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 wi

SUBMITTER: Tsuji T 

PROVIDER: S-EPMC5590685 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature