{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:24:12Z","timestamp":1792787052228,"version":"4.5.0"},"reference-count":24,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,2,28]],"date-time":"2019-02-28T00:00:00Z","timestamp":1551312000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Daiichi Sankyo, Inc."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims\/Introduction<\/jats:title>\n                    <jats:p>\n                      This study evaluated the efficacy and safety of mirogabalin, a novel, potent, selective ligand of the \u03b1\n                      <jats:sub>2<\/jats:sub>\n                      \u03b4 subunit of voltage\u2010dependent Ca\n                      <jats:sup>2+<\/jats:sup>\n                      channels, for the treatment of diabetic peripheral neuropathic pain (\n                      <jats:styled-content style=\"fixed-case\">DPNP<\/jats:styled-content>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      During this double\u2010blind, multisite, placebo\u2010controlled phase\u00a0III study, Asian patients aged \u226520\u00a0years with type\u00a01 or 2 diabetes and\n                      <jats:styled-content style=\"fixed-case\">DPNP<\/jats:styled-content>\n                      were randomized 2:1:1:1 to a placebo, mirogabalin 15, 20 or 30\u00a0mg\/day for up to 14\u00a0weeks, with a 1\u2010 to 2\u2010week titration (\n                      <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>\n                      02318706). The primary endpoint was the change from baseline in average daily pain score (\n                      <jats:styled-content style=\"fixed-case\">ADPS<\/jats:styled-content>\n                      ) at week\u00a014, defined as a weekly average of daily pain (0\u00a0=\u00a0no pain to 10\u00a0=\u00a0worst possible pain, for the past 24\u00a0h).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 834 randomized patients, 330, 164, 165 and 165 received placebo, mirogabalin 15, 20 or 30\u00a0mg\/day, respectively, and were included in analyses (modified intention\u2010to\u2010treat population,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0824); 755 (90.5%) completed the study. At week\u00a014, the least squares mean\n                      <jats:styled-content style=\"fixed-case\">average daily pain score<\/jats:styled-content>\n                      change from baseline was \u22121.31, \u22121.34, \u22121.47 and \u22121.81, respectively, showing statistical significance for mirogabalin 30\u00a0mg\/day versus placebo (\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      =\n                      <jats:italic>\u00a0<\/jats:italic>\n                      0.0027). The treatment\u2010emergent adverse events observed were mostly mild\u2010to\u2010moderate in all mirogabalin doses, and the most frequent\n                      <jats:styled-content style=\"fixed-case\">treatment\u2010emergent adverse events<\/jats:styled-content>\n                      were nasopharyngitis, somnolence, dizziness, peripheral edema and weight increase.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Mirogabalin relieved\n                      <jats:styled-content style=\"fixed-case\">DPNP<\/jats:styled-content>\n                      in a dose\u2010dependent manner; mirogabalin 30\u00a0mg\/day showed statistically significant pain relief (vs placebo) in Asian\n                      <jats:styled-content style=\"fixed-case\">DPNP<\/jats:styled-content>\n                      patients. All doses of mirogabalin tested were well tolerated.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jdi.13013","type":"journal-article","created":{"date-parts":[[2019,1,24]],"date-time":"2019-01-24T08:53:56Z","timestamp":1548320036000},"page":"1299-1306","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":116,"title":["Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double\u2010blind, placebo\u2010controlled phase\u00a0III study in Asian patients"],"prefix":"10.1111","volume":"10","author":[{"given":"Masayuki","family":"Baba","sequence":"first","affiliation":[{"name":"Aomori Prefectural Central Hospital Aomori Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norimitsu","family":"Matsui","sequence":"additional","affiliation":[{"name":"Clinical Development Department Daiichi Sankyo Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masanori","family":"Kuroha","sequence":"additional","affiliation":[{"name":"Clinical Development Department Daiichi Sankyo Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Wasaki","sequence":"additional","affiliation":[{"name":"Asia Development Department Daiichi Sankyo Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoichi","family":"Ohwada","sequence":"additional","affiliation":[{"name":"Biostatistics and Data Management Department Daiichi Sankyo Co., Ltd. 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