Abstract | OBJECTIVES: 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:
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Authors | Robert A Hauser, Stephane Heritier, Gerald J Rowse, L Arthur Hewitt, Stuart H Isaacson |
Journal | Clinical neuropharmacology
(Clin Neuropharmacol)
2016 Sep-Oct
Vol. 39
Issue 5
Pg. 220-6
ISSN: 1537-162X [Electronic] United States |
PMID | 27332626
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antiparkinson Agents
- Droxidopa
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Topics |
- Accidental Falls
- Adult
- Aged
- Aged, 80 and over
- Antiparkinson Agents
(therapeutic use)
- Double-Blind Method
- Droxidopa
(therapeutic use)
- Female
- Humans
- Hypotension, Orthostatic
(complications)
- Male
- Middle Aged
- Parkinson Disease
(complications, drug therapy)
- Severity of Illness Index
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