TY - JOUR
T1 - Long-term safety of droxidopa in patients with symptomatic neurogenic orthostatic hypotension
AU - Isaacson, Stuart
AU - Vernino, Steven
AU - Ziemann, Adam
AU - Rowse, Gerald J.
AU - Kalu, Uwa
AU - White, William B.
N1 - Funding Information:
The authors received editorial assistance from CHC Group (North Wales, PA), which was supported by Lundbeck LLC.
Publisher Copyright:
© 2016 The Author
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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.
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.
KW - Supine hypertension
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U2 - 10.1016/j.jash.2016.07.010
DO - 10.1016/j.jash.2016.07.010
M3 - Article
C2 - 27614923
AN - SCOPUS:84992127887
SN - 1933-1711
VL - 10
SP - 755
EP - 762
JO - Journal of the American Society of Hypertension
JF - Journal of the American Society of Hypertension
IS - 10
ER -