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Background: Neurogenic orthostatic hypotension (nOH) results from impaired vasoconstriction due to dysfunction of the autonomic nervous system and is commonly associated with Parkinson disease (PD), multiple system atrophy (MSA), and pure autonomic failure. nOH can increase the risk of falls due to symptoms that include postural lightheadedness or dizziness, presyncope, and syncope. The purpose of this study was to obtain information from patients and caregivers regarding the symptoms and burden of nOH to expand on limited knowledge regarding the impact of nOH on quality of life., Methods: This author-designed survey included questions regarding nOH (e.g., frequency and impact of symptoms, management) and was conducted online by Harris Poll via distribution to individuals who agreed to participate in Harris Poll online surveys or who were members of relevant disease advocacy organizations. Eligible patients were aged ≥ 18 years with PD, MSA, or pure autonomic failure and ≥ 1 of the following: orthostatic hypotension (OH), nOH, low blood pressure upon standing, or OH/nOH symptoms. Eligible caregivers cared for such patients but were not necessarily linked to any patient participant., Results: Survey responses were received from 363 patients and 128 caregivers. PD was the most frequent underlying disorder (90% of patients; 88% of individuals managed by the caregivers). Despite meeting survey diagnosis criteria, a formal diagnosis of OH or nOH was reported by only 36% of patients and 16% of caregivers. The most frequent symptoms of nOH were dizziness or lightheadedness, fatigue when standing, and difficulty walking. A negative impact on patient quality of life caused by nOH symptoms was reported by 59% of patients and 75% of caregivers. Most respondents (≥87%) reported that nOH symptoms adversely affected patients' ability to perform everyday activities (most frequently physical activity/exercise, housework, and traveling). Falls (≥1) in the previous year due to nOH symptoms were reported by 57% of patients and 80% of caregivers., Conclusions: These survey results support the premise that nOH symptoms have a substantial negative impact on patient function and quality of life. The relatively low rates of formal nOH/OH diagnosis suggest the need for heightened awareness regarding the condition and its symptom burden.

Background: Droxidopa is an orally active prodrug that significantly improved dizziness/lightheadedness measured using the Orthostatic Hypotension Symptom Assessment (OHSA) Item 1 in patients with neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson disease, multiple system atrophy, and pure autonomic failure), dopamine β-hydroxylase deficiency, or nondiabetic autonomic neuropathy. The efficacy and safety of droxidopa were assessed by determining the number needed to treat (NNT) and the number needed to harm (NNH)., Methods: Data collected in randomized, placebo-controlled clinical studies in adults with a clinical diagnosis of symptomatic nOH were pooled for efficacy and safety analyses. NNT and NNH were calculated as reciprocals of the risk difference (difference in event rates) for droxidopa versus placebo., Results: The NNT for droxidopa for improvement in OHSA Item 1 was <10. The NNH for adverse events (AEs) leading to discontinuation in the pooled studies was 81. The likelihood of being helped or harmed (LHH) calculated from pooled analysis of the NNT for ≥2 units of improvement in OHSA Item 1 score and the NNH for discontinuations due to AEs were 7.8, 8.8, 3.1, and 3.5 for weeks 1, 2, 4, and 8 after randomization, respectively., Conclusions: Droxidopa is efficacious for treatment of nOH, with an NNT below 10 and an acceptable tolerability profile with NNH ranging from 23 to 302 in the pooled analysis of frequently occurring AEs. Based on the LHH for the pooled analysis at week 1, droxidopa is 7.8 times more likely than placebo to show a clinical benefit than result in discontinuation because of an AE., Trial Registrations: ClinicalTrials.gov identifiers: NCT00782340 , first received October 29, 2008; NCT00633880 , first received March 5, 2008; and NCT01176240 , first received July 30, 2010.