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Articles
October 23, 2006

A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain

October 24, 2006 issue
67 (8) 1411-1420

Abstract

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.

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Information & Authors

Information

Published In

Neurology®
Volume 67Number 8October 24, 2006
Pages: 1411-1420
PubMed: 17060567

Publication History

Published online: October 23, 2006
Published in print: October 24, 2006

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Authors

Affiliations & Disclosures

J. F. Wernicke, PhD, MD
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.
Y. L. Pritchett, PhD
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.
D. N. D’Souza, PhD, MBA
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.
A. Waninger, BS
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.
P. Tran, MD
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.
S. Iyengar, PhD
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.
J. Raskin, MD, FRCPC
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.

Notes

Address correspondence and reprint requests to Dr. Joachim Wernicke, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285; e-mail: [email protected]

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  2. Efficacy of Pregabalin and Duloxetine in Patients with Painful Diabetic Peripheral Neuropathy (PDPN): A Multi-Centre Phase IV Clinical Trial—BLOSSOM, Pharmaceuticals, 16, 7, (1017), (2023).https://doi.org/10.3390/ph16071017
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  3. Comparing the Efficacy of Duloxetine with High Tone Power Therapy in Diabetic Peripheral Neuropathic Pain: A Double-Blind Randomized Phase III Clinical Trial, Journal of Advances in Medical and Biomedical Research, 31, 147, (316-322), (2023).https://doi.org/10.30699/jambs.31.147.316
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  4. Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials, Systematic Reviews, 12, 1, (2023).https://doi.org/10.1186/s13643-023-02185-6
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  5. Effectiveness of Duloxetine on Oxaliplatin-induced Allodynia and Hyperalgesia in Rats, Biological Research For Nursing, (2023).https://doi.org/10.1177/10998004231209444
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  8. Polyneuropathie mit Erfolg behandeln, Polyneuropathie, (119-160), (2023).https://doi.org/10.1007/978-3-662-67144-3_8
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  9. Antidepressants for pain management in adults with chronic pain: a network meta-analysis, Cochrane Database of Systematic Reviews, 2023, 5, (2023).https://doi.org/10.1002/14651858.CD014682.pub2
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