Objective: To understand the characteristics of patients initiating droxidopa therapy for the treatment of neurogenic orthostatic hypotension (nOH).

Background: nOH is defined as a fall in systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg within 3 minutes of standing. This condition occurs in patients with neurodegenerative disorders of the autonomic nervous system, leading to dizziness, falls, or syncope. Droxidopa was approved by the US Food and Drug Administration for the treatment of nOH in 2014. This is the first data available reflecting the real-world use of droxidopa following approval.

Methods: A 6-month noninterventional, US-based, prospective cohort study of caregivers and patients newly initiating therapy with droxidopa for the treatment of nOH is being conducted with 200 patients. This presentation is an interim examination of patient baseline characteristics before initiating treatment with droxidopa.

Results: An interim analysis was conducted with 121 patients; most had autonomic failure (without an identifiable cause, 62.8%), followed by Parkinson’s disease (36.4%) and nondiabetic autonomic neuropathy (0.8%). The mean age of patients was 63.1 years; 49.6% were male. Many patients were taking midodrine (31.4%) and/or fludrocortisone acetate (28.9%) or have in the past (38.9%). Patients also experienced high rates of arthritis (31.4%) and depression (28.1%). More than half of the patients (51.7%) had fallen in the past month, with an average of 1.32 (SD=5.3) falls requiring medical services. On Orthostatic Hypotension Symptom Assessment Item 1, where patients rated “dizziness, lightheadedness, feeling faint, or feeling like you might black out” over the past week on a scale of 0 (none) to 10 (worst possible), 34.5% chose a rating of 8–10. On the Sheehan Disability Scale, patients selected “markedly” or “extremely” disrupted for social life activities (47.5%) and family life responsibilities (56.0%). On the Short Form-8, 33.3% of patients rated their health as poor or very poor.

Conclusions: Real-world experience suggests that many patients starting therapy with droxidopa have moderate to severe nOH symptoms, have recently fallen, and have high levels of disability and poor health.

« Back to 2016 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/characteristics-of-patients-initiating-droxidopa-for-the-treatment-of-neurogenic-orthostatic-hypotension-noh/