HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Figures Only Full Text Full Text (PDF) CME: Take the course for this article: Volume 67, Number 8, October 24, 2006 JapaneseTranslation Correspondence: Submit a response Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Wernicke, J. F. Articles by Raskin, J. Search for Related Content PubMed PubMed Citation Articles by Wernicke, J. F. Articles by Raskin, J. Related Collections Endocrine Peripheral neuropathy All Clinical trials Clinical trials Randomized controlled (CONSORT agreement) Neuropathic pain

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.

This article has been cited by other articles:

				S. Perrot, R.-M. Javier, M. Marty, C. Le Jeunne, F. Laroche, and the CEDR (Cercle d'Etude de la Douleur en Rhumatol Is there any evidence to support the use of anti-depressants in painful rheumatological conditions? Systematic review of pharmacological and clinical studies Rheumatology, August 1, 2008; 47(8): 1117 - 1123. [Abstract] [Full Text] [PDF]

				D. Ziegler Treatment of Diabetic Neuropathy and Neuropathic Pain: How far have we come? Diabetes Care, February 1, 2008; 31(Supplement_2): S255 - S261. [Abstract] [Full Text] [PDF]

				Z.-Q. Zhao, S. Chiechio, Y.-G. Sun, K.-H. Zhang, C.-S. Zhao, M. Scott, R. L. Johnson, E. S. Deneris, K. J. Renner, R. W. Gereau IV, et al. Mice Lacking Central Serotonergic Neurons Show Enhanced Inflammatory Pain and an Impaired Analgesic Response to Antidepressant Drugs J. Neurosci., May 30, 2007; 27(22): 6045 - 6053. [Abstract] [Full Text] [PDF]

				Is there a place for {blacktriangledown}duloxetine? DTB, April 1, 2007; 45(4): 29 - 32. [Abstract] [Full Text] [PDF]

				D. Ziegler, Y. L. Pritchett, F. Wang, D. Desaiah, M. J. Robinson, J. A. Hall, and A. S. Chappell Impact of Disease Characteristics on the Efficacy of Duloxetine in Diabetic Peripheral Neuropathic Pain Diabetes Care, March 1, 2007; 30(3): 664 - 669. [Abstract] [Full Text] [PDF]

				Duloxetine for Diabetic Peripheral Neuropathic Pain Journal Watch Neurology, February 6, 2007; 2007(206): 7 - 7. [Full Text]

				M. D. Hix Pain Management in Elderly Patients Journal of Pharmacy Practice, February 1, 2007; 20(1): 49 - 63. [Abstract] [PDF]

				Endocrinology & Metabolism News, December 2006 J. Clin. Endocrinol. Metab., December 1, 2006; 91(12): 17a - 17a. [Full Text] [PDF]