Implications of Individual QT/RR Profiles-Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes.

ABSTRACT:

Introduction

In studies of drug-induced corrected QT (QTc) changes, fixed universal heart rate (HR) corrections (e.g., the Fridericia correction) are potentially misleading when assessing the effects of drugs that change HR. When data-specific corrections are designed, tests of their validity are needed. The proposed tests include zero correlations between QTc and corresponding RR values in the complete study data (pooling on-treatment and off-treatment interval measurements).

Objective

To document that this approach is potentially highly misleading, a statistical modeling study was conducted based on the full profiles of QT/RR data of 523 healthy subjects-254 females, mean age 33.5 years.

Methods

In each of the subjects, 50 baseline QT/RR readings were selected to mo

SUBMITTER: Malik M 

PROVIDER: S-EPMC6426831 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature