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JAMA. 2014 Apr 23-30;311(16):1641-51. doi: 10.1001/jama.2014.3312.

Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial.

Collaborators (306)

Wall M, Corbett J, Feldon S, Friedman D, Keltner J, Kieburtz K, Kupersmith M, McDermott MP, Schron EB, Katz D, Hales T, Casaceli C, Banik R, Kedhar S, Levin F, Feistmann J, Tai K, Yang A, Tobias K, Rivas M, Dominguez L, Perez V, Longmuir R, Thurtell M, Eden T, Kardon R, Lesser R, O'Neil Y, Heaton S, Gintowt N, Rudich D, Digre K, Warner J, Hart B, Wegner K, Carlstrom B, Allman S, Katz B, Haroldsen A, Lam BL, Pasol J, Rosa PR, Morante A, Verriotto J, Katz D, Asbury T, Gerwin R, Barnett M, Hamilton S, Tongco C, Gangadharan B, May E, Patel A, Farris B, Siatkowsk R, Miller H, Bergman V, White K, O'Dell S, Andrezik J, Tytle T, Shindler K, Dupont J, Salvo R, Drossner S, Ward S, Lo J, Engelhard S, Windsor E, Khella S, Tamhankar M, Van Stavern G, Kambarian J, Van Stavern R, Civitelli K, Shepherd J, Bruce BB, Biousse V, Newman NJ, Brower J, Curtis L, Vaphiades M, Searcey K, Kline L, McDonald R, Givre SJ, Hales T, Bye P, Fuller K, Carnes KM, James K, Ragland M, Chung SM, Govreau DM, Lind JT, Williams Z, O'Gara G, Steinmetz K, Perevich M, Skrine K, Carter E, Ramchandran R, Katz S, Criden M, Coman G, McGregor J, Inman A, Subramanian PS, Hoffman PN, Medura M, Hartnett M, Siddiqui M, Brown D, Arnold E, Boring J, Miller NR, Quiros P, Ramos S, Padilla M, Cisneros L, Kao A, Chicani CF, Na K, Tang R, Frishman L, Cajavilca P, Newland S, Gantz L, