PMID- 28159196
OWN - NLM
STAT- MEDLINE
DCOM- 20170518
LR  - 20170518
IS  - 1879-1913 (Electronic)
IS  - 0002-9149 (Linking)
VI  - 119
IP  - 7
DP  - 2017 Apr 1
TI  - Cardiovascular Safety of Droxidopa in Patients With Symptomatic Neurogenic 
      Orthostatic Hypotension.
PG  - 1111-1115
LID - S0002-9149(16)32020-3 [pii]
LID - 10.1016/j.amjcard.2016.11.066 [doi]
AB  - The norepinephrine prodrug droxidopa improves symptoms of neurogenic orthostatic 
      hypotension, a condition that is associated with diseases of neurogenic autonomic 
      failure (e.g., Parkinson disease, multiple system atrophy, pure autonomic 
      failure). These conditions are more prevalent in older patients who also have 
      cardiovascular co-morbidities. Hence, we evaluated the cardiovascular safety of 
      droxidopa in patients with symptomatic neurogenic orthostatic hypotension who 
      participated in randomized controlled studies (short-term studies of 1 to 2 weeks 
      and an intermediate 8- to 10-week study) and long-term open-label studies. Rates 
      of cardiovascular adverse events (AEs) for patients treated with droxidopa were 
      4.4% in the intermediate study and 10.8% in the long-term open-label studies. 
      Adjusting for exposure time, cardiovascular AE rates were 0.30 
      events/patient-year in the short-term and intermediate studies and 0.15 
      events/patient-year in the long-term open-label studies. The incidence of 
      treatment discontinuation due to blood pressure-related events was approximately 
      2.5%. Among patients with a history of cardiac disorders at baseline, the rates 
      of cardiovascular-related and blood pressure-related AEs were nominally higher 
      with droxidopa compared to placebo. Most of these events were minor atrial 
      arrhythmias; none were major adverse cardiovascular events or deaths. In 
      conclusion, small increases in cardiovascular AEs were observed with droxidopa 
      compared to placebo; this was most evident in patients with preexisting cardiac 
      disorders.
CI  - Copyright (c) 2017 The Author(s). Published by Elsevier Inc. All rights reserved.
FAU - White, William B
AU  - White WB
AD  - Calhoun Cardiology Center, University of Connecticut School of Medicine, 
      Farmington, Connecticut. Electronic address: wwhite@uchc.edu.
FAU - Hauser, Robert A
AU  - Hauser RA
AD  - Department of Neurology, University of South Florida, Tampa, Florida.
FAU - Rowse, Gerald J
AU  - Rowse GJ
AD  - Lundbeck LLC, Deerfield, Illinois.
FAU - Ziemann, Adam
AU  - Ziemann A
AD  - Lundbeck LLC, Deerfield, Illinois.
FAU - Hewitt, L Arthur
AU  - Hewitt LA
AD  - Lundbeck LLC, Deerfield, Illinois.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20170106
PL  - United States
TA  - Am J Cardiol
JT  - The American journal of cardiology
JID - 0207277
RN  - 0 (Antiparkinson Agents)
RN  - J7A92W69L7 (Droxidopa)
SB  - IM
MH  - Antiparkinson Agents/*therapeutic use
MH  - Cardiovascular Diseases/*complications
MH  - Droxidopa/*therapeutic use
MH  - Humans
MH  - Hypotension, Orthostatic/complications/*drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
EDAT- 2017/02/06 06:00
MHDA- 2017/05/19 06:00
CRDT- 2017/02/05 06:00
PHST- 2016/10/24 00:00 [received]
PHST- 2016/11/29 00:00 [revised]
PHST- 2016/11/29 00:00 [accepted]
PHST- 2017/02/06 06:00 [pubmed]
PHST- 2017/05/19 06:00 [medline]
PHST- 2017/02/05 06:00 [entrez]
AID - S0002-9149(16)32020-3 [pii]
AID - 10.1016/j.amjcard.2016.11.066 [doi]
PST - ppublish
SO  - Am J Cardiol. 2017 Apr 1;119(7):1111-1115. doi: 10.1016/j.amjcard.2016.11.066. 
      Epub 2017 Jan 6.