Abstract Details

Title Patient-Reported Falls and Fear of Falling in a Prospective Study of Droxidopa for Treatment of Neurogenic Orthostatic Hypotension

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) S18 - Autonomic Disorders (3:41 PM-3:52 PM)

Poster/Presentation
Number 002

Objective To assess the long-term effectiveness of droxidopa in reducing the risk of falling and fear of falling (FoF) in patients with neurogenic orthostatic hypotension (nOH)

Background nOH, a sustained blood pressure drop upon standing, may increase fall incidence, which can trigger FoF and future fall risk. Droxidopa is approved to treat nOH symptoms; fall benefits were suggested in pivotal trials.

Design/Methods Patients newly initiating droxidopa enrolled in an open-label, prospective cohort study. The number of falls in the past month and FoF were recorded at baseline, 1, 3, and 6 months using a falls questionnaire and the Short Falls Efficacy Scale-International. P values were calculated using paired t test for continuous measures and generalized estimating equations with multinomial distributions for categorical measures.

Results 179 patients were enrolled (Parkinson disease, 33%; autonomic failure without identifiable cause, 65%; other, 2%); 135, 119, and 105 remained at 1, 3, and 6 months. Patients reported fewer falls in the previous month at 1, 3, and 6 months vs baseline (P<0.01, P=0.06, P<0.05, respectively). Among patients who fell ≥1 time at baseline, fewer falls were reported during droxidopa treatment; 59% fell ≥3 times at baseline and only 36% fell ≥3 times at 6 months. At 1, 3, and 6 months, significantly less concern about falling vs baseline were indicated by reductions in FoF scores (all P<0.0001) and categorical changes in level of concern about falling (all P<0.01).

Conclusions In this “real-world” study patients taking droxidopa were at a lower risk of falling after 1, 3, and 6 months of treatment. Those who fell ≥1 time in the prior month reported fewer falls per month vs baseline. Patients reported reduced FoF during treatment. These results suggest persistence of beneficial effects at 6 months of treatment, but conclusions are limited by the lack of a control cohort.

Authors/Disclosures
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center) PRESENTER	Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroDerm. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance Therapeutics. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Supernus Pharma. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Regenxbio. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Forsee Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KiefeRx. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Intrance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Truebinding. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Serina Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nano PharmaSolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sorridi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Conterra Pharma. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clario. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Theravance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Photopharmics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Cerevance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NDP Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoparkinson. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. The institution of Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stoparkinson. The institution of Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Photopharmics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Hauser has stock in Inhibikase. Dr. Hauser has stock in Axial Therapeutics. Dr. Hauser has stock in Enterin. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from UCB BioPharma. The institution of Dr. Hauser has received research support from UCB. The institution of Dr. Hauser has received research support from Amneal Pharmaceuticals. The institution of Dr. Hauser has received research support from Motric Bio, Inc.. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research Company. The institution of Dr. Hauser has received research support from Teva Branded Pharmaceuticals. The institution of Dr. Hauser has received research support from Truebinding, Inc.. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Steven Kymes	Steven Kymes has received personal compensation for serving as an employee of Lundbeck. Steven Kymes has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Journal of Ophthalmology. Steven Kymes has received research support from Emmes Corporation.
Clement Francois	No disclosure on file
	No disclosure on file
Amy M. Duhig, PhD (Xcenda, LLC)	No disclosure on file
	No disclosure on file
	No disclosure on file
Joan Cannon (Lundbeck)	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

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