Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension: A randomized, double-blind multicenter study

Phillip Anson Low, Janice L. Gilden, Roy Freeman, Ke Ning Sheng, Mary Ann McElligott

Research output: Contribution to journalArticle

392 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1046-1051
Number of pages6
JournalJournal of the American Medical Association
Volume277
Issue number13
StatePublished - Apr 2 1997

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Midodrine
Orthostatic Hypotension
Double-Blind Method
Multicenter Studies
Placebos
Blood Pressure
Fludrocortisone
Research Personnel
Single-Blind Method
Clothing
Urinary Retention
Dizziness
Referral and Consultation
Outcome Assessment (Health Care)
Hypertension

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension : A randomized, double-blind multicenter study. / Low, Phillip Anson; Gilden, Janice L.; Freeman, Roy; Sheng, Ke Ning; McElligott, Mary Ann.

In: Journal of the American Medical Association, Vol. 277, No. 13, 02.04.1997, p. 1046-1051.

Research output: Contribution to journalArticle

Low, Phillip Anson ; Gilden, Janice L. ; Freeman, Roy ; Sheng, Ke Ning ; McElligott, Mary Ann. / Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension : A randomized, double-blind multicenter study. In: Journal of the American Medical Association. 1997 ; Vol. 277, No. 13. pp. 1046-1051.
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