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A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain

From Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN (J.F.W., Y.L.P., D.N.D., A.W., S.I.); Xenoport Inc., Santa Clara, CA (P.T.); and Lilly Research Laboratories, Eli Lilly Canada, Toronto, Ontario, Canada (J.R.). Y.L.P. current address: Abbott Laboratories, Abbott Park, IL.

Address correspondence and reprint requests to Dr. Joachim Wernicke, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285; e-mail: jfwernicke{at}lilly.com

Background: Serotonin (5-HT) and norepinephrine (NE) are involved in pain modulation via descending inhibitory pathways in the brain and spinal cord.

Objective: To assess the efficacy of duloxetine, a dual reuptake inhibitor of 5-HT and NE, on the reduction of pain severity, as well as secondary outcome measures in patients with diabetic peripheral neuropathic pain (DPNP).

Methods: In this double-blind study, patients with DPNP and without comorbid depression were randomly assigned to treatment with duloxetine 60 mg once daily (QD), duloxetine 60 mg twice daily (BID), or placebo for 12 weeks. The primary outcome measure was the weekly mean score of 24-hour average pain severity on the 11-point Likert scale. Secondary measures and health outcome measures were also assessed.

Results: Duloxetine 60 mg QD and 60 mg BID demonstrated improvement in the management of DPNP and showed rapid onset of action, with separation from placebo beginning at week 1 on the 24-hour average pain severity score. For all secondary measures for pain (except allodynia), mean changes showed an advantage of duloxetine over placebo, with no significant difference between 60 mg QD and 60 mg BID. Clinical Global Impression of Severity and Patient’s Global Impression of Improvement evaluation demonstrated greater improvement on duloxetine- vs placebo-treated patients. Duloxetine showed no notable interference on diabetic controls, and both doses were safely administered.

Conclusions: This study confirms previous findings that duloxetine at 60 mg QD and 60 mg BID is effective and safe in the management of diabetic peripheral neuropathic pain.

Research for this study was funded by Eli Lilly and Company.

Disclosure: Authors (J.F.W., D.N.D., A.W., S.I., J.R.) are employees and stockholders of Eli Lilly and Company. P.T. and Y.L.P. are former employees of Eli Lilly and Company. J.F.W., Y.L.P., P.T., and J.R. hold equity in Eli Lilly and Company in excess of $10,000.

Received June 30, 2004. Accepted in final form May 15, 2006.

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