Effects of Droxidopa Treatment for Neurogenic Orthostatic Hypotension in Patients Concomitantly on Dopa Decarboxylase Inhibitors (P3.6-048)

Effects of Droxidopa Treatment for Neurogenic Orthostatic Hypotension in Patients Concomitantly on Dopa Decarboxylase Inhibitors (P3.6-048)

2019 Neurology

Kymes, S. | François, C. | Sullivan, C. | McLeod, K. | Duhig, A. | Ogbonnaya, A. | Quillen, A. | Cannon, J. | Biaggioni, I. | Shibao, C. A. | Yue, B. | Hauser, R. | Volume: 92, Issue: 15 Supplement, Pages: P3.6-048,

Objective: To assess long-term efficacy of droxidopa for treatment of neurogenic orthostatic hypotension (nOH) in patients concomitantly on dopa decarboxylase (DDC) inhibitors (DDCIs)Background: nOH is a non-motor symptom of Parkinson disease (PD). Treatment of PD frequently includes DDCIs. Droxidopa, a treatment for symptomatic nOH, is converted to norepinephrine by DDC.Design/Methods: Patients were enrolled in a prospective cohort study comparing outcomes before initiation of droxidopa and after 1, 3, and 6 months of treatment. Patients recorded monthly number of falls using a questionnaire and dizziness/lightheadedness using Orthostatic Hypotension Symptom Assessment, Item 1 (OHSA-1). Post-hoc analysis compared outcomes in patients on DDCIs vs without DDCIs. “DDCI treatment” defined as receiving carbidopa alone or in combination with levodopa or entacapone. Influence of DDCIs was compared across time points using generalized linear mixed models adjusting for repeated measures within individuals.Results: 168 patients were included (PD: 32.1%, autonomic failure: 66.1%, other: 1.8%). 61.8% of patients on DDCIs (n=55) reported ≥1 fall at baseline vs 46.9% of patients not on DDCIs (n=113). Patients on DDCIs experienced significant reduction in fall rate (30.1%, 36.4 point reduction) and improvement in OHSA-1 scores (−1.8) from baseline to 6 months (both P<0.05). Patients not on DDCIs also experienced significant OHSA-1 scores improvement (−1.9, P<0.05), but fall rate reduction was not significant (39.8%, 6.2 point reduction, P=0.49). The differences in change from baseline to 6 months for fall risk and OHSA-1 score were not significant between groups (P=0.15, P=0.96, respectively). DDCI users (66.6%) had a greater prevalence of >1 falls vs nonusers (46.6%) at baseline.Conclusions: These post-hoc analyses suggest that DDCI users and nonusers experienced reductions in fall rate and dizziness/lightheadedness with droxidopa. Additional studies are needed to examine the impact of DDCIs on droxidopa because the current study was not powered for subgroup analyses and data were patient self-reported.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. Sullivan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with 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. 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). Dr. Shibao has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Lundbeck. Dr. Shibao h s 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, LLC., 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.