title: An open-label, long-term, phase III extension trial of duloxetine in Japanese patients with fibromyalgia.
abstract: OBJECTIVE
  We aimed to evaluate the long-term safety and efficacy of duloxetine 60 mg in Japanese patients with fibromyalgia enrolled from a preceding randomized, placebo-controlled, phase III duloxetine trial.
  
  
  METHODS
  This was a long-term, open-label extension study. Patients received oral duloxetine once daily at a dose of 20 mg for 1 week, followed by 40 mg for 1 week, and then 60 mg for 48 weeks. The primary outcome was the frequency of adverse events (AEs) and adverse drug reactions (ADRs) of duloxetine. Efficacy and health outcomes were assessed.
  
  
  RESULTS
  In total, 149 patients were enrolled from the preceding study. The median length of treatment was 364.0 days. The incidence of AEs and ADRs was 92.6 and 63.8%, respectively. ADRs occurring at an incidence of ≥5% were somnolence, constipation, nausea, weight increase, thirst, and malaise. The proportion of patients with mild, moderate, and severe AEs was 80.5, 10.1, and 2.0%. There were no serious treatment-related AEs in this study. The Brief Pain Inventory average pain score improved at all time-points compared with baseline (mean change ± standard deviation at Week 50 was -1.31 ± 1.70).
  
  
  CONCLUSIONS
  Duloxetine was safe and effective in the long-term treatment of Japanese patients with fibromyalgia.
authors: a Department of Psychosomatic Medicine , Nihon University School of Medicine , Tokyo , Japan.
authors: Masato
authors: M
authors: Murakami
authors: b Department of Neuropsychiatry , St. Marianna University School of Medicine , Kawasaki , Japan.
authors: Kenichi
authors: K
authors: Osada
authors: c Shionogi & Co. Ltd , Osaka , Japan.
authors: Hisao
authors: H
authors: Ichibayashi
authors: c Shionogi & Co. Ltd , Osaka , Japan.
authors: Hiromichi
authors: H
authors: Mizuno
authors: c Shionogi & Co. Ltd , Osaka , Japan.
authors: Toshimitsu
authors: T
authors: Ochiai
authors: c Shionogi & Co. Ltd , Osaka , Japan.
authors: Mitsuhiro
authors: M
authors: Ishida
authors: d Eli Lilly Japan K.K , Kobe , Japan , and.
authors: Levent
authors: L
authors: Alev
authors: e Institute of Medical Science , Tokyo Medical University , Tokyo , Japan.
authors: Kusuki
authors: K
authors: Nishioka
mesh_terms: D000328:Adult; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D003248:Constipation / Q000139:chemically induced; D000068736:Duloxetine Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
chemical_list: D000700:Analgesics; D000068736:Duloxetine Hydrochloride
keywords: Duloxetine; Fibromyalgia; Japan; Long-term safety; Open-label