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.

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

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-SR(16)), 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.

Effectiveness of antidepressants in the treatment of major depressive disorder in Latin America.

Objective. Painful physical symptoms occur frequently in patients with major depressive disorder (MDD), and although numerous studies report the effect of antidepressants on emotional aspects of depression, few focus on their effect on physical symptoms. This observational study was conducted, in a clinical practice setting, to determine antidepressant treatment decisions and their outcome on the physical and emotional symptoms of MDD. Methods. Patients with a mean score ≥2 for pain-related items on the Somatic Symptom Inventory (SSI) were classified with painful physical symptoms (PPS +) and differentiated from the remaining patients (PPS -). Severity of depression and physical pain were determined using the 17-item Hamilton Depression Rating Scale (HAMD17) and Clinical Global Impressions of Severity Scale (CGI-S), and Visual Analog Scale (VAS), respectively. Results. At baseline, 72.6% of patients were PPS+. Compared to PPS- patients, PPS +patients were, on average, significantly more depressed at baseline (mean difference [95% CI]: HAMD17 4.6 [3.6, 5.5] and CGI-S 0.3 [0.2, 0.4]; all p<0.0001), and remained more depressed and in greater pain at endpoint (HAMD17p=0.0074, CGI-S P =0.0151, and VAS P <0.0001). In addition, fewer PPS+ patients (65.8%) achieved remission (total HAMD17≤7) compared to PPS- patients (74.6%, P =0.0180). Conclusions. Painful physical symptoms are prevalent in MDD patients, highlighting the importance of addressing both the physical and emotional symptoms of depression.