A statistical assessment of QT data following placebo and moxifloxacin dosing in thorough QT studies.
The ICH guidelines indicate that a single "thorough QT study" should be conducted to evaluate the effects of new drugs on cardiac repolarization. A positive control, such as moxifloxacin, is required to be assessed as part of the thorough QT study to validate the assay sensitivity of each study. In order to better understand the effect of moxifloxacin, a meta-analysis of nine thorough QT studies has been undertaken to assess the overall moxifloxacin effect. The data was analyzed using a repeated measures mixed model to test various covariance structures to identify the most suitable model for this and future meta-analyses of thorough QT studies.
Stylianou
Anastasia
A
Discovery Biometrics, GlaxoSmithKline, Harlow, Essex, UK. Anastasia.2.Stylianou@gsk.com
Roger
James
J
Stephens
Kimberley
K
D000890:Anti-Infective Agents / Q000009:adverse effects*; D001372:Aza Compounds / Q000009:adverse effects*; D018592:Cross-Over Studies; D004562:Electrocardiography / Q000706:statistics & numerical data*; D005260:Female; D024841:Fluoroquinolones; D017408:Guidelines as Topic; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced / Q000175:diagnosis / Q000503:physiopathology; D008297:Male; D015201:Meta-Analysis as Topic; D015233:Models, Statistical; D000077266:Moxifloxacin; D010919:Placebos; D011804:Quinolines / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*
D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D010919:Placebos; D011804:Quinolines; D000077266:Moxifloxacin