Frequency of treatment-emergent sexual dysfunction and treatment effectiveness during SSRI or duloxetine therapy: 8-week data from a 6-month observational study

Abstract

Background. In randomised controlled trials, the frequency of treatment-emergent sexual dysfunction (TESD) in patients with major depressive disorder (MDD) at week 8 was lower with duloxetine than selective serotonin reuptake inhibitor (SSRI) therapy. Methods. This 6-month, prospective, observational study compared the frequency of TESD (using the Arizona Sexual Experience [ASEX] scale) in MDD patients treated with duloxetine or SSRI monotherapy in the first 8 weeks in normal clinical practice. Results. Physician-assessed TESD frequency at week 8 was comparable with duloxetine and SSRI monotherapy (23.9 and 26.2%, respectively; P = 0.545). Improvements in Clinical Global Impressions of Severity (CGI-S), 16-item Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR16), Integral Inventory for Depression (IID) total scores and remission rates were statistically significantly greater with duloxetine than SSRI monotherapy (P < 0.001, 0.010, <0.001, and 0.002, respectively), but TESD attenuated improvements in quality of life measures (EuroQoL questionnaire-5 dimensions [EQ-5D] and Sheehan Disability Scale [SDS] scores: ≤0.012). Several factors were significantly (P ≤ 0.05) associated with TESD at week 8 in this study. Conclusions. TESD rates with duloxetine and SSRIs at week 8 were comparable, however, significant differences in effectiveness were observed in favour of duloxetine. Antidepressant tolerability with respect to TESD must be managed to maximize remission of depressed patients.

Key Words::

• Major depressive disorder (MDD)
• treatment emergent sexual dysfunction (TESD)
• duloxetine
• selective serotonin reuptake inhibitor (SSRI)
• observational study

Acknowledgements

Study sponsorship was provided by Eli Lilly and Company. The authors would like to thank Professor Pedro Delgado (Department of Psychiatry, School of Medicine, University of Texas, Texas, US), Margaret McBride (formerly of Intercontinental Information Services, Eli Lilly Australia Pty Ltd), Adam Meyers (Eli Lilly and Company) and Jo Wood (Meditech Media Asia Pacific Pty Ltd) for assistance with the study design, study description document, data analysis and provision of writing support, respectively. The contributions of all of the investigators, assistants and patients that participated in this study are also gratefully acknowledged.

Statement of interest

Hector Dueñas, Alan Brnabic, Martin Dossenbach and Arier Lee are employees of Eli Lilly. Ka-Fai Chung has been an advisory board member and has received research funding from various pharmaceutical companies, including Eli Lilly. Mohamed Gamal Badr, Hu Jian, Chien-Han Lai, Tiffany Uy-Ponio, Jorge Rodríguez Ruiz and Padmaraju Varrey have no conflicts of interest to disclose.