Trial reportBMC musculoskeletal disorders2013
Safety and efficacy of duloxetine treatment in older and younger patients with osteoarthritis knee pain: a post hoc, subgroup analysis of two randomized, placebo-controlled trials.
Trial report in BMC musculoskeletal disorders, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Efficacy and safety of antidepressants for pain in older adults: A systematic review and meta-analysis.British journal of clinical pharmacology · 2024Pooled it
- Antidepressants for hip and knee osteoarthritis.The Cochrane database of systematic reviews · 2022Pooled it
- Does postoperative low-dose duloxetine provide analgesic effect and lower morphine consumption after primary total knee arthroplasty? A prospective, double-blind, randomized controlled trial.Archives of orthopaedic and trauma surgery · 2024Trial
- Duloxetine in OsteoArthritis (DOA) study: effects of duloxetine on pain and function in end-stage hip and knee OA - a pragmatic enriched randomized controlled trial.BMC musculoskeletal disorders · 2022Trial
- Efficacy of duloxetine and gabapentin in pain reduction in patients with knee osteoarthritis.Clinical rheumatology · 2019Trial
- Navigating the Efficacy and Safety Landscape of Duloxetine in Osteoarthritis Management: A Meta-Analysis of Randomized Controlled Trials.Indian journal of orthopaedics · 2025Review
- Comparative Cardiovascular Safety of Duloxetine and Gabapentin in Patients with Hip Osteoarthritis.Journal of pain research · 2025Article
- Article
- New Drug Treatments for Osteoarthritis: What is on the Horizon?European medical journal. Rheumatology · 2017Article
- Future directions for the management of pain in osteoarthritis.International journal of clinical rheumatology · 2014Article
- Clinical experience with duloxetine in the management of chronic musculoskeletal pain. A focus on osteoarthritis of the knee.Therapeutic advances in musculoskeletal disease · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOsteoarthritis (OA) knee pain is common in older patients and contributes to decreased quality of life. Older patients are generally at higher risk of adverse drug reactions due to age-related changes in physiology that affect drug disposition, metabolism, and response. These analyses examined efficacy and safety outcomes of older (≥65 years) versus younger patients from clinical trials of duloxetine in the management of OA knee pain.
methodsThis is a post hoc analysis of two 13-week studies, in which patients were randomized to duloxetine 60 mg/day or placebo. Both studies allowed potential dose changes after 7 weeks of dosing, with Study I re-randomizing duloxetine treated patients to either stay on 60 mg/day or increase to 120 mg/day; while Study II more closely mimicked clinical practice by escalating only non-responding patients to 120 mg/day. For all analyses patients were subgrouped by age: older (≥65 years) and younger (40-64 years). Overall efficacy and safety age-group comparisons of duloxetine versus placebo were performed using pooled data from both studies with all duloxetine dose levels combined. Safety analyses included discontinuation rates, treatment-emergent adverse events, and serious adverse events. To evaluate the effects of increasing the dose in non-responding patients, only Study II data were evaluated. Treatment arms were defined post hoc as placebo, duloxetine 60 mg/day, and duloxetine 60/120 mg/day.
resultsAt study end, patients in each age group who were treated with duloxetine versus placebo had significantly greater improvement in pain (both, p<.05), and there was no significant effect of age on treatment (p=.72). Increasing the dose to 120 mg in non-responding patients was not found to have a significant advantage. Among treatment-emergent adverse events with duloxetine treatment, only dizziness had a significantly differential treatment effect (p=.02) with greater incidence over placebo in younger patients (6.6% versus 0.6%, p=.02), but not in older patients (1.0% versus 3.2%, p=.29).
conclusionsDuloxetine was efficacious and generally well tolerated for management of symptomatic knee OA in both older and younger patients, but increasing the dose to 120 mg in non-responding patients did not provide additional benefit.
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