April 2, 1997
View Full PaperEfficacy of Midodrine vs Placebo in Neurogenic Orthostatic Hypotension
Key Result
Midodrine 10 mg three times daily significantly improved standing systolic blood pressure (P<0.001) and global symptom relief scores compared to placebo in neurogenic orthostatic hypotension.
Key Points
- The aim is to assess the efficacy of midodrine on blood pressure and symptoms in neurogenic orthostatic hypotension patients.
- 171 patients with orthostatic hypotension participated in a multicenter, randomized, placebo-controlled study.
- Patients were assigned to receive 10 mg of midodrine or placebo three times daily for six weeks.
- The study included a single-blind run-in period and a double-blind treatment period.
- Midodrine improved standing systolic BP at all time points, P<.001 at visits 2, 3, 4, and 5.
- Symptoms improved by the second week of treatment, P=.001.
- Global symptom relief scores rated by patients and investigators showed significant improvement, P=.03 and P<.001, respectively.
Study Design
Type
RCT (n=171)
Blinding
Double-blind
Randomization
randomized
Multicenter
Yes
Structured PICO
Does midodrine improve standing systolic blood pressure and symptoms in patients with neurogenic orthostatic hypotension?
P
Population
171 patients with neurogenic orthostatic hypotension
I
Intervention
Midodrine 10 mg 3 times per day
C
Comparator
Placebo 3 times per day
O
Outcome
Improvement in standing systolic BP, symptoms of lightheadedness, and a global symptom relief score (by the investigator and patient separately)
Midodrine 10 mg three times daily is effective and safe for improving standing systolic blood pressure and ameliorating symptoms in patients with neurogenic orthostatic hypotension.
Main Result
p-value: p=<.001
Abstract
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.