title: Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine.
abstract: OBJECTIVE
  To investigate the efficacy and safety of midodrine for treatment of patients with orthostatic hypotension due to autonomic failure.
  
  
  METHODS
  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 midodrine-treated patients, was most frequent. Other reported side effects included supine hypertension (8%) and feelings of urinary urgency (4%).
  
  
  CONCLUSIONS
  We conclude that midodrine is an effective and well-tolerated treatment for moderate-to-severe orthostatic hypotension associated with autonomic failure.
authors.affiliation: Department of Neurology, Baylor College of Medicine, Houston, Texas 77030.
authors.forename: J
authors.initials: J
authors.lastname: Jankovic
authors.forename: J L
authors.initials: JL
authors.lastname: Gilden
authors.forename: B C
authors.initials: BC
authors.lastname: Hiner
authors.forename: H
authors.initials: H
authors.lastname: Kaufmann
authors.forename: D C
authors.initials: DC
authors.lastname: Brown
authors.forename: C H
authors.initials: CH
authors.lastname: Coghlan
authors.forename: M
authors.initials: M
authors.lastname: Rubin
authors.forename: F M
authors.initials: FM
authors.lastname: Fouad-Tarazi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001342:Autonomic Nervous System Diseases / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007024:Hypotension, Orthostatic / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D008879:Midodrine / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D008879:Midodrine