Key result
An alternative software algorithm corroborated FDA findings for detecting drug-induced cardiac ion channel block, resulting in an average 25% reduction in the 95% confidence intervals.
Why the study?
Does an alternative software algorithm corroborate FDA findings for detecting drug-induced cardiac ion channel block compared to the FDA published software algorithm?
Does an alternative software algorithm corroborate FDA findings for detecting drug-induced cardiac ion channel block compared to the FDA published software algorithm?
Answers are grounded in this paper and cite their sources.
An alternative automated ECG algorithm corroborated FDA findings for detecting drug-induced ion channel block while providing tighter confidence intervals.
) repolarization duration can differentiate selective potassium block with a high arrhythmia risk from multichannel block with lower risk in subjects receiving dofetilide, verapamil, quinidine, or ranolazine. The purpose of this study was to determine if the findings by the FDA using their published software algorithm could be corroborated using an alternative software algorithm for the same metrics and to determine if methodological differences resulted in clinically meaningful differences in interpretation. Exposure-response relationships computed with linear mixed effects models and mean maximal effects on ECG intervals measured by the two algorithms were similar, corroborating the FDA findings, but with some differences in the modeled slopes and magnitude of changes. The alternative software resulted in an average 25% reduction in the 95% confidence intervals of the mixed effects models with generally lower Akaike Information Criterion values.
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Brockway et al. (2017) studied Drug-induced cardiac ion channel block. Alternative software algorithm vs. FDA published software algorithm was evaluated on Exposure-response relationships and mean maximal effects on ECG intervals. An alternative software algorithm corroborated FDA findings for detecting drug-induced cardiac ion channel block, resulting in an average 25% reduction in the 95% confidence intervals.
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