PMID- 26587993
OWN - NLM
STAT- MEDLINE
DCOM- 20161110
LR  - 20220408
IS  - 1536-5166 (Electronic)
IS  - 1070-8022 (Linking)
VI  - 36
IP  - 1
DP  - 2016 Mar
TI  - Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial 
      Hypertension Treatment Trial.
PG  - 13-9
LID - 10.1097/WNO.0000000000000322 [doi]
AB  - 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. MAIN OUTCOMES MEASURES: 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 infinity; 95% CI 3.99-infinity), 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. 
      CONCLUSION: 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.
FAU - ten Hove, Martin W
AU  - ten Hove MW
AD  - 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.
FAU - Friedman, Deborah I
AU  - Friedman DI
FAU - Patel, Anil D
AU  - Patel AD
FAU - Irrcher, Isabella
AU  - Irrcher I
FAU - Wall, Michael
AU  - Wall M
FAU - McDermott, Michael P
AU  - McDermott MP
CN  - NORDIC Idiopathic Intracranial Hypertension Study Group
LA  - eng
GR  - U10 EY017281-01A1/EY/NEI NIH HHS/United States
GR  - U10 EY017387-01A/EY/NEI NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - J Neuroophthalmol
JT  - Journal of neuro-ophthalmology : the official journal of the North American 
      Neuro-Ophthalmology Society
JID - 9431308
RN  - 0 (Carbonic Anhydrase Inhibitors)
RN  - O3FX965V0I (Acetazolamide)
SB  - IM
MH  - Acetazolamide/adverse effects/*therapeutic use
MH  - Adolescent
MH  - Adult
MH  - Carbonic Anhydrase Inhibitors/adverse effects/*therapeutic use
MH  - Combined Modality Therapy
MH  - *Diet, Sodium-Restricted
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Intracranial Pressure/drug effects
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Papilledema/physiopathology
MH  - Pseudotumor Cerebri/*diet therapy/*drug therapy/physiopathology
MH  - Quality of Life
MH  - Vision Disorders/drug therapy/physiopathology
MH  - Visual Fields/drug effects/physiology
EDAT- 2015/11/21 06:00
MHDA- 2016/11/12 06:00
CRDT- 2015/11/21 06:00
PHST- 2015/11/21 06:00 [entrez]
PHST- 2015/11/21 06:00 [pubmed]
PHST- 2016/11/12 06:00 [medline]
AID - 10.1097/WNO.0000000000000322 [doi]
PST - ppublish
SO  - J Neuroophthalmol. 2016 Mar;36(1):13-9. doi: 10.1097/WNO.0000000000000322.