{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T20:47:06Z","timestamp":1791665226488,"version":"4.3.4"},"reference-count":20,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,5,27]],"date-time":"2020-05-27T00:00:00Z","timestamp":1590537600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013327","name":"H. Lundbeck A\/S","doi-asserted-by":"publisher","award":["Grant No.:N\/A"],"award-info":[{"award-number":["Grant No.:N\/A"]}],"id":[{"id":"10.13039\/501100013327","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100007132","name":"Otsuka Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007132","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":[[2020,8]]},"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>The safety and efficacy of nalmefene in Japanese patients with high or very high World Health Organization drinking risk level of alcohol dependence were assessed in a multicenter, randomized, double\u2010blind, placebo\u2010controlled, phase 3 (lead\u2010in) study. Here, the long\u2010term safety and efficacy of nalmefene in an open\u2010label extension of the lead\u2010in study are presented.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients who completed the 24\u2010week lead\u2010in study were eligible for the extension study, where they were treated with nalmefene 20\u2009mg as needed for 24\u2009weeks. The long\u2010term safety and efficacy of nalmefene 20\u2009mg during the total 48\u2010week period were evaluated. Treatment\u2010emergent adverse events during the study period were recorded and change from baseline in the number of heavy drinking days and total alcohol consumption were calculated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, long\u2010term nalmefene 20\u2009mg was well tolerated; the main treatment\u2010emergent adverse events reported in \u22655% of patients included nasopharyngitis (37.2%), nausea (36.5%), somnolence (21.2%), dizziness (16.8%), malaise (14.6%), and vomiting (12.4%). The number of heavy drinking days and total alcohol consumption decreased from baseline to 48\u2009weeks (mixed model for repeated measures, least squares mean\u2009\u00b1\u2009standard error, \u221215.09\u2009\u00b1\u20090.77\u2009days\/month and\u2009\u221253.20\u2009\u00b1\u20092.29 g\/day, respectively) during the study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This long\u2010term evaluation in Japanese patients with high or very high drinking risk levels of alcohol dependence indicated that nalmefene was safe, well tolerated, and efficacious.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pcn.13017","type":"journal-article","created":{"date-parts":[[2020,5,2]],"date-time":"2020-05-02T10:43:56Z","timestamp":1588416236000},"page":"431-438","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Long\u2010term safety and efficacy of nalmefene in Japanese patients with alcohol dependence"],"prefix":"10.1111","volume":"74","author":[{"given":"Susumu","family":"Higuchi","sequence":"first","affiliation":[{"name":"National Hospital Organization, Kurihama Medical and Addiction Center  Yokosuka 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\/0000-0002-3872-2434","authenticated-orcid":false,"given":"Izuru","family":"Nakamura","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 H. Lundbeck A\/S  Valby Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisatsugu","family":"Miyata","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Jikei University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,5,27]]},"reference":[{"key":"e_1_2_8_2_1","volume-title":"Global Status Report on Alcohol and Health","author":"World Health Organization","year":"2014"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/agw002"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/agp096"},{"key":"e_1_2_8_5_1","unstructured":"European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). Guideline on the development of medicinal products for the treatment of alcohol dependence. European Medicines Agency; 2010. [Cited 19 June 2017.] Available from URL:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2010\/03\/WC500074898.pdf"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2017.1750101"},{"key":"e_1_2_8_7_1","volume-title":"New Diagnostic and Treatment Guidelines for Alcohol and Drug Use Disorders","author":"Higuchi S","year":"2018"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.npp.1300811"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2016.10.008"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2013.02.006"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopsych.2012.10.020"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/agt061"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/0269881114527362"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/pcn.12914"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/00131746-200603000-00003"},{"key":"e_1_2_8_16_1","volume-title":"Combining Medication and Psychosocial Treatments for Addictions: The BRENDA Approach","author":"Volpicelli J","year":"2001"},{"key":"e_1_2_8_17_1","first-page":"341","article-title":"Double\u2010blind comparison of clinical effects of ID 540 (fludiazepam) diazepam and placebo on psychoneurotic patients and a tentative draft of dependency questionnaire","volume":"5","author":"Kurihara M","year":"1977","journal-title":"Rinsho. 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