{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,12]],"date-time":"2026-07-12T04:20:44Z","timestamp":1783830044661,"version":"3.55.0"},"reference-count":33,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,9,10]],"date-time":"2020-09-10T00:00:00Z","timestamp":1599696000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100003122","name":"Ferring","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003122","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["LUTS"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To investigate the long\u2010term efficacy, quality of life (QoL), and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese patients with nocturia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A long\u2010term, multicenter phase 3 study was conducted that enrolled Japanese male and female patients with nocturia (NCT03051009). Male patients received desmopressin 25\u2010 or 50\u2010\u03bcg ODTs, and female patients received desmopressin 25\u2010\u03bcg ODTs for up to 1\u2009year. The primary endpoint was safety. Secondary endpoints included change from baseline in number of nocturnal voids, time to first awakening to void, and QoL assessments (nocturia\u2010specific zQoL [N\u2010QoL], Insomnia Severity Index [ISI], and Hsu bother score).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 503 patients were enrolled. Reductions from baseline in mean number of nocturnal voids were observed in all treatment groups from week 1 (\u22120.62 to \u22121.00), with improvements continuing through week 52 (\u22121.39 to \u22121.71). Changes from baseline above or approximating a clinically meaningful improvement were seen by week 52 in the disease\u2010specific N\u2010QoL total score (improved by 11.5\u201022.6), ISI (improved by \u22123.9 to \u22127.1), and Hsu bother scores (improved by \u22121.5 to \u22122.0). Adverse events (AEs) were reported in 54.9% of desmopressin\u2010treated patients. Most AEs were mild or moderate in severity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Desmopressin ODTs (25 and 50\u2009\u03bcg) demonstrated long\u2010term efficacy, improved QoL, and were well tolerated in Japanese male and female patients with nocturia treated for up to 1\u2009year. Clinically meaningful improvements in patients\u2019 QoL, assessed by N\u2010QoL, sleep quality, and bother, occur later than objective symptom improvements, such as voids.<\/jats:p><\/jats:sec>","DOI":"10.1111\/luts.12347","type":"journal-article","created":{"date-parts":[[2020,9,21]],"date-time":"2020-09-21T07:22:20Z","timestamp":1600672940000},"page":"129-138","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Achieving clinically meaningful quality of life benefits in nocturia takes time: Results from a long\u2010term, multicenter phase 3 study of desmopressin in Japanese patients"],"prefix":"10.1111","volume":"13","author":[{"given":"Kristian V.","family":"Juul","sequence":"first","affiliation":[{"name":"Ferring International Pharmascience Center  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fredrik L.","family":"Andersson","sequence":"additional","affiliation":[{"name":"Ferring International Pharmascience Center  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osamu","family":"Yamaguchi","sequence":"additional","affiliation":[{"name":"Division of Lower Urinary Tract Symptom Research Nihon University School of Engineering  Koriyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,9,10]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23917"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2009.03.080"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2019.07.005"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2012.07.004"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euf.2018.04.017"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/13696998.2016.1211136"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijcp.13408"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2010.03.002"},{"issue":"1","key":"e_1_2_10_10_1","first-page":"9","article-title":"Comprehensive health\u2010related quality of life is influenced by Nocturia and sleep disturbance: investigation based on the SF\u20108","volume":"62","author":"Suekane S","year":"2016","journal-title":"Kurume Med J"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2015.01.021"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2013.02.037"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2012.12.112"},{"issue":"1","key":"e_1_2_10_14_1","article-title":"Efficacy and safety of 25 and 50 \u03bcg desmopressin orally disintegrating tablets in Japanese patients with nocturia due to nocturnal polyuria: results from two phase 3 studies of a multicenter randomized double\u2010blind placebo\u2010controlled parallel\u2010group development program","volume":"12","author":"Yamaguchi O","year":"2019","journal-title":"Low Urin Tract Sympt"},{"key":"e_1_2_10_15_1","unstructured":"Kissei Pharmaceutical Co. Ltd. Launch of MINIRIN MELT\u00ae OD tablet 25\u2009\u03bcg and 50\u2009\u03bcg for the treatment of nocturia due to nocturnal polyuria in males 2019.2019."},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2003.10.019"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2008.04.014"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2007.05.001"},{"key":"e_1_2_10_19_1","first-page":"833","article-title":"Development of the Japanese version of the nocturia QOL questionnaire (ICIQ\u2010Nqol)","volume":"23","author":"Yoshida M","year":"2010","journal-title":"Jpn J Urol Surg"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2005.10.054"},{"key":"e_1_2_10_21_1","unstructured":"DaneshgariF KleinB Holm\u2010LarsenT. Treatment of nocturia increases QoL. ICS\/IUGA; Toronto Canada 2010. p. 212."},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1389-9457(00)00065-4"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007990903167415"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/34.5.601"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000000600"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.MLR.0000062554.74615.4C"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22306"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.ju.0000136203.76320.f6"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.03.012"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2014.05.013"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.4364"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2016.07.088"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2016.09.009"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1159\/000321895"}],"container-title":["LUTS: Lower Urinary Tract Symptoms"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fluts.12347","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/luts.12347","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/luts.12347","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/luts.12347","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,3]],"date-time":"2023-09-03T06:37:36Z","timestamp":1693723056000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/luts.12347"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,10]]},"references-count":33,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,1]]}},"alternative-id":["10.1111\/luts.12347"],"URL":"https:\/\/doi.org\/10.1111\/luts.12347","archive":["Portico"],"relation":{},"ISSN":["1757-5664","1757-5672"],"issn-type":[{"value":"1757-5664","type":"print"},{"value":"1757-5672","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,10]]},"assertion":[{"value":"2020-04-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-08-07","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-10","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}