title: Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial.
abstract: OBJECTIVE
  To examine the tolerability and adverse events reported in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT).
  
  
  METHODS
  Randomized, double-masked, placebo-controlled clinical trial. Trial participants (n = 165) with mild visual loss concurrently receiving low-sodium weight-reduction diet plus the maximally tolerated dosage of acetazolamide (up to 4 g/d) or placebo for 6 months.
  
  
  METHODS
  adverse events (AEs), assessment of clinical and laboratory findings at study visits.
  
  
  RESULTS
  Thirty-eight of 86 participants randomized to the acetazolamide group (44.1%) tolerated the maximum allowed dosage of 4 g/d. The average time to achieve maximum study dosage in the acetazolamide group was 13 weeks (median 12 weeks; range 10-24 weeks). A total of 676 AEs (acetazolamide, n = 480; placebo, n = 196) and 9 serious AEs (acetazolamide, n = 6; placebo, n = 3) were reported. Notably, the percentages of participants reporting at least 1 AE in the nervous, gastrointestinal, metabolic, and renal organ systems were significantly higher in the acetazolamide group (P < 0.05). The odds of paresthesia (OR 9.82; 95% CI 3.87-27.82), dysgeusia (OR ∞; 95% CI 3.99-∞), vomiting and diarrhea (OR 4.11; 95% CI 1.04-23.41), nausea (OR 2.99; 95% CI 1.26-7.49) and fatigue (OR 16.48; 95% CI 2.39-702.40) were higher in the acetazolamide group than in the placebo group.
  
  
  CONCLUSIONS
  Acetazolamide appears to have an acceptable safety profile at dosages up to 4 g/d in the treatment of idiopathic intracranial hypertension. The majority of participants in the Idiopathic Intracranial Hypertension Treatment Trial were able to tolerate acetazolamide above 1 g/d for 6 months.
authors.affiliation: Department of Ophthalmology (MWtH, II), Queen's University and Hotel Dieu Hospital, Kingston, Ontario, Canada; Departments of Neurology and Neurotherapeutics and Ophthalmology (DIF), University of Texas Southwestern Medical Center, Dallas, Texas; Department of Ophthalmology (ADP), Dean McGee Eye Institute, University of Oklahoma, Oklahoma City, Oklahoma; Department of Neurology (MW), University of Iowa, Iowa City, Iowa; and Department of Biostatistics and Computational Biology (MPM), University of Rochester, Rochester, New York.
authors.forename: Martin W
authors.initials: MW
authors.lastname: ten Hove
authors.forename: Deborah I
authors.initials: DI
authors.lastname: Friedman
authors.forename: Anil D
authors.initials: AD
authors.lastname: Patel
authors.forename: Isabella
authors.initials: I
authors.lastname: Irrcher
authors.forename: Michael
authors.initials: M
authors.lastname: Wall
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
mesh_terms: D000086:Acetazolamide / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D002257:Carbonic Anhydrase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004039:Diet, Sodium-Restricted; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007427:Intracranial Pressure / Q000187:drug effects; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010211:Papilledema / Q000503:physiopathology; D011559:Pseudotumor Cerebri / Q000178:diet therapy* / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D014786:Vision Disorders / Q000188:drug therapy / Q000503:physiopathology; D014794:Visual Fields / Q000187:drug effects / Q000502:physiology
chemical_list: D002257:Carbonic Anhydrase Inhibitors; D000086:Acetazolamide