Duloxetine 60 mg for chronic low back pain: post hoc responder analysis of double-blind, placebo-controlled trials
Authors Alev L, Fujikoshi S, Yoshikawa A, Enomoto H, Ishida M, Tsuji T, Ogawa K, Konno S
Received 29 March 2017
Accepted for publication 21 June 2017
Published 24 July 2017 Volume 2017:10 Pages 1723—1731
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 3
Editor who approved publication: Dr Michael Schatman
Levent Alev,1 Shinji Fujikoshi,2 Aki Yoshikawa,3 Hiroyuki Enomoto,1 Mitsuhiro Ishida,4 Toshinaga Tsuji,5 Kei Ogawa,1 Shinichi Konno6
1Bio-Medicine, 2Statistical Science, 3Scientific Communications, Medicines Development Unit, Eli Lilly Japan K.K., Kobe, 4Clinical Research Development, 5Medical Affairs Department, Shionogi & Co. Ltd, Osaka, 6Department of Orthopedic Surgery, Fukushima Medical University, Fukushima, Japan
Introduction: Duloxetine has demonstrated efficacy in chronic low back pain (CLBP). We examined the predictors of response to duloxetine for CLBP.
Patients and methods: This was a post hoc analysis of pooled data from 4 double-blind, randomized, placebo-controlled trials of duloxetine (60 mg/day for 12–14 weeks) in adult patients with CLBP. Primary outcome was proportion of patients with ≥30% reduction in Brief Pain Inventory (BPI) average pain (“pain reduction”) at 12–14 weeks. The proportion of patients with ≥30% and ≥50% (secondary outcome) pain reduction in duloxetine and placebo groups was compared. Variables for responder analyses were early improvement (≥15% pain reduction at Week 2), sex, age, baseline BPI average pain score, duration of CLBP, and number of painful body sites according to the Michigan Body Map (≥2 vs 1 [isolated CLBP]; 1 trial); relative risk (RR) and 95% confidence interval (CI) were calculated.
Results: Compared with placebo (n = 653), a greater proportion of duloxetine-treated patients (n = 642) achieved ≥30% (59.7% vs 47.8%; P < 0.001) and ≥50% pain reduction (48.6% vs 35.1%; P < 0.001). Among duloxetine-treated patients, early improvement was associated with greater likelihood of ≥30% (RR [95% CI], 2.91 [2.30–3.67]) or ≥50% (3.24 [2.44–4.31]) pain reduction. Women were slightly more likely than men to achieve ≥30% (RR [95% CI], 1.14 [1.00–1.30]) or ≥50% (1.17 [0.99–1.38]) pain reduction. Response rates were similar between age, CLBP duration, and baseline BPI average pain score subgroups. Patients with ≥2 painful sites were more likely to respond to duloxetine 60 mg relative to placebo than patients with isolated CLBP (RR, duloxetine vs placebo [95% CI]: ≥30% reduction, ≥2 painful sites 1.40 [1.18–1.66], isolated CLBP 1.07 [0.78–1.48]; ≥50% reduction, ≥2 painful sites 1.51 [1.20–1.89], isolated CLBP 1.23 [0.81–1.88]).
Conclusion: Early pain reduction was indicative of overall response. Patients with multiple painful sites had more benefit from duloxetine than patients with isolated CLBP.
Keywords: Brief Pain Inventory, chronic pain, SNRI, low back pain, Michigan Body Map, multiple painful sites
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