Investigator Anita Clayton, MD, shares insights into the new vortioxetine data and its implications for patients with depression and treatment-emergent sexual dysfunction.
Anita H. Clayton, MD
The US Food and Drug Administration (FDA) recently updated the label for vortioxetine (Trintellix) with new data added about sexual dysfunction. Vortioxetine showed improvements in treatment-emergent sexual dysfunction in a head-to-head trial with escitalopram (Lexapro).
The study included patients with well-managed depression who also experienced treatment-emergent sexual dysfunction (TESD) while taking an SSRI, such as paroxetine, sertraline, or citalopram. Participants were switched from their SSRI to either vortioxetine or escitalopram.
In an interview with MD Magazine® about the label update, lead study investigator Anita H. Clayton, MD, Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, VA, shared that the new data is important because TESD is a common problem for patients with depression. In fact, she said that in clinical trials for depression, about 70% of participants experience treatment-emergent sexual dysfunction.
“If patients are experiencing sexual dysfunction with an SSRI, I think it's reasonable to offer them the option to switch to another medication, and vortioxetine has clearly demonstrated a benefit for patients with treatment-emergent sexual dysfunction,” Clayton told MD Magazine®.
The 8-week, randomized, double-blind study in adult patients with major depressive disorder (MDD) and TESD included participants (n = 447) who were switched to either vortioxetine (n = 225) or escitalopram (n = 222) from citalopram, paroxetine, or sertraline.
Using the Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14), the research team found that patients receiving vortioxetine showed significantly greater improvements (8.8 ± .64, mean ± standard error) compared to those receiving escitalopram (6.6 ± .64; P = .013).
The difference between vortioxetine and escitalopram was not only statistically significant, but also clinically relevant, according to Clayton. She said that on the CSFQ-14, which she developed, a difference of 2 to 2.5 indicates an improvement that is meaningful to patients.
Nausea was the most common adverse effect reported in the study for patients receiving vortioxetine (n = 9, 4.0%). However, Clayton noted that this symptom could dissipate with time, while sexual dysfunction is an ongoing concern that can also affect a patient’s level of depression. Other adverse effects (incidence ≥ 5% and at least double that of placebo) noted on the vortioxetine prescribing information include constipation and vomiting.
“Sexual dysfunction is chronic. It goes on and on and on, whereas some of the acute side effects of vortioxetine, like nausea, are temporary,” said Clayton.
Clayton mentioned that she asks patients with depression what potential side effects they are most concerned about to inform what treatments to begin with. The most common answers she receives are about weight gain and sexual dysfunction.
“If a patient’s primary concern is that they don't want to have sexual dysfunction I would consider starting them on vortioxetine from the beginning, because then you don't have to switch,” said Clayton.
Clayton’s advice to other clinicians is be aware that patients whose dosages are increased to 20mg per day may experience TESD at that dosage. In those cases, she recommends reducing the dose to 15mg or 10mg per day.
Vortioxetine was originally approved by the FDA in September 2013. Earlier this year, the FDA approved a label update for vortioxetine indicating that the drug demonstrated an improvement in processing speed, a cognitive function that affects many patients with major depressive disorder.