JSM 2004 - Toronto

Abstract #300244

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Activity Number: 318
Type: Invited
Date/Time: Wednesday, August 11, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #300244
Title: A Maximum Likelihood Approach for Estimating the QT Correction Factor Using Mixed-effects Model
Author(s): Amrik Shah*+
Companies: Schering-Plough Corporation
Address: 2015 Galloping Hill Road, Kenilworth, NJ, 07033,
Keywords: Bazett ; QT ; QTc ; prolongation ; Friderecia
Abstract:

Assessment of QT interval prolongation is often used for assessing the cardiac safety of a new drug. However, the correction of the QT interval for varying heart rates has potential bias due to various different correction factors. We propose a maximum-likelihood (ML) approach for calculating the appropriate individual correction factor using the data. The data come from a study with 24 subjects participating in a 10-day multiple dose (NEW RX), placebo-controlled crossover trial with repeat ECG's obtained at baseline and at Day 10. ML techniques were used to fit a random-effects model to observed QT and HR values for estimating the pooled and individual correction factors. QTc values using four correction factors (Bazett, Friderecia, Pooled, and Individual) were also investigated. The relative performance of the various correction factors are given in terms of variability and graphical techniques.

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