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Title: Duloxetine Effective for Knee Osteoarthritis Pain: Presented at AAPM

"Duloxetine Effective for Knee Osteoarthritis Pain: Presented at AAPM"

By Emma Hitt, PhD HONOLULU -- January 30, 2009 -- Duloxetine was superior to placebo in managing the pain associated with knee osteoarthritis (OA) over 13 weeks of treatment, according to a study presented here at the American Academy of Pain Medicine (AAPM) 25th Annual Meeting. Results from the 13-week, randomised, double-blind, placebo-controlled trial were presented on January 29. In their study, Vladimir Skljarevski, MD, Lilly Research Laboratories, Indianapolis, Indiana, and colleagues enrolled 256 patients with OA of the knee who had pain for at least 14 days of each month for 3 months and a mean 24-hour average pain score of at least 4. Patients received duloxetine 60 mg or placebo for 7 weeks, at which time those who did not respond to duloxetine were given an increased dose of 120 mg for the remainder of the study. The primary outcome was Brief Pain Inventory 24-hour average pain. Compared with placebo, duloxetine resulted in significantly greater reductions in 24-hour average pain from visits 3 through 5 ([P < .001).

Other measures were also significantly improved compared with placebo from visit 3 through visit 5, including pain and physical total scores using the Western Ontario and McMaster Universities index (P = .044), the 24-hour average pain weekly score (P = .008), the Clinical Global Impressions-Severity score (P = .009), and the Patient's Global Impressions-Improvement scale (P <= .05).

Treatment-related adverse events observed with greater frequency in the duloxetine arm included nausea, constipation, and hyperhidrosis (P <= .05). In addition, more patients receiving duloxetine discontinued treatment compared with the placebo arm (P = .002).

"This is new data on duloxetine in osteoarthritis pain of the knee that has never been presented before," Dr. Skljarevski said in an interview. "They suggest that duloxetine 60 to 120 mg, taken once daily, reduced pain severity significantly, compared with placebo, in patients with osteoarthritis pain of the knee."

Duloxetine is a relatively balanced serotonin and norepinephrine reuptake inhibitor also under evaluation for the treatment of fibromyalgia and chronic low back pain. Duloxetine is approved in the United States in adults for acute and maintenance treatment of major depressive disorder, acute treatment of generalised anxiety disorder, and the management of diabetic peripheral neuropathic pain and fibromyalgia.

Funding for the study was provided by Eli Lilly and Company. A Lilly spokesperson noted that plans to resubmit its duloxetine supplemental new drug application for chronic pain to the US Food and Drug Administration in the first half of 2009, including the results of this new osteoarthritis knee pain study.

[Presentation title: Duloxetine 60 to 120 mg Once Daily Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain. Abstract 207]

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