Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine.

Abstract

PURPOSE:

To investigate the efficacy and safety of midodrine for treatment of patients with orthostatic hypotension due to autonomic failure.

PATIENTS:

Ninety-seven patients with orthostatic hypotension were randomized in a 4-week, double-blinded, placebo-controlled study with a 1-week placebo run-in period. Patients ranged in age from 22 to 86 years (mean: 61 years).

METHODS:

After a 1-week run-in phase, either placebo or midodrine at a dose of 2.5 mg, 5 mg, or 10 mg was administered three times a day for 4 weeks. Both the placebo group and the 2.5-mg midodrine group received constant doses throughout the double-blind phase. The patients receiving 5 mg or 10 mg of midodrine were given doses that were increased at weekly intervals by 2.5-mg increments until the designated dose was reached. Efficacy evaluations were based on an improvement at 1-hour postdose in standing systolic blood pressure and in symptoms of orthostatic hypotension (syncope, dizziness/lightheadedness, weakness/fatigue, and low energy level).

RESULTS:

Midodrine (10 mg) increased standing systolic blood pressure by 22 mm Hg (28%, p < 0.001 versus placebo). Midodrine improved (p < 0.05) the following symptoms of orthostatic hypotension compared to placebo: dizziness/lightheadedness, weakness/fatigue, syncope, low energy level, impaired ability to stand, and feelings of depression. The overall side effects were mainly mild to moderate. One or more side effects were reported by 22% of the placebo group compared with 27% of the midodrine-treated group. Scalp pruritus/tingling, which was reported by 10 of 74 (13.5%) of the midodrine-treated patients, was most frequent. Other reported side effects included supine hypertension (8%) and feelings of urinary urgency (4%).

CONCLUSION:

We conclude that midodrine is an effective and well-tolerated treatment for moderate-to-severe orthostatic hypotension associated with autonomic failure.

• Authors: J Jankovic, J L Gilden, B C Hiner, H Kaufmann, D C Brown, C H Coghlan, M Rubin, F M Fouad-Tarazi
• Journal: The American journal of medicine (Am J Med) Vol. 95 Issue 1 Pg. 38-48 (Jul 1993) ISSN: 0002-9343 [Print] United States
• PMID: 7687093 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Midodrine

Topics

• Adult
• Aged
• Aged, 80 and over
• Autonomic Nervous System Diseases (complications)
• Double-Blind Method
• Female
• Humans
• Hypotension, Orthostatic (drug therapy, etiology)
• Male
• Middle Aged
• Midodrine (adverse effects, therapeutic use)