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April 2, 1997JAMA

Efficacy of Midodrine vs Placebo in Neurogenic Orthostatic Hypotension

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Why the study?

Does midodrine improve standing systolic blood pressure and symptoms in patients with neurogenic orthostatic hypotension?

Population

171 patients with neurogenic orthostatic hypotension

Comparison

Midodrine 10 mg 3 times per day vs Placebo 3 times per day

Design

RCT, randomized, single-blind run-in and washout, with an intervening…

Follow-up

6 weeks

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.

Authors

PLPhillip A. Low

Discussion

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Overview

Supports midodrine for neurogenic orthostatic hypotension; confirms efficacy on standing BP and symptoms in multicenter RCT.

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)

Main Result

p-value: p=<.001

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.

Cite This Study

Phillip A. Low (1997) conducted an RCT in neurogenic orthostatic hypotension (n=171). midodrine vs. placebo was evaluated on improvement in standing systolic BP, symptoms of lightheadedness, and a global symptom relief score (p=<.001). 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.

synapsesocial.com/papers/6a0719ee964d5135c0d3f205https://doi.org/10.1001/jama.1997.03540370036033
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