Improvement and limitation of the reliability of automated QT measurement by recent algorithms.

BACKGROUND: Newer algorithms for automated QT interval measurements may be more reliable than previous algorithms. OBJECTIVE: This study compares Bazett-corrected QTc obtained by an older algorithm (Old12SL) and by 2 newer ones (New12SL and v3.19) to semiautomated measurement performed by experienced cardiologists. METHODS: A total of 6105 randomly selected electrocardiograms were classified by the cardiologists as normal (4227), borderline (1254), abnormal (575), or not analyzable (49). Errors of automated measurement were defined by more than 30 milliseconds of absolute difference between Bazett-corrected QTc obtained by automated algorithms and semiautomated measurement. RESULTS: The Old12SL had approximately twice as many errors (5.25%) as the New12SL (2.33%) and v3.19 (2.30%), P < .0001. Abnormal tracings resulted in more errors than did normal ones (Old12SL: 16.52% vs 3.45%, New12SL: 7.30% vs 1.51%, and v3.19: 10.61% vs 1.21%). CONCLUSION: Newer automated algorithms for QT measurements are highly reliable in normal tracings. However, electrocardiogram abnormalities increase the risk of QT measurement errors.

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.

The effect of bilastine on cardiac repolarization was studied in 30 healthy participants during a multiple-dose, triple-dummy, crossover, thorough QT study that included 5 arms: placebo, active control (400 mg moxifloxacin), bilastine at therapeutic and supratherapeutic doses (20 mg and 100 mg once daily, respectively), and bilastine 20 mg administered with ketoconazole 400 mg. Time-matched, triplicate electrocardiograms (ECGs) were recorded with 13 time points extracted predose and 16 extracted over 72 hours post day 4 dosing. Four QT/RR corrections were implemented: QTcB; QTcF; a linear individual correction (QTcNi), the primary correction; and a nonlinear one (QTcNnl). Moxifloxacin was associated with a significant increase in QTcNi at all time points between 1 and 12 hours, inclusively. Bilastine administration at 20 mg and 100 mg had no clinically significant impact on QTc (maximum increase in QTcNi, 5.02 ms; upper confidence limit [UCL] of the 1-sided, 95% confidence interval, 7.87 ms). Concomitant administration of ketoconazole and bilastine 20 mg induced a clinically relevant increase in QTc (maximum increase in QTcNi, 9.3 ms; UCL, 12.16 ms). This result was most likely related to the cardiac effect of ketoconazole because for all time points, bilastine plasma concentrations were lower than those observed following the supratherapeutic dose.