{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T22:07:24Z","timestamp":1783548444864,"version":"3.55.0"},"reference-count":28,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2010,12,19]],"date-time":"2010-12-19T00:00:00Z","timestamp":1292716800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetic Medicine"],"published-print":{"date-parts":[[2011,1]]},"abstract":"<jats:sec><jats:label\/><jats:p>Diabet. Med. 28, 109\u2013116 (2011)<\/jats:p><\/jats:sec><jats:sec><jats:title>Abstract<\/jats:title><jats:p><jats:bold>Aims\u2002<\/jats:bold> To evaluate the efficacy, safety and pharmacokinetics of pregabalin in treating neuropathic pain associated with diabetic peripheral neuropathy in Japanese patients.<\/jats:p><jats:p><jats:bold>Methods\u2002<\/jats:bold> A randomized, double\u2010blind, placebo\u2010controlled, multicentre 14\u2003week clinical trial was conducted. Japanese patients with diabetic peripheral neuropathy (<jats:italic>n<\/jats:italic>\u2003=\u2003317) were randomized to receive placebo or pregabalin at 300 or 600\u2003mg\/day. The primary efficacy measure was a change of mean pain score from baseline to end\u2010point from patients\u2019 daily pain diaries.<\/jats:p><jats:p><jats:bold>Results\u2002<\/jats:bold> Significant reductions in pain were observed in patients treated with pregabalin at 300 and 600\u2003mg\/day vs. placebo (<jats:italic>P<\/jats:italic>\u2003&lt;\u20030.05). Improvements in weekly pain scores were observed as early as week\u20031 and were sustained throughout the study period (300 and 600\u2003mg\/day difference from placebo at study end\u2010point, \u20130.63 and \u20130.74, respectively). Pregabalin produced significant improvements in weekly sleep interference scores, the short\u2010form McGill Pain Questionnaire, the Medical Outcomes Study\u2013Sleep Scale, the 36\u2010item Short\u2010Form Health Survey scale, and the Patient and Clinical Global Impression of Change. Patient impressions of numbness, pain and paraesthesia were also significantly improved. Regarding treatment responders, 29.1 and 35.6% of patients treated with 300 and 600\u2003mg\/day, respectively, reported \u226550% improvement in mean pain scores (vs. 21.5% for placebo). Pregabalin was well tolerated; somnolence (26%), dizziness (24%), peripheral oedema (13%) and weight gain (11%) were the most common adverse events and generally were reported as mild to moderate.<\/jats:p><jats:p><jats:bold>Conclusions\u2002<\/jats:bold> Pregabalin was effective in reducing pain and improving sleep disturbances due to pain, and was well tolerated in Japanese patients with painful DPN.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1464-5491.2010.03152.x","type":"journal-article","created":{"date-parts":[[2010,10,7]],"date-time":"2010-10-07T19:51:28Z","timestamp":1286481088000},"page":"109-116","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":124,"title":["Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14\u2003week, randomized, double\u2010blind, placebo\u2010controlled 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