Trial reportBMC neurology2017
Integrated analysis of droxidopa trials for neurogenic orthostatic hypotension.
Trial report in BMC neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 41 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase III, Multi-Center, Study to Assess the Clinical Effect of Droxidopa in Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic NOH
Phase III, Multi-Center, Study to Assess the Clinical Effect of Droxidopa in Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic NOH
A Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease
Who cites it
41 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.
- Management of Hypertension and Blood Pressure Dysregulation in Patients with Parkinson's Disease-a Systematic Review.Current hypertension reports · 2021Pooled it
- Establishing minimally clinically important differences for the orthostatic hypotension questionnaire (OHQ).Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2026Trial
- Clinical Correlates of Efficacy of Pyridostigmine in the Treatment of Orthostatic Hypotension.Hypertension (Dallas, Tex. : 1979) · 2025Trial
- Safety and efficacy of ampreloxetine in symptomatic neurogenic orthostatic hypotension: a phase 2 trial.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2021Trial
- Comparison of the Pharmacokinetics of Droxidopa After Dosing in the Fed Versus Fasted State and with 3-Times-Daily Dosing in Healthy Elderly Subjects.Drugs in R&D · 2018Trial
- Hypertensive emergency with vasogenic cerebral edema following droxidopa initiation in pure autonomic failure.Frontiers in neurology · 2026Article
- Review
- Update on the Treatment of Autonomic Disorders.Current treatment options in neurology · 2025Article
- Cardiovascular Autonomic Dysfunction Before and After Chemotherapy in Cancer Patients.Journal of clinical neurology (Seoul, Korea) · 2024Review
- Orthostatic Hypotension in Adults With Hypertension: A Scientific Statement From the American Heart Association.Hypertension (Dallas, Tex. : 1979) · 2024Review
- Recent Advances and Future Directions in Syncope Management: A Comprehensive Narrative Review.Journal of clinical medicine · 2024Review
- Ampreloxetine Versus Droxidopa in Neurogenic Orthostatic Hypotension: A Comparative Review.Cureus · 2023Review
- Advances in the Pharmacological and Non-pharmacological Management of Non-motor Symptoms in Parkinson's Disease: An Update Since 2017.Current neuropharmacology · 2023Review
- Orthostatic Hypotension in Multiple System Atrophy: Related Factors and Disease Prognosis.Journal of Parkinson's disease · 2023Article
- Management of Patients With Hypertension and Orthostatic Hypotension. Parallel Progress.Hypertension (Dallas, Tex. : 1979) · 2022Article
- Diagnosis and treatment of orthostatic hypotension.The Lancet. Neurology · 2022Review
- Advances in the Pathophysiology and Management of Supine Hypertension in Patients with Neurogenic Orthostatic Hypotension.Current hypertension reports · 2022Review
- The Pathogenesis and Treatment of Cardiovascular Autonomic Dysfunction in Parkinson's Disease: What We Know and Where to Go.Aging and disease · 2021Review
- Neurogenic Orthostatic Hypotension. Lessons From Synucleinopathies.American journal of hypertension · 2021Review
- Arterial Blood Pressure Variability and Other Vascular Factors Contribution to the Cognitive Decline in Parkinson's Disease.Molecules (Basel, Switzerland) · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDroxidopa, a prodrug of norepinephrine, was approved for treatment of neurogenic orthostatic hypotension (nOH) due to primary autonomic disorders based on 3 randomized double-blind studies. We performed safety and efficacy analyses of this pooled dataset (n = 460).
methodsEfficacy was assessed using Orthostatic Hypotension Questionnaire (OHQ) scores (composite and individual items). Safety and tolerability were also examined.
resultsDroxidopa improved virtually all nOH symptom scores compared with placebo, significantly reducing OHQ composite score (-2.68 ± 2.20 vs -1.82 ± 2.34 units; P < 0.001), dizziness/lightheadedness score (-3.0 ± 2.9 vs -1.8 ± 3.1 units; P < 0.001), and 3 of 5 other symptom assessments (visual disturbances, weakness, and fatigue [P ≤ 0.010]). Droxidopa significantly improved 3 of 4 measures of activities of daily living (standing a long time, walking a short time, and walking a long time [P ≤ 0.003]) and significantly increased upright systolic blood pressure (11.5 ± 20.5 vs 4.8 ± 21.0 mmHg for placebo; P < 0.001). Droxidopa was effective in patients using inhibitors of dopa decarboxylase (DDCI; the enzyme that converts droxidopa to norepinephrine), but its efficacy was numerically greater in non-DDCI users. Droxidopa was well-tolerated. Rates of most adverse events were similar between groups. Supine hypertension rates were low, but slightly higher in patients receiving droxidopa (≤7.9% vs ≤4.6% for placebo); patients with severe hypertension at screening were excluded from these studies.
conclusionsDroxidopa is effective for the treatment of nOH in patients with primary autonomic disorders and is generally well-tolerated. A longer trial is underway to confirm efficacy beyond the ≤2 to 10 - week period assessed in the current trials.
trial registrationClinicalTrials.gov identifiers: NCT00782340 , first received October 29, 2008; NCT00633880 , first received March 5, 2008; and NCT01176240 , first received July 30, 2010.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.