Objective: To assess the impact of droxidopa on fear of falling in patients with symptomatic neurogenic orthostatic hypotension (nOH) in 2 studies.

Background: nOH results from an inadequate noradrenergic response to postural change due to autonomic failure and is associated with dizziness/lightheadedness. These symptoms may increase falls and cause a fear of falling, which could negatively affect quality of life and activity levels, leading to physical deconditioning. Droxidopa is approved for treatment of the symptoms of nOH, and there is evidence to suggest treatment is associated with a decreased risk of falling.

Methods: Two studies captured fear of falling: 1) an 8-week double-blind phase 3 randomized controlled trial (RCT; n=222) of droxidopa vs placebo in which falls and fear of falling in patients who reported falls were assessed using an electronic diary and 2) a 6-month open-label prospective cohort study of patients initiating droxidopa (HUB study; n=179) in which data on falls (Patient Falls Questionnaire) and fear of falling (Short Falls Efficacy Scale – International [FES-I]) were collected at baseline and each follow-up visit (1, 3, and 6 months) from all participants. Univariate comparisons were made.

Results: In the RCT, 57.9% of patients in the placebo (62/108) and 51.8% in the droxidopa (58/114) groups reported ≥1 fall; by week 8 the placebo group had 907 falls vs 325 for droxidopa. Among the patients who fell in the RCT, 61/62 in the placebo group and 56/58 in the droxidopa group completed the fear of falling question; “no fear of falling” was reported by more patients receiving droxidopa vs placebo (57.1% vs 42.6%; P=0.12). In the HUB study, 129, 126, 112, and 98 patients completed the FES-I at the baseline, 1-, 3-, and 6-month visits, respectively. Compared with baseline, mean FES-I scores were significantly decreased at the 1-, 3-, and 6-month visits (17.1 vs 15.5, 14.1, and 14.0, respectively; P<0.0001 for all). Compared with baseline, fewer patients in the HUB study reported ≥1 fall in the past month at the 1-, 3-, and 6-month visits (52.6% vs 43.0% [P=0.004], 44.5% [P=0.059], and 40.0% [P=0.034], respectively).

Conclusions: Data from a RCT and a “real-world” study indicate that droxidopa might be associated with a reduction in falls and the fear of falling. These results suggest additional benefit of droxidopa beyond relief of nOH symptoms.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-droxidopa-treatment-on-fear-of-falling-in-patients-with-neurogenic-orthostatic-hypotension-clinical-trial-and-real-world-results/