{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T11:52:55Z","timestamp":1788349975090,"version":"build-2803163510"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,12,25]],"date-time":"2019-12-25T00:00:00Z","timestamp":1577232000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims\/Introduction<\/jats:title><jats:p>Diabetic peripheral neuropathic pain (DPNP) affects the functionality, mood and sleep patterns of patients with diabetes. Mirogabalin, an \u03b1<jats:sub>2<\/jats:sub>\u03b4 ligand with a slower dissociation for \u03b1<jats:sub>2<\/jats:sub>\u03b4\u20101 versus \u03b1<jats:sub>2<\/jats:sub>\u03b4\u20102 subunits, showed efficacy and safety in a randomized, double\u2010blind, placebo\u2010controlled, 14\u2010week study in Asian patients with DPNP. This open\u2010label extension study evaluated the long\u2010term safety and efficacy of mirogabalin in Asian patients with DPNP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Material and Methods<\/jats:title><jats:p>This 52\u2010week open\u2010label extension study was carried out in Japan, Korea and Taiwan in patients with DPNP. Patients received mirogabalin, initiated at 5\u00a0mg twice daily and increased to a flexible maintenance dosage of 10 or 15\u00a0mg twice daily. Adverse events were monitored throughout the study. Patients provided a self\u2010assessment of pain using the Short\u2010Form McGill Pain Questionnaire.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 214 patients who entered the study, 172 (80.4%) completed the extension study. Of 172 patients who completed the study, 149 received the highest dosage of mirogabalin (15\u00a0mg twice daily). The most common treatment\u2010emergent adverse events were nasopharyngitis, diabetic retinopathy, peripheral edema, somnolence, diarrhea, increased weight and dizziness. Most treatment\u2010emergent adverse events were mild or moderate in severity. The incidence of treatment\u2010emergent adverse events leading to treatment discontinuation was 13.1%. The visual analog scale and all other Short\u2010Form McGill Pain Questionnaire subscales (sensory score, affective score, total score and present pain intensity) generally decreased over time from baseline until week\u00a052.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This extension study showed the safety and efficacy of a long\u2010term flexible dosing regimen of mirogabalin 10 or 15\u00a0mg twice daily in patients with DPNP.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.13178","type":"journal-article","created":{"date-parts":[[2019,11,13]],"date-time":"2019-11-13T10:26:12Z","timestamp":1573640772000},"page":"693-698","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["Long\u2010term safety and efficacy of mirogabalin in Asian patients with diabetic peripheral neuropathic pain"],"prefix":"10.1111","volume":"11","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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