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.
Highlights
Low back pain has a lifetime prevalence rate of 80% in the United States and is one of the primary causes of disability in individuals younger than 45 years of age [1, 2]
There was a higher percentage of duloxetine-treated patients versus placebo, who discontinued due to adverse events (AEs) in the nonsteroidal anti-inflammatory drugs (NSAIDs)/APAP nonuser subgroup (P = .002)
Patients were stratified according to NSAID/APAP use at baseline: duloxetine NSAID/APAP user (n = 137), placebo NSAID/APAP
Summary
Low back pain has a lifetime prevalence rate of 80% in the United States and is one of the primary causes of disability in individuals younger than 45 years of age [1, 2]. Low back pain usually resolves spontaneously within a few days or weeks, but for some individuals, this pain becomes chronic [1]. Prescribed medications for chronic low back pain (CLBP) include nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, muscle relaxants, anticonvulsants, and tricyclic antidepressants (TCAs) [3]. A number of these treatments pose safety risks that include sedation, respiratory depression and addiction (opioids), gastrointestinal bleeding and ulcers, and cardiovascular events (NSAIDs) [6]. Antidepressants with serotonin reuptake inhibition properties may increase the risk of bleeding events [7, 8], either when taken alone or in combination with other drugs that affect coagulation, such as NSAIDs [9]
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