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Integrated analysis of droxidopa trials for neurogenic orthostatic hypotension #MMPMID28494751
Biaggioni I; Arthur Hewitt L; Rowse GJ; Kaufmann H
BMC Neurol 2017[]; 17 (ä): ä PMID28494751show ga
Background: Droxidopa, 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). Methods: Efficacy was assessed using Orthostatic Hypotension Questionnaire (OHQ) scores (composite and individual items). Safety and tolerability were also examined. Results: Droxidopa 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. Conclusions: Droxidopa 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 registration: ClinicalTrials.gov identifiers: NCT00782340, first received October 29, 2008; NCT00633880, first received March 5, 2008; and NCT01176240, first received July 30, 2010.
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BMC+Neurol 2017 ; 17 (ä): ä
