Treatment-emergent sexual dysfunction with SSRIs and duloxetine: Effectiveness and functional outcomes over a 6-month observational period

Abstract

Objective. To evaluate frequencies of treatment-emergent sexual dysfunction (TESD) in patients with major depressive disorder (MDD) treated with duloxetine or selective serotonin reuptake inhibitor (SSRI) monotherapy for up to 6 months in a prospective, observational study. Methods. Sexually active MDD patients without sexual dysfunction at entry were enrolled from twelve countries (N = 1,647). TESD was assessed over the study period using the Arizona sexual experience (ASEX) scale. A priori-specified secondary 6-month clinical endpoints were also examined. Results. The frequency of TESD at 6 months with duloxetine was comparable to that with SSRI monotherapy (23.4 and 28.7%, respectively; P = 0.087). 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, remission and sustained remission rates were statistically significantly greater with duloxetine than SSRI monotherapy at 6 months (P < 0.001 for each), but TESD attenuated improvements in quality of life measures. Four factors were consistently significantly (P ≤ 0.05) associated with TESD at week 8 and 6 months. Conclusions. Six-month TESD rates were comparable between duloxetine and SSRIs, with greater MDD effectiveness in favour of duloxetine. Improved recognition and management of TESD may improve quality of life for MDD patients in usual clinical practice.

Key Words::

• Antidepressant effectiveness
• Arizona Sexual Experience (ASEX) scale
• duloxetine
• selective serotonin reuptake inhibitor (SSRI)
• treatment-emergent sexual dysfunction (TESD)

Acknowledgements

Study sponsorship was provided by Eli Lilly and Company. The authors would like to thank 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 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, Arier Lee, Adam L. Meyers and Joel Raskin are employees and shareholders of Eli Lilly and Company. Ma. Luz S. Casimiro-Querubin has participated on advisory boards and speakers’ bureau for AstraZeneca, Eli Lilly and Company and GlaxoSmithKline. Mohamed Khaled has received grants from Eli Lilly and Company. Angel L Montejo has participated on advisory boards and/or has received grants and/or honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb/Otsuka, Eli Lilly and Company, GlaxoSmithKline, Lundbeck, Pfizer, Sanofi-Aventis, Servier Laboratories and Wyeth. Siva Prakash has no conflicts of interest to declare.