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

• Published in: The American journal of medicine Vol. 95; no. 1; pp. 38 - 48
• Main Authors: Jankovic, Joseph, Gilden, Janice L., Hiner, Bradley C., Kaufmann, Horacio, Brown, David C., Coghlan, Cecil H., Rubin, Michael, Fouad-Tarazi, Fetnat M.
• Format: Journal Article
• Language: English
• Published: Legacy CDMS Elsevier Inc 01.07.1993; Elsevier; Elsevier Sequoia S.A
• Subjects: Adult; Aerospace Medicine; Aged; Aged, 80 and over; Autonomic Nervous System Diseases - complications; Biological and medical sciences; Blood pressure; Cardiovascular system; Double-Blind Method; Drug therapy; Female; Humans; Hypotension, Orthostatic - drug therapy; Hypotension, Orthostatic - etiology; Male; Medical research; Medical sciences; Middle Aged; Midodrine - adverse effects; Midodrine - therapeutic use; Pharmacology. Drug treatments; Vascular wall; Nasa Discipline Cardiopulmonary; Clinical Trial; Nasa Discipline Number 14-10; Nasa Program Space Physiology And Countermeasures; Non-Nasa Center; Multicenter Study; Randomized Controlled Trial; Human; Postural hypotension; Chemotherapy; Treatment; Diseases of the autonomic nervous system; Double blind study; Cardiovascular disease; Result; NASA Discipline Cardiopulmonary; NASA Program Space Physiology and Countermeasures; NASA Discipline Number 14-10; Non-NASA Center
• ISSN: 0002-9343; 1555-7162
• DOI: 10.1016/0002-9343(93)90230-M

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 1-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/lightheadedness, weakness/fatigue, and low energy level). results: Midodrine (10 mg) increased standing systolic blood pressure by 22 mm Hg (28%, p <0.001 versus placebo). Midodrine improved (p<0.05) the following symptoms of orthostatic hypotension compared to placebo: dizziness/lightheadedness, 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 midodrinetreated 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.