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| |  Duloxetine, SSRIs Produce Similar Rates of Sexual Dysfunction in Patients With Depression: Presented at WCBP By Jill Stein PARIS -- July 2, 2009 -- The frequency of treatment-emergent sexual dysfunction (TESD) in patients with major depressive disorder (MDD) is about the same whether patients are treated with duloxetine hydrochloride or a selective serotonin reuptake inhibitor (SSRI), investigators reported on June 30 here at the 9th World Congress of Biological Psychiatry (WCBP). The results, from the first 8 weeks of a 24-week trial, also show that duloxetine was superior to SSRI monotherapy on important treatment outcome measures. Hector Duenas, MD, Eli Lilly, Barranca, Mexico, and colleagues prospectively compared the frequency of TESD in 1,533 male and female outpatients aged 18 years and older who were receiving 8 weeks of treatment with duloxetine or SSRI monotherapy. All patients had a primary diagnosis of MDD diagnosed by International Classification of Diseases, Tenth Revision or Diagnostic and Statistical Manual (Fourth Edition, Text Revision) criteria and did not have sexual dysfunction at the time of enrolment. Initiation of and changes to treatment were done at the discretion of the physician and patient. Assessment tools included the Arizona Sexual Experience Scale (ASEX), the Clinical Global Impressions of Severity scale, and the EuroQol questionnaire (EQ-5D). Patients underwent assessments at the start of the study and at weeks 8, 16, and 24, with ongoing compilation of ASEX and medication data throughout the study. The estimated frequency of TESD at 8 weeks was not statistically significantly different between the 2 monotherapy cohorts (23.9% for duloxetine vs 26.2% for SSRIs; P = .55). Unexpectedly, physician estimates of TESD were higher than patient-reported estimates at other time points, despite using the same scale (ASEX). Based on patient-reported estimates from day 14 to 42, patients in the duloxetine monotherapy group experienced significantly lower odds of TESD compared with patients receiving SSRI monotherapies (P = .005). Regardless of treatment, all patients experienced improvement in clinical symptoms over time. Patients in the duloxetine group were 1.6 times more likely to achieve remission compared with patients in the SSRI monotherapy group (P = .002). Patients on duloxetine monotherapy experienced significantly greater improvements in EQ-5D health state and Sheehan Disability Scale total scores compared with patients on SSRI monotherapies. However, these improvements were significantly attenuated in patients with TESD at 8 weeks, "thereby highlighting the added burden of these symptoms for patients with MDD," Dr. Duenas said. He also noted that the study is a naturalistic evaluation of outpatients in diverse actual clinical practice settings. He also emphasised that the results represent interim 8-week data and that 6-month follow-up data are currently being collected. Funding for this study was provided by Eli Lilly. [Presentation title: Frequency of Treatment-Emergent Sexual Dysfunction in Outpatients With Major Depressive Disorder Treated With Either Duloxetine or a Selective Serotonin Reuptake Inhibitor Antidepressant: 8-Week Observational Data. Abstract P-29-002]
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