Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: A 13-week, randomized, placebo-controlled trial

Abstract

Pain is a common cause of disability in osteoarthritis. Duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI), has demonstrated analgesic effects in diabetic peripheral neuropathy and fibromyalgia. Considering its central mechanism of action, duloxetine may be effective in other pain states with evidence of central sensitization. Herein, we report the results of a 13-week, randomized, double-blind, placebo-controlled trial of duloxetine (60-120 mg/day) versus placebo in the treatment of knee pain in 231 patients meeting clinical and radiographic criteria for osteoarthritis of the knee. Duloxetine was superior to placebo on the primary efficacy measure (weekly mean 24-h pain scores) beginning at Week 1 and continuing through the treatment period (P < or = .05). There was also a significant improvement in the WOMAC physical functioning subscale and several other secondary outcomes. Adverse-event rates did not differ significantly between treatment groups (49.5% for duloxetine 60-120 mg/day, and 40.8% for placebo).

Osteoarthritis: a holistic approach

“…However, when duloxetine, a serotonin and noradrenaline reuptake inhibitor, was used in a 13-week randomised controlled trial, significant benefits in pain and functional scores were reported in patients with OA of the knee. 11 Further studies are necessary to establish its long-term clinical utility.…”

Long-Term Treatment of Osteoarthritis Pain: Achieving a Balance Between Efficacy and Tolerability for a Successful Chronic Therapy

“…Because osteoarthritis pain perception can have a central sensitization component (ArendtNielsen et al, 2010;Gwilym et al, 2009;Hochman et al, 2010;Woolf, 2011), recent studies have investigated the analgesic efficacy of the SNRI duloxetine for the management of chronic osteoarthritis pain (Chappell et al, 2009;Chappell et al, 2011;Sullivan et al, 2009). In 2 randomized, double-blind, placebo-controlled trials in patients with moderate to severe osteoarthritis knee pain (n = 231 and n = 256, respectively), 13 weeks of treatment with duloxetine (60-120 mg/day) was associated with significantly reduced weekly average 24-hour pain scores and significant improvements in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index physical functioning scores (Chappell et al, 2009;Chappell et al, 2011).…”

“…In 2 randomized, double-blind, placebo-controlled trials in patients with moderate to severe osteoarthritis knee pain (n = 231 and n = 256, respectively), 13 weeks of treatment with duloxetine (60-120 mg/day) was associated with significantly reduced weekly average 24-hour pain scores and significant improvements in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index physical functioning scores (Chappell et al, 2009;Chappell et al, 2011). Duloxetine was associated with significantly higher incidences of nausea, constipation, and hyperhidrosis (all P ≤0.05) and a significantly higher rate of discontinuation due to AEs (P = 0.002) compared with placebo (Chappell et al, 2011).…”

Cost Effectiveness of Duloxetine for Osteoarthritis: A Quebec Societal Perspective

“…Its efficacy with respect to pain inhibition is believed to result from potentiation of descending inhibitory pain pathways within the central nervous system (8). Multiple phase III clinical trials have demonstrated the efficacy of duloxetine in management of OA (9,10). Although a link between depression and physical symptoms such as pain has been established (11), the trials used to establish the efficacy of duloxetine in OA excluded patients with psychiatric disorders, including major depressive disorder (9,10).…”

“…Multiple phase III clinical trials have demonstrated the efficacy of duloxetine in management of OA (9,10). Although a link between depression and physical symptoms such as pain has been established (11), the trials used to establish the efficacy of duloxetine in OA excluded patients with psychiatric disorders, including major depressive disorder (9,10). In addition, duloxetine has demonstrated a safety profile whereby most AEs are mild and transitory in nature (12).…”