Long-term safety of droxidopa in patients with symptomatic neurogenic orthostatic hypotension.
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.
Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA. Electronic address: isaacson@ParkinsonsCenter.org.
Stuart
S
Isaacson
Department of Neurology & Neurotherapeutics, UT Southwestern Medical Center, Dallas, TX, USA.
Steven
S
Vernino
Lundbeck LLC, Deerfield, IL, USA.
Adam
A
Ziemann
Lundbeck LLC, Deerfield, IL, USA.
Gerald J
GJ
Rowse
Lundbeck LLC, Deerfield, IL, USA.
Uwa
U
Kalu
Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT 06032, USA.
William B
WB
White
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001341:Autonomic Nervous System / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects*; D015103:Droxidopa / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000139:chemically induced* / Q000453:epidemiology; D007024:Hypotension, Orthostatic / Q000188:drug therapy* / Q000209:etiology; D000069451:Long Term Adverse Effects / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D019578:Multiple System Atrophy / Q000150:complications / Q000188:drug therapy; D009638:Norepinephrine / Q000009:adverse effects* / Q000627:therapeutic use; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy; D011355:Prodrugs / Q000009:adverse effects* / Q000627:therapeutic use; D054970:Pure Autonomic Failure / Q000150:complications / Q000188:drug therapy; D014662:Vasoconstrictor Agents / Q000009:adverse effects* / Q000627:therapeutic use; D055815:Young Adult
D011355:Prodrugs; D014662:Vasoconstrictor Agents; D015103:Droxidopa; D009638:Norepinephrine
Supine hypertension