scholarly journals Response to duloxetine in chronic low back pain: exploratory post hoc analysis of a Japanese Phase III randomized study

2017 ◽  
Vol Volume 10 ◽  
pp. 2157-2168 ◽  
Author(s):  
Toshinaga Tsuji ◽  
Naohiro Itoh ◽  
Mitsuhiro Ishida ◽  
Toshimitsu Ochiai ◽  
Shin-ichi Konno
2015 ◽  
Vol 2015 ◽  
pp. 1-8
Author(s):  
Michael A. Ueberall ◽  
Alice Eberhardt ◽  
Gerhard H. H. Mueller-Schwefe

Objective. To describe physicians’ daily life experience with WHO-step III opioids in the treatment of chronic (low) back pain (CLBP). Methods. Post hoc analysis of data from a cross-sectional online survey with 4.283 Germany physicians. Results. With a reported median use in 17% of affected patients, WHO-step III opioids play a minor role in treatment of CLBP in daily practice associated with a broad spectrum of positive and negative effects. If prescribed, potent opioids were reported to show clinically relevant effects (such as ≥50% pain relief) in approximately 3 of 4 patients (median 72%). Analgesic effects reported are frequently related with adverse events (AEs). Only 20% of patients were reported to remain free of any AE. Most frequently reported AE was constipation (50%), also graded highest for AE-related daily life restrictions (median 46%). Specific AE countermeasures were reported to be necessary in approximately half of patients (median 45%); nevertheless AE-related premature discontinuation rates reported were high (median 22%). Fentanyl/morphine were the most/least prevalently prescribed potent opioids mentioned (median 20 versus 8%). Conclusion. Overall, use of WHO-step III opioids for CLBP is low. AEs, especially constipation, are commonly reported and interfere significantly with analgesic effects in daily practice. Nevertheless, beneficial effects outweigh related AEs in most patients with CLBP.


2014 ◽  
Vol 36 (4) ◽  
pp. 544-551 ◽  
Author(s):  
Owen D. Williamson ◽  
Melissa Schroer ◽  
Dustin D. Ruff ◽  
Jonna Ahl ◽  
Anthony Margherita ◽  
...  

2019 ◽  
Vol 20 (1) ◽  
pp. 1-8
Author(s):  
Ana Carolina Kanitz ◽  
Bruna Machado Barroso ◽  
Guano Zambelli Barbosa ◽  
Andre Ivaniski Mello ◽  
Natalia Carvalho Bagatini ◽  
...  

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Vladimir Skljarevski ◽  
Peng Liu ◽  
Shuyu Zhang ◽  
Jonna Ahl ◽  
James M. Martinez

This subgroup analysis assessed the efficacy of duloxetine in patients with chronic low back pain (CLBP) who did or did not use concomitant nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen (APAP). Data were pooled from two 13-week randomized trials in patients with CLBP who were stratified according to NSAID/APAP use at baseline: duloxetine NSAID/APAP user (), placebo NSAID/APAP user (), duloxetine NSAID/APAP nonuser (), and placebo NSAID/APAP nonuser (). NSAID/APAP users were those patients who took NSAID/APAP for at least 14 days per month during 3 months prior to study entry. An analysis of covariance model that included therapy, study, baseline NSAID/APAP use (yes/no), and therapy-by-NSAID/APAP subgroup interaction was used to assess the efficacy. The treatment-by-NSAID/APAP use interaction was not statistically significant () suggesting no substantial evidence of differential efficacy for duloxetine over placebo on pain reduction or improvement in physical function between concomitant NSAID/APAP users and non-users.


Author(s):  
Donna M. Urquhart ◽  
Anita E. Wluka ◽  
Stephane Heritier ◽  
Chris Fong ◽  
Yuanyuan Wang ◽  
...  

2013 ◽  
Vol 18 (2) ◽  
pp. 75-82 ◽  
Author(s):  
C Cloutier ◽  
J Taliano ◽  
W O’Mahony ◽  
M Csanadi ◽  
G Cohen ◽  
...  

BACKGROUND: For Canadian regulatory purposes, an analgesic study was required to complement previously completed, pivotal studies on bowel effects and analgesia associated with controlled-release (CR) oxycodone/CR naloxone.OBJECTIVES: To compare the analgesic efficacy and safety of CR oxycodone/CR naloxone versus placebo in patients with chronic low back pain.METHODS: Patients requiring opioid therapy underwent a two- to seven-day opioid washout before being randomly assigned to receive either 10 mg/5 mg CR oxycodone/CR naloxone or placebo every 12 h, titrated weekly according to efficacy and tolerability to 20 mg/10 mg, 30 mg/15 mg or 40 mg/20 mg every 12 h. After four weeks, patients crossed over to the alternative treatment for an additional four weeks. Acetaminophen/codeine (300 mg/30 mg every 4 h to 6 h as needed) was provided as rescue medication.RESULTS: Of the 83 randomized patients, 54 (65%) comprised the per-protocol population. According to per-protocol analysis, CR oxycodone/CR naloxone resulted in significantly lower mean (± SD) pain scores measured on a visual analogue scale (48.6±23.1 mm versus 55.9±25.4 mm; P=0.0296) and five-point ordinal pain intensity scores (2.1±0.8 versus 2.4±0.9; P=0.0415) compared with placebo. After the double-blinded phase, patients and investigators both preferred CR oxycodone/CR naloxone over placebo. These outcomes continued in the 79% of patients who chose to continue receiving CR oxycodone/CR naloxone in a six-month, open-label evaluation.CONCLUSIONS: In patients complying with treatment as per protocol, CR oxycodone/CR naloxone was effective for the management of chronic low back pain of moderate or severe intensity.


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