Cymbalta now indicated for managing chronic OA knee pain

Health Canada has approved a new indication for Eli Lilly’s Cymbalta (duloxetine HCl). The drug is now indicated for the management of chronic pain associated with osteoarthritis (OA) of the knee.This is the sixth Health Canada-approved indication for Cymbalta. The drug had already received Health Canada approval for use in major depressive disorder, generalized anxiety disorder, neuropathic pain associated with diabetic peripheral neuropathy, fibromyalgia, and chronic low back pain.Duloxetine is a selective serotonin norepinephrine reuptake inhibitor with a centrally-acting analgesic effect.The recommended dosage of duloxetine for managing chronic pain associated with OA of the knee is 60 mg once daily.If tolerability is a concern, patients can be started on 30 mg once daily, increasing to the target dose of 60 mg/day within one to two weeks. Some patients respond within the first week.The maximum recommended dosage is 120 mg per day; this higher dosage may cause more frequent adverse effects. The efficacy of duloxetine beyond 13 weeks of therapy in OA has not been evaluated in controlled clinical trials.Several clinical trials have shown that duloxetine (alone or added to NSAIDs) is superior to placebo in reducing pain and improving function in patients with OA of the knee.Many of these trials were conducted by the drug’s manufacturer.The American College of Rheumatology provides both “strong” and “conditional” consensus recommendations regarding OA management in its 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee.(Strong recommendations mean that most informed patients would choose the recommended management and that clinicians can structure their interactions with patients accordingly. Conditional recommendations mean that the majority of informed patients would choose the recommended management but many would not, so clinicians must ensure that patients’ care is in keeping with their values and preferences.)Patients with knee OA are strongly recommended to participate in cardiovascular (aerobic) and/or resistance land-based exercise, participate in aquatic exercise, and lose weight (if overweight).No strong recommendations are made for the initial pharmacologic management of knee OA. Acetaminophen, oral and topical NSAIDs, tramadol, and intraarticular corticosteroid injections are conditionally recommended pharmacologic modalities for the initial management of patients with knee OA.Intra-articular hyaluronate injections, duloxetine, and opioids are conditionally recommended in patients who have an inadequate response to initial therapy.ReferencesEli Lilly Canada Inc. Cymbalta (duloxetine HCl) product monograph. Toronto, ON: July 30, 2012.Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res 2012;64:465-74. www.rheumatology.org/practice/clinical/guidelines/PDFs/ACR_OA_Guidelines_FINAL.pdf#toolbar=1 (accessed August 10, 2012).Abou-Raya S, Abou-Raya A, Helmii M. Duloxetine for the management of pain in older adults with knee osteoarthritis: randomised placebo-controlled trial. Age Ageing 2012;Jul 20. [Epub ahead of print]Hochberg MC, Wohlreich M, Gaynor P, et al. Clinically relevant outcomes based on analysis of pooled data from 2 trials of duloxetine in patients with knee osteoarthritis. J Rheumatol 2012;39:352-8.Chappell AS, Ossanna MJ, Liu-Seifert H, et al. Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: a 13-week, randomized, placebo-controlled trial. Pain 2009;146:253-60.Chappell AS, Desaiah D, Liu-Seifert H, et al. A double-blind, randomized, placebo-controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Pain Pract 2011;11:33-41.Frakes EP, Risser RC, Ball TD, et al. Duloxetine added to oral nonsteroidal anti-inflammatory drugs for treatment of knee pain due to osteoarthritis: results of a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin 2011;27:2361-72.

Cymbalta now indicated for managing chronic OA knee pain

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