PMID- 27614923
OWN - NLM
STAT- MEDLINE
DCOM- 20171204
LR  - 20220331
IS  - 1878-7436 (Electronic)
IS  - 1878-7436 (Linking)
VI  - 10
IP  - 10
DP  - 2016 Oct
TI  - Long-term safety of droxidopa in patients with symptomatic neurogenic orthostatic 
      hypotension.
PG  - 755-762
LID - S1933-1711(16)30451-X [pii]
LID - 10.1016/j.jash.2016.07.010 [doi]
AB  - The long-term safety of droxidopa for the treatment of symptomatic neurogenic 
      orthostatic hypotension in patients with Parkinson disease, pure autonomic 
      failure, multiple system atrophy, or nondiabetic autonomic neuropathy was 
      evaluated in a phase 3, multinational, open-label study in patients who 
      previously participated in a double-blind, placebo-controlled clinical trial of 
      droxidopa. A total of 350 patients received droxidopa 100 to 600 mg three times 
      daily. Mean duration of droxidopa exposure was 363 days (range, 2-1133 days). 
      Rates of serious adverse events (AEs), cardiac-related AEs, and supine 
      hypertension were 24%, 5%, and 5%, respectively. Most AEs, including those of a 
      cardiovascular nature, were not attributed by investigators to droxidopa. In this 
      large cohort of patients with neurogenic orthostatic hypotension, droxidopa was 
      well tolerated during long-term use.
CI  - Copyright (c) 2016 The Author. Published by Elsevier Inc. All rights reserved.
FAU - Isaacson, Stuart
AU  - Isaacson S
AD  - Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, 
      USA. Electronic address: isaacson@ParkinsonsCenter.org.
FAU - Vernino, Steven
AU  - Vernino S
AD  - Department of Neurology & Neurotherapeutics, UT Southwestern Medical Center, 
      Dallas, TX, USA.
FAU - Ziemann, Adam
AU  - Ziemann A
AD  - Lundbeck LLC, Deerfield, IL, USA.
FAU - Rowse, Gerald J
AU  - Rowse GJ
AD  - Lundbeck LLC, Deerfield, IL, USA.
FAU - Kalu, Uwa
AU  - Kalu U
AD  - Lundbeck LLC, Deerfield, IL, USA.
FAU - White, William B
AU  - White WB
AD  - Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center, 
      University of Connecticut School of Medicine, Farmington, CT 06032, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20160804
PL  - United States
TA  - J Am Soc Hypertens
JT  - Journal of the American Society of Hypertension : JASH
JID - 101312518
RN  - 0 (Prodrugs)
RN  - 0 (Vasoconstrictor Agents)
RN  - J7A92W69L7 (Droxidopa)
RN  - X4W3ENH1CV (Norepinephrine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Autonomic Nervous System/drug effects
MH  - Blood Pressure/*drug effects
MH  - Droxidopa/*adverse effects/therapeutic use
MH  - Female
MH  - Heart Rate/drug effects
MH  - Humans
MH  - Hypertension/*chemically induced/epidemiology
MH  - Hypotension, Orthostatic/*drug therapy/etiology
MH  - Long Term Adverse Effects/chemically induced/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Multiple System Atrophy/complications/drug therapy
MH  - Norepinephrine/*adverse effects/therapeutic use
MH  - Parkinson Disease/complications/drug therapy
MH  - Prodrugs/*adverse effects/therapeutic use
MH  - Pure Autonomic Failure/complications/drug therapy
MH  - Vasoconstrictor Agents/*adverse effects/therapeutic use
MH  - Young Adult
OTO - NOTNLM
OT  - Supine hypertension
EDAT- 2016/09/12 06:00
MHDA- 2017/12/05 06:00
CRDT- 2016/09/12 06:00
PHST- 2016/05/13 00:00 [received]
PHST- 2016/07/15 00:00 [revised]
PHST- 2016/07/18 00:00 [accepted]
PHST- 2016/09/12 06:00 [pubmed]
PHST- 2017/12/05 06:00 [medline]
PHST- 2016/09/12 06:00 [entrez]
AID - S1933-1711(16)30451-X [pii]
AID - 10.1016/j.jash.2016.07.010 [doi]
PST - ppublish
SO  - J Am Soc Hypertens. 2016 Oct;10(10):755-762. doi: 10.1016/j.jash.2016.07.010. 
      Epub 2016 Aug 4.