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Droxidopa and Reduced Falls in a Trial of Parkinson Disease Patients With Neurogenic Orthostatic Hypotension.
Clin Neuropharmacol. 2016 Sep-Oct; 39(5):220-6.CN

Abstract

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.

Authors+Show Affiliations

*Parkinson's Disease and Movement Disorders Center, University of South Florida Health, Byrd Institute, Tampa, FL; †Monash University, Melbourne, Australia; ‡Lundbeck, Deerfield, IL; and §Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27332626

Citation

Hauser, Robert A., et al. "Droxidopa and Reduced Falls in a Trial of Parkinson Disease Patients With Neurogenic Orthostatic Hypotension." Clinical Neuropharmacology, vol. 39, no. 5, 2016, pp. 220-6.
Hauser RA, Heritier S, Rowse GJ, et al. Droxidopa and Reduced Falls in a Trial of Parkinson Disease Patients With Neurogenic Orthostatic Hypotension. Clin Neuropharmacol. 2016;39(5):220-6.
Hauser, R. A., Heritier, S., Rowse, G. J., Hewitt, L. A., & Isaacson, S. H. (2016). Droxidopa and Reduced Falls in a Trial of Parkinson Disease Patients With Neurogenic Orthostatic Hypotension. Clinical Neuropharmacology, 39(5), 220-6. https://doi.org/10.1097/WNF.0000000000000168
Hauser RA, et al. Droxidopa and Reduced Falls in a Trial of Parkinson Disease Patients With Neurogenic Orthostatic Hypotension. Clin Neuropharmacol. 2016 Sep-Oct;39(5):220-6. PubMed PMID: 27332626.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Droxidopa and Reduced Falls in a Trial of Parkinson Disease Patients With Neurogenic Orthostatic Hypotension. AU - Hauser,Robert A, AU - Heritier,Stephane, AU - Rowse,Gerald J, AU - Hewitt,L Arthur, AU - Isaacson,Stuart H, PY - 2016/6/23/entrez PY - 2016/6/23/pubmed PY - 2017/1/21/medline SP - 220 EP - 6 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 39 IS - 5 N2 - 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. SN - 1537-162X UR - https://www.unboundmedicine.com/medline/citation/27332626/Droxidopa_and_Reduced_Falls_in_a_Trial_of_Parkinson_Disease_Patients_With_Neurogenic_Orthostatic_Hypotension_ L2 - https://doi.org/10.1097/WNF.0000000000000168 DB - PRIME DP - Unbound Medicine ER -