{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Mwesigwa N"],"funding":["National Center for Research Resources FDA Office for Orphan Product   Development","National Center for Research Resources FDA Office for Orphan Product Development","Center for Clinical and Translational Science, University of Illinois at Chicago","FDA HHS","U.S. Food and Drug Administration"],"pagination":["561-569"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11543771"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["34(6)"],"pubmed_abstract":["<h4>Purpose</h4>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.<h4>Methods</h4>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 mg 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.<h4>Results</h4>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 (-0.3 ± 1.7 versus -0.4 ± 1.5; P = 0.806) and 4 weeks (-0.6 ± 2.4 versus -0.5 ± 1.6; P = 0.251). There were no differences either in the OHSA scores at 2 weeks (3 ± 1.9 versus 4 ± 2.1; P = 0.062) and at 4 weeks (3 ± 2.2 versus 3 ± 2.0; P = 1.000) or in the OH daily activity scores (OHDAS) at 2 weeks (4 ± 3.0 versus 5 ± 3.1, P = 0.102) and 4 weeks (4 ± 3.0 versus 4 ± 2.7, P = 0.095). Atomoxetine was well-tolerated.<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov; NCT02316821."],"journal":["Clinical autonomic research : official journal of the Clinical Autonomic Research Society"],"pubmed_title":["Atomoxetine on neurogenic orthostatic hypotension: a randomized, double-blind, placebo-controlled crossover trial."],"pmcid":["PMC11543771"],"funding_grant_id":["ULTR000445","R01 FD004778","R01 FD04778-02","R01FD04778"],"pubmed_authors":["Kaufmann H","Martinez J","Millar Vernetti P","Ding T","Mwesigwa N","Palma JA","Black B","Kirabo A","Biaggioni I","Shibao CA"],"additional_accession":[]},"is_claimable":false,"name":"Atomoxetine on neurogenic orthostatic hypotension: a randomized, double-blind, placebo-controlled crossover trial.","description":"<h4>Purpose</h4>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.<h4>Methods</h4>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 mg 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.<h4>Results</h4>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 (-0.3 ± 1.7 versus -0.4 ± 1.5; P = 0.806) and 4 weeks (-0.6 ± 2.4 versus -0.5 ± 1.6; P = 0.251). There were no differences either in the OHSA scores at 2 weeks (3 ± 1.9 versus 4 ± 2.1; P = 0.062) and at 4 weeks (3 ± 2.2 versus 3 ± 2.0; P = 1.000) or in the OH daily activity scores (OHDAS) at 2 weeks (4 ± 3.0 versus 5 ± 3.1, P = 0.102) and 4 weeks (4 ± 3.0 versus 4 ± 2.7, P = 0.095). Atomoxetine was well-tolerated.<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov; NCT02316821.","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Dec","modification":"2026-06-03T00:35:06.755Z","creation":"2025-04-06T22:42:57.152Z"},"accession":"S-EPMC11543771","cross_references":{"pubmed":["39294522"],"doi":["10.1007/s10286-024-01051-2"]}}