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


ABSTRACT: PURPOSE:Duloxetine is efficacious for chronic low back pain (CLBP). This post hoc analysis of a Japanese randomized, placebo-controlled trial (ClinicalTrials.gov, NCT01855919) assessed whether patients with CLBP with early pain reduction or treatment-related adverse events of special interest (TR-AESIs; nausea, somnolence, constipation) have enhanced responses to duloxetine. PATIENTS AND METHODS:Patients (N = 456) with CLBP for ?6 months and Brief Pain Inventory (BPI) average pain severity score of ?4 were randomized (1:1) to duloxetine 60 mg/day or placebo for 14 weeks. Primary outcome was change from baseline in BPI average pain severity score (pain reduction). Subgroup analyses included early pain reduction (?30%, 10%-30%, or <10% at Week 4) and early TR-AESIs (with or without TR-AESIs by Week 2). Measures included changes from baseline in BPI average pain severity score and BPI Interference scores (quality of life; QOL), and response rate (?30% or ?50% pain reduction at Week 14). RESULTS:Patients with ?30% early pain reduction (n = 108) or early TR-AESIs (n = 50) had significantly greater improvements in pain and QOL than placebo-treated patients (n = 226), whereas patients with 10%-30% (n = 63) or <10% (n = 48) pain reduction did not; patients without early TR-AESIs (n = 180) had significant improvements in pain at Week 14. Response rates (?30%/?50% pain reduction) were 94.4%/82.4%, 66.7%/49.2%, and 25.0%/18.8% for patients with ?30%, 10%-30%, and <10% early pain reduction, respectively, 74.0%/64.0% for patients with early TR-AESIs, 67.2%/54.4% for patients without early TR-AESIs, and 52.2%/39.4% for placebo. CONCLUSION:Early pain reduction or TR-AESIs may predict which CLBP patients are most likely to respond to duloxetine with improvements in pain and QOL.

SUBMITTER: Tsuji T 

PROVIDER: S-EPMC5590685 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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

Tsuji Toshinaga T   Itoh Naohiro N   Ishida Mitsuhiro M   Ochiai Toshimitsu T   Konno Shinichi S  

Journal of pain research 20170904


<h4>Purpose</h4>Duloxetine is efficacious for chronic low back pain (CLBP). This post hoc analysis of a Japanese randomized, placebo-controlled trial (ClinicalTrials.gov, NCT01855919) assessed whether patients with CLBP with early pain reduction or treatment-related adverse events of special interest (TR-AESIs; nausea, somnolence, constipation) have enhanced responses to duloxetine.<h4>Patients and methods</h4>Patients (N = 456) with CLBP for ≥6 months and Brief Pain Inventory (BPI) average pain  ...[more]

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