PMID- 27796152
OWN - NLM
STAT- MEDLINE
DCOM- 20180326
LR  - 20220321
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 27
IP  - 4
DP  - 2017 Jul
TI  - An open-label, long-term, phase III extension trial of duloxetine in Japanese 
      patients with fibromyalgia.
PG  - 688-695
LID - 10.1080/14397595.2016.1245237 [doi]
AB  - OBJECTIVES: 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.
FAU - Murakami, Masato
AU  - Murakami M
AD  - a Department of Psychosomatic Medicine , Nihon University School of Medicine , 
      Tokyo , Japan.
FAU - Osada, Kenichi
AU  - Osada K
AD  - b Department of Neuropsychiatry , St. Marianna University School of Medicine , 
      Kawasaki , Japan.
FAU - Ichibayashi, Hisao
AU  - Ichibayashi H
AD  - c Shionogi & Co. Ltd , Osaka , Japan.
FAU - Mizuno, Hiromichi
AU  - Mizuno H
AD  - c Shionogi & Co. Ltd , Osaka , Japan.
FAU - Ochiai, Toshimitsu
AU  - Ochiai T
AD  - c Shionogi & Co. Ltd , Osaka , Japan.
FAU - Ishida, Mitsuhiro
AU  - Ishida M
AD  - c Shionogi & Co. Ltd , Osaka , Japan.
FAU - Alev, Levent
AU  - Alev L
AD  - d Eli Lilly Japan K.K , Kobe , Japan , and.
FAU - Nishioka, Kusuki
AU  - Nishioka K
AD  - e Institute of Medical Science , Tokyo Medical University , Tokyo , Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20161031
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Analgesics)
RN  - 9044SC542W (Duloxetine Hydrochloride)
SB  - IM
MH  - Adult
MH  - Analgesics/adverse effects/*therapeutic use
MH  - Constipation/chemically induced
MH  - Duloxetine Hydrochloride/adverse effects/*therapeutic use
MH  - Female
MH  - Fibromyalgia/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Treatment Outcome
MH  - Weight Gain/drug effects
OTO - NOTNLM
OT  - Duloxetine
OT  - Fibromyalgia
OT  - Japan
OT  - Long-term safety
OT  - Open-label
EDAT- 2016/11/01 06:00
MHDA- 2018/03/27 06:00
CRDT- 2016/11/01 06:00
PHST- 2016/11/01 06:00 [pubmed]
PHST- 2018/03/27 06:00 [medline]
PHST- 2016/11/01 06:00 [entrez]
AID - 10.1080/14397595.2016.1245237 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2017 Jul;27(4):688-695. doi: 10.1080/14397595.2016.1245237. Epub 
      2016 Oct 31.