Objective: The aim of this study was to review the published evidence for the efficacy, safety, and dosing practices of droxidopa treatment for symptomatic neurogenic orthostatic hypotension (nOH) in patients with parkinsonism.

Background: Symptomatic nOH can be a disabling disorder defined as a sustained blood pressure reduction on standing. The disorder results from postganglionic, noradrenergic impairment in Parkinson’s disease (PD) or from autonomic dysfunction in multiple system atrophy (MSA). Droxidopa (L-threo-3,4-dihydroxyphenylserine) is currently indicated for the management of symptomatic nOH.

Methods: A systematic literature search (PubMed, Cochrane Library, EMBASE) was performed to identify published randomized controlled trials and other comparative clinical studies of droxidopa. Study methodology, patient, and treatment-level data were extracted and summarized using descriptive statistics. Each study underwent quality assessment for bias based on Cochrane metrics. Documentation of inclusion and exclusion process is presented in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) format.

Results: Of 1059 relevant articles identified, 72 were studies and 9 met the inclusion/exclusion and data extraction eligibility criteria. Five of the included studies were randomized controlled trials (RCTs). All RCTs fulfilled criteria for low risk reporting bias. Effective doses ranged between 300 mg and 500 mg tid. Droxidopa was effective in patients with PD and MSA with the majority of studies demonstrating significant benefits measured by reduction in Orthostatic Hypotension Questionnaire (OHQ) composite score and dizziness/lightheadedness score. In 7 of 9 studies, droxidopa was associated with significantly less blood pressure reduction after standing. Reported adverse events included falls, headache, dizziness, fatigue, and nausea. In the majority of studies, occurrence of supine hypertension was similar to placebo.

Conclusions: Based on data extracted from 9 RCTs or prospective, open-label studies, a strong evidence base exists for the use of droxidopa to treat nOH in parkinsonism.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/systematic-literature-review-of-droxidopa-in-clinical-trials-for-neurogenic-orthostatic-hypotension-noh-in-parkinsonism/