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Neurogenic orthostatic hypotension: A double-blind, placebo-controlled study with midodrine

, : Neurogenic orthostatic hypotension: A double-blind, placebo-controlled study with midodrine. American Journal of Medicine 95(1): 38-48

Purpose: To investigate the efficacy and safety of midodrine for treatment of patients with orthostatic hypotension due to autonomic failure. Patients: Ninety-seven patients with orthostatic hypotension were randomized in a 4-week, double-blinded, placebo-controlled study with a I-week placebo run-in period. Patients ranged in age from 22 to 86 years (mean: 61 years). Methods: After a 1-week run-in phase, either placebo or midodrine at a dose of 2.5 mg, 5 mg, or 10 mg was administered three times a day for 4 weeks. Both the placebo group and the 2.5-mg midodrine group received constant doses throughout the double-blind phase. The patients receiving 5 mg or 10 mg of midodrine were given doses that were increased at weekly intervals by 2.5-mg increments until the designated dose was reached. Efficacy evaluations were based on an improvement at 1-hour postdose in standing systolic blood pressure and in symptoms of orthostatic hypotension (syncope, dizziness/light-headedness, weakess/fatigue, and low energy level). Results: Midodrine (10 mg) increased standing systolic blood pressure by 22 mm Hg (28%, p lt 0.001 versus placebo). Midodrine improved (p lt 0.05) the following symptoms of orthostatic hypotension compared to placebo: dizziness/light-headedness, weakness/fatigue, syncope, low energy level, impaired ability to stand, and feelings of depression. The overall side effects were mainly mild to moderate. One or more side effects were reported by 22% of the placebo group compared with 27% of the midodrine-treated group. Scalp pruritus/tingling, which was reported by 10 of 74 (13.5%) of the midorine-treated patients, was most frequent. Other reported side effects included supine hypertension (8%) and feelings of urinary urgency (4%). Conclusion: We conclude that midodrine is an effective and well-tolerated treatment for moderate-to-severe orthostatic hypotension associated with autonomic failure.


PMID: 7687093

DOI: 10.1016/0002-9343(93)90230-m

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