{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T22:22:20Z","timestamp":1783549340427,"version":"3.55.0"},"reference-count":41,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,11,1]],"date-time":"2017-11-01T00:00:00Z","timestamp":1509494400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Diabetes"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Limited information exists regarding the efficacy of pregabalin in Chinese patients with painful diabetic peripheral neuropathy (pDPN).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>An 11\u2010week double\u2010blind placebo\u2010controlled trial was performed in Chinese pDPN patients randomized (1 : 1) to 300 mg\/day pregabalin or placebo. The primary outcome was change from baseline to endpoint in mean pain score (MPS; 0, no pain; 10, worst possible pain; using the mean of the last seven daily pain scores). Secondary outcomes included weekly MPS and responder status (MPS reduced by \u226530% or \u226550% vs baseline). Subgroup analysis assessed patients with severe (\u22657) baseline MPS. Adverse events (AEs) were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In all, 620 patients were randomized (pregabalin,<jats:italic>n<\/jats:italic>= 313; placebo,<jats:italic>n<\/jats:italic>= 307). Improvement in MPS with pregabalin versus placebo was not significant (<jats:italic>P<\/jats:italic>= 0.0559). Post hoc sensitivity analyses, excluding one patient\/site due to Good Clinical Practice (GCP) non\u2010compliance, showed pregabalin significantly improved MPS when excluding the patient (<jats:italic>P<\/jats:italic>= 0.0448) or site (<jats:italic>P<\/jats:italic>= 0.0142). Pregabalin significantly improved weekly MPS (<jats:italic>P<\/jats:italic>= 0.0164) and \u226550% responders at endpoint (<jats:italic>P<\/jats:italic>= 0.0384). Improvement in proportion of \u226530% responders, impression of change, pain intensity, and sleep did not differ significantly between the treatment groups. In the severe pDPN subpopulation, pregabalin significantly improved MPS versus placebo (<jats:italic>P<\/jats:italic>= 0.0040). The most commonly reported AE was dizziness (9.6% vs 3.9% with placebo).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Pregabalin did not significantly improve the primary measure of pain in the trial. Significant reductions in MPS were observed when excluding the GCP non\u2010compliant patient\/site and in the severe pDPN subpopulation. Pregabalin was well tolerated in Chinese pDPN patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1753-0407.12585","type":"journal-article","created":{"date-parts":[[2017,7,20]],"date-time":"2017-07-20T14:18:53Z","timestamp":1500560333000},"page":"256-265","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Efficacy and safety of pregabalin for painful diabetic peripheral neuropathy in a population of Chinese patients: A randomized placebo\u2010controlled trial"],"prefix":"10.1111","volume":"10","author":[{"given":"Yiming","family":"Mu","sequence":"first","affiliation":[{"name":"Department of Endocrinology, Chinese PLA General Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaomin","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, The First Affiliated Hospital Harbin Medical University Harbin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quanmin","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, The Second Artillery General Hospital of PLA Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kangning","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Neurology, Southwest Hospital of Third Military Medical University Chongqing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, The Second Hospital of Jilin University Changchun China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaofeng","family":"Lv","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Metabolism, General Hospital of Beijing Military Region Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangjin","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Fuzhou General Hospital of Nanjing Military Command Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongsheng","family":"Fan","sequence":"additional","affiliation":[{"name":"Department of Neurology, Peking University Third Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ningxiu","family":"Shang","sequence":"additional","affiliation":[{"name":"Global Product Development \u2010 Clinical Sciences &amp; Operations \u2010 Development, Pfizer Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruoyong","family":"Yang","sequence":"additional","affiliation":[{"name":"Global Biometrics &amp; Data Management \u2010 Statistics Pfizer New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynne","family":"Pauer","sequence":"additional","affiliation":[{"name":"Global Product Development \u2010 Clinical Sciences &amp; Operations Pfizer, Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Changyu","family":"Pan","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Chinese PLA General Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,11]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc05-2228"},{"key":"e_1_2_7_3_1","first-page":"638","article-title":"The algorithm of diagnosis and treatment of diabetic peripheral neuropathy. 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