PMID- 30856270
OWN - NLM
STAT- MEDLINE
DCOM- 20200824
LR  - 20200824
IS  - 1526-4637 (Electronic)
IS  - 1526-2375 (Linking)
VI  - 20
IP  - 8
DP  - 2019 Aug 1
TI  - An Open-Label, 52-Week, Phase III Trial of Duloxetine in Japanese Patients with 
      Chronic Low Back Pain.
PG  - 1479-1488
LID - 10.1093/pm/pnz027 [doi]
AB  - OBJECTIVE: To evaluate the safety and efficacy of duloxetine treatment for 
      52 weeks. DESIGN: Multicenter, open-label, phase III clinical study. SETTING: 
      Forty-one medical institutions in Japan. SUBJECTS: Japanese patients with chronic 
      low back pain (CLBP). METHODS: Duloxetine 60 mg once-daily was administered for 
      52 weeks. Safety was evaluated based on adverse events (AEs), vital signs, 
      laboratory test values, electrocardiogram, Columbia-Suicide Severity Rating 
      Scale, and occurrence of falls. The efficacy outcome measures were the Brief Pain 
      Inventory (BPI; average pain, worst pain, least pain, and pain right now), BPI 
      Interference, Patient's Global Impression of Improvement (PGI-I), Clinical Global 
      Impressions of Severity (CGI-S), Roland-Morris Disability Questionnaire-24 
      (RDQ-24), 36-Item Short-Form Health Survey (SF-36), and European Quality of 
      Life-5 Dimensions Questionnaire (EQ-5D). RESULTS: In total, 151 patients (83 who 
      completed a 14-week placebo-controlled superiority trial and 68 newly registered 
      patients) were enrolled. The incidence rates of AEs and adverse drug reactions 
      (ADRs) were 86.1% and 50.3%, respectively. ADRs with an incidence of >/=5% were 
      somnolence, constipation, nausea, and dry mouth. Treatment discontinuation for 
      AEs occurred in 16 patients. A significant reduction in the BPI average pain 
      score (mean +/- SD) was observed at all assessment time points from week 2 
      (-1.02 +/- 1.37) to week 50 (-2.26 +/- 1.63), compared with baseline. BPI pain 
      severity (worst pain, least pain, and pain right now), BPI Interference, PGI-I, 
      CGI-S, RDQ-24, SF-36, and EQ-5D showed significant improvement. CONCLUSION: 
      Japanese patients with CLBP had significant pain reduction over 52 weeks without 
      new safety concerns.
CI  - (c) 2019 American Academy of Pain Medicine. All rights reserved. For permissions, 
      please e-mail: journals.permissions@oup.com.
FAU - Konno, Shin-Ichi
AU  - Konno SI
AD  - Department of Orthopaedic Surgery, Fukushima Medical University, Fukushima, 
      Japan.
FAU - Alev, Levent
AU  - Alev L
AD  - Eli Lilly Turkey, Istanbul, Turkey.
FAU - Oda, Natsuko
AU  - Oda N
AD  - Shionogi & Co., Ltd., Osaka, Japan.
FAU - Ochiai, Toshimitsu
AU  - Ochiai T
AD  - Shionogi & Co., Ltd., Osaka, Japan.
FAU - Enomoto, Hiroyuki
AU  - Enomoto H
AD  - Eli Lilly Japan K.K., Kobe, Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - Pain Med
JT  - Pain medicine (Malden, Mass.)
JID - 100894201
RN  - 0 (Analgesics)
RN  - 9044SC542W (Duloxetine Hydrochloride)
RN  - F7IY6HZG9D (Triethylenemelamine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Analgesics/*therapeutic use
MH  - Chronic Pain/*drug therapy
MH  - Constipation/chemically induced
MH  - Duloxetine Hydrochloride/*therapeutic use
MH  - Female
MH  - Humans
MH  - Japan
MH  - Low Back Pain/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Pain Measurement
MH  - Sleepiness
MH  - Triethylenemelamine
MH  - Xerostomia/chemically induced
OTO - NOTNLM
OT  - Chronic Low Back Pain
OT  - Duloxetine
OT  - Efficacy
OT  - Japan
OT  - Long Term
OT  - Safety
EDAT- 2019/03/12 06:00
MHDA- 2020/08/25 06:00
CRDT- 2019/03/12 06:00
PHST- 2019/03/12 06:00 [pubmed]
PHST- 2020/08/25 06:00 [medline]
PHST- 2019/03/12 06:00 [entrez]
AID - 5374657 [pii]
AID - 10.1093/pm/pnz027 [doi]
PST - ppublish
SO  - Pain Med. 2019 Aug 1;20(8):1479-1488. doi: 10.1093/pm/pnz027.