Key result
Sotalol-induced QTc prolongation was significantly greater in women than in men (26.5 vs 13.0 ms; P<0.0001), but the extent of prolongation was not influenced by baseline QTc.
Why the study?
The extent of sotalol-induced QTc prolongation varies and is influenced by sex, but the influence of baseline QTc on drug-induced QTc prolongation remains unclear.
Does baseline QTc influence the extent of sotalol-induced QTc prolongation in healthy men and women?
Cohort (n=990)
Does baseline QTc influence the extent of sotalol-induced QTc prolongation in healthy men and women?
Absolute Event Rate: 26.5% vs 13%
p-value: p=<.0001
The extent of sotalol-induced QTc prolongation is greater in women but is independent of baseline QTc, suggesting that assessing QTc after drug administration is more important than baseline measurement.
Post-dose QTc assessment may matter more than baseline in women on sotalol; extends sex-difference data but leaves open outcome validation.
The extent of sotalol‐induced QTc prolongation on the electrocardiogram, is variable among subjects and influenced by sex. However, the influence of baseline QTc on the extent of drug‐induced QTc prolongation remains unclear. This was studied around peak plasma concentration in a large cohort of 376 healthy male and 614 healthy female subjects who received 80 mg of sotalol orally. Baseline QTc was 379 ± 16 ms in men and 393 ± 15 ms in women (P < .0001). The change in QTc from baseline was highly variable among both sexes and was greater in women than in men (26.5 ± 13.2 vs.13.0 ± 10.8 ms; P < .0001). The slope of the regression line between QTc on sotalol and baseline QTc did not significantly differ from unity in men and in women, indicating that the extent of QTc prolongation with sotalol was not influenced by baseline QTc. Assessing QTc after administration of an IKr blocker may be more important than measuring a baseline QTc.
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Funck‐Brentano et al. (2021) conducted a cohort in Healthy (n=990). Sotalol was evaluated on Change in QTc from baseline (p=<.0001). Sotalol-induced QTc prolongation was significantly greater in women than in men (26.5 vs 13.0 ms; P<0.0001), but the extent of prolongation was not influenced by baseline QTc.
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