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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

Authors Kuga A, Tsuji T, Hayashi S, Fujikoshi S, Tokuoka H, Yoshikawa A, Escobar R, Tanaka K, Azekawa T

Received 8 March 2017

Accepted for publication 10 July 2017

Published 4 August 2017 Volume 2017:13 Pages 2115—2124

DOI https://doi.org/10.2147/NDT.S136448

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Lucy Goodman

Peer reviewer comments 2

Editor who approved publication: Dr Taro Kishi


Atsushi Kuga,1 Toshinaga Tsuji,2 Shinji Hayashi,2 Shinji Fujikoshi,3 Hirofumi Tokuoka,1 Aki Yoshikawa,4 Rodrigo Escobar,5 Kazuhide Tanaka,6 Takaharu Azekawa7

1Bio Medicine, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, 2Medical Affairs Department, Shionogi & Co., Ltd., Osaka, 3Statistical Science, 4Scientific Communications, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 5Bio-Medicines, Eli Lilly and Company, Indianapolis, IN, USA; 6Hitsuji Clinic, Kusatsu, Japan; 7Shioiri Mental Clinic, Yokosuka, Japan

Objective: To examine how clinical and demographic patient baseline characteristics influence effectiveness of duloxetine versus selective serotonin reuptake inhibitor (SSRI) treatment, in real-world Japanese clinical settings of patients with major depressive disorder (MDD) and associated painful physical symptoms (PPS).
Methods: This was a multicenter, 12-week, prospective, observational study in patients with MDD (Quick Inventory of Depressive Symptomatology ≥16) and at least moderate PPS (Brief Pain Inventory-Short Form [BPI-SF] average pain ≥3). Patients received duloxetine or SSRIs (escitalopram, sertraline, paroxetine, or fluvoxamine). Assessments were made by using BPI-SF average pain, 17-item Hamilton Rating Scale for Depression (HAM-D17), EuroQol 5-dimension questionnaire, Social Adaptation Self-Evaluation Scale, Global Assessment of Functioning, and ability to work. Predefined subgroups included the number of previous episodes of depression (0 vs ≥1), baseline BPI-SF average pain score (≤6 vs >6), baseline HAM-D17 total score (≤18 vs >18), baseline HAM-D17 retardation (≤7 vs >7) and anxiety somatic subscale scores (≤6 vs >6), and age (<65 vs ≥65 years).
Results: Treatment effectiveness was evaluated in 523 patients (duloxetine N=273, SSRIs N=250). Treatment with duloxetine was superior to SSRIs on most outcome measures in patients experiencing their first depressive episode, those with higher baseline PPS levels, and in patients with more severe baseline depression. This was also the case for older patients. In patients with less severe depression, SSRI treatment tended to show more improvements in depression and quality of life measures versus duloxetine treatment.
Conclusion: These preplanned subgroup analyses of data from a prospective observational study suggest that, for Japanese MDD patients with PPS, duloxetine is more effective than SSRIs in patients with a first episode of MDD, with more severe depression, or more severe PPS.

Keywords: depression, duloxetine, pain, selective serotonin reuptake inhibitors, first episode

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