Patient-Reported Falls and Fear of Falling in a Prospective Study of Droxidopa for Treatment of Neurogenic Orthostatic Hypotension (S18.002)

Patient-Reported Falls and Fear of Falling in a Prospective Study of Droxidopa for Treatment of Neurogenic Orthostatic Hypotension (S18.002)

2019 AAN

Kymes, S. | François, C. | McLeod, K. | Duhig, A. | Ogbonnaya, A. | Quillen, A. | Cannon, J. | Shibao, C.A. | Yue, B. | Hauser, R. A. | Biaggioni, I. | Volume: 92, Issue: 15 Supplement, Pages: S18.002,

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.Disclosure: Dr. Kymes has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Lundbeck and CVS Health. Dr. Kymes holds stock and/or stock options in Lundbeck that is greater than $10,000 in value which sponsored research in which Dr. Kymes was involved as an investigator. Dr. Francois has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Lundbeck and Creativ-Ceutical. Dr. Francois holds stock and/or stock options in Lundbeck. Dr. McLeod has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Xcenda, LLC. Dr. Duhig has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Xcenda, LLC. Dr. Ogbonnaya has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Xcenda LLC. Dr. Quillen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Xcenda LLC. Dr. Cannon has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Lundbeck. Dr. Shibao has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Lundbeck. Dr. Shibao has received research support from Lundbeck. Dr. Yue has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Xcenda LLC. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc., Acorda Therapeutics, Academy for Continued Healthcare Learning, Acadia Pharmaceuticals, Inc., Adamas Pharmaceuticals, AstraZeneca, ApoPharma, Back Bay Life Science, Biotie Therapies, Bracket, Cerecor, Inc., ClearView Healthcare Partners, ClinicalMind Medical and Therapeutic Communications, CNS Ratings, LL ., Cowen and Company, Cynapsus Therapeutics, DDB Health LLC, Decision Resources Group (DRG), Eli Lilly & Company, eResearch Technology, Inc., Expert Connect, Extera Partners, GE Healthcare, Health Advances, HealthLogix, Health and Wellness Partners, Huron Consulting Group, Impax Laboratories, Impel Neuropharma, Intec Pharma Ltd., Jazz Pharmaceuticals, Kashiv Pharma LLC, Kyowa Kirin Pharmaceutical Development, Ltd., LCN Consulting, LifeMax, Life Sciences, Lundbeck LLC, The Lockwood Group, MEDACorp, Medscape, Medtronic, Michael J. Fox Foundation, Mitsubishi Tanabe Pharmaceuticals, Movement Disorder Society, National Institutes of Health (NIH), Neurocea LLC, Neurocrine Biosciences, Neuroderm, Neuropore Therapies, Orbes Medical Group, Outcomes Insights, Parkinson Study Group, Peerview Press, Pennside Partners, Pfizer, Inc., Pharma Two B, Ltd, Phase Five Communications, Prescott Medical Group, Prexton Therapeutics, Prilenia Development Ltd., Projects in Knowledge, Putnam Associates, Quintiles, RMEI Medical Education for Better Outcomes, SAI Med Partners LLC, Sarepta Therapeutics, Schlesinger Associates, Scion Neurostim, LLC, Seagrove Partners, LLC, Slingshot Insights, Sunovion Pharmaceuticals, Inc., Sun Pharma, Teva Pharmaceutical Industries, US WorldMeds, Vista Research, WebMD, Windrose Consulting Group. Dr. Hauser has received royalty, license fees, or contractual rights payments from the University of South Florida. Dr. Hauser has received research support from AbbVie Inc., Acorda Therapeutics, AstraZeneca, Axovant Sciences , Biogen Inc., Cavion, Enterin Inc., Impax Laboratories, LLC., Intec Pharma Ltd, Jazz Pharmaceuticals, NeuroDerm Ltd., Lundbeck, Michael J Fox Foundation for Parkinson’s Research, F. Hoffman-La Roche, Dart NeuroScience LLC, Prexton Therapeutics, Revance Therapeutics Inc., Sunovion Pharmaceuticals. Dr. Biaggioni has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Lundbeck, Theravance Biopharma. Dr. Biaggioni has received research support from Lundbeck (investigator-initiated grant) and Theravance Biopharma (Clinical Trial).