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Efficacy of Midodrine vs Placebo in Neurogenic Orthostatic Hypotension: A Randomized, Double-blind Multicenter Study
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 (P<.001 at visits 2,3,4, and 5), in reported symptoms by the end of the second week of treatment (P=.001), and in the global symptom relief score rated by both the patient (P=.03) and the investigator (P<.001). There was no effect by center, severity of orthostatic hypotension, use of fludrocortisone or compression garments, or diagnosis. The main adverse effects were those of pilomotor reactions, urinary retention, and supine hypertension. Conclusions. —Midodrine is efficacious and safe in the treatment of neurogenic orthostatic hypotension.
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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 [325]
In the citing paper
“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 [325]
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“Clinical studies have shown that midodrine improves upright BP in patients with orthostatic hypotension (Kaufmann et al., 1988; Jankovic et al., 1993; Low et al., 1997).”
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“There is a dose-dependent effect, nding blood pressure.(459,460,462,463,466,467) Its use may be limited by de effects include scalp tingling, piloerection, and urinary”
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“Additional data in patients with neurogenic orthostatic hypotension suggested a durable response to midodrine 10 mg 3 times/day, with sustained increases in SBP during the 3-week study period.(67) This reliable dose response secondary to targeted a-1 agonist activity has led to increased use of off-label midodrine in…”
BackgroundEfficacy of atomoxetine versus midodrine for neurogenic orthostatic hypotension
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“The underlying mechanism that supports its use is vasoconstriction of both the arterial and venous vascular beds (30, 31).”
BackgroundPharmacological treatment of reflex syncope
Kaufmann, H., & Freeman, R. L. (2004) · Clinical Autonomic Research · doi:10.1007/s10286-004-1010-4 · Cited by 18
Ortíz, J. F., Betté, S., Tambo, W., Tao, F., Cozar, J. C., & Isaacson, S. (2020) · Cureus · doi:10.7759/cureus.10741 · Cited by 17
“We reviewed the main findings of the three clinical trials in Table 5 [29-31].”
BackgroundMethodIsaacson, S., Dashtipour, K., MEHDIRAD, A. A., & Peltier, A. (2021) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-021-01104-3 · Cited by 20
Clinical Relevance of Orthostatic Hypotension in Neurodegenerative Disease
McDonell, K. E., Shibao, C. A., & Claassen, D. O. (2015) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-015-0599-0 · Cited by 17
Management of acute intradialytic cardiovascular complications: Updated overview (Review)
Timofte, D., Tănăsescu, M., Balan, D., Tulin, A., Știru, O., Vacaroiu, I., Mihai, A., Popa, C., Cosconel, C.-I., Enyedi, M., et al. (2021) · Experimental and Therapeutic Medicine · doi:10.3892/etm.2021.9713 · Cited by 15
Midodrine-Induced Vascular Ischemia in a Hemodialysis Patient: A Case Report and Literature Review
Rubinstein, S., Haimov, M., & Ross, M. J. (2008) · Renal Failure · doi:10.1080/08860220802249025 · Cited by 17
“The tolerability profile of midodrine has been confirmed in patients with normal renal function([17,18]) as well as in HD population.”
Background
Metadata
- Authors
- Low, P. A.
- Corresponding author
- Low, Phillip A.
- ORCID
- Low, Phillip A.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 1997-04-02
- Volume
- 277
- Issue
- 13
- Pages
- 1046
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W4294549596
- Cited by
- 425
- References
- 0
- Citations by year
- 2026: 9 · 2025: 17 · 2024: 11 · 2023: 10 · 2022: 13 · 2021: 16 · 2020: 23 · 2019: 18 · 2018: 15 · 2017: 22 · 2016: 20 · 2015: 25 · 2014: 27 · 2013: 18 · 2012: 20
- FWCI
- 8.21
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (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
- midodrine, neurogenic orthostatic hypotension, alpha-adrenergic agonists, blood pressure, lightheadedness, symptom relief, vascular tone, adverse effects, urinary retention, supine hypertension
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