Journal
CLINICAL NEUROPHARMACOLOGY
Volume 39, Issue 5, Pages 220-226Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/WNF.0000000000000168
Keywords
droxidopa; falls; Parkinson disease; neurogenic orthostatic hypotension; treatment
Categories
Funding
- Lundbeck
- Acadia Pharmaceuticals
- Auspex Pharmaceuticals
- Acorda Therapeutics
- AstraZeneca
- Cowen Group
- Allergan Neuroscience
- AbbVie
- Biotie Therapies
- Lundbeck NA Ltd
- Cynapsus Therapeutics
- Eli Lilly and Company
- Impax Laboratories
- Lundbeck Pharmaceuticals
- Michael J. Fox Foundation for Parkinson's Research
- Neurocrine Biosciences
- Novartis
- Pfizer
- Sarepta Therapeutics
- Teva Pharmaceuticals
- National Institute of Neurological Disorders and Stroke
- Orion
- ProPhase
- UCB BioSciences, Inc
- USWorldMeds
- CHC Group (North Wales, PA)
- Lundbeck LLC
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Objectives Droxidopa is a prodrug of norepinephrine indicated for the treatment of orthostatic dizziness, lightheadedness, or the feeling that you are about to black out in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure including Parkinson disease (PD). The objective of this study was to compare fall rates in PD patients with symptomatic neurogenic orthostatic hypotension randomized to droxidopa or placebo. Methods Study NOH306 was a 10-week, phase 3, randomized, placebo-controlled, double-blind trial of droxidopa in PD patients with symptomatic neurogenic orthostatic hypotension that included assessments of falls as a key secondary end point. In this report, the principal analysis consisted of a comparison of the rate of patient-reported falls from randomization to end of study in droxidopa versus placebo groups. Results A total of 225 patients were randomized; 222 patients were included in the safety analyses, and 197 patients provided efficacy data and were included in the falls analyses. The 92 droxidopa patients reported 308 falls, and the 105 placebo patients reported 908 falls. In the droxidopa group, the fall rate was 0.4 falls per patient-week; in the placebo group, the rate was 1.05 falls per patient-week (prespecified Wilcoxon rank sum P = 0.704; post hoc Poisson-inverse Gaussian test P = 0.014), yielding a relative risk reduction of 77% using the Poisson-inverse Gaussian model. Fall-related injuries occurred in 16.7% of droxidopa-treated patients and 26.9% of placebo-treated patients. Conclusions Treatment with droxidopa appears to reduce falls in PD patients with symptomatic neurogenic orthostatic hypotension, but this finding must be confirmed.
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