ArticleDuloxetine vs. placebo in patients with painful diabetic neuropathyGoldstein, David J.a; Lu, Yilib; Detke, Michael J.b,c,d,*; Lee, Thomas C.b; Iyengar, SmritibAuthor Information aPRN Consulting and Department of Pharmacology and Toxicology, Indiana University School of Medicine, Indianapolis, IN, USA bLilly Corporate Center, Lilly Research Laboratories, Indianapolis, IN 46285, USA cDepartment of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA dDepartment of Psychiatry, McLean Hospital, Belmont, MA and Harvard Medical School, Boston, MA, USA *Corresponding author. Address: Lilly Corporate Center, Indianapolis, IN 46285, USA. Tel.: +1 317 277 6420; fax: +1 317 276 6026. E-mail: [email protected] Submitted November 1, 2004; revised February 21, 2005; accepted March 30, 2005. ☆ This work was sponsored by Eli Lilly and Company and PRN Consulting. Pain: July 2005 - Volume 116 - Issue 1 - p 109-118 doi: 10.1016/j.pain.2005.03.029 Buy Metrics Abstract The aim of this study was to examine the efficacy and safety of duloxetine, a balanced and potent dual reuptake inhibitor of serotonin and norepinephrine, in the management of diabetic peripheral neuropathic pain. Serotonin and norepinephrine are thought to inhibit pain via descending pain pathways. In a 12-week, multicenter, double-blind study, 457 patients experiencing pain due to polyneuropathy caused by Type 1 or Type 2 diabetes mellitus were randomly assigned to treatment with duloxetine 20 mg/d (20 mg QD), 60 mg/d (60 mg QD), 120 mg/d (60 mg BID), or placebo. The diagnosis was confirmed by a score of at least 3 on the Michigan Neuropathy Screening Instrument. The primary efficacy measure was the weekly mean score of the 24-h Average Pain Score, which was rated on an 11-point (0–10) Likert scale (no pain to worst possible pain) and computed from diary scores between two site visits. Duloxetine 60 and 120 mg/d demonstrated statistically significant greater improvement compared with placebo on the 24-h Average Pain Score, beginning 1 week after randomization and continuing through the 12-week trial. Duloxetine also separated from placebo on nearly all the secondary measures including health-related outcome measures. Significantly more patients in all three active-treatment groups achieved a 50% reduction in the 24-h Average Pain Score compared with placebo. Duloxetine treatment was considered to be safe and well tolerated with less than 20 percent discontinuation due to adverse events. Duloxetine at 60 and 120 mg/d was safe and effective in the management of diabetic peripheral neuropathic pain. © 2005 Lippincott Williams & Wilkins, Inc.