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

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...

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Main Authors: Kuga A, Tsuji T, Hayashi S, Fujikoshi S, Tokuoka H, Yoshikawa A, Escobar R, Tanaka K, Azekawa T
Format: Article
Language:English
Published: Dove Medical Press 2017-08-01
Series:Neuropsychiatric Disease and Treatment
Subjects:
Online Access:https://www.dovepress.com/an-observational-study-of-duloxetine-versus-ssri-monotherapy-in-japane-peer-reviewed-article-NDT
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author Kuga A
Tsuji T
Hayashi S
Fujikoshi S
Tokuoka H
Yoshikawa A
Escobar R
Tanaka K
Azekawa T
author_facet Kuga A
Tsuji T
Hayashi S
Fujikoshi S
Tokuoka H
Yoshikawa A
Escobar R
Tanaka K
Azekawa T
author_sort Kuga A
collection DOAJ
description 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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spelling doaj.art-c86ec896afe3461f81703781ef0ccbd02022-12-21T22:58:49ZengDove Medical PressNeuropsychiatric Disease and Treatment1178-20212017-08-01Volume 132115212434112An 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 lifeKuga ATsuji THayashi SFujikoshi STokuoka HYoshikawa AEscobar RTanaka KAzekawa TAtsushi 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 episodehttps://www.dovepress.com/an-observational-study-of-duloxetine-versus-ssri-monotherapy-in-japane-peer-reviewed-article-NDTdepressionduloxetinepainselective serotonin reuptake inhibitorsfirst episode
spellingShingle Kuga A
Tsuji T
Hayashi S
Fujikoshi S
Tokuoka H
Yoshikawa A
Escobar R
Tanaka K
Azekawa T
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
Neuropsychiatric Disease and Treatment
depression
duloxetine
pain
selective serotonin reuptake inhibitors
first episode
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic depression
duloxetine
pain
selective serotonin reuptake inhibitors
first episode
url https://www.dovepress.com/an-observational-study-of-duloxetine-versus-ssri-monotherapy-in-japane-peer-reviewed-article-NDT
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