%0 Randomized Controlled Trial
%T T-wave morphology abnormalities in the STREAM stage 1 trial.
%A Hughes G
%A Young WJ
%A Bern H
%A Crook A
%A Lambiase PD
%A Goodall RL
%A Nunn AJ
%A Meredith SK
%J Expert Opin Drug Saf
%V 23
%N 4
%D 2024 Apr 10
%M 38462751
%F 4.011
%R 10.1080/14740338.2024.2322116
%X <B>UNASSIGNED: </B>Shorter regimens for drug-resistant tuberculosis (DR-TB) have non-inferior efficacy compared with longer regimens, but QT prolongation is a concern. T-wave morphology abnormalities may be a predictor of QT prolongation.<BR><B>UNASSIGNED: </B>STREAM Stage 1 was a randomized controlled trial in rifampicin-resistant TB, comparing short and long regimens. All participants had regular ECGs. QT/QTcF prolongation (≥500 ms or increase in ≥60 ms from baseline) was more common on the short regimen which contained high-dose moxifloxacin and clofazimine. Blinded ECGs were selected from the baseline, early (weeks 1-4), and late (weeks 12-36) time points. T-wave morphology was categorized as normal or abnormal (notched, asymmetric, flat-wave, flat peak, or broad). Differences between groups were assessed using Chi-Square tests (paired/unpaired, as appropriate).<BR><B>UNASSIGNED: </B>Two-hundred participants with available ECGs at relevant times were analyzed (QT prolongation group n = 82; non-prolongation group n = 118). At baseline, 23% (45/200) of participants displayed abnormal T-waves, increasing to 45% (90/200, p < 0.001) at the late time point. Abnormalities were more common in participants allocated the Short regimen (75/117, 64%) than the Long (14/38, 36.8%, p = 0.003); these occurred prior to QT/QTcF ≥500 ms in 53% of the participants (Long 2/5; Short 14/25).<BR><B>UNASSIGNED: </B>T-wave abnormalities may help identify patients at risk of QT prolongation on DR-TB treatment.<BR><B>UNASSIGNED: </B>The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT02409290). Current Controlled Trial number, ISRCTN78372190.