Why the study?
Does terfenadine increase the QTc interval compared to placebo in healthy volunteers and patients with stable cardiovascular disease?
Population
56 participants, comprising 28 normal healthy volunteers and 28 patients with stable cardiovascular disease.
Comparison
Terfenadine vs Placebo
Design
RCT, double-blind
Authors
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Terfenadine's modest QTc effects may not exceed spontaneous variability; challenges reliance on small changes to detect drug-induced prolongation in trials.
Does terfenadine increase the QTc interval compared to placebo in healthy volunteers and patients with stable cardiovascular disease?
While terfenadine causes statistically significant increases in the QTc interval, the magnitude of spontaneous variability is much greater, suggesting that a QTc increase of at least 35 msec is required to reliably distinguish a drug effect.
Pratt et al. (1996) studied this question.
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