Systematic review of gender bias in vortioxetine clinical trials

Santos-Casado, María; Guisado-Gil, Ana Belén; Santos-Ramos, Bernardo

doi:10.1016/j.pnpbp.2020.110088

Cited by 4 publications

(2 citation statements)

References 44 publications

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“…However, at odds with the bulk of vortioxetine studies [ 78 ], we investigated the effects of gender and age and found that women’s depressive episodes respond less than those of men regardless ofwhether they were treated with vortioxetine or OADs and that age influenced MADRS scores without changing the direction of interactions. This partially matches the finding that vortioxetine and sertraline did not differ in efficacy or safety measures in a sample of elderly people with MDD after 6 weeks [ 79 ].…”

Section: Discussionmentioning

confidence: 99%

Vortioxetine vs. Other Antidepressants in Patients with Major Depressive Episode With or Without Substance Use Disorder

Kotzalidis¹,

Lombardozzi²,

Matrone³

et al. 2021

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Background: Major Depressive Episodes (MDEs) may characterise many psychiatric disorders. Its pharmacotherapy is laid with unmet needs, rendering the testing of new drugs necessary. Objective: To compare the effects of vortioxetine with those of other antidepressants (OADs) in a 1-year naturalistic setting. Methods: We included 126 adult patients with a MDE in the course of major depressive (MDD), bipolar (BD), or schizophrenia spectrum disorders (SSOPDs), with or without substance use disorder (SUD), who received 5-20 mg/day oral vortioxetine, and compared them with 100 patients receiving OADs at baseline and after 1, 3, 8, and 12 months on their scores on the MADRS, the CGI-S, the 24-item BPRS, the YMRS, the Hamilton Anxiety Rating Scale, a Visual Analogue Scale for craving, the Columbia-Suicide Severity Rating Scale, and the WHOQOL-BREF. Results: Patients on vortioxetine improved similarly to those on OADs on all measures, independently from having or not a comorbid SUD. However, they improved with time better than their OADs counterparts if affected by BD or SSOPDs, but not MDD, on the CGI-S, BPRS depression, anxiety, and manic symptoms. SUD hampered the response of anxiety to treatment. Men improved on depression with time better than women. Conclusion: MDEs responded to vortioxetine similarly to OADs by improving in depression general psychopathology, anxiety, suicidal thinking, and quality-of-life, independently from SUD comorbidity. MDEs of patients with BD or SSOPDs on vortioxetine responded better than that of patients on OADs.

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Section: Discussionmentioning

confidence: 99%

Vortioxetine vs. Other Antidepressants in Patients with Major Depressive Episode With or Without Substance Use Disorder

Kotzalidis¹,

Lombardozzi²,

Matrone³

et al. 2021

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“…Gender bias is a well-established term used in biomedical research to show the low sensitivity to gender among low women representation and absence of analysis separately by sex in CTs [ 6 – 9 ]. In Psychiatry, three studies about gender bias remarked that results were poorly stratified by sex [ 10 – 12 ]. In Neurology, one study conducted in 2015 highlighted that women were only represented in 19% of CTs included [ 13 ] and a systematic review in multiple sclerosis pointed out that only 15 of 55 studies included an analysis by sex of the primary endpoint [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Gender bias in clinical trials of biological agents for severe asthma: A systematic review

2021

Self Cite

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Asthma is one of the most common chronic diseases characterized by sex disparities. Gender bias is a well-documented issue detected in the design of published clinical trials (CTs). International guidelines encourage researchers to analyze clinical data by sex, gender, or both where appropriate. The objective of this work was to evaluate gender bias in the published CTs of biological agents for the treatment of severe asthma. A systematic review of randomized controlled CTs of the biological agents (omalizumab, benralizumab, reslizumab, mepolizumab or dupilumab) for the treatment of severe asthma was conducted. The literature search was performed using PubMed and EMBASE without language restrictions. This study followed the corresponding international recommendations. We identified a total of 426 articles, of which 37 were finally included. Women represented 60.4% of patients included. The mean percentage of women in these trials was 59.9%, ranged from 40.8% to 76.7%. The separate analysis by sex of the main variable was only performed in 5 of the 37 publications included, and none of the trials analyzed secondary variables by sex. Only 1 of the articles discussed the results separately by sex. No study included the concept of gender in the text or analyzed the results separately by gender. The proportion of women included in CTs was higher compared to publications of other disciplines, where women were under-represented. The analysis of the main and secondary variables by sex or gender, even the discussion separately by sex, was insufficient. This gives rise to potential gender bias in these CTs.

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Trauma and gender in primary care

Christiansen¹

2023

Principles of Gender-Specific Medicine

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Systematic review of gender bias in vortioxetine clinical trials

Cited by 4 publications

References 44 publications

Vortioxetine vs. Other Antidepressants in Patients with Major Depressive Episode With or Without Substance Use Disorder

Vortioxetine vs. Other Antidepressants in Patients with Major Depressive Episode With or Without Substance Use Disorder

Gender bias in clinical trials of biological agents for severe asthma: A systematic review

Trauma and gender in primary care

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