{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T06:07:11Z","timestamp":1791612431471,"version":"4.3.4"},"reference-count":33,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2015,5,18]],"date-time":"2015-05-18T00:00:00Z","timestamp":1431907200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005612","name":"Shionogi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005612","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2016,1]]},"abstract":"Abstract<\/jats:title>Introduction<\/jats:title>To examine the long\u2010term efficacy and safety of duloxetine in the treatment of J<\/jats:styled-content>apanese patients with diabetic neuropathic pain, we carried out a 52\u2010week, randomized, open\u2010label extension of a 12\u2010week, double\u2010blind, placebo\u2010controlled study.<\/jats:p><\/jats:sec>Materials and Methods<\/jats:title>Japanese adults with diabetic neuropathic pain who completed the double\u2010blind study were eligible for this long\u2010term study, carried out at 71 sites in J<\/jats:styled-content>apan (M<\/jats:styled-content>arch 2008 to M<\/jats:styled-content>arch 2010). Participants (n<\/jats:italic>\u00a0=\u00a0258) were re\u2010randomized (1:1) to 40\u00a0mg\/day or 60\u00a0mg\/day duloxetine. Pain (B<\/jats:styled-content>rief P<\/jats:styled-content>ain I<\/jats:styled-content>nventory severity and interference), quality of life (P<\/jats:styled-content>atient's G<\/jats:styled-content>lobal I<\/jats:styled-content>mpression of I<\/jats:styled-content>mprovement), and safety (primary outcome; adverse events, vital signs, metabolic measures) were measured.<\/jats:p><\/jats:sec>Results<\/jats:title>Significant (P<\/jats:italic>\u00a0<\u00a00.0001) and sustained improvements (change\u00a0\u00b1\u00a0standard deviation; n<\/jats:italic>\u00a0=\u00a0257) were observed in B<\/jats:styled-content>rief P<\/jats:styled-content>ain I<\/jats:styled-content>nventory severity (average pain score \u22122.1\u00a0\u00b1\u00a01.7). Improvements were also seen in B<\/jats:styled-content>rief P<\/jats:styled-content>ain I<\/jats:styled-content>nventory interference (mean of subscores \u22120.96\u00a0\u00b1\u00a01.52) and P<\/jats:styled-content>atient's G<\/jats:styled-content>lobal I<\/jats:styled-content>mpression of I<\/jats:styled-content>mprovement (\u22120.9\u00a0\u00b1\u00a01.1) scores; these scores decreased significantly (P<\/jats:italic>\u00a0<\u00a00.0001) during the long\u2010term study. Frequently reported adverse events included somnolence (13.6%), constipation (13.2%) and nausea (10.5%). Increases were observed in plasma glucose, glycosylated hemoglobin and total cholesterol levels, and in bodyweight and heart rate; however, none of these were clinically meaningful. Overall, there were no clinically significant safety concerns.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>This is the first publication of a long\u2010term study carried out in A<\/jats:styled-content>sia with an entirely J<\/jats:styled-content>apanese patient population to suggest that long\u2010term duloxetine therapy for diabetic neuropathic pain is effective and has an acceptable safety profile.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.12361","type":"journal-article","created":{"date-parts":[[2015,4,9]],"date-time":"2015-04-09T02:51:36Z","timestamp":1428547896000},"page":"100-108","source":"Crossref","is-referenced-by-count":25,"title":["Efficacy and safety of 40\u00a0mg or 60\u00a0mg duloxetine in J<\/scp>apanese adults with diabetic neuropathic pain: Results from a randomized, 52\u2010week, open\u2010label study"],"prefix":"10.1111","volume":"7","author":[{"given":"Hitoshi","family":"Yasuda","sequence":"first","affiliation":[{"name":"Faculty of Public Health Nursing Shiga University of Medical Science Shiga Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nigishi","family":"Hotta","sequence":"additional","affiliation":[{"name":"Japan Labor Health and Welfare Organization Chubu Rosai Hospital Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masato","family":"Kasuga","sequence":"additional","affiliation":[{"name":"Research Institute National Center for Global Health and Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsunori","family":"Kashiwagi","sequence":"additional","affiliation":[{"name":"Kusatsu General Hospital Shiga Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryuzo","family":"Kawamori","sequence":"additional","affiliation":[{"name":"Department of Medicine, Metabolism & Endocrinology Juntendo University Graduate School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadaaki","family":"Yamada","sequence":"additional","affiliation":[{"name":"Shionogi & Co., Ltd. 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