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  • Title: Long-term safety of droxidopa in patients with symptomatic neurogenic orthostatic hypotension.
    Author: Isaacson S, Vernino S, Ziemann A, Rowse GJ, Kalu U, White WB.
    Journal: J Am Soc Hypertens; 2016 Oct; 10(10):755-762. PubMed ID: 27614923.
    Abstract:
    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.
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