title: Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China.
abstract: BACKGROUND
  Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain (DPNP) in the United States, European Union, and many other countries. This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain.
  
  
  METHODS
  This double-blind, randomized, placebo-controlled, flexible-dose study treated adult patients with diabetic peripheral neuropathic pain and baseline Brief Pain Inventory (BPI) 24-hour average pain severity ratings ≥ 4 with duloxetine 60 mg to 120 mg once daily or placebo for 12 weeks. Dose adjustments of duloxetine or matching placebo were based upon investigator's judgment of clinical response. Change from baseline to endpoint in BPI average pain was the primary efficacy outcome. Secondary outcome measures included BPI-severity and -Interference, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, EuroQol: 5 Dimensions, Athens Insomnia Scale, and safety measures.
  
  
  RESULTS
  Of 215 patients randomized, 88.4% and 82.1% of patients in placebo and duloxetine groups, respectively, completed the study. Mean change from baseline to endpoint in BPI average pain was not statistically different between the treatment groups (P = 0.124). Duloxetine- treated patients showed significantly greater pain reduction compared with those in placebo group at weeks 1, 2, and 4 (P = 0.004, P = 0.009, and P = 0.006, respectively), but not at weeks 8 (P = 0.125) and 12 (P = 0.107). Duloxetine-treated patients experienced statistically significant improvement in Patient Global Impression of Improvement, Clinical Global Impression of Severity, area under the curve for pain relief, BPI-severity pain right now, and BPI-interference walking ability. Patients treated with duloxetine 120 mg once daily showed significantly greater pain reduction on the Brief Pain Inventory average pain score relative to placebo. Duloxetine-treated patients reported nausea, somnolence, anorexia, and dysuria significantly more than placebo.
  
  
  CONCLUSIONS
  Although the primary study endpoint was not achieved, the overall observed response pattern suggests the efficacy of duloxetine in the treatment of Chinese patients with diabetic peripheral neuropathic pain. The safety profile for duloxetine is similar to that reported in other global trials.
authors.affiliation: Department of Endocrinology, Peking University First Hospital, Beijing 100034, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Gao
authors.forename: Guang
authors.initials: G
authors.lastname: Ning
authors.forename: Wei-Ping
authors.initials: WP
authors.lastname: Jia
authors.forename: Zhi-Guang
authors.initials: ZG
authors.lastname: Zhou
authors.forename: Zhang-Rong
authors.initials: ZR
authors.lastname: Xu
authors.forename: Zhi-Min
authors.initials: ZM
authors.lastname: Liu
authors.forename: Chao
authors.initials: C
authors.lastname: Liu
authors.forename: Jian-Hua
authors.initials: JH
authors.lastname: Ma
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.forename: Lu-Lu
authors.initials: LL
authors.lastname: Cheng
authors.forename: Chong-Yuan
authors.initials: CY
authors.lastname: Wen
authors.forename: Shu-Yu
authors.initials: SY
authors.lastname: Zhang
authors.forename: Qi
authors.initials: Q
authors.lastname: Zhang
authors.forename: Durisala
authors.initials: D
authors.lastname: Desaiah
authors.forename: Vladimir
authors.initials: V
authors.lastname: Skljarevski
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000368:Aged; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018759:Adrenergic Uptake Inhibitors; D010919:Placebos; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride