Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial

Martin W ten Hove; Deborah I Friedman; Anil D Patel; Isabella Irrcher; Michael Wall; Michael P McDermott

doi:10.1097/WNO.0000000000000322

Back

Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial

Journal article

Peer reviewed

Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial

Martin W ten Hove, Deborah I Friedman, Anil D Patel, Isabella Irrcher, Michael Wall and Michael P McDermott

Journal of neuro-ophthalmology, Vol.36(1), pp.13-19

03/2016

DOI: 10.1097/WNO.0000000000000322

PMID: 26587993

View Online

Abstract

To examine the tolerability and adverse events reported in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT). 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. adverse events (AEs), assessment of clinical and laboratory findings at study visits. 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. 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.

Quality of Life

Intracranial Pressure - drug effects

Pseudotumor Cerebri - drug therapy

Visual Fields - physiology

Double-Blind Method

Pseudotumor Cerebri - diet therapy

Humans

Middle Aged

Male

Combined Modality Therapy

Visual Fields - drug effects

Vision Disorders - drug therapy

Pseudotumor Cerebri - physiopathology

Acetazolamide - adverse effects

Vision Disorders - physiopathology

Maximum Tolerated Dose

Papilledema - physiopathology

Adolescent

Diet, Sodium-Restricted

Adult

Female

Carbonic Anhydrase Inhibitors - adverse effects

Acetazolamide - therapeutic use

Carbonic Anhydrase Inhibitors - therapeutic use

Details

Title: Subtitle: Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial
Creators: Martin W ten Hove - Queen's University
Deborah I Friedman
Anil D Patel
Isabella Irrcher
Michael Wall
Michael P McDermott
Contributors: NORDIC Idiopathic Intracranial Hypertension Study Group (Institution)
Resource Type: Journal article
Publication Details: Journal of neuro-ophthalmology, Vol.36(1), pp.13-19
DOI: 10.1097/WNO.0000000000000322
PMID: 26587993
NLM abbreviation: J Neuroophthalmol
ISSN: 1070-8022
eISSN: 1536-5166
Publisher: United States
Grant note: U10 EY017281-01A1 / NEI NIH HHS U10 EY017387-01A / NEI NIH HHS
Language: English
Date published: 03/2016
Academic Unit: Neurology; Ophthalmology and Visual Sciences
Record Identifier: 9983979948902771

Metrics

32 Record Views

69 Times Cited - Web of Science