with Risperidone in Children with Autism Spectrum Disorder

QT prolongation is over-estimated by Bazett compared to Friderica in Japanese child and adolescent inpatients

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