Duloxetine 60 mg for chronic low back pain: post hoc responder analysis of double-blind, placebo-controlled trials

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.