{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T20:48:18Z","timestamp":1791665298613,"version":"4.3.4"},"reference-count":34,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2019,8,5]],"date-time":"2019-08-05T00:00:00Z","timestamp":1564963200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100007132","name":"Otsuka Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007132","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100013327","name":"H. Lundbeck A\/S","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013327","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Psychiatry Clin Neurosci"],"published-print":{"date-parts":[[2019,11]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Reducing alcohol consumption is one treatment approach for alcohol\u2010dependent patients. This study compared nalmefene 20\u2009mg and 10\u2009mg with placebo, combined with psychosocial support, in alcohol\u2010dependent Japanese patients with a high or very high drinking risk level (DRL).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a multicenter, randomized, double\u2010blind, phase 3 study conducted in alcohol\u2010dependent patients with a high or very high DRL. Patients were randomized to 24\u2009weeks of treatment with as\u2010needed nalmefene 20\u2009mg, 10\u2009mg, or placebo with psychosocial support. The primary endpoint was change in heavy drinking days (HDD) from baseline to week 12. A key secondary endpoint was the change in total alcohol consumption (TAC) from baseline to week 12.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At week 12, 234, 206, and 154 patients who received placebo, nalmefene 20 mg, and 10 mg were included in the primary endpoint analysis. Compared with placebo, nalmefene was associated with significant reductions in HDD at week 12 (difference in 20\u2009mg group, \u22124.34\u2009days\/month; 95% confidence interval [CI]: \u22126.05 to \u22122.62;\n                      <jats:italic>P<\/jats:italic>\n                      &lt;\u20090.0001; difference in 10\u2009mg group, \u22124.18\u2009days\/month; 95%CI: \u22126.05 to \u22122.32;\n                      <jats:italic>P<\/jats:italic>\n                      &lt;\u20090.0001), as well as a significant reduction in TAC at week 12 (\n                      <jats:italic>P<\/jats:italic>\n                      &lt;\u20090.0001). The incidence of treatment\u2010emergent adverse events was 87.9%, 84.8%, and 79.2% in the groups receiving nalmefene 20\u2009mg, 10\u2009mg, and placebo, respectively. These events were mostly of mild or moderate severity.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Nalmefene 20\u2009mg or 10\u2009mg effectively reduced alcohol consumption and was well tolerated in alcohol\u2010dependent patients with a high or very high DRL.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pcn.12914","type":"journal-article","created":{"date-parts":[[2019,7,12]],"date-time":"2019-07-12T09:39:09Z","timestamp":1562924349000},"page":"697-706","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":60,"title":["Nalmefene in alcohol\u2010dependent patients with a high drinking risk: Randomized controlled trial"],"prefix":"10.1111","volume":"73","author":[{"given":"Hisatsugu","family":"Miyata","sequence":"first","affiliation":[{"name":"Department of Psychiatry Jikei University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayoshi","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Clinical Management Clinical Development Headquarters, Otsuka Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiyuki","family":"Murai","sequence":"additional","affiliation":[{"name":"Department of Clinical Management Clinical Development Headquarters, Otsuka Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kana","family":"Tsuneyoshi","sequence":"additional","affiliation":[{"name":"Department of Biometrics Clinical Development Headquarters, Otsuka Pharmaceutical Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9916-1784","authenticated-orcid":false,"given":"Takako","family":"Hayashi","sequence":"additional","affiliation":[{"name":"Medical Affairs, Otsuka Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Didier","family":"Meulien","sequence":"additional","affiliation":[{"name":"Clinical Research and Development \u2013 Neurology H. Lundbeck SAS, Issy\u2010les\u2010Moulineaux  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Per","family":"S\u00f8rensen","sequence":"additional","affiliation":[{"name":"Global Analytics, H. Lundbeck  Valby Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susumu","family":"Higuchi","sequence":"additional","affiliation":[{"name":"National Hospital Organization, Kurihama Medical and Addiction Center  Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,8,5]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"World Health Organisation.Global status report on alcohol and health. 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