{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T12:48:29Z","timestamp":1783428509668,"version":"3.54.6"},"reference-count":8,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2014,2,4]],"date-time":"2014-02-04T00:00:00Z","timestamp":1391472000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"funder":[{"name":"Boehringer Ingelheim GmbH"},{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim Pharmaceuticals Inc. (BIPI)","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Euro J of Neurology"],"published-print":{"date-parts":[[2014,5]]},"abstract":"<jats:sec><jats:title>Background and purpose<\/jats:title><jats:p>To assess the long\u2010term safety and efficacy of pramipexole as a once\u2010daily (q.d.) extended\u2010release oral formulation in early or advanced <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>arkinson's disease (<jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In two double\u2010blind (<jats:styled-content style=\"fixed-case\">DB<\/jats:styled-content>) studies of early <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content> and one of advanced <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content>, active\u2010treatment arms received pramipexole immediate release (<jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>) or extended release (<jats:styled-content style=\"fixed-case\">ER<\/jats:styled-content>), with exposure lasting up to 33\u00a0weeks. In open\u2010label (<jats:styled-content style=\"fixed-case\">OL<\/jats:styled-content>) extensions that followed immediately, subjects took <jats:styled-content style=\"fixed-case\">ER<\/jats:styled-content> q.d. for up to 80\u00a0weeks, with dosage adjustment permitted (range 0.375\u20134.5\u00a0mg q.d.).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 590 subjects completing an early\u2010<jats:styled-content style=\"fixed-case\">PD DB<\/jats:styled-content> study, 511 entered the early\u2010<jats:styled-content style=\"fixed-case\">PD OL<\/jats:styled-content> extension; 408 completed it. Reported adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) with incidence \u226510.0% were somnolence (15.1%), peripheral edema (11.7%) and back pain (10.6%). Of 465 subjects completing the advanced\u2010<jats:styled-content style=\"fixed-case\">PD DB<\/jats:styled-content> study, 391 entered the advanced\u2010<jats:styled-content style=\"fixed-case\">PD OL<\/jats:styled-content> extension; 329 completed it. Reported <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s with incidence \u226510.0% were dyskinesia (27.4%) and somnolence (13.6%). Impulse control disorders were identified by semi\u2010structured interview in 13 subjects (1.4% of 902). In exploratory analyses, adjusted mean Unified Parkinson's Disease Rating Scale (<jats:styled-content style=\"fixed-case\">UPDRS<\/jats:styled-content>) Parts II\u00a0+\u00a0III scores (excluding ex\u2010placebo recipients) remained substantially improved from <jats:styled-content style=\"fixed-case\">DB<\/jats:styled-content> baseline scores prior to pramipexole introduction, at \u22126.6 and \u22126.3 points amongst ex\u2010<jats:styled-content style=\"fixed-case\">DB<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">ER<\/jats:styled-content> and ex\u2010<jats:styled-content style=\"fixed-case\">DB<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content> recipients after 113\u00a0weeks of pramipexole (33 <jats:styled-content style=\"fixed-case\">DB<\/jats:styled-content> plus 80 <jats:styled-content style=\"fixed-case\">OL<\/jats:styled-content>) in early <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content>, and \u221211.5 and \u22129.1 after up to 113\u00a0weeks (up to 33 <jats:styled-content style=\"fixed-case\">DB<\/jats:styled-content> plus 80 <jats:styled-content style=\"fixed-case\">OL<\/jats:styled-content>) in advanced <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These results support the long\u2010term safety and efficacy of pramipexole <jats:styled-content style=\"fixed-case\">ER<\/jats:styled-content> in early and advanced <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content>. <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were typical for dopaminergic medications, and <jats:styled-content style=\"fixed-case\">UPDRS<\/jats:styled-content> scores suggested sustained symptomatic benefit.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ene.12375","type":"journal-article","created":{"date-parts":[[2014,2,4]],"date-time":"2014-02-04T23:04:07Z","timestamp":1391555047000},"page":"736-743","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Long\u2010term safety and sustained efficacy of extended\u2010release pramipexole in early and advanced <scp>P<\/scp>arkinson's disease"],"prefix":"10.1111","volume":"21","author":[{"given":"R. A.","family":"Hauser","sequence":"first","affiliation":[{"name":"University of South Florida College of Medicine Tampa FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. H. V.","family":"Schapira","sequence":"additional","affiliation":[{"name":"Institute of Neurology University College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Barone","sequence":"additional","affiliation":[{"name":"Neurodegenerative Disease Centre University of Salerno and IDC Hermitage\u2010Capodimonte Naples Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y.","family":"Mizuno","sequence":"additional","affiliation":[{"name":"Juntendo University School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"O.","family":"Rascol","sequence":"additional","affiliation":[{"name":"Clinical Investigation Center INSERM CIC\u20109203 and UMR 825 Toulouse University Hospital Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Busse","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG Ingelheim am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Debieuvre","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim France S.A.S. Reims France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Fraessdorf","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG Ingelheim am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Poewe","sequence":"additional","affiliation":[{"name":"Medical University Innsbruck Innsbruck Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the Pramipexole ER Studies Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,2,4]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e31822affb0"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/mds.23262"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e31822affdb"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.17.5.427"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.162.11.2184"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/14.6.540"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0404.2007.00818.x"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1331.2012.03712.x"}],"container-title":["European Journal of Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fene.12375","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ene.12375","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ene.12375","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ene.12375","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,23]],"date-time":"2023-09-23T17:15:16Z","timestamp":1695489316000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ene.12375"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,2,4]]},"references-count":8,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2014,5]]}},"alternative-id":["10.1111\/ene.12375"],"URL":"https:\/\/doi.org\/10.1111\/ene.12375","archive":["Portico"],"relation":{},"ISSN":["1351-5101","1468-1331"],"issn-type":[{"value":"1351-5101","type":"print"},{"value":"1468-1331","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,2,4]]},"assertion":[{"value":"2013-08-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-12-27","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2014-02-04","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}