Efficacy of Midodrine vs Placebo in Neurogenic Orthostatic Hypotension

Objective. —To evaluate the efficacy of a 10-mg dose of midodrine 3 times per day in improving blood pressure (BP) and ameliorating symptoms of orthostatic hypotension in patients with neurogenic orthostatic hypotension. Midodrine hydrochloride, an α=agonist, could improve orthostatic BP by increasing vasomotor and venomotor tone. Design/Methods. —A total of 171 patients with orthostatic hypotension participated in a multicenter, randomized, placebo-controlled study. They were randomized to a 10-mg dose of midodrine or placebo 3 times per day in a 6-week study, comprising single-blind run-in (at week 1) and washout at weeks 5 and 6, with an intervening double-blind period (weeks 2 to 4). Setting. —Twenty-five centers, with most patients evaluated in referral centers. Main Outcome Measures. —The primary end points were improvement in standing systolic BP, symptoms of lightheadedness, and a global symptom relief score (by the investigator and patient separately). Results. —Nine patients were not evaluable because of noncompliance or taking concomitant vasoactive medications (3 in the midodrine group, 6 in the placebo group). In the evaluable patients, midodrine resulted in improvements in standing systolic BP at all time points (PP=.001), and in the global symptom relief score rated by both the patient (P=.03) and the investigator (PConclusions. —Midodrine is efficacious and safe in the treatment of neurogenic orthostatic hypotension.