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

J Child Adolesc Psychopharmacol. 2016 Jun;26(5):449-57. doi: 10.1089/cap.2015.0151. Epub 2016 Jan 18.

Abstract

Background: Prescriptions of antipsychotic drugs (AP) in children and adolescents have significantly increased in Europe as well as in the United States. However, there is limited evidence of the cardiac safety of second-generation antipsychotics (SGA) in the pediatric population.

Objective: The aim of the study is to evaluate the cardiac side effects of SGA in children and adolescents, and how they are influenced by clinical, demographic, and treatment factors.

Methods: This article presents a naturalistic, longitudinal, multicenter study conducted in 216 treatment-naïve or quasi-naïve children and adolescents receiving AP treatment. It analyzed the possible influence of AP treatment on variables such as corrected QT (QTc) intervals and heart rate for a period of 12 months (baseline, 3 months, 6 months, and 12 months). Differences among the three main prescribed drugs used in the sample (risperidone, quetiapine, and olanzapine) were assessed.

Results: A total of 211 received one of the three most prescribed AP (quetiapine, risperidone or olanzapine). There were no significant QTc variations in the sample during follow-up (p = 0.54). There were no differences in QTc rates between the different SGA (risperidone-olanzapine p = 0.43; risperidone-quetiapine p = 0.42; olanzapine-quetiapine p = 0.23). When demographic, clinical, or concomitant treatment variables were considered, only baseline overweight correlated with QTc prolongation (p = 0.003). The heart rate in the whole sample tended to decrease during follow-up (p = 0.054). However, patients on quetiapine showed increased heart rate compared with those on risperidone (p = 0.04).

Conclusions: 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Adolescent
  • Antipsychotic Agents / adverse effects*
  • Antipsychotic Agents / therapeutic use*
  • Benzodiazepines / adverse effects*
  • Benzodiazepines / therapeutic use*
  • Biomarkers, Pharmacological
  • Child
  • Child, Preschool
  • Electrocardiography / drug effects*
  • Female
  • Heart Rate / drug effects
  • Humans
  • Long QT Syndrome / chemically induced*
  • Long QT Syndrome / diagnosis
  • Longitudinal Studies
  • Male
  • Olanzapine
  • Prospective Studies
  • Quetiapine Fumarate / adverse effects*
  • Quetiapine Fumarate / therapeutic use*
  • Risperidone / adverse effects*
  • Risperidone / therapeutic use*

Substances

  • Antipsychotic Agents
  • Biomarkers, Pharmacological
  • Benzodiazepines
  • Quetiapine Fumarate
  • Risperidone
  • Olanzapine