The safety and tolerability of vortioxetine: analysis of data from randomised placebo-controlled trials and open-label extension studies
The safety and tolerability of vortioxetine in adults with major depressive disorder (MDD) was assessed. Tolerability was based on the nature, incidence and severity of treatment-emergent adverse events (TEAEs) during acute (6/8) week treatment in 11 randomised, double-blind placebo-controlled short...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
2016-02-23.
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| Subjects: | |
| Online Access: | Get fulltext Get fulltext |
| Summary: | The safety and tolerability of vortioxetine in adults with major depressive disorder (MDD) was assessed. Tolerability was based on the nature, incidence and severity of treatment-emergent adverse events (TEAEs) during acute (6/8) week treatment in 11 randomised, double-blind placebo-controlled short-term studies in MDD: 6 with an active reference. Symptoms following discontinuation were assessed through the Discontinuation-Emergent Signs and Symptoms (DESS) checklist in 3 studies. Long-term (?52 weeks) tolerability was evaluated in 5 open-label extension studies. 5701 patients were acutely treated with either placebo (n=1817), vortioxetine (5-20mg/day) (n=3018), venlafaxine XR (225mg/day) (n=113), or duloxetine (60mg/day) (n=753). The withdrawal rate due to TEAEs during treatment with vortioxetine (5-20mg/day) was 4.5-7.8%, compared to placebo (3.6%), venlafaxine XR (14.2%) or duloxetine (8.8%). Common TEAEs (incidence ?5% and >2x placebo) with vortioxetine (5-20mg/day) were nausea (20.9-31.2%) and vomiting (2.9-6.5%). For vortioxetine (5-20mg/day), the incidence of TEAEs associated with insomnia was 2.0-5.1% versus 4.0% for placebo, and with sexual dysfunction 1.6-1.8% versus 1.0% for placebo. Discontinuation symptoms as assessed by the mean DESS total score after abrupt discontinuation were comparable to placebo in the first and second week. Vortioxetine had no effect relative to placebo on clinical laboratory parameters, body weight, heart rate, or blood pressure. Vortioxetine showed no clinically relevant effect on ECG parameters, including the QTcF interval. In long-term treatment, no new types of TEAEs were seen; the mean weight gain was 0.7-0.8kg. Thus, vortioxetine (5-20mg/day) appears safe and generally well tolerated in the treatment of MDD. |
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