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Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial.
J Neuroophthalmol. 2016 Mar; 36(1):13-9.JN

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.

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 ∞; 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.

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.

Authors+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

26587993

Citation

ten Hove, Martin W., et al. "Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial." Journal of Neuro-ophthalmology : the Official Journal of the North American Neuro-Ophthalmology Society, vol. 36, no. 1, 2016, pp. 13-9.
ten Hove MW, Friedman DI, Patel AD, et al. Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial. J Neuroophthalmol. 2016;36(1):13-9.
ten Hove, M. W., Friedman, D. I., Patel, A. D., Irrcher, I., Wall, M., & McDermott, M. P. (2016). Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial. Journal of Neuro-ophthalmology : the Official Journal of the North American Neuro-Ophthalmology Society, 36(1), 13-9. https://doi.org/10.1097/WNO.0000000000000322
ten Hove MW, et al. Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial. J Neuroophthalmol. 2016;36(1):13-9. PubMed PMID: 26587993.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and Tolerability of Acetazolamide in the Idiopathic Intracranial Hypertension Treatment Trial. AU - ten Hove,Martin W, AU - Friedman,Deborah I, AU - Patel,Anil D, AU - Irrcher,Isabella, AU - Wall,Michael, AU - McDermott,Michael P, AU - ,, PY - 2015/11/21/entrez PY - 2015/11/21/pubmed PY - 2016/11/12/medline SP - 13 EP - 9 JF - Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society JO - J Neuroophthalmol VL - 36 IS - 1 N2 - 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 ∞; 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. 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. SN - 1536-5166 UR - https://www.unboundmedicine.com/medline/citation/26587993/Safety_and_Tolerability_of_Acetazolamide_in_the_Idiopathic_Intracranial_Hypertension_Treatment_Trial_ L2 - https://doi.org/10.1097/WNO.0000000000000322 DB - PRIME DP - Unbound Medicine ER -