Key result
Women exposed to d,l-sotalol had a threefold greater adjusted odds of developing torsade de pointes compared to men (4.1% vs 1.9%; P<0.001).
Why the study?
Does female sex increase the risk of torsade de pointes in adult patients treated with oral d,l-sotalol?
Population
3,135 adult patients who received oral d,l-sotalol, derived from a database of 22 clinical trials
Comparison
Female sex vs Male sex (in patients receiving oral d,l-sotalol)
Design
Cohort
Follow-up
median 164 days
Authors
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May warrant closer QT monitoring in women on d,l-sotalol; leaves open need for sex-specific dosing trials.
Cohort (n=3,135)
Yes
Does female sex increase the risk of torsade de pointes in adult patients treated with oral d,l-sotalol?
Effect estimate: OR 3.0
Absolute Event Rate: 4.1% vs 1.9%
p-value: p=<0.001
Women have a threefold greater adjusted odds of developing torsade de pointes compared to men when treated with d,l-sotalol, highlighting the need for sex-specific caution with QT-prolonging drugs.
Lehmann et al. (1996) conducted a cohort in Patients requiring antiarrhythmic therapy (n=3,135). Female sex (exposure to d,l-sotalol) vs. Male sex was evaluated on Torsade de pointes (TdP) (OR 3.0, p=<0.001). Women exposed to d,l-sotalol had a threefold greater adjusted odds of developing torsade de pointes compared to men (4.1% vs 1.9%; P<0.001).
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