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Drospirenone may contribute to QTc prolongation
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When combined with sotalol, the oral contraceptive drospirenone was associated with QTc prolongation, a marker for torsades de pointes, according to new findings.
According to the study background, women have higher risk than men for drug-induced torsades de pointes, and androgens are protective for it, but the influence of oral contraceptives on drug-induced torsades de pointes and QTc prolongation was not definitively known.
The researchers analyzed 498 healthy nonmenopausal women who received 80 mg of sotalol, a beta-blocker that is used to treat ventricular tachycardia and is known to elevate risk for drug-induced torsades de pointes.
Among the cohort, 207 women took no oral contraceptives; 137 took levonorgestrel, which has high androgenic potency; 41 took desogestrel and 51 took gestodene, both of which have intermediate androgenic potency; and 62 took drospirenone, which has antiandrogenic properties.
The outcome of interest was electrocardiographic changes 3 hours after sotalol administration.
The groups did not differ in baseline QTc duration, plasma sotalol levels or potassium levels, Joe-Elie Salem, MD, PhD, from Centre d'Investigation Clinique Paris-Est, Hôpital Pitié-Salpêtrière, Paris, and colleagues wrote.
At 3 hours after exposure to sotalol, the drospirenone group had greater QTc prolongation than the no-contraceptive group in terms of mean increase from baseline (31.2 milliseconds vs. 24.6 milliseconds; P = .005); the drospirenone group also had greater QTc prolongation than the levonorgestrel group (31.2 milliseconds vs. 24.2 milliseconds; P = .005), Salem and colleagues wrote.
Sotalol-induced T-wave alteration was more frequent in the drospirenone group (21%) than the levonorgestrel group (14.6%) or the no-contraceptive group (11.6%; P = .01), according to the researchers.
When the researchers conducted a disproportionality analysis using a European pharmacovigilance database, they found the reported rate of oral contraceptive-induced prolonged QT and ventricular arrhythmias was higher in women taking drospirenone than in those taking levonorgestrel (reporting OR for drug-induced long QT syndrome = 6.2; 95% CI, 1.3-30.8; reporting OR for ventricular arrhythmias = 3.03; 95% CI, 1.7-6.3).
“The findings of this study call for careful history-taking of [oral contraceptive] use, and the type of [oral contraceptive] taken could be useful in shared decision making in women with preexisting risk factors for drug-induced [torsades de pointes],” Salem and colleagues wrote. – by Erik Swain
Disclosure: Salem and two other authors report holding a patent related to treatment of torsades de pointes. Salem and four other authors report holding a patent related to QTc technology.
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