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Efficacy and safety of duloxetine in Chinese patients with chronic pain due to osteoarthritis: a randomized, double- blind, placebo-controlled study

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单位: [1]Rheumatology Department, China-Japan Friendship Hospital, Beijing, PR China [2]Rheumatology Department, China-Japan Union Hospital of Jilin University, Changchun, PR China [3]Rheumatology Department, Anhui Provincial Hospital, Hefei, PR China [4]Rheumatology Department, Affiliated Hospital of Bengbu Medical College, Bengbu, PR China [5]Rheumatology Department, Shanghai Changhai Hospital, The 2nd Military Medical University, Shanghai, PR China [6]Rheumatology Department, The Second Xiangya Hospital of Central South University, Changsha, PR China [7]Rheumatology Department, Shanghai Guanghua Hospital, Shanghai, PR China [8]Asian-Pacific Statistical Sciences, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai Branch, Shanghai, PR China [9]EMBU Regional Medical Affairs, Eli Lilly de Mexico, Mexico City, Mexico [10]Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA [11]Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai Branch, Shanghai, PR China
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关键词: Duloxetine Osteoarthritis Chronic pain Treatment Chinese

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Objective: We assessed the efficacy and safety of duloxetine (60 mg, once daily), compared with placebo, during a 13-week treatment period in Chinese patients with chronic pain due to osteoarthritis (OA). Design: Patients were at least 40 years old (male or female) who met American College of Rheumatology clinical and radiographic criteria for the diagnosis of OA of the knee or hip. The primary efficacy measure in this phase 3, randomized, double-blind, placebo-controlled clinical trial was assessment of pain severity by the Brief Pain Inventory (BPI) 24-h Average Pain rating. The clinical trial was conducted at 17 study centers. Statistical approaches included mixed-effects model repeated measures and analysis of covariance. A Fisher exact test was applied to categorical variables. Results: Of 407 patients randomized (duloxetine: N = 205; placebo: N = 202), 166 (81.0%) patients from the duloxetine group and 176 (87.1%) patients from the placebo group completed the 13-week treatment phase. The majority (76.4%) of patients was female; mean age was 60.5 years. Duloxetine-treated patients reported significant pain reduction, compared with placebo treatment, on the BPI 24-h Average Pain rating (least-squares mean (LS Mean) change from baseline to endpoint [95% confidence interval (CI)], duloxetine: -2.23; placebo: -1.73; difference = - 0.50 [- 0.80, - 0.20]; P = 0.001). The incidence of discontinuations due to adverse events was 9.0% in duloxetine-treated patients and 4.5% in placebotreated patients (P = 0.109). Conclusions: This study demonstrated the efficacy of duloxetine in Chinese patients with chronic pain due to OA. The safety profile of duloxetine observed in this study was consistent with that in previous duloxetine trials. (C) 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd.

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出版当年[2016]版:
大类 | 2 区 医学
小类 | 1 区 骨科 2 区 风湿病学
最新[2025]版:
大类 | 1 区 医学
小类 | 2 区 骨科 2 区 风湿病学
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出版当年[2015]版:
Q1 ORTHOPEDICS Q1 RHEUMATOLOGY
最新[2023]版:
Q1 ORTHOPEDICS Q1 RHEUMATOLOGY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2015版] 出版当年五年平均[2011-2015] 出版前一年[2014版] 出版后一年[2016版]

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第一作者单位: [1]Rheumatology Department, China-Japan Friendship Hospital, Beijing, PR China
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通讯机构: [11]Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai Branch, Shanghai, PR China [*1]Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai Branch 21F, 1 Corporate Avenue, 222 Hu Bin Road, Shanghai, 200021, PR China
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