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

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-SR(16)), 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.