Objective: To assess the effect of droxidopa treatment on function, depression, and health-related quality of life (HRQoL) in patients with neurogenic orthostatic hypotension (nOH).

Background: nOH is a sustained decrease in blood pressure upon standing associated with autonomic failure; the cardinal symptoms are dizziness/lightheadedness, which may increase the risk of falls and related co-morbidities. nOH symptoms negatively affect outcomes related to function, mood, and HRQoL. Because droxidopa is approved to treat symptoms of dizziness/lightheadedness associated with nOH, it may improve these outcomes.

Methods: We enrolled patients newly initiating droxidopa. Data were collected on baseline characteristics and patient-reported outcomes including fall frequency (Patient Falls Questionnaire), functional impairment (Sheehan Disability Scale [SDS]), depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]), HRQoL (Short Form-8 [SF-8]), and “good” and “bad” day assessments at baseline and follow-up visits (1, 3, and 6 months). P-values were calculated with paired t-test and generalized estimation equation models.

Results: Of the 179 patients enrolled (mean age, 62.8 years; 51.4% women), 140, 121, and 109 completed assessments at 1, 3, and 6 months, respectively. At baseline, 52.6% of patients reported a fall in the past month; decreases in fall rates vs baseline were reported at the 1-month (43.0%; P=0.004, corrected for individual baseline values), 3-month (44.5%; P=0.059), and 6-month visits (40.0%; P=0.034). Significant improvements in SDS global functional impairment score vs baseline were found at 1, 3, and 6 months (P≤0.001) among participants who completed all individual items; individual rating of symptom impact on family life/home responsibilities was significantly improved at these time points vs baseline (P≤0.048). Significant improvements from baseline were also found in the global PHQ-9 mean score (P≤0.009), number of “good” and “bad” days assessments (P<0.0001 for both), SF-8 physical summary score (P≤0.009), and in the SF-8 mental summary score (P=0.007) at 6 months.

Conclusions: With the caveat that this is an observational study without a parallel control group, the results from this “real-world” study suggest that droxidopa treatment may be associated with a positive and sustained impact on falls, functionality, depression, and HRQoL in patients with nOH.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/patient-reported-outcomes-in-a-prospective-real-world-study-of-droxidopa-for-the-treatment-of-neurogenic-orthostatic-hypotension/