Objective: To assess the long-term efficacy of droxidopa for managing symptoms and falls in patients with neurogenic orthostatic hypotension (nOH).
Background: Patients with nOH are at greater risk of falling and poor quality of life (QoL). In an 8-week clinical trial, droxidopa was shown to reduce nOH symptoms and falls. A noninterventional, prospective, 6-month cohort study of patients with nOH was conducted to further assess the impact of droxidopa treatment. Significant improvement in symptoms, health-related QoL (HRQoL), and falls were reported in interim analyses at 1 month.
Design/Methods: Patients newly initiating droxidopa were invited to participate. Demographic and clinical data were collected at baseline. At each follow-up visit (1, 3, and 6 months), data were collected on dizziness/lightheadedness symptoms (Orthostatic Hypotension Symptom Assessment [OHSA] Item 1), self-reported falling, fear of falling (Falls Efficacy Scale-International), functional impairment (Sheehan Disability Scale), depressive symptoms (Patient Health Questionnaire-9), and HRQoL (Short Form-8). Scores at the 3- and 6-month follow-ups were compared with baseline (paired t test).
Results: At baseline, 179 participants were enrolled; 121 (67.6 %) and 109 (60.9%) provided data at 3 and 6 months, respectively. OHSA Item 1 improvement at 3 and 6 months following treatment initiation was 1.9 and 2.0 points (on an 11-point scale; P<0.0001 for both). At baseline, 52.6% of participants reported ≥1 fall in the previous month; at 3 and 6 months post-droxidopa initiation, 44.5% and 40.0% of participants reported ≥1 fall in the previous month (−8.1% and −12.6%; P=0.059 and P=0.034). Significant improvements were also found in fear of falling, functional impairment, depressive symptoms, and HRQoL scores. Conclusions: In this noninterventional prospective study, patients initiating droxidopa reported fewer falls and improved HRQoL during 6 months of treatment. These real-world findings indicate the persistence of the nOH symptom and fall risk reduction benefits with droxidopa observed in the 8-week clinical trial.