{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T15:43:19Z","timestamp":1747150999684,"version":"3.40.5"},"reference-count":11,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T00:00:00Z","timestamp":1654041600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neuropsychopharm Rep"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Early Post\u2010Marketing Phase Vigilance (EPPV) is a unique system that encourages reporting of serious adverse reactions for medications newly introduced to Japan. When a once\u2010monthly paliperidone palmitate formulation (PP1M) was introduced in Japan in 2013, EPPV detected a signal of increased mortality, but this signal was not subsequently confirmed. To clarify whether that signal reflected increased adverse event reporting or an atypically high baseline mortality risk among early adopters of PP1M, we evaluated the baseline risk characteristics of early, mid, and later adopters of PP1M in a Japanese database and did a similar evaluation of PP1M and the three\u2010monthly formulation (PP3M) in two US databases. In Japan, early adopters compared with later adopters were older (mean 39.16 vs 33.70\u2009years) but had a lower proportion of male patients (32.0% vs 44.44%), and a lower mean number of antipsychotic medications (distinct active medical substances) other than paliperidone (2.62 vs 2.85). In the United States, the baseline characteristics of early adopters of PP1M and PP3M did not suggest higher mortality risk than later adopters. These results offer no convincing evidence that the unconfirmed early signal of increased mortality with PP1M was due to increased baseline mortality risk among early adopters.<\/jats:p>","DOI":"10.1002\/npr2.12260","type":"journal-article","created":{"date-parts":[[2022,6,2]],"date-time":"2022-06-02T02:33:37Z","timestamp":1654137217000},"page":"347-351","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Baseline risk characterization of early versus later adopters of long\u2010acting paliperidone palmitate formulations"],"prefix":"10.1002","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6572-2990","authenticated-orcid":false,"given":"Daniel","family":"Fife","sequence":"first","affiliation":[{"name":"Department of Epidemiology Janssen Research &amp; Development, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Fortin","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Janssen Research &amp; Development, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hong","family":"Qiu","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Janssen Research &amp; Development, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michiyo","family":"Yamazaki","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Janssen Research &amp; Development, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dean","family":"Najarian","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erica A","family":"Voss","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Janssen Research &amp; Development, LLC  Titusville New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,6]]},"reference":[{"issue":"3","key":"e_1_2_13_2_1","first-page":"143","article-title":"The effect of paliperidone palmitate long\u2010acting injectable (PP\u2010LAI) on \u201cnon\u2010core\u201d symptoms of schizophrenia: a retrospective, collaborative, multicenter study in the \u201creal world\u201d everyday clinical practice","volume":"56","author":"De Berardis D","year":"2021","journal-title":"Riv Psichiatr"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm10071408"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2016.1198755"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2012.05.002"},{"key":"e_1_2_13_6_1","first-page":"574","article-title":"Observational health data sciences and informatics (OHDSI): opportunities for observational researchers","volume":"216","author":"Hripcsak G","year":"2015","journal-title":"Stud Health Technol Inform"},{"key":"e_1_2_13_7_1","unstructured":"OHDSI\/CommonDataModel: GitHub Inc.2021. Available from:https:\/\/github.com\/OHDSI\/CommonDataModel[Accessed May 5]"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/0895-4356(93)90103-8"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/03610910902859574"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/da.23138"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.2188\/jea.JE20200048"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2020.559312"}],"container-title":["Neuropsychopharmacology Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/npr2.12260","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/npr2.12260","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/npr2.12260","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T13:57:20Z","timestamp":1692626240000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/npr2.12260"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,6]]},"references-count":11,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,9]]}},"alternative-id":["10.1002\/npr2.12260"],"URL":"https:\/\/doi.org\/10.1002\/npr2.12260","archive":["Portico"],"relation":{},"ISSN":["2574-173X","2574-173X"],"issn-type":[{"type":"print","value":"2574-173X"},{"type":"electronic","value":"2574-173X"}],"subject":[],"published":{"date-parts":[[2022,6]]},"assertion":[{"value":"2022-01-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-05-02","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-06-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}