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Efficacy and safety of duloxetine in patients with chronic low back pain.

AbstractSTUDY DESIGN:
This was a randomized, double-blind, placebo-controlled clinical trial.
OBJECTIVE:
To assess the efficacy and safety of duloxetine in the treatment of chronic low back pain (CLBP).
SUMMARY OF BACKGROUND DATA:
Imbalance of serotonin and norepinephrine within modulatory pain pathways has been implicated in the development and maintenance of chronic pain. Duloxetine, a selective reuptake inhibitor of serotonin and norepinephrine, has demonstrated clinical efficacy in 3 distinct chronic pain conditions: diabetic peripheral neuropathic pain, fibromyalgia, and chronic pain because of osteoarthritis.
METHODS:
In this randomized double-blind trial, adult nondepressed patients with a non-neuropathic CLBP and a weekly mean of the 24-hour average pain score>or=4 at baseline (0-10 scale) were treated with either duloxetine or placebo for 13 weeks. The dose of duloxetine during first 7 weeks was 60 mg once daily. At week 7, patients reporting<30% pain reduction had their dose increased to 120 mg. The primary outcome measure was the Brief Pain Inventory (BPI) 24-hour average pain rating. Secondary measures included Roland-Morris Disability Questionnaire-24; Patient's Global Impressions of Improvement; Clinical Global Impressions-Severity (CGI-S); BPI-Severity and -Interference (BPI-I); and weekly means of the 24-hour average pain, night pain, and worst pain scores from patient diaries. Quality-of-life, safety, and tolerability outcomes were also assessed.
RESULTS:
Compared with placebo-treated patients (least-squares mean change of -1.50), patients on duloxetine (least-squares mean change of -2.32) had a significantly greater reduction in the BPI 24-hour average pain from baseline to endpoint (P=0.004 at week 13). Additionally, the duloxetine group significantly improved on Patient's Global Impressions of Improvement; Roland-Morris Disability Questionnaire-24; BPI-Severity and average BPI-Interference; weekly mean of the 24-hour average pain, night pain, and worst pain. Significantly more patients in the duloxetine group (13.9%) compared with placebo (5.8%) discontinued because of adverse events (P=0.047). The most common treatment-emergent adverse events in the duloxetine group included nausea, dry mouth, fatigue, diarrhea, hyperhidrosis, dizziness, and constipation.
CONCLUSION:
Duloxetine significantly reduced pain and improved functioning in patients with CLBP. The safety and tolerability were similar to those reported in earlier studies.
AuthorsVladimir Skljarevski, Durisala Desaiah, Hong Liu-Seifert, Qi Zhang, Amy S Chappell, Michael J Detke, Smriti Iyengar, Joseph H Atkinson, Miroslav Backonja
JournalSpine (Spine (Phila Pa 1976)) Vol. 35 Issue 13 Pg. E578-85 (Jun 01 2010) ISSN: 1528-1159 [Electronic] United States
PMID20461028 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Serotonin Uptake Inhibitors
  • Thiophenes
  • Duloxetine Hydrochloride
Topics
  • Adult
  • Aged
  • Chronic Disease
  • Diarrhea (chemically induced)
  • Double-Blind Method
  • Duloxetine Hydrochloride
  • Fatigue (chemically induced)
  • Female
  • Humans
  • Low Back Pain (drug therapy, physiopathology)
  • Male
  • Middle Aged
  • Nausea (chemically induced)
  • Pain Measurement
  • Selective Serotonin Reuptake Inhibitors (adverse effects, therapeutic use)
  • Thiophenes (adverse effects, therapeutic use)
  • Time Factors
  • Treatment Outcome

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