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

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.

Pharmacogenetic study of second-generation antipsychotic long-term treatment metabolic side effects (the SLiM Study): rationale, objectives, design and sample description.

AIM: Weight gain is an important and common side effect of second generation antipsychotics (SGAs). Furthermore, these drugs can induce other side effects associated with higher cardiovascular morbidity and mortality, such as insulin resistance, diabetes or metabolic syndrome. Preliminary studies show that inter-individual genetic differences produce varying degrees of vulnerability to the different SGA-induced side effects. The Second-generation antipsychotic Long-term treatment Metabolic side effects (SLiM) study aims to identify clinical, environmental and genetic factors that explain inter-individual differences in weight gain and metabolic changes in drug-naïve patients after six months of treatment with SGAs. MATERIALS AND METHODS: The SLIM study is a multicenter, observational, six-month pharmacogenetic study where a cohort of 307 drug-naïve paediatric and adult patients (age range 8.8-90.1 years) and a cohort of 150 age- and sex- matched healthy controls (7.8-73.2 years) were recruited. RESULTS: This paper describes the rationale, objectives and design of the study and provides a description of the sample at baseline. CONCLUSIONS: Results from the SLiM study will provide a better understanding of the clinical, environmental, and genetic factors involved in weight gain and metabolic disturbances associated with SGA treatment.

Estudio farmacogenético del tratamiento a largo plazo con antipsicóticos de segunda generación y sus efectos adversos metabólicos (Estudio SLiM): justificación, objetivos, diseño y descripción de la muestra / Pharmacogenetic study of second-generation antipsychotic long-term treatment metabolic side effects (the SLiM Study): rationale, objectives, design and sample description

Objetivo. El aumento de peso es un efecto secundario frecuente e importante de los antipsicóticos de segunda generación (ASG). Además, estos fármacos pueden inducir otros efectos secundarios que están asociados a un aumento de la morbimortalidad cardiovascular, tales como la resistencia a la insulina, la diabetes o el síndrome metabólico. Estudios preliminares indican que las diferencias genéticas interindividuales producen distintos grados de vulnerabilidad a los efectos secundarios inducidos por los ASG. El estudio SLiM (por sus siglas en inglés, Second-generation antipsychotic Long-term treatment Metabolic side effects) tiene como objetivo identificar en pacientes no tratados previamente con ASG (pacientes naive), aquellos factores clínicos, genéticos y ambientales que expliquen las diferencias interindividuales en relación con el aumento de peso y los cambios metabólicos generados tras 6 meses de tratamiento con estos fármacos. Material y métodos. El estudio SLiM es un estudio farmacogenético multicéntrico, observacional, prospectivo, de 6 meses de duración, en el que se ha reclutado una cohorte de 307 pacientes pediátricos y adultos (rango de edad entre 8,8 a 90,1 años) naive a ASG y una cohorte de 150 controles sanos (rango de edad entre 7,8 y 73,2 años) emparejados por edad y sexo. Resultados. En este artículo se presentan la justificación, los objetivos y el diseño del estudio y se ofrece una descripción de la muestra al inicio del estudio. Conclusiones. Los resultados del estudio SLiM permitirán una mejor comprensión de los factores clínicos, ambientales y genéticos implicados en el aumento de peso y los trastornos metabólicos asociados al tratamiento con ASG (AU)

Aim. Weight gain is an important and common side effect of second generation antipsychotics (SGAs). Furthermore, these drugs can induce other side effects associated with higher cardiovascular morbidity and mortality, such as insulin resistance, diabetes or metabolic syndrome. Preliminary studies show that inter-individual genetic differences produce varying degrees of vulnerability to the different SGA-induced side effects. The Second-generation antipsychotic Long-term treatment Metabolic side effects (SLiM) study aims to identify clinical, environmental and genetic factors that explain inter-individual differences in weight gain and metabolic changes in drug-naïve patients after six months of treatment with SGAs. Materials and methods. The SLIM study is a multicenter, observational, six-month pharmacogenetic study where a cohort of 307 drug-naïve paediatric and adult patients (age range 8.8-90.1 years) and a cohort of 150 age- and sex- matched healthy controls (7.8-73.2 years) were recruited. Results. This paper describes the rationale, objectives and design of the study and provides a description of the sample at baseline. Conclusions. Results from the SLiM study will provide a better understanding of the clinical, environmental, and genetic factors involved in weight gain and metabolic disturbances associated with SGA treatment (AU)