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G150 CONTRIBUTING TO DEVELOPMENTALLY NORMAL PHYSIOLOGICAL VALUES FOR CHILDREN AND ADOLESCENTS: AN ANALYSIS OF BASELINE QTC INTERVALS IN PAEDIATRIC PATIENTS WITH ADHD ON ENTRY TO A PHARMACOTHERAPY CLINICAL TRIAL PROGRAMME
A. Furr1, S. Zhang2, A. Allen2, S. Ball3, S. Prasad4.1Indiana University School of Medicine, Indianapolis, IN, USA; 2Lilly Research Laboratories, Indianapolis, IN, USA; 3Medfocus, Indianapolis, IN, USA; 4Eli Lilly and Company, Ltd, Basingstoke, Hampshire, UK
Aims: The effect of medications on cardiac function is an area of increasing focus in the treatment of children with chronic conditions, as cardiac parameters such as the QT interval may be affected resulting in a potentially increased risk for adverse cardiac events. Given their developmental progression there is continuing debate about normal values of QTc in children and adolescents. This analysis, from all paediatric patient entering the atomoxetine clinical trial program provides age appropriate ECG baseline values from approximately 6000 children and adolescents who presented with the neurodevelopmental condition attention-deficit/hyperactivity disorder (ADHD), and contributes a significant body of information to normal values for QTc intervals in a paediatric population.
Methods: ECGs were taken of subjects aged 6–18 years as part of their screening for participation in the atomoxetine clinical development and registration programme. Baseline QT intervals were corrected for heart rate variability using three correction methods: Bazett’s, Fridericia’s, and a data derived method based on a population sample.
Results: ECG data were obtained from 5930 children and adolescents across 17 countries. Descriptive means, standard deviations, and percentiles for the ECG parameters and QTc intervals are provided by age, sex, developmental level (denoted by pubertal status) and by country. Using the data derived correction method, postpubertal males demonstrated significantly shorter QTc intervals (mean QTc = 402.8 ms, SD = 18.8) than postpubertal females (mean QTc = 409.5 ms, SD = 16.9, p<0.001). An unexpected finding was that the non-North American group in comparison to the North American group had small, greater mean ECG values on most measures, and …