{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T22:07:09Z","timestamp":1790546829094,"version":"4.1.0"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T00:00:00Z","timestamp":1726704000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T00:00:00Z","timestamp":1726704000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["R01 FD04778-02"],"award-info":[{"award-number":["R01 FD04778-02"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008523","name":"Center for Clinical and Translational Science, University of Illinois at Chicago","doi-asserted-by":"publisher","award":["ULTR000445"],"award-info":[{"award-number":["ULTR000445"]}],"id":[{"id":"10.13039\/100008523","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Center for Research Resources FDA Office for Orphan Product   Development","award":["R01FD04778"],"award-info":[{"award-number":["R01FD04778"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Auton Res"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>We previously reported that single doses of the norepinephrine transporter inhibitor, atomoxetine, increased standing blood pressure (BP) and ameliorated symptoms in patients with neurogenic orthostatic hypotension (nOH). We aimed to evaluate the effect of atomoxetine over four weeks in patients with nOH.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A randomized, double-blind, placebo-controlled crossover clinical trial between July 2016 and May 2021 was carried out with an initial open-label, single-dose phase (10 or 18\u00a0mg atomoxetine), followed by a 1-week wash-out, and a subsequent double-blind 4-week treatment sequence (period 1: atomoxetine followed by placebo) or vice versa (period 2). The trial included a 2-week wash-out period. The primary endpoint was symptoms of nOH as measured by the orthostatic hypotension questionnaire (OHQ) assessed at 2 weeks.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 68 patients were screened, 40 were randomized, and 37 completed the study. We found no differences in the OHQ composite score between atomoxetine and placebo at 2 weeks (\u22120.3\u2009\u00b1\u20091.7 versus \u22120.4\u2009\u00b1\u20091.5; <jats:italic>P<\/jats:italic>\u2009=\u20090.806) and 4 weeks (\u22120.6\u2009\u00b1\u20092.4 versus \u22120.5\u2009\u00b1\u20091.6; <jats:italic>P<\/jats:italic>\u2009=\u20090.251). There were no differences either in the OHSA scores at 2 weeks (3\u2009\u00b1\u20091.9 versus 4\u2009\u00b1\u20092.1; <jats:italic>P<\/jats:italic>\u2009=\u20090.062) and at 4 weeks (3\u2009\u00b1\u20092.2 versus 3\u2009\u00b1\u20092.0; <jats:italic>P<\/jats:italic>\u2009=\u20091.000) or in the OH daily activity scores (OHDAS) at 2 weeks (4\u2009\u00b1\u20093.0 versus 5\u2009\u00b1\u20093.1, <jats:italic>P<\/jats:italic>\u2009=\u20090.102) and 4 weeks (4\u2009\u00b1\u20093.0 versus 4\u2009\u00b1\u20092.7, <jats:italic>P<\/jats:italic>\u2009=\u20090.095). Atomoxetine was well-tolerated.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>While previous evidence suggested that acute doses of atomoxetine might be efficacious in treating nOH; results of this clinical trial indicated that it was not superior to placebo to ameliorate symptoms of nOH.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov; NCT02316821.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10286-024-01051-2","type":"journal-article","created":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T03:33:55Z","timestamp":1726716835000},"page":"561-569","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Atomoxetine on neurogenic orthostatic hypotension: a randomized, double-blind, placebo-controlled crossover trial"],"prefix":"10.1007","volume":"34","author":[{"given":"Naome","family":"Mwesigwa","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricio","family":"Millar Vernetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annet","family":"Kirabo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie","family":"Black","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tan","family":"Ding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose","family":"Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose-Alberto","family":"Palma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Italo","family":"Biaggioni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Horacio","family":"Kaufmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4518-6801","authenticated-orcid":false,"given":"Cyndya A.","family":"Shibao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,9,19]]},"reference":[{"key":"1051_CR1","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1186\/s12883-018-1129-x","volume":"18","author":"DO Claassen","year":"2018","unstructured":"Claassen DO, Adler CH, Hewitt LA, Gibbons C (2018) Characterization of the symptoms of neurogenic orthostatic hypotension and their impact from a survey of patients and caregivers. 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Shibao has received a research grant from the Doris Duke Foundation. I. Biaggioni, C.A. Shibao, and H. Kaufmann received grant support from the Office of Orphan Products Development. Food and Drug Administration, grant no. FD-R-04778\u201301-A3. C.A. Shibao has received a speaker honorarium from Lundbeck Pharmaceuticals. C.A. Shibao is the principal investigator of the trial funded by TheraVance Biopharma. H. Kaufmann is Editor-in-Chief of Clinical Autonomic Research, published by Springer-Nature, and serves as PI of studies sponsored by Biogen MA Inc. (TRACK MSA, S19-01846) and Vaxxinity Inc. (UB-312, S22-01332). He has received consultant fees from Takeda Pharmaceutical Company Ltd, Ono Pharma UK Ltd, Theravance Biopharma US Inc., and Parexel. He receives royalties from Up to Date. He receives research support from NIH-NINDS, the Food and Drug Administration, the Familial Dysautonomia Foundation, and the HSAN IV Foundation. I. Biaggioni is a consultant for Theravance Biopharma, Amneal Pharmaceuticals, Regeneron Pharmaceuticals, Takeda Pharmaceuticals, and Neurawell Therapeutics for the development of therapies for orthostatic hypotension and postural tachycardia syndrome. He is also a patent holder for an automated abdominal binder for the treatment of orthostatic hypotension and has submitted a patent application for the use of guanfacine for the treatment of Postural Tachycardia and Chronic Fatigue Syndromes. J.-A. Palma reports research funding from the NIH and salary from Eli Lilly. P.M. Vernetti has received funding from Theravance Biopharma for research related to nOH and is a principal investigator of the clinical trial\u00a0(NCT05696717) funded by Theravance Biopharma for the development of ampreloxetine for nOH.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}