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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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Items 401–428 of 428
Multiple System Atrophy, Orthostatic Hypotension, and Autonomic Dysfunction and Cognition
Peralta, C. (2019) · Springer eBooks · doi:10.1007/978-3-030-14895-9_5
Ribstein, J., du Cailar, G., Halimi, J., & Mimran, A. (2006) · EMC - Cardiologie · doi:10.1016/s1166-4568(01)00042-0
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Schächter, M. (2003) · Side effects of drugs annual · doi:10.1016/s0378-6080(03)80020-x
Orthostatic Hypotension and Vasovagal Syncope
Shaw, B. H., Ng, J., & Raj, S. R. (2017) · Elsevier eBooks · doi:10.1016/b978-0-12-809657-4.99798-9 · Cited by 2
Khashaba, P. Y., Derayea, S. M., Naggi, D. M., et al. (2023) · SSRN Electronic Journal · doi:10.2139/ssrn.4522528
Synkopen – Differenzialdiagnosen und Behandlungsmöglichkeiten
Vogel, M., & Fischer, T. H. (2024) · DMW - Deutsche Medizinische Wochenschrift · doi:10.1055/a-2186-1100 · Cited by 1
“Insbesondere Midodrin hatte in früheren randomisiert-kontrollierten Studien einen Therapienutzen bei Patienten mit neurogener ortho-statischer Hypotonie gezeigt [17, 18].”
Background(2000) · Time to knit · doi:10.1016/s1166-4568(22)91323-3
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Chaudhuri, К. R., Jenner, P. G., Leta, V., Jones, S., & Boura, I. (2025) · Cambridge University Press eBooks · doi:10.1017/9781009222648.029
Space pharmaceutical technology
Patil, S., Li, D., Liang, R., Jin, X., Tian, Y., & Qian, A. (2025) · Elsevier eBooks · doi:10.1016/b978-0-443-36338-2.00012-2
Mahmoud, M. A., Osman, H. A. M., & Hamed, K. A. E. (2025) · Anaesthesia Pain & Intensive Care · doi:10.35975/apic.v29i3.2752
Hadžić, B., Romčević, N. Ž., Markovic, N., Petrovic, M. G., Bojić, M., & Milovanović, B. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14186386
“A systematic review of clinical trials demonstrated that Midodrine significantly improves standing systolic blood pressure and relieves symptoms associated with OH [4].”
Approaches for treating cardiovascular symptoms in Parkinson’s disease
Jost, W. H., & Koschel, J. (2025) · Therapeutic Advances in Neurological Disorders · doi:10.1177/17562864251375181
Orthostatic Hypotension and Postural Orthostatic Tachycardia
Cherchi, M. (2025) · Springer eBooks · doi:10.1007/978-3-031-94841-1_141
Cherchi, M. (2025) · Springer eBooks · doi:10.1007/978-3-031-94841-1_242
Blétry, O. (2009) · Elsevier eBooks · doi:10.1016/b978-2-294-01781-0.50122-9
Tremblay, J.-A., Laramée, P., Lamarche, Y., Denault, A. Y., Beaubien‐Souligny, W., Frenette, A.-J., Kontar, L., Serri, K., & Charbonney, E. (2020) · Figshare · doi:10.6084/m9.figshare.12955873
Tremblay, J.-A., Laramée, P., Lamarche, Y., Denault, A. Y., Beaubien‐Souligny, W., Frenette, A.-J., Kontar, L., Serri, K., & Charbonney, E. (2020) · Figshare · doi:10.6084/m9.figshare.12955876
Tremblay, J.-A., Laramée, P., Lamarche, Y., Denault, A. Y., Beaubien‐Souligny, W., Frenette, A.-J., Kontar, L., Serri, K., & Charbonney, E. (2020) · Figshare · doi:10.6084/m9.figshare.12955870
Doyle, K., Rice, C. P., Kenny, R. A., Briggs, R., & Lavan, A. H. (2026) · Blood Pressure · doi:10.1080/08037051.2026.2618319
Writers, A. M. (2013) · Drugs & Therapy Perspectives · doi:10.1007/s40267-013-0103-3
Basunlu, M. T., Akdeniz, C., Sarı, G., & Tuzcu, V. (2026) · Cardiology in the Young · doi:10.1017/s1047951126111500
Gibson, G. A., Lista, A. D., & Pouliot, J. D. (2026) · Journal of Pharmacy Practice · doi:10.1177/08971900261431490
Castellanos, J. R. L. (2026) · Clinical Autonomic Research · doi:10.1007/s10286-026-01213-4
Rajesh, S., Lee, G. R., Gao, K. J., Verma, A., & Juraschek, S. P. (2026) · Current Hypertension Reports · doi:10.1007/s11906-026-01368-5
Orthostatic hypotension: new frontiers in pharmacotherapeutic management
Baker, J. R., & Raj, S. R. (2026) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2026.2688305
“In randomized trials, midodrine increased standing systolic blood pressure by about 22 mmHg at a dose of 10 mg three times daily, with dose-response data showing 1-hour increases of 34 mmHg with 10 mg and 43 mmHg with 20 mg [63–65].”
Khetan, A., Gadgil, S., Rainchwar, S., et al. (2026) · Neurology and Clinical Neuroscience · doi:10.1002/ncn3.70152
Hypotension orthostatique : mécanismes, étiologies et principes de traitement
Blétry, O., & Marroun, I. (2013) · Time to knit · doi:10.1016/s1634-6939(13)59290-8
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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