Evidence map›Paper›PMID 39294522›Full record

Trial reportClinical autonomic research : official journal of the Clinical Autonomic Research Society2024

Atomoxetine on neurogenic orthostatic hypotension: a randomized, double-blind, placebo-controlled crossover trial.

Naome Mwesigwa, Patricio Millar Vernetti, Annet Kirabo, Bonnie Black, Tan Ding, Jose Martinez, Jose-Alberto Palma, Italo Biaggioni, Horacio Kaufmann, Cyndya A Shibao

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical autonomic research : official journal of the Clinical Autonomic Research Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02316821 (RTA 402 Phase 2 Clinical Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02316821 phase2completednot on this map

RTA 402 Phase 2 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Chronic Kidney Disease and Type 2 Diabetes)

TypeinterventionalSponsorKyowa Kirin Co., Ltd.Ran2014 to 2017Enrolled216ConditionsChronic Kidney Disease, Type 2 DiabetesArmsRTA 402, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. How to treat cardiovascular autonomic failure in Parkinson's disease.Journal of neural transmission (Vienna, Austria : 1996) · 2026
    Review
  2. Review
  3. Review
  4. Update on the Treatment of Autonomic Disorders.Current treatment options in neurology · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Naome MwesigwaDivision of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232-8802, USA.
Patricio Millar VernettiDepartment of Neurology, New York University Grossman School of Medicine, New York, NY, USA.
Annet KiraboDivision of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232-8802, USA.
Bonnie BlackDivision of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232-8802, USA.
Tan DingDivision of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232-8802, USA.
Jose MartinezDepartment of Neurology, New York University Grossman School of Medicine, New York, NY, USA.
Jose-Alberto PalmaDepartment of Neurology, New York University Grossman School of Medicine, New York, NY, USA.
Italo BiaggioniDivision of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232-8802, USA.
Horacio KaufmannDepartment of Neurology, New York University Grossman School of Medicine, New York, NY, USA.
Cyndya A ShibaoDivision of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232-8802, USA. Cyndya.shibao@vumc.org.ORCID http://orcid.org/0000-0002-4518-6801

Funding

Phase 2 Norepinephrine Transporter Blockade, Autonomic Failure IND117394 12/28/12R01FD004778 · FDA · VANDERBILT UNIVERSITY MEDICAL CENTER · PI KAUFMANN, HORACIO, SHIBAO, CYNDYA ADRIANA · 2016 to 2019
$1.6M
Center for Clinical and Translational Science, University of Illinois at Chicago ULTR000445FDA HHS R01 FD004778National Center for Research Resources FDA Office for Orphan Product Development R01FD04778U.S. Food and Drug Administration R01 FD04778-02
6 · The paper itself

Abstract

purposeWe 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.

methodsA 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.

resultsA 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.

conclusionsWhile 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.

trial registrationClinicalTrials.gov; NCT02316821.

Indexed as

Adrenergic Uptake InhibitorsAtomoxetine HydrochlorideCross-Over StudiesHypotension, OrthostaticAdultAgedBlood PressureDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAdrenergic Uptake InhibitorsAtomoxetine HydrochlorideAutonomic failureDysautonomiaNorepinephrine reuptake inhibitorNorepinephrine transporter blockerSyncope

Identifiers

PMID39294522
PMCPMC11543771

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.