Efficacy and Safety of Duloxetine 60 mg Once Daily in the Treatment of Pain in Patients With Major Depressive Disorder and At Least Moderate Pain of Unknown Etiology

Abstract

Depression is generally diagnosed through the core mood symptoms and a variety of associated emotional and physical symptoms that are persistent during a 2-week period. In primary care, the diagnosis of depression is complicated due to the combination of core mood symptoms and associated symptoms such as painful physical symptoms. 1,3-5 Among primary care patients, 65% of patients with MDD were shown to have some type of painful physical symptoms. 6,7 A greater severity of painful physical symptoms, including back pain, gastrointestinal pain, and headache, is associated with increased severity of depression and reduces quality of life. 8 The presence of painful physical symptoms in patients with depression impairs treatment outcome, 6,7 decreases remission rates, 9 and creates loss of productivity and quality of life. 3,4,10 Patients with residual symptoms, including painful symptoms, are more likely to relapse. 11 Pain in depression receives inadequate attention for treatment due to poor diagnosis. 12 Treatment of depression ideally should include both core mood symptoms and associated symp-

Does Pain Improve Earlier than Mood in Depressed Patients with Painful Physical Symptoms Treated with Duloxetine?

“…The mean diff erence in time to response concerning pain vs. mood of 1.3 days is smaller than what has been reported in other studies [ 20 ] (diff erence of 7 days for overall pain and 15.5 days for back pain), but the literature on this topic is not consistent and there have been other studies reporting no such diff erences [ 27 ] . In these studies, however, mood and pain were assessed mostly by weekly ratings (e. g., [ 28 ] ) and not on a daily basis as in our study. It might be argued that the temporal separation of the mean improvement curves suggests that pain and mood change at least in part independently from each other [ 29 ] .…”

Duloxetine in acute major depression: review of comparisons to placebo and standard antidepressants using dissimilar methods

“…With 60 mg/day of DLX in elderly MDD patients, the most frequently reported ADRs were dry mouth and moderate nausea, and at rates similar to those reported with several SRIs in older patients, and without appreciable increases or decreases in blood pressure or pulse than with a PBO or SRIs (Raskin et al, 2008a). However, other studies have reported higher rates of treatment-related nausea with DLX than PBO or SRIs (Detke et al, 2002a,b;Goldstein et al, 2004;Brannan et al, 2005;Perahia et al, 2006bPerahia et al, , 2008Brecht et al, 2007;Lee et al, 2007;Nierenberg et al, 2007;Dunner et al, 2008). In one open label trial with more prolonged treatment with DLX, newly arising ADRs were rare, but some symptoms have been reported (Dunner et al, 2008) to begin or increase (e.g., decreased libido, abnormal orgasms, weight-gain orloss, hypersomnia, night-sweats, nightmares or early awakening, increased blood pressure, tachycardia, tremor, dizziness or unsteadiness, aggression, hypomania, or suicidal ideation).…”

“…Data analyses were based on standard commercial statistical programs (Stata.8 1 , StataCorp, College Station, TX; Statview.5 1 , SAS, Cary, NC). Brecht et al, 2007;Khan et al, 2007;Lee et al, 2007;Nierenberg et al, 2007;Raskin et al, 2007Raskin et al, , 2008aWade et al, 2007) (Tables 2 and 3). Age averaged 44.1 AE 6.7 years; one trial selected patients averaging 73 years of age (reported in Raskin et al, 2007Raskin et al, , 2008a Abbreviations: DLX, duloxetine; PBO, placebo; SRI, serotonin-reuptake inhibitor comparators (FLX…”

“…FDA approval of DLX for the treatment of MDD was supported by at least 17 controlled trials, including two proof-of-concept studies, two short-term dose-finding trials, four phase-III short-and long-term trials, and one relapse-prevention trial (Goldstein et al, , 2004Detke et al, 2002aDetke et al, ,b, 2004Company, 2004c,f, 2006e;Brannan et al, 2005;Burt et al, 2005;Perahia et al, 2006aPerahia et al, ,b, 2008Brecht et al, 2007;Khan et al, 2007;Lee et al, 2007;Nierenberg et al, 2007;Raskin et al, 2007Raskin et al, , 2008aWade et al, 2007). At least three of these trials remain unpublished in peer-reviewed journals; two did not find statistical superiority of relatively low doses of DLX over PBO (Eli Lilly and Company, 2004c,f).…”

Duloxetine in the treatment of burning mouth syndrome refractory to conventional treatment: A case report

“…6 No definitive treatment for BMS has been established, to date. The current approach combines medications, nerve block and supportive psychotherapy.…”