Efficacy of duloxetine in the treatment of generalized anxiety disorder in patients with clinically significant pain symptoms

Abstract

Anxiety disorders often are accompanied by painful physical symptoms. This report assessed the effectiveness of duloxetine in improving anxiety symptoms, pain severity, and patient functioning in adults diagnosed with generalized anxiety disorder (GAD), who presented with clinically significant pain symptoms. Data were pooled from two multicenter, randomized, double-blind, placebo-controlled clinical studies evaluating the efficacy of duloxetine 60-120 mg once daily compared with placebo in the treatment of GAD. The primary patient population for these analyses was patients with baseline Visual Analog Scale (VAS) overall pain severity score > or =30. Of the 798 randomized patients that had baseline VAS scores, approximately 44.4% of GAD patients were identified as having baseline VAS overall pain severity score > or =30 (duloxetine N=208, placebo N=146). Duloxetine-treated patients had significantly greater improvement compared with placebo-treated patients on anxiety symptoms (measured by Hamilton Anxiety Scale total score), on patient functioning (measured by the Sheehan Disability Scale Global Functional Impairment Score and across all Sheehan Disability Scale domains), and on all VAS pain items. Patients achieving remission at endpoint, and patients with lower scores on the Clinical Global Impression of Improvement and Patient Global Impression of Improvement scales had greater improvement in VAS pain severity scores. These results suggest that in patients with GAD who present with clinically significant pain symptoms, duloxetine is effective in reducing anxiety symptoms, pain severity, and in improving patient functioning.

The short- and long-term effect of duloxetine on painful physical symptoms in patients with generalized anxiety disorder: Results from three clinical trials

“…These analyses also showed that among both relapsers and nonrelapsers, duloxetine-treated patients tended to have lower pain severity than placebo-treated patients, particularly among nonrelapsers. Our finding that relapsers tended to have a better response to duloxetine than to placebo on most pain scales supports a previous finding that suggested that duloxetine's effect on pain is at least in part independent of changes in anxiety symptoms (Russell, Weisberg et al, 2008). These findings, combined with our observation that some GAD nonrelapsers experienced worsening of their pain symptoms, especially when switched to placebo, suggest that painful physical symptoms may be somewhat independent of other core anxiety symptoms in GAD.…”

“…Nevertheless, at study entry, the mean VAS scores for overall pain and time in pain exceeded 30 and were therefore indicative of clinically significant pain (Collins, Moore, McQuay, 1997). This study differs from previous analyses in that patients were not selected on the basis of pain at baseline Russell, Weisberg et al, 2008); the findings in this large general clinical population of patients with GAD suggest that painful physical symptoms are common in GAD and are relevant as a part of this disease state.…”

“…In more recent clinical studies, duloxetine was also found to effectively reduce somatic symptoms and pain severity in patients with GAD Nicolini et al, 2008;Russell, Weisberg et al, 2008). Because previous analyses were based on the subgroup of patients who had clinically significant pain levels (visual analogue scale [VAS] scores !30 at baseline) Russell, Weisberg et al, 2008), additional investigation of the effect of duloxetine on painful physical symptoms in GAD patients from the overall clinical trial population would be informative to describe the presence and course of painful physical symptoms in patients with GAD.…”

Factors associated with pain interference in an epidemiologic sample of adults with bipolar I disorder

“…To date, dual-action medications that enhance serotonergic and noradrenergic neurotransmission simultaneously have been shown to improve both pain and symptoms of depression (Detke et al, 2002) or anxiety (Russell JM, 2007). However, use of these agents in BD is problematic because of the significant risk of inducing mania (Ghaemi et al, 2003) There is also evidence supporting the use of non-pharmacologic interventions targeting anxiety or depression as well as pain (Christie et al, 2007; Otto et al, 2007; Rooks et al, 2007).…”

Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

“…While there are few data available, duloxetine has demonstrated efficacy for both GAD and pain symptoms in RCTs [1435-1437]. TCAs, and to a lesser extent SSRIs, have been shown to reduce headache attacks in patients with migraine [1438], and provide moderate relief of neuropathic pain [1439].…”