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. 2012:2012:296710.
doi: 10.1155/2012/296710. Epub 2012 Mar 18.

Efficacy and Safety of Duloxetine in Patients with Chronic Low Back Pain Who Used versus Did Not Use Concomitant Nonsteroidal Anti-Inflammatory Drugs or Acetaminophen: A Post Hoc Pooled Analysis of 2 Randomized, Placebo-Controlled Trials

Vladimir Skljarevski  1 , Peng Liu, Shuyu Zhang, Jonna Ahl, James M Martinez
Affiliations

Efficacy and Safety of Duloxetine in Patients with Chronic Low Back Pain Who Used versus Did Not Use Concomitant Nonsteroidal Anti-Inflammatory Drugs or Acetaminophen: A Post Hoc Pooled Analysis of 2 Randomized, Placebo-Controlled Trials

Vladimir Skljarevski et al. Pain Res Treat. 2012.

Abstract

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 (n = 137), placebo NSAID/APAP user (n = 82), duloxetine NSAID/APAP nonuser (n = 206), and placebo NSAID/APAP nonuser (n = 156). 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 (P = 0.31) 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.

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Figures

Figure 1
Figure 1
Estimated least-squares (LS) mean changes from baseline and standard errors in BPI average pain severity in patients who concomitantly used or did not use NSAID or APAP.
Figure 2
Figure 2
Estimated least-squares (LS) mean changes from baseline and standard errors in RMDQ rating in patients who concomitantly used or did not use NSAID or APAP.
Figure 3
Figure 3
Percentage of patients who felt “much better” or “very much better” at endpoint.
See this image and copyright information in PMC

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