title: Efficacy and safety of duloxetine in Chinese patients with chronic pain due to osteoarthritis: a randomized, double-blind, placebo-controlled study.
abstract: 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).
  
  
  
  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.
  
  
  
  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 placebo-treated patients (P = 0.109).
  
  
  
  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. This trial is registered with ClinicalTrials.gov (NCT01931475).
authors.affiliation: Rheumatology Department, China-Japan Friendship Hospital, Beijing, PR China. Electronic address: guochunwang@hotmail.com.
authors.forename: G
authors.initials: G
authors.lastname: Wang
authors.affiliation: Rheumatology Department, China-Japan Union Hospital of Jilin University, Changchun, PR China. Electronic address: biliqi66@126.com.
authors.forename: L
authors.initials: L
authors.lastname: Bi
authors.affiliation: Rheumatology Department, Anhui Provincial Hospital, Hefei, PR China. Electronic address: lixiangpei55@126.com.
authors.forename: X
authors.initials: X
authors.lastname: Li
authors.affiliation: Rheumatology Department, Affiliated Hospital of Bengbu Medical College, Bengbu, PR China. Electronic address: lizhijundr@126.com.
authors.forename: Z
authors.initials: Z
authors.lastname: Li
authors.affiliation: Rheumatology Department, Shanghai Changhai Hospital, The 2nd Military Medical University, Shanghai, PR China. Electronic address: dongbaozhao@163.com.
authors.forename: D
authors.initials: D
authors.lastname: Zhao
authors.affiliation: Rheumatology Department, The Second Xiangya Hospital of Central South University, Changsha, PR China. Electronic address: jinwei7310@163.com.
authors.forename: J
authors.initials: J
authors.lastname: Chen
authors.affiliation: Rheumatology Department, Shanghai Guanghua Hospital, Shanghai, PR China. Electronic address: dongyihe@medmail.com.cn.
authors.forename: D
authors.initials: D
authors.lastname: He
authors.affiliation: Asian-Pacific Statistical Sciences, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai Branch, Shanghai, PR China. Electronic address: wang_jia_ning_sh@lilly.com.
authors.forename: C-N
authors.initials: CN
authors.lastname: Wang
authors.affiliation: EMBU Regional Medical Affairs, Eli Lilly de Mexico, Mexico City, Mexico. Electronic address: duenas_hector@lilly.com.
authors.forename: H
authors.initials: H
authors.lastname: Dueñas
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA. Electronic address: skljarevski_vladimir@lilly.com.
authors.forename: V
authors.initials: V
authors.lastname: Skljarevski
authors.affiliation: Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai Branch, Shanghai, PR China. Electronic address: yue_li_sh@lilly.com.
authors.forename: L
authors.initials: L
authors.lastname: Yue
mesh_terms: D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D044466:Asian People; D059350:Chronic Pain / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000150:complications / Q000188:drug therapy*; D020370:Osteoarthritis, Knee / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000068736:Duloxetine Hydrochloride
keywords: Chinese; Chronic pain; Duloxetine; Osteoarthritis; Treatment