{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T10:06:02Z","timestamp":1792058762030,"version":"4.4.0"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,12,10]],"date-time":"2020-12-10T00:00:00Z","timestamp":1607558400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neuropsychopharm Rep"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Previously, we reported on the efficacy and safety of guanfacine extended\u2010release (GXR) in Japanese adults with attention\u2010deficit\/hyperactivity disorder (ADHD) from a phase 3, double\u2010blind, placebo\u2010controlled, randomized trial. In this exploratory post hoc analysis, we assessed the efficacy and\/or safety of GXR in the following subgroups: ADHD\u2010combined (ADHD\u2010C) and ADHD\u2010predominantly inattentive (ADHD\u2010I) subtypes, age (\u226531, &lt;31\u00a0years), sex (male, female), and body weight (\u226550, &lt;50\u00a0kg).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The primary efficacy endpoint was change from baseline in the Japanese version of the investigator\u2010rated ADHD\u2010Rating Scale\u2010IV (ADHD\u2010RS\u2010IV) with adult prompts (total scores) at week 10.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The efficacy analysis population included 200 patients (GXR, 100; placebo, 100). ADHD\u2010RS\u2010IV total score effect sizes (GXR vs placebo) were similar across all subgroups (total population: 0.52, ADHD\u2010C: 0.51, ADHD\u2010I: 0.52, \u226531\u00a0years: 0.61, &lt;31\u00a0years: 0.47, male: 0.50, female: 0.57). There were no major differences in the incidence\/types of treatment\u2010emergent adverse events (TEAEs) across the subgroups. The incidence of significant TEAEs (34.3%, 10.6%) and TEAEs leading to discontinuation (34.3%, 12.1%) were approximately three times higher in females than males, respectively. The incidence of TEAEs in patients weighing\u00a0&lt;50\u00a0kg and\u00a0\u226550\u00a0kg was 100% and 73.6% during dose optimization and 40% and 24.4% during the maintenance period, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Findings from this post hoc analysis in adults with ADHD support the efficacy and safety of GXR regardless of ADHD subtype, age, or sex and suggest that careful monitoring for TEAEs and GXR dose optimization is considered for all patients, as needed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/npr2.12152","type":"journal-article","created":{"date-parts":[[2020,12,11]],"date-time":"2020-12-11T01:55:15Z","timestamp":1607651715000},"page":"26-39","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Efficacy and safety of guanfacine extended\u2010release in Japanese adults with attention\u2010deficit\/hyperactivity disorder: Exploratory post hoc subgroup analyses of a randomized, double\u2010blind, placebo\u2010controlled study"],"prefix":"10.1002","volume":"41","author":[{"given":"Noriyuki","family":"Naya","sequence":"first","affiliation":[{"name":"Medical Affairs Department Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chika","family":"Sakai","sequence":"additional","affiliation":[{"name":"Medical Affairs Department Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daiki","family":"Okutsu","sequence":"additional","affiliation":[{"name":"Clinical Research Department Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryo","family":"Kiguchi","sequence":"additional","affiliation":[{"name":"Data Science Office Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masakazu","family":"Fujiwara","sequence":"additional","affiliation":[{"name":"Data Science Office Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshinaga","family":"Tsuji","sequence":"additional","affiliation":[{"name":"Medical Affairs Department Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akira","family":"Iwanami","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Showa University, School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,12,10]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2015.14101266"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12402-016-0208-3"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.107.048827"},{"key":"e_1_2_13_5_1","first-page":"155","article-title":"Epidemiological survey of adult attention deficit hyperactivity disorder (ADHD) in Japan","volume":"28","author":"Nakamura S","year":"2013","journal-title":"Jpn J Psychiatr Treat"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.157.5.816"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1017\/S003329170500471X"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-244X-10-67"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0033291706008713"},{"issue":"5","key":"e_1_2_13_10_1","first-page":"10","article-title":"The quality of life of adults with attention deficit hyperactivity disorder: a systematic review","volume":"9","author":"Agarwal R","year":"2012","journal-title":"Innov Clin Neurosci"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1017\/S1092852900017107"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00787-018-1113-4"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2008.0080"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.19m12979"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12888-020-02867-8"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2014.09.014"},{"issue":"8","key":"e_1_2_13_17_1","first-page":"1093","article-title":"Efficacy and safety of guanfacine hydrochloride extended\u2010release tablet for children and adolescents with ADHD: a phase 2\/3 placebo\u2010controlled, double\u2010blind study in Japan","volume":"21","author":"Ichikawa H","year":"2018","journal-title":"Jpn J Clin Psychopharmacol"},{"issue":"12","key":"e_1_2_13_18_1","first-page":"1645","article-title":"Long\u2010term safety and efficacy of guanfacine hydrochloride extended\u2010release tablet for children and adolescents with ADHD: a phase 2\/3 long\u2010term, open\u2010label extension study in Japan","volume":"21","author":"Ichikawa H","year":"2018","journal-title":"Jpn J Clin Psychopharmacol"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaac.2015.08.016"},{"key":"e_1_2_13_20_1","unstructured":"National Institute for Care and Health Excellence [internet]. Attention deficit hyperactivity disorder: diagnosis and management. NICE guideline [NG87]; March 2018. [updated September 2019; cited 3 Mar 2020]. Available from:https:\/\/www.nice.org.uk\/guidance\/ng87\/chapter\/Recommendations"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2018.05.012"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2010.0135"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.books.9780890425596"},{"key":"e_1_2_13_24_1","volume-title":"ADHD Rating Scale\u2010IV: Checklists, Norms, and Clinical Interpretation","author":"DuPaul GJ","year":"1998"},{"key":"e_1_2_13_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-005-8325-z"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-007-9254-9"},{"key":"e_1_2_13_27_1","volume-title":"Behavior Rating Inventory of Executive Function\u2010Adult Version","author":"Roth RM","year":"2005"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.psychres.2015.12.017"},{"issue":"4","key":"e_1_2_13_29_1","first-page":"301","article-title":"A thorough QT study of guanfacine","volume":"53","author":"Martin P","year":"2015","journal-title":"Int J Clin Pharmacol Ther"},{"key":"e_1_2_13_30_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S97088"}],"container-title":["Neuropsychopharmacology Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/npr2.12152","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/npr2.12152","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/npr2.12152","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T01:47:27Z","timestamp":1693532847000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/npr2.12152"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,10]]},"references-count":29,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["10.1002\/npr2.12152"],"URL":"https:\/\/doi.org\/10.1002\/npr2.12152","archive":["Portico"],"relation":{},"ISSN":["2574-173X","2574-173X"],"issn-type":[{"value":"2574-173X","type":"print"},{"value":"2574-173X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,10]]},"assertion":[{"value":"2020-07-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-16","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-10","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}