Abstract | IMPORTANCE: OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, double-masked, placebo-controlled study of acetazolamide in 165 participants with IIH and mild visual loss who received a low- sodium weight-reduction diet. Participants were enrolled at 38 academic and private practice sites in North America from March 2010 to November 2012 and followed up for 6 months (last visit in June 2013). All participants met the modified Dandy criteria for IIH and had a perimetric mean deviation (PMD) between -2 dB and -7 dB. The mean age was 29 years and all but 4 participants were women. INTERVENTIONS: MAIN OUTCOMES AND MEASURES: The planned primary outcome variable was the change in PMD from baseline to month 6 in the most affected eye, as measured by Humphrey Field Analyzer. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to -32 dB; larger negative values indicate greater vision loss. Secondary outcome variables included changes in papilledema grade, quality of life (Visual Function Questionnaire 25 [VFQ-25] and 36-Item Short Form Health Survey), headache disability, and weight at month 6. RESULTS: The mean improvement in PMD was greater with acetazolamide (1.43 dB, from -3.53 dB at baseline to -2.10 dB at month 6; n = 86) than with placebo (0.71 dB, from -3.53 dB to -2.82 dB; n = 79); the difference was 0.71 dB (95% CI, 0 to 1.43 dB; P = .050). Mean improvements in papilledema grade ( acetazolamide: -1.31, from 2.76 to 1.45; placebo: -0.61, from 2.76 to 2.15; treatment effect, -0.70; 95% CI, -0.99 to -0.41; P < .001) and vision-related quality of life as measured by the National Eye Institute VFQ-25 ( acetazolamide: 8.33, from 82.97 to 91.30; placebo: 1.98, from 82.97 to 84.95; treatment effect, 6.35; 95% CI, 2.22 to 10.47; P = .003) and its 10-item neuro-ophthalmic supplement ( acetazolamide: 9.82, from 75.45 to 85.27; placebo: 1.59, from 75.45 to 77.04; treatment effect, 8.23; 95% CI, 3.89 to 12.56; P < .001) were also observed with acetazolamide. Participants assigned to acetazolamide also experienced a reduction in weight ( acetazolamide: -7.50 kg, from 107.72 kg to 100.22 kg; placebo: -3.45 kg, from 107.72 kg to 104.27 kg; treatment effect, -4.05 kg, 95% CI, -6.27 to -1.83 kg; P < .001). CONCLUSIONS AND RELEVANCE: In patients with IIH and mild visual loss, the use of acetazolamide with a low- sodium weight-reduction diet compared with diet alone resulted in modest improvement in visual field function. The clinical importance of this improvement remains to be determined. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01003639.
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Authors | NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee, Michael Wall, Michael P McDermott, Karl D Kieburtz, James J Corbett, Steven E Feldon, Deborah I Friedman, David M Katz, John L Keltner, Eleanor B Schron, Mark J Kupersmith |
Journal | JAMA
(JAMA)
2014 Apr 23-30
Vol. 311
Issue 16
Pg. 1641-51
ISSN: 1538-3598 [Electronic] United States |
PMID | 24756514
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, American Recovery and Reinvestment Act, Research Support, N.I.H., Extramural)
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Chemical References |
- Carbonic Anhydrase Inhibitors
- Acetazolamide
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Topics |
- Acetazolamide
(therapeutic use)
- Adult
- Carbonic Anhydrase Inhibitors
(therapeutic use)
- Combined Modality Therapy
- Diet, Sodium-Restricted
- Female
- Humans
- Male
- Pseudotumor Cerebri
(complications, diet therapy, drug therapy)
- Quality of Life
- Treatment Outcome
- Vision Disorders
(drug therapy, etiology)
- Weight Loss
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