title: Efficacy and safety of 40 mg or 60 mg duloxetine in Japanese adults with diabetic neuropathic pain: Results from a randomized, 52-week, open-label study.
abstract: BACKGROUND
  To examine the long-term efficacy and safety of duloxetine in the treatment of Japanese patients with diabetic neuropathic pain, we carried out a 52-week, randomized, open-label extension of a 12-week, double-blind, placebo-controlled study.
  
  
  METHODS
  Japanese adults with diabetic neuropathic pain who completed the double-blind study were eligible for this long-term study, carried out at 71 sites in Japan (March 2008 to March 2010). Participants (n = 258) were re-randomized (1:1) to 40 mg/day or 60 mg/day duloxetine. Pain (Brief Pain Inventory severity and interference), quality of life (Patient's Global Impression of Improvement), and safety (primary outcome; adverse events, vital signs, metabolic measures) were measured.
  
  
  RESULTS
  Significant (P < 0.0001) and sustained improvements (change ± standard deviation; n = 257) were observed in Brief Pain Inventory severity (average pain score -2.1 ± 1.7). Improvements were also seen in Brief Pain Inventory interference (mean of subscores -0.96 ± 1.52) and Patient's Global Impression of Improvement (-0.9 ± 1.1) scores; these scores decreased significantly (P < 0.0001) during the long-term study. Frequently reported adverse events included somnolence (13.6%), constipation (13.2%) and nausea (10.5%). Increases were observed in plasma glucose, glycosylated hemoglobin and total cholesterol levels, and in bodyweight and heart rate; however, none of these were clinically meaningful. Overall, there were no clinically significant safety concerns.
  
  
  CONCLUSIONS
  This is the first publication of a long-term study carried out in Asia with an entirely Japanese patient population to suggest that long-term duloxetine therapy for diabetic neuropathic pain is effective and has an acceptable safety profile.
authors.affiliation: Faculty of Public Health Nursing Shiga University of Medical Science Shiga Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Yasuda
authors.affiliation: Japan Labor Health and Welfare Organization Chubu Rosai Hospital Nagoya Japan.
authors.forename: Nigishi
authors.initials: N
authors.lastname: Hotta
authors.affiliation: Research Institute National Center for Global Health and Medicine Tokyo Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Kasuga
authors.affiliation: Kusatsu General Hospital Shiga Japan.
authors.forename: Atsunori
authors.initials: A
authors.lastname: Kashiwagi
authors.affiliation: Department of Medicine, Metabolism & Endocrinology Juntendo University Graduate School of Medicine Tokyo Japan.
authors.forename: Ryuzo
authors.initials: R
authors.lastname: Kawamori
authors.affiliation: Shionogi & Co., Ltd. Osaka Japan.
authors.forename: Tadaaki
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Shionogi & Co., Ltd. Osaka Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Baba
authors.affiliation: Lilly Research Laboratories Eli Lilly Japan K.K. Kobe Japan.
authors.forename: Levent
authors.initials: L
authors.lastname: Alev
authors.affiliation: Lilly Research Laboratories Eli Lilly Japan K.K. Kobe Japan.
authors.forename: Ko
authors.initials: K
authors.lastname: Nakajo
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D003929:Diabetic Neuropathies / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010147:Pain Measurement / Q000187:drug effects* / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000068736:Duloxetine Hydrochloride
keywords: Diabetes‐related complications; Diabetic neuropathy (painful); Duloxetine
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