The safety and tolerability of vortioxetine: Analysis of data from randomized placebo-controlled trials and open-label extension studies.
The safety and tolerability of vortioxetine in adults with major depressive disorder 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 randomized, double-blind placebo-controlled short-term studies in major depressive disorder: six with an active reference. Symptoms following discontinuation were assessed through the Discontinuation-Emergent Signs and Symptoms checklist in three studies. Long-term (⩽52 weeks) tolerability was evaluated in five open-label extension studies. Patients (n =5701) 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 with placebo (3.6%), venlafaxine XR (14.2%) or duloxetine (8.8%). Common TEAEs (incidence ⩾5% and >2 × 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 Discontinuation-Emergent Signs and Symptoms 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 major depressive disorder.
['Baldwin|David S|DS|', 'Chrones|Lambros|L|', 'Florea|Ioana|I|', 'Nielsen|Rebecca|R|', 'Nomikos|George G|GG|', 'Palo|William|W|', 'Reines|Elin|E|']
D000293:Adolescent D000328:Adult D000368:Aged D003865:Depressive Disorder, Major D004311:Double-Blind Method D000068736:Duloxetine Hydrochloride D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D010879:Piperazines D011569:Psychiatric Status Rating Scales D016032:Randomized Controlled Trials as Topic D017367:Serotonin Uptake Inhibitors D013440:Sulfides D000069470:Venlafaxine Hydrochloride D000078784:Vortioxetine D055815:Young Adult
safety tolerability vortioxetine Major depressive disorder