Integrated analysis of droxidopa trials for neurogenic orthostatic hypotension

BMC Neurology
I BiaggioniHoracio Kaufmann

Abstract

Droxidopa, a prodrug of norepinephrine, was approved for treatment of neurogenic orthostatic hypotension (nOH) due to primary autonomic disorders based on 3 randomized double-blind studies. We performed safety and efficacy analyses of this pooled dataset (n = 460). Efficacy was assessed using Orthostatic Hypotension Questionnaire (OHQ) scores (composite and individual items). Safety and tolerability were also examined. Droxidopa improved virtually all nOH symptom scores compared with placebo, significantly reducing OHQ composite score (-2.68 ± 2.20 vs -1.82 ± 2.34 units; P < 0.001), dizziness/lightheadedness score (-3.0 ± 2.9 vs -1.8 ± 3.1 units; P < 0.001), and 3 of 5 other symptom assessments (visual disturbances, weakness, and fatigue [P ≤ 0.010]). Droxidopa significantly improved 3 of 4 measures of activities of daily living (standing a long time, walking a short time, and walking a long time [P ≤ 0.003]) and significantly increased upright systolic blood pressure (11.5 ± 20.5 vs 4.8 ± 21.0 mmHg for placebo; P < 0.001). Droxidopa was effective in patients using inhibitors of dopa decarboxylase (DDCI; the enzyme that converts droxidopa to norepinephrine), but its efficacy was numerically greater in non-DDCI users. Droxidopa ...Continue Reading

References

Jun 1, 1996·American Journal of Epidemiology·W C GraafmansP Lips
Jul 30, 2003·Circulation·Horacio KaufmannRoy Freeman
Apr 23, 2008·Clinical Autonomic Research : Official Journal of the Clinical Autonomic Research Society·Christopher J Mathias
Jan 7, 2009·Circulation·David S Goldstein, Yehonatan Sharabi
Apr 1, 2002·Expert Review of Pharmacoeconomics & Outcomes Research·Michael R Hufford, Saul Shiffman
Mar 25, 2011·Clinical Autonomic Research : Official Journal of the Clinical Autonomic Research Society·Roy FreemanJ Gert van Dijk
Nov 3, 2011·Clinical Autonomic Research : Official Journal of the Clinical Autonomic Research Society·Horacio KaufmannRoy Freeman
Jun 19, 2013·Journal of General Internal Medicine·Ajay K ParsaikM Hassan Murad
Dec 12, 2013·Journal of Parkinson's Disease·Robert A HauserStuart Isaacson
Jun 20, 2014·Neurology·Horacio KaufmannUNKNOWN NOH301 Investigators
Oct 29, 2014·Hypertension·Italo BiaggioniUNKNOWN Droxidopa 302 Investigators
Dec 10, 2014·Movement Disorders : Official Journal of the Movement Disorder Society·Robert A HauserGerry Rowse
Feb 14, 2015·Movement Disorders : Official Journal of the Movement Disorder Society·Jose-Alberto PalmaHoracio Kaufmann
Mar 15, 2015·American Journal of Hypertension·Nicola VeroneseGiuseppe Sergi
Jun 21, 2015·Expert Review of Cardiovascular Therapy·Horacio KaufmannJose-Alberto Palma
Sep 12, 2016·Journal of the American Society of Hypertension : JASH·Stuart IsaacsonWilliam B White

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Citations

Oct 28, 2017·CNS Drugs·Cyndya A Shibao, Horacio Kaufmann
Nov 1, 2018·Expert Opinion on Pharmacotherapy·William P Cheshire
Oct 3, 2018·PM & R : the Journal of Injury, Function, and Rehabilitation·Zoe K SarafisAndrei V Krassioukov
Feb 8, 2019·Expert Opinion on Pharmacotherapy·Santiago Pérez-LloretOlivier Rascol
Oct 11, 2019·The Journal of Clinical Hypertension·David S Cannom
Jul 11, 2019·Movement Disorders : Official Journal of the Movement Disorder Society·Wolfgang H OertelFanni F Geibl
Nov 26, 2019·Cardiology in Review·Pravin Khemani, Ali A Mehdirad
Oct 7, 2017·Current Opinion in Cardiology·Philip L Mar, Satish R Raj
Feb 20, 2020·Journal of Clinical Neuromuscular Disease·Coreen Schwartzlow, Mohamed Kazamel
Jul 11, 2020·The Journal of Neuroscience Nursing : Journal of the American Association of Neuroscience Nurses·Mo-Kyung Sin, Pravin Khemani
Jan 25, 2018·Expert Opinion on Drug Discovery·Ivana CacciatoreAntonio Di Stefano
Sep 19, 2020·Clinical Medicine Insights. Cardiology·Dinesh K KalraSumit Sohal
Aug 9, 2020·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Matthew R Burns, Nikolaus R McFarland
Jun 18, 2017·Clinical Autonomic Research : Official Journal of the Clinical Autonomic Research Society·Horacio Kaufmann
Jan 31, 2020·Continuum : Lifelong Learning in Neurology·Jose-Alberto Palma, Horacio Kaufmann
Jan 9, 2020·The New England Journal of Medicine·Horacio KaufmannJose-Alberto Palma
Aug 29, 2019·Neurology and Therapy·Jeremy K Cutsforth-Gregory, Phillip A Low
Oct 16, 2020·Seminars in Neurology·Cyndya A Shibao, Italo Biaggioni
Mar 10, 2021·Current Neurology and Neuroscience Reports·Stuart H IsaacsonAmanda C Peltier
Mar 12, 2021·American Journal of Hypertension·Juan Francisco IdiaquezItalo Biaggioni
Mar 25, 2020·The American Journal of Cardiology·Brian Olshansky, James Muldowney
Apr 4, 2021·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Anna PierzchlińskaMonika Białecka
May 8, 2021·Current Hypertension Reports·Vasiliki KatsiKonstantinos Tsioufis
Aug 24, 2021·International Journal of General Medicine·Fahd AmjadAntonella Favit

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Clinical Trials Mentioned

NCT00782340
NCT00633880
NCT01176240

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