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Title: Duloxetine Improves Functional Outcomes in Diabetic Neuropathic Pain: Presented at AAPM

"Duloxetine Improves Functional Outcomes in Diabetic Neuropathic Pain: Presented at AAPM"

By Crystal Phend SAN DIEGO, C.A. -- March 1, 2006 -- Duloxetine treatment for diabetic peripheral neuropathic pain yields significant improvements in functional outcomes compared to placebo, according to a study presented here at the annual meeting of the American Academy of Pain Medicine. (AAPM). Duloxetine (Cymbalta) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) approved in the United States to treat depression and diabetic peripheral neuropathic pain. The researchers pooled results from three 12-week double blind, placebo-controlled studies of patients with diabetic peripheral neuropathic pain. A total of 1175 patients in the three studies were randomized to receive duloxetine 20 mg four times daily, 60 mg four times daily, 60 mg twice daily, or placebo. "We all know pain doesn't exist without some coexisting depression," said coauthor Jerry Hall, MD, Clinical Research Physician, Eli Lilly and Company, Indianapolis, Indiana, United States, in a presentation on February 23[^rd.

However, to separate out the effects of duloxetine on pain, patients with depressive disorders were excluded from the studies. Only patients that completed treatment and received the 60 mg dose of duloxetine were included in the pooled analysis.

Functional outcomes were measured by the interference portion of the Brief Pain Inventory, Short Form 36 (SF36), and the European Quality of Life Instrument 5D (EQ-5D).

Both 60 mg duloxetine dosing groups had significantly better scores compared to placebo on the SF-36 subscales for general health, bodily pain, vitality, physical score, physical functioning, and role physical (function as an employee, parent, etc).

Both dose groups were also significantly superior compared to placebo in the Brief Pain Inventory scales, which identifies how much the patient's pain interferes with daily life activities and sleep.

Quality of life scores were also significantly higher for patients treated with either dose of duloxetine compared to placebo.

"It works well," Dr. Hall said. However, he cautioned that the improvement could not be directly related to pain relief from duloxetine.

This study was funded by Eli Lilly and Company.

[Presentation title: Duloxetine in the Treatment of Diabetic Peripheral Neuropathic Pain: Evaluation of Functional Outcomes. Poster 108]

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