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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.
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“There is no doubt that midodrine increases BP both in the supine and upright posture, and ameliorates the symptoms of OH.”
From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [324]
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“Midodrine (2.5-10 mg t.i.d) was shown to be effective in three randomized placebo-controlled trials. 324-326”
From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [324]
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Metadata
- Authors
- Jankovic, J., Gilden, J. L., Hiner, B. C., Kaufmann, H., Brown, D. C., Coghlan, C. H., Rubin, M., & Fouad-Tarazi, F. M.
- Affiliations
- Baylor College of Medicine (US)
- Marshfield Clinic (US)
- Mount Sinai Health System (US)
- Abbott Northwestern Hospital (US)
- University of Alabama at Birmingham (US)
- Cornell University (US)
- Cleveland Clinic (US)
- Corresponding author
- Jankovic, Joseph
- Venue
- The American Journal of Medicine
- Publisher
- Elsevier BV
- Published
- 1993-07
- Volume
- 95
- Issue
- 1
- Pages
- 38-48
- ISSN
- 0002-9343 (ISSN-L)
- OpenAlex
- W2029445782
- Cited by
- 396
- References
- 49
- Citations by year
- 2026: 8 · 2025: 17 · 2024: 6 · 2023: 7 · 2022: 8 · 2021: 14 · 2020: 17 · 2019: 9 · 2018: 9 · 2017: 24 · 2016: 14 · 2015: 17 · 2014: 24 · 2013: 18 · 2012: 8
- FWCI
- 4.51
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The American Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Syncope and Autonomic Disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Keywords
- neurogenic orthostatic hypotension, midodrine, autonomic failure, syncope, dizziness, drug safety and efficacy, adverse effects, supine hypertension, urinary urgency
- MeSH terms
- Adult, Aged, Aged, 80 and over, Autonomic Nervous System Diseases, Double-Blind Method, Female, Humans, Hypotension, Orthostatic, Male, Middle Aged, Midodrine
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