Effects of Bilastine on T-wave Morphology and the QTc Interval

@article{Graff2012EffectsOB,
  title={Effects of Bilastine on T-wave Morphology and the QTc Interval},
  author={Claus Graff and Johannes Jan Struijk and J{\o}rgen K. Kanters and Mads P. Andersen and Egon Toft and Beno{\^i}t Tyl},
  journal={Clinical Drug Investigation},
  year={2012},
  volume={32},
  pages={339-351}
}
AbstractBackground and Objectives: The International Conference of Harmonisation (ICH) E14 guideline for thorough QT studies requires assessing the propensity of new non-antiarrhythmic drugs to affect cardiac repolarization. The present study investigates whether a composite ECG measure of T-wave morphology (Morphology Combination Score [MCS]) can be used together with the heart rate corrected QT interval (QTc) in a fully ICH E14-compliant thorough QT study to exclude clinically relevant… 

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References

SHOWING 1-10 OF 37 REFERENCES

Lack of Significant Effect of Bilastine Administered at Therapeutic and Supratherapeutic Doses and Concomitantly With Ketoconazole on Ventricular Repolarization: Results of a Thorough QT Study (TQTS) With QT‐Concentration Analysis

Moxifloxacin was associated with a significant increase in QTcNi at all time points between 1 and 12 hours, inclusively, and this result was most likely related to the cardiac effect of ketoconazole.

Improving the detection of subtle I(Kr)-inhibition: assessing electrocardiographic abnormalities of repolarization induced by moxifloxacin.

New parameters reflecting the morphology of the T-wave outperformed QTc measurements when identifying moxifloxacin-induced blockade of the outward rapid components of the delayed rectifier repolarizing potassium current (I(Kr).

Covariate Analysis of QTc and T‐Wave Morphology: New Possibilities in the Evaluation of Drugs That Affect Cardiac Repolarization

New insights are offered into the repolarization behavior of a drug associated with low cardiac risk vs. one associated with a high risk and the added benefits of a T‐wave MCS are described as a covariate to the assessment of the QTc interval.

Identifying Drug-Induced Repolarization Abnormalities from Distinct ECG Patterns in Congenital Long QT Syndrome

Distinct ECG patterns in LQT2 carriers effectively quantified repolarization changes induced by sotalol, and further studies are needed to validate whether this measure has general validity for the identification of drug-induced disturbed repolarizations.

Quantitative Analysis of T‐wave Morphology Increases Confidence in Drug‐Induced Cardiac Repolarization Abnormalities: Evidence From the Investigational IKr Inhibitor Lu 35–138

As a covariate to the assessment of QT interval liability, MCS offered important additive information to the effect of Lu 35–138 on cardiac repolarization.

Co-administration of ketoconazole with H1-antagonists ebastine and loratadine in healthy subjects: pharmacokinetic and pharmacodynamic effects.

Ketoconazole altered the pharmacokinetic profiles of both ebastine and loratadine although the effect was greater for the former drug, and changes in uncorrected QT intervals for both antihistamines were not statistically different from those observed with ketoconazoles alone.

Performance Characteristics for Some Typical QT Study Designs Under the ICH E‐14 Guidance

This report assesses the IUT false positive rate for 4 recently conducted TQT trials using simple simulation experiments and reveals significant limitations of the I UT with respect to excluding an effect and study interpretation for certain trial designs.