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. (18th March 2012)

• Record Type: Journal Article
• Authors: Skljarevski, Vladimir; Liu, Peng; Zhang, Shuyu; Ahl, Jonna; Martinez, James M.
• Other Names: Ortiz Mario I. Academic Editor.
• Is Part Of: Pain research and treatment. Volume 2012(2012)
• Publication Date: 2012-03-18
• Subjects: Pain -- Periodicals; Pain -- Research -- Periodicals; Pain -- Prevention -- Periodicals; Pain -- Treatment -- Periodicals; 616.047205
• DOI: 10.1155/2012/296710
• Languages: English
• ISSNs: 2090-1542

Abstract

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.