Key result
A single dose of sotalol increased individual alpha coefficients for QT correction compared to placebo (0.454 vs 0.309, P<.0001), indicating placebo-derived formulas may not be valid on-drug.
Why the study?
Does a single dose of sotalol alter the individual alpha coefficients for QT correction compared to placebo in healthy subjects?
Population
39 healthy subjects, mean age 27.4 +/- 8.0 years
Comparison
Single dose of sotalol vs Placebo
Design
Other
Authors
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Placebo-derived QT formulas may not apply on sotalol; leaves open need for drug-specific validation before clinical adoption.
Does a single dose of sotalol alter the individual alpha coefficients for QT correction compared to placebo in healthy subjects?
Absolute Event Rate: 0.454% vs 0.309%
p-value: p=<.0001
The individual correction formula calculated from the placebo condition cannot always be used for QT correction on a drug, as the drug itself may alter the QT-RR relationship.
Extramiana et al. (2007) studied Healthy subjects (n=39). Sotalol vs. Placebo was evaluated on Individual alpha coefficients for QT correction (p=<.0001). A single dose of sotalol increased individual alpha coefficients for QT correction compared to placebo (0.454 vs 0.309, P<.0001), indicating placebo-derived formulas may not be valid on-drug.
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