An observational study of duloxetine versus SSRI monotherapy for the treatment of painful physical symptoms in Japanese patients with major depressive disorder: primary analysis

Abstract

ObjectiveThe objective of this study was to assess the effectiveness of duloxetine monotherapy, in comparison with selective serotonin reuptake inhibitor (SSRI) monotherapy, in the treatment of painful physical symptoms (PPS) in Japanese patients with major depressive disorder (MDD) in real-world clinical settings.MethodsThis was a multicenter, 12-week prospective, observational study. This study enrolled MDD patients with at least moderate PPS, defined as a Brief Pain Inventory-Short Form (BPI-SF) average pain score (item 5) ≥3. Patients were treated with duloxetine or SSRIs (escitalopram, sertraline, paroxetine, or fluvoxamine) for 12 weeks, and PPS were assessed by BPI-SF average pain score. The primary outcome was early improvement in the BPI-SF average pain score at 4 weeks post-baseline.ResultsA total of 523 patients were evaluated for treatment effectiveness (duloxetine N=273, SSRIs N=250). The difference in BPI-SF average pain score between the two groups was not statistically significant at 4 weeks post-baseline, the primary endpoint (least-squares mean change from baseline [95% confidence interval]: duloxetine, −2.8 [−3.1, −2.6]; SSRIs, −2.5 [−2.8, −2.3]; P=0.166). There was a numerical advantage for duloxetine in improvement from 4 to 12 weeks post-baseline, and the difference was statistically significant at 8 weeks post-baseline (least-squares mean change from baseline [95% confidence interval]: duloxetine, −3.6 [−3.9, −3.3]; SSRIs, −3.1 [−3.4, −2.8]; P=0.023). The 30% and 50% responder rates were significantly higher in patients treated with duloxetine at 4 and 8 weeks post-baseline. There were no serious adverse events experienced by duloxetine-treated patients. The rate of discontinuations due to adverse events was similar for duloxetine and the SSRIs (1.0% and 0.8% of patients, respectively).ConclusionIn this observational study, BPI-SF improvement was not significantly different at 4 weeks, the primary endpoint; however, patients treated with duloxetine tended to show better improvement in PPS compared to those treated with SSRIs.

An observational study of duloxetine versus SSRI monotherapy in Japanese patients with major depressive disorder: subgroup analyses of treatment effectiveness for pain, depressive symptoms, and quality of life

“…Patient disposition, demographics, and baseline characteristics, and information about safety (adverse events, serious adverse events, and discontinuations due to adverse events) are presented in a study by Kuga et al 21 …”

“…Additional details regarding study design and patient selection are presented in the primary study publication. 21 …”

“…At 4 weeks post-baseline (the primary endpoint), there was no statistically significant difference between treatment groups for change in Brief Pain Inventory-Short Form (BPI-SF) average pain score. 21 Additionally, no statistically significant differences between treatment groups were noted for the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score, the EuroQol 5-dimension questionnaire (EQ-5D), the Global Assessment of Functioning (GAF), or the Social Adaptation Self-Evaluation Scale (SASS). However, patients who received duloxetine presented a higher responder rate and a greater improvement in BPI-SF average pain score over time compared with patients receiving SSRIs.…”

Comparison of duloxetine and SSRI as a treatment option of painful physical symptoms associated with major depressive disorder

“…Harada et al2 in their report were very much aware of this and showed that initially the direct effect of duloxetine on PPS associated with MDD was greater than its indirect effect, whereas later the indirect effect through improvement in depressive symptoms predominated. In our study,3 we were concerned with showing how to optimize the treatment of MDD with PPS. This clinical question led us to plan our study comparing duloxetine and selective serotonin reuptake inhibitors (SSRIs) 3,4…”

“…In our study,3 we were concerned with showing how to optimize the treatment of MDD with PPS. This clinical question led us to plan our study comparing duloxetine and selective serotonin reuptake inhibitors (SSRIs) 3,4…”