Sexual Functioning Assessed in 4 Double-Blind Placebo- and Paroxetine-Controlled Trials of Duloxetine for Major Depressive Disorder

Delgado, Pedro L.; Brannan, Stephen K.; Mallinckrodt, Craig; Trân, Pierre V.; McNamara, Robert K.; Wang, Fujun; Watkin, John G.; Detke, Michael J.

doi:10.4088/jcp.v66n0603

Cited by 125 publications

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“…There were no discontinuations due to sexual side effects during long-term treatment. We also note as a limitation the underreporting of sexual dysfunction and refer the reader to a better discussion of sexual dysfunction in duloxetinetreated patients [Delgado et al, 2005].…”

Section: Discussionmentioning

confidence: 99%

Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation

et al. 2006

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Duloxetine has demonstrated efficacy for the treatment of major depressive disorder (MDD) at a dose of 60 mg/day (given once daily). Whereas the target dose for the majority of patients is 60 mg/day, higher duloxetine doses (up to 120 mg/day) have been studied using a twice-daily dosing schedule. To further investigate the pharmacological profile of duloxetine within a once-daily dosing regimen at doses above 60 mg, we examined the safety and tolerability of duloxetine during a dose escalation from 60 mg/day to 120 mg/day. This singlearm, non-placebo-controlled study incorporated a 7-week dose escalation phase, in which patients and investigators were blinded as to timing of dose increases, followed by an open-label extension phase of up to 2 years duration. Patients (age Z18 years) meeting DSM-IV criteria for MDD (n 5 128) received placebo for 1 week, followed by duloxetine (60 mg/day) titrated after 1 week to 90 mg/day, and after a further week to 120 mg/day. The dose of 120 mg/day was then maintained for 4 weeks. The extension phase comprised an initial 6-week dose stabilization period, during which duloxetine was tapered to the lowest effective dose, followed by continuation therapy at the stabilized dose. We assessed safety using spontaneously reported treatment-emergent adverse events (TEAEs), changes in vital signs, electrocardiograms (ECGs), laboratory analytes, and visual analogue scales (VAS) for gastrointestinal (GI) disturbance. Efficacy measures included the 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score, the Clinical Global Impression of Severity (CGI-S) and Patient Global Impression of Improvement (PGI-I) scales, and VAS assessments of pain severity and interference. The rate of discontinuation due to adverse events during the acute phase of the study was 15.6%. The most frequently reported TEAEs were nausea, headache, dry mouth, dizziness, and decreased appetite. The majority of TEAEs were associated with initial duloxetine dosing; further escalations in dose produced few additional adverse events. VAS measures of GI disturbance worsened significantly compared with baseline values after 1 week of duloxetine treatment. Subsequent assessments of GI disturbance, following dose escalation to 90 mg/day and 120 mg/day, showed either no significant difference or a significant improvement from baseline. Significant improvements (Po.001) were observed in all assessed depression efficacy measures, and in five of six VAS pain outcomes, during acute phase treatment. During 2 years of extension phase therapy, the rate of discontinuation due to adverse events was 11.9%, and the only TEAEs reported by 410% of patients were upper respiratory tract infection (13.1%), headache (10.7%), and insomnia (10.7%). Mean changes from baseline to the end of the extension phase in supine systolic and diastolic blood pressure were 3.8 and 0.5 mm Hg, respectively, and there were no reports of sustained hypertension. Mean increase in heart rate was 5.9 bpm, while patients exhibited a mean weight increase of...

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Section: Discussionmentioning

confidence: 99%

Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation

et al. 2006

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“…This systematic review updates part of a larger comparative effectiveness review on SGAD funded by and conducted for the U.S. Agency for Healthcare Research and Quality (AHRQ) [19].…”

Section: Methodsmentioning

confidence: 99%

“…A few systematic reviews addressed the issue of sexual dysfunction associated with SGAD in patients with MDD [10,[15][16][17][18][19]. With the exception of an updated meta-analysis by Gartlehner et al [11], which also included data from observational studies, previous systematic reviews focused on efficacy trials.…”

