Abstract
This study adds the dimension of a T-wave morphology composite score (MCS) to the QTc interval-based evaluation of drugs that affect cardiac repolarization. Electrocardiographic recordings from 62 subjects on placebo and 400mg moxifloxacin were compared with those from 21 subjects on 160 and 320mg D,L-sotalol. T-wave morphology changes, as assessed by ΔMCS, are larger after 320mg D,L-sotalol than after 160mg D,L-sotalol; and the changes associated with 160mg D,L-sotalol are, in turn, larger than those associated with moxifloxacin and placebo. Covariate analyses of ΔQTc and ΔMCS showed that changes in T-wave morphology are a significant effect of D,L-sotalol. By contrast, moxifloxacin was found to have no significant effect on T-wave morphology (ΔMCS) at any given change in QTc. This study offers new insights into the repolarization behavior of a drug associated with low cardiac risk vs. one associated with a high risk and describes the added benefits of a T-wave MCS as a covariate to the assessment of the QTc interval.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Clinical Pharmacology and Therapeutics |
| Vol/bind | 88 |
| Udgave nummer | 1 |
| Sider (fra-til) | 88-94 |
| Antal sider | 7 |
| ISSN | 0009-9236 |
| DOI | |
| Status | Udgivet - 24 jul. 2010 |