Cited by 428Cardiovascular Syncope and Autonomic DisordersHeart Rate Variability and Autonomic ControlBlood Pressure and Hypertension Studies

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Efficacy of Midodrine vs Placebo in Neurogenic Orthostatic Hypotension: A Randomized, Double-blind Multicenter Study

Low, Phillip A.·1997·JAMA

DOI 10.1001/jama.1997.03540370036033

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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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“En cas d’inefficacité de ces mesures, deux médicaments ont fait la preuve de leur efficacité : la fludrocortisone [75] (dose quotidienne 10–300 mg en une prise), minéralocorticoı̈de favorisant la rétention hydrosodée, et la midodrine [76] (trois prises quotidiennes de 2,5–10 mg, à ne pas donner le soir), agoniste a-ad…”
Background
Combination therapy of midodrine and droxidopa for refractory hypotension in heart failure with preserved ejection fraction per a pharmacist’s proposal: a case report
Asai, Y., Sato, T., Kito, D., Yamamoto, T., Hioki, I., Urata, Y., & Abe, Y. (2021) · Journal of Pharmaceutical Health Care and Sciences · doi:10.1186/s40780-021-00193-z · Cited by 4
Droxidopa for the treatment of neurogenic orthostatic hypotension and other symptoms of neurodegenerative disorders
Perez‐Lloret, S., Rey, M. V., Traon, A. P., & Rascol, O. (2014) · Expert Opinion on Orphan Drugs · doi:10.1517/21678707.2014.901167 · Cited by 4
“It is the only drug approved for OH treatment by the FDA and in many European countries [69,70].”
Background
Hemodynamic effects of 3 months of therapy with midodrine in cirrhotic patients with and without ascites
Oda, A. M. A., Basuni, A. A., Badran, H. M., et al. (2011) · Egyptian Liver Journal · doi:10.1097/01.elx.0000398638.27770.14 · Cited by 4
Parkinson’s Disease: An Overview of Etiology, Clinical Manifestations, and Treatment
Dalvi, A., Lyons, K. E., & Pahwa, R. (2014) · Springer eBooks · doi:10.1007/978-3-319-08046-8_1 · Cited by 4
Prospects for Droxidopa in Neurogenic Orthostatic Hypotension
Ross, A. J., & Stewart, J. M. (2014) · Hypertension · doi:10.1161/hypertensionaha.114.04204 · Cited by 4
Multiple System Atrophy: Clinical, Genetics, and Neuropathology
Schottlaender, L., Sailer, A., Ahmed, Z., Dickson, D. W., Houlden, H., & Ross, O. A. (2017) · Neurodegeneration · doi:10.1002/9781118661895.ch7 · Cited by 4
Case Forum
Twardowski, Z. J., Schreiber, M. J., Burkart, J. M., et al. (1998) · Peritoneal Dialysis International · doi:10.1177/089686089801800622 · Cited by 4

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
DOI: 10.1001/jama.1997.03540370036033
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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Efficacy of Midodrine vs Placebo in Neurogenic Orthostatic Hypotension: A Randomized, Double-blind Multicenter Study

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