Droxidopa for neurogenic orthostatic hypotension: a randomized, placebo-controlled, phase 3 trial.

ABSTRACT:

Objective

To determine whether droxidopa, an oral norepinephrine precursor, improves symptomatic neurogenic orthostatic hypotension (nOH).

Methods

Patients with symptomatic nOH due to Parkinson disease, multiple system atrophy, pure autonomic failure, or nondiabetic autonomic neuropathy underwent open-label droxidopa dose optimization (100-600 mg 3 times daily), followed, in responders, by 7-day washout and then a 7-day double-blind trial of droxidopa vs placebo. Outcome measures included patient self-ratings on the Orthostatic Hypotension Questionnaire (OHQ), a validated, nOH-specific tool that assesses symptom severity and symptom impact on daily activities.

Results

From randomization to endpoint (n = 162), improvement in mean OHQ composite score favored droxidopa o

SUBMITTER: Kaufmann H 

PROVIDER: S-EPMC4115605 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature