Eli Lilly and Company, Chappell AS, Wise TN
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Duloxetine Versus Placebo for Osteoarthritis Knee Pain

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Registry of Trials clinicaltrials.gov
Year 2006
Links Registry of Trials
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The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.

Primary study

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

Journal Pain
Year 2009
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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).

Primary study

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Duloxetine 60 to 120 mg once daily versus placebo in the treatment of patients with osteoarthritis knee pain

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Journal Pain Medicine
Year 2009
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Duloxetine in the treatment of osteoarthritis knee pain.

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Authors Wise TN
Journal Current psychiatry reports
Year 2010
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Primary study

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Clinically relevant outcomes based on analysis of pooled data from 2 trials of duloxetine in patients with knee osteoarthritis.

Journal The Journal of rheumatology
Year 2012
Links Pubmed DOI www.cochranelibrary.com
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<b>OBJECTIVE: </b>To determine response with duloxetine versus placebo in patients with osteoarthritis (OA) of the knee using the Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder index and other clinically relevant outcomes including minimal clinically important improvement (MCII) and patient acceptable symptom state (PASS) for pain and function.<b>METHODS: </b>Data were pooled from two 13-week, randomized, double-blind, placebo-controlled trials comparing duloxetine 60 to 120 mg/day with placebo in patients with symptomatic OA of the knee. Treatment response was determined according to the OMERACT-OARSI responder index, ≥ 30% pain reduction, ≥ 50% pain reduction, and MCII and PASS for pain and function. (ClinicalTrials.gov identifiers NCT00433290 and NCT00408421)<b>RESULTS: </b>Duloxetine-treated patients were 33% more likely to experience an OMERACT-OARSI response than placebo-treated patients [p &lt; 0.001, number needed to treat (NNT) = 6]. A significantly greater percentage of duloxetine-treated patients, compared with placebo-treated patients, reported ≥ 30% improvement in pain from baseline to endpoint (p &lt; 0.001, NNT = 5) and ≥ 50% improvement in pain relative to baseline (p &lt; 0.001, NNT = 7). The duloxetine-treated patients were also more likely to fulfill MCII criteria for pain (p &lt; 0.001, NNT = 6) and function (p &lt; 0.001, NNT = 7), and to achieve PASS for pain (p &lt; 0.001, NNT = 6) and function (p = 0.009, NNT = 9). More duloxetine-treated patients compared with placebo-treated patients experienced ≥ 1 treatment-emergent adverse event (p = 0.003, number needed to harm = 8).<b>CONCLUSION: </b>Significantly more patients receiving duloxetine than placebo achieved an OMERACT-OARSI response, improvements in pain and function exceeding the level accepted as MCII, and reached PASS. Results support the clinical relevance of outcomes of prior duloxetine studies in symptomatic OA of the knee.

Primary study

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Onset of Response with Duloxetine Treatment in Patients with Osteoarthritis Knee Pain and Chronic Low Back Pain: A Post Hoc Analysis of Placebo-Controlled Trials.

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Journal Clinical therapeutics
Year 2014
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BACKGROUND: Knowing when to change pain- medication strategy is not well researched and remains a gap in treating chronic pain. OBJECTIVE: Our aim was to determine how long to treat osteoarthritis (OA) knee pain and chronic low back pain (CLBP) with duloxetine before considering a change in medication strategy. METHODS: We employed a post hoc analysis of changes in pain-severity data from placebo- controlled studies of duloxetine treatment in nondepressed patients with OA knee pain and CLBP. The studies were selected for inclusion in the analyses based on similarity of study design. Pain severity was recorded daily in patient diaries using an ordinal 11-point numerical rating scale (0 = no pain to 10 = most severe pain). The weekly means of the daily 24-hour average pain severity ratings from these diaries were pooled within disease states. Moderate response was defined as at least a 30% reduction from baseline in pain severity, and minimal improvement was defined as &lt;10% reduction from baseline. The probability of achieving at least moderate pain reduction during 3 months treatment with duloxetine was estimated by Kaplan-Meier methods in patients with no or minimal improvement after 2, 4, and 6 weeks of treatment, as well as in all patients who had not yet achieved a moderate response (&lt; 30% reduction in pain severity). RESULTS: There were 239 OA patients and 541 CLBP patients who were randomly assigned to treatment with duloxetine 60/120 mg/d. OA and CLBP patients with minimal improvement at 2 weeks of treatment had &lt; 40% probability of achieving a moderate response, and at 4 weeks of treatment their chances were reduced to &lt; 30% in OA patients and 25% in CLBP patients. In patients showing &lt; 30% improvement at week 2 of treatment, OA patients had a 62% probability of achieving a moderate response, and CLBP patients had a 52% probability for a moderate response, and at 4 weeks of treatment, their chances were reduced to &lt; 50% in OA patients and 40% in CLBP patients. CONCLUSIONS: Patients taking duloxetine for OA or CLBP who have &lt; 10% reduction in pain after 4 weeks of treatment have limited possibility for eventually achieving even moderate pain reduction by the end of 12 weeks.