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Statistical analysis methods for QT/QTc prolongation.

Publication ,  Journal Article
Ma, H; Smith, B; Dmitrienko, A
Published in: J Biopharm Stat
2008

Prolonged QT interval is associated with life-threatening arrhythmias. Regulatory authorities have paid special attention to investigating the drug-induced delay of cardiac repolarization. Studies aimed at evaluating QT prolongation have become a routine part of safety packages across the pharmaceutical industry. However, the assessment of QT interval prolongation on the surface electrocardiogram is complicated by the fact that many factors influence the duration of the QT interval, among which heart rate plays a predominant role. Some widely used corrections of the QT interval for varying heart rate are known to be inadequate. Many alternatives have been proposed in the literature. Using information obtained from Eli Lilly thorough QT studies, we examine the performance of several approaches to the analysis of QT changes, including subject-specific (individual) QT corrections and model-based QT analysis methods. The simulation results indicate that the mixed-effects modeling approach proposed in this paper is more powerful than the other methods, all of which are commonly used in QT studies.

Duke Scholars

Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

2008

Volume

18

Issue

3

Start / End Page

553 / 563

Location

England

Related Subject Headings

  • Statistics & Probability
  • Randomized Controlled Trials as Topic
  • Models, Statistical
  • Long QT Syndrome
  • International Cooperation
  • Humans
  • Heart Rate
  • Guidelines as Topic
  • Electrocardiography
  • Drug Industry
 

Citation

APA
Chicago
ICMJE
MLA
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Ma, H., Smith, B., & Dmitrienko, A. (2008). Statistical analysis methods for QT/QTc prolongation. J Biopharm Stat, 18(3), 553–563. https://doi.org/10.1080/10543400801995494
Ma, Haijun, Brian Smith, and Alex Dmitrienko. “Statistical analysis methods for QT/QTc prolongation.J Biopharm Stat 18, no. 3 (2008): 553–63. https://doi.org/10.1080/10543400801995494.
Ma H, Smith B, Dmitrienko A. Statistical analysis methods for QT/QTc prolongation. J Biopharm Stat. 2008;18(3):553–63.
Ma, Haijun, et al. “Statistical analysis methods for QT/QTc prolongation.J Biopharm Stat, vol. 18, no. 3, 2008, pp. 553–63. Pubmed, doi:10.1080/10543400801995494.
Ma H, Smith B, Dmitrienko A. Statistical analysis methods for QT/QTc prolongation. J Biopharm Stat. 2008;18(3):553–563.

Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

2008

Volume

18

Issue

3

Start / End Page

553 / 563

Location

England

Related Subject Headings

  • Statistics & Probability
  • Randomized Controlled Trials as Topic
  • Models, Statistical
  • Long QT Syndrome
  • International Cooperation
  • Humans
  • Heart Rate
  • Guidelines as Topic
  • Electrocardiography
  • Drug Industry