Efficacy and safety of 40 mg or 60 mg duloxetine in Japanese adults with diabetic neuropathic pain: Results from a randomized, 52-week, open-label study

Journal of Diabetes Investigation
Hitoshi YasudaKo Nakajo

Abstract

To examine the long-term efficacy and safety of duloxetine in the treatment of Japanese patients with diabetic neuropathic pain, we carried out a 52-week, randomized, open-label extension of a 12-week, double-blind, placebo-controlled study. Japanese adults with diabetic neuropathic pain who completed the double-blind study were eligible for this long-term study, carried out at 71 sites in Japan (March 2008 to March 2010). Participants (n = 258) were re-randomized (1:1) to 40 mg/day or 60 mg/day duloxetine. Pain (Brief Pain Inventory severity and interference), quality of life (Patient's Global Impression of Improvement), and safety (primary outcome; adverse events, vital signs, metabolic measures) were measured. Significant (P < 0.0001) and sustained improvements (change ± standard deviation; n = 257) were observed in Brief Pain Inventory severity (average pain score -2.1 ± 1.7). Improvements were also seen in Brief Pain Inventory interference (mean of subscores -0.96 ± 1.52) and Patient's Global Impression of Improvement (-0.9 ± 1.1) scores; these scores decreased significantly (P < 0.0001) during the long-term study. Frequently reported adverse events included somnolence (13.6%), constipation (13.2%) and nausea (10.5%). Incr...Continue Reading

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Citations

Mar 12, 2019·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Shin-Ichi KonnoHiroyuki Enomoto
Nov 17, 2019·International Journal of Molecular Sciences·Stephania ParedesNebojsa Nick Knezevic
Jun 30, 2019·Pain Research & Management : the Journal of the Canadian Pain Society = Journal De La Société Canadienne Pour Le Traitement De La Douleur·Ayesha GirachPanagiotis Zis
Nov 17, 2020·Frontiers in Psychiatry·Daniela Rodrigues-AmorimTania Rivera-Baltanás
Oct 3, 2020·Best Practice & Research. Clinical Anaesthesiology·Ivan UritsOmar Viswanath
Apr 11, 2018·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Mohamed BalahaAhmed Kabel

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Methods Mentioned

BETA
pharmacotherapy

Clinical Trials Mentioned

NCT00641719

Software Mentioned

SAS

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