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Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrinePURPOSE: 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.
Document ID
20040199395
Acquisition Source
Legacy CDMS
Document Type
Reprint (Version printed in journal)
Authors
Jankovic, J.
(Baylor College of Medicine Houston, Texas 77030)
Gilden, J. L.
Hiner, B. C.
Kaufmann, H.
Brown, D. C.
Coghlan, C. H.
Rubin, M.
Fouad-Tarazi, F. M.
Date Acquired
August 22, 2013
Publication Date
July 1, 1993
Publication Information
Publication: The American journal of medicine
Volume: 95
Issue: 1
ISSN: 0002-9343
Subject Category
Aerospace Medicine
Distribution Limits
Public
Copyright
Other
Keywords
NASA Discipline Number 14-10
NASA Discipline Cardiopulmonary
Multicenter Study
Randomized Controlled Trial
NASA Program Space Physiology and Countermeasures
Clinical Trial
Non-NASA Center

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