Section: Introductionmentioning

confidence: 99%

Sexual Dysfunction associated with Second-Generation Antidepressants in Patients with Major Depressive Disorder: Results from a Systematic Review with Network Meta-Analysis

et al. 2013

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BACKGROUND: Sexual dysfunction (SD) is prevalent in patients with major depressive disorder (MDD) and is also associated with second-generation antidepressants (SGAD) which are commonly used to treat the condition. Evidence indicates underreporting of SD in efficacy studies. SD associated with antidepressant treatment is a serious side effect that may lead to early termination of treatment and worsening of quality of life. OBJECTIVES: To systematically assess the harms of SD associated with SGAD in adult patients with MDD by drug type. METHODS: We retrieved English-language abstracts from PubMed, EMBASE, the Cochrane Library, PsycINFO, and International Pharmaceutical Abstracts from 1980 to October 2012 as well as from reference lists of pertinent review articles and grey literature searches. Two independent reviewers identified randomized controlled trials (RCTs) of at least six weeks' duration and observational studies with at least 1,000 participants. STUDY SELECTION: Reviewers abstracted data on study design, conduct, participants, interventions, outcomes and method of SD ascertainment, and rated risk of bias. A senior reviewer checked and confirmed extracted data and risk of bias ratings. ANALYSES: Random effects network meta-analysis using Bayesian methods for data from head-to-head trials and placebo-controlled comparisons; descriptive analyses calculating weighted mean rates from individual trials and observational studies. RESULTS/ SYNTHESIS: Data from sixty-three studies of low and moderate risk of bias (58 RCTs, five observational studies) with more than 26,000 patients treated with SGAD were included. Based on network meta-analyses of 66 pairwise comparisons from 37 RCTs, most comparisons showed a similar risk of sexual dysfunction among included SGAD. Credible intervals, however, were wide and included differences that would be considered clinically relevant. We observed three main patterns: Bupropion had a statistically significantly lower risk of sexual dysfunction than some other SGAD, and both escitalopram, and paroxetine showed a statistically significantly higher risk of sexual dysfunction than some other SGAD. We found reporting of harms related to sexual dysfunction inconsistent and insufficient in some trials. LIMITATIONS: Most trials were conducted in highly selected populations. Search was restricted to English-language only. CONCLUSION AND IMPLICATIONS: Because of the indirect nature of the comparisons, the often wide credible intervals, and the high variation in magnitude of 2 outcome, we rated the overall strength of evidence with respect to our findings low. The current degree of evidence does not allow a precise estimate of comparative risk of sexual dysfunction associated with a specific antidepressant. In the absence of such evidence, clinicians need to be aware of SD as a common adverse event and should discuss patients' preferences before initiating antidepressant therapy.

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“…Comparative studies of duloxetine and SSRIs have shown that treatment -emergent sexual dysfunction was significantly lower with duloxetine than paroxetine orescitalopram but this difference was not maintained after 12 weeks of treatment, suggesting that duloxetine may only have a short term advantage over SSRIs [29][30][31].…”

Section: Role Of Agents With Dual Actions On Serotonin and Norepinephmentioning

confidence: 99%

Sexual Dysfunctions in Depression

J¹,

Rao²,

Chandran³

et al. 2017

Clin Depress

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Sexual dysfunction is one of the common symptoms seen in depression. Presentations include decreased libido, erectile dysfunction, arousal difficulties and orgasm related dysfunctions. The probable causes of sexual dysfunction in such patients are complex and biological, psychological as well as psychosocial factors are likely to play an important role. Sexual dysfunction could also occur as an adverse effect of anti-depressants although it is difficult to establish whether the dysfunction is due to the illness or the medication. Awareness among professionals about sexual dysfunction is essential as it can have a profound impact in terms of relationship conflict, marital satisfaction, quality of life and compliance with treatment in patients with depression.

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Sexual Functioning Assessed in 4 Double-Blind Placebo- and Paroxetine-Controlled Trials of Duloxetine for Major Depressive Disorder

Cited by 125 publications

References 0 publications

Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation

Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation

Sexual Dysfunction associated with Second-Generation Antidepressants in Patients with Major Depressive Disorder: Results from a Systematic Review with Network Meta-Analysis

Sexual Dysfunctions in Depression

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