medwireNews: Adding duloxetine to usual care does not improve pain outcomes for people with chronic osteoarthritis (OA), suggest findings from a randomized controlled trial conducted in the primary care setting.
Writing in Arthritis & Rheumatology, Jacoline van den Driest (Erasmus University Medical Center, Rotterdam, the Netherlands) and team say that the Osteoarthritis Research Society International recommends duloxetine use for people with knee OA plus depression and/or widespread pain, while the American College of Rheumatology conditionally recommends the serotonin and norepinephrine reuptake inhibitor for OA.
The authors note that these recommendations are based on trials evaluating “short-term use of duloxetine in placebo-controlled trials in highly controlled secondary care settings,” but its effectiveness when added to standard care in the primary care setting is unknown, even though “most OA patients are treated in this setting for many years.”
To address this gap in knowledge, the team carried out a pragmatic cluster randomized trial in which 132 people with chronic hip or knee OA pain from 66 primary care practices were allocated to receive duloxetine 60 mg/day in addition to usual care, or to receive usual care alone. The majority of participants (77–86%) in both groups had knee OA, and none were taking antidepressants at the time of enrollment.
The average WOMAC pain score decreased from 9.8 points at baseline to 8.0 points at 3 months for duloxetine-treated patients, and from 10.5 to 9.3 points in the control group, translating into an adjusted between-group difference of 0.6 points that was neither “clinically relevant nor statistically significant,” say van den Driest et al.
There was also no significant between-group difference in WOMAC pain scores at the 1-year follow-up, nor in a range of secondary outcomes – including WOMAC function, quality of life, and patient satisfaction – at all timepoints measured. Moreover, these measures did not significantly differ with versus without duloxetine treatment in a subgroup of 60 patients with symptoms of centrally sensitized pain.
“To conclude, there was no clinically relevant effect of duloxetine added to usual care compared to usual care alone for chronic OA pain and it should not be implemented,” summarize the investigators.
A total of 89.3% of participants given duloxetine and 72.5% of those in the control group reported adverse events, with nausea, weight loss, constipation, yawning, and hyperhidrosis occurring more frequently in the duloxetine arm.
The authors note that “[t]hese are well known side-effects of duloxetine.”
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