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ARTICLE |

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

Phillip A. Low, MD; Janice L. Gilden, MD; Roy Freeman, MD; Ke-Ning Sheng, PhD; Mary Ann McElligott, PhD
JAMA. 1997;277(13):1046-1051. doi:10.1001/jama.1997.03540370036033.
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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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The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
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