Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic PainReport as inadecuate




Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain - Download this document for free, or read online. Document in PDF available to download.

Pain Research and TreatmentVolume 2012 2012, Article ID 898347, 12 pages

Review Article

Department of Neuroscience, Eli Lilly and Company, Indianapolis, IN 46285, USA

Department of Neuroscience, Eli Lilly Canada, Toronto, ON, Canada M1N 2E8

Department of Strategic Resourcing, PharmaNet-i3, Ann Arbor, MI 48108, USA

Department of Neuroscience, Eli Lilly de México, 03900 México, Mexico

Received 10 January 2012; Revised 16 April 2012; Accepted 7 May 2012

Academic Editor: Bjorn Meyerson

Copyright © 2012 Vladimir Skljarevski et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

We summarize efficacy and safety findings from 4 double-blind, placebo-controlled, 12-week studies and 1 open-label, uncontrolled, 34-week maintenance-of-effect MOE study that examine duloxetine 40 and 60 mg once daily QD in patients with diabetic peripheral neuropathic pain DPNP. In all placebo-controlled studies, duloxetine showed significantly 𝑃 ≤ . 0 1 greater reduction in pain severity weekly mean of 24-hour average pain severity ratings, primary outcome measure compared with placebo. In all placebo-controlled studies, duloxetine showed significantly 𝑃 ≤ . 0 5 greater improvement on brief pain inventory-Interference ratings. Patient global impression of improvement ratings were superior to placebo 𝑃 ≤ . 0 1 for duloxetine patients in all placebo-controlled studies. Response rates based on 30% pain reduction ranged from 57% to 68% for duloxetine and from 35% to 47% for placebo and were statistically significantly different 𝑃 ≤ . 0 1 between treatment groups in 3 out of 4 studies. The open-label study showed maintenance of analgesic effect of duloxetine in DPNP. In the duloxetine groups, 4.3% to 14.9% of patients discontinued because of adverse events placebo groups: 2.6% to 7.4%. Most commonly reported treatment-emergent adverse events were nausea, somnolence, and headache. Duloxetine 40 and 60 mg QD was efficacious and well tolerated in the management of DPNP.





Author: Vladimir Skljarevski, Elijah P. Frakes, Doron Sagman, Sarah Lipsius, Alexandra N. Heinloth, and Héctor J. Dueñas Tentori

Source: https://www.hindawi.com/



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