Evaluation of acute cardiovascular effects of immediate-release XXXX in @entity1 and adolescents with @entity71 .

@entity1 @entity17196 @entity71 @entity7541 @entity2727 @entity1480
@entity71 is a frequent condition in @entity1 and often extends into adulthood. Use of immediate-release @entity2727 ( @entity7541 ) has raised concerns about potential cardiovascular adverse effects within a few hours after administration. This study was carried out to investigate acute effects of @entity7541 on electrocardiogram (ECG) in a pediatric population. A total of 54 consecutive @entity1 with @entity71 (51 males and 3 females; mean age =12.14  2.6 years, range 6-19 years), receiving a new prescription of @entity7541 , underwent a standard @entity17196 hours before and after the administration of @entity7541 10 mg per os. Basal and posttreatment ECG parameters, including mean QT (QT interval when corrected for heart rate [QTc]), @entity1480 ( @entity1480 ) interval duration, T-peak to T-end (TpTe) intervals, and TpTe/QT ratio were compared. Significant modifications of both QTc and @entity1480 values were not found after drug administration. @entity1480 fluctuated slightly from 25.7  9.3 milliseconds to 25.1  8.4 milliseconds; QTc varied from 407.6  12.4 milliseconds to 409.8  12.7 milliseconds. A significant variation in blood pressure (systolic blood pressure 105.4  10.3 vs 109.6  11.5; P<0.05; diastolic blood pressure 59.2  7.1 vs 63.1  7.9; P<0.05) was observed, but all the data were within normal range. Heart rate moved from 80.5  15.5 bpm to 87.7  18.8 bpm. No change in TpTe values was found, but a statistically significant increase in TpTe/QTc intervals was found with respect to basal values (0.207  0.02 milliseconds vs 0.214  0.02 milliseconds; P<0.01). The findings of this study show no significant changes in ECG parameters. TpTe values can be an additional parameter to evaluate borderline cases.
