Key result
Supratherapeutic duloxetine does not prolong the QTc interval versus placebo.
Why the study?
Does duloxetine at supratherapeutic doses prolong the QT interval in healthy female subjects?
Population
117 healthy female subjects aged 19 to 74 years
Comparison
Duloxetine dosages escalated from 60 mg twice… vs Placebo and a single moxifloxacin 400 mg dose
Design
RCT, randomized, double-blind
Authors
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Supports high-dose duloxetine without QTc monitoring; confirms cardiac safety in this supratherapeutic RCT.
RCT (n=117)
Double-blind
Randomized crossover
Yes
Does duloxetine at supratherapeutic doses prolong the QT interval in healthy female subjects?
Duloxetine at supratherapeutic doses does not prolong the QT interval, indicating a favorable cardiac safety profile regarding ventricular repolarization.
Zhang et al. (2007) conducted an RCT in Healthy (n=117). Duloxetine vs. Placebo was evaluated on Mean change from baseline in QTc. Duloxetine at supratherapeutic doses up to 200 mg twice daily did not prolong the QTc interval compared with placebo (upper limit of 90% CI <0 msec).
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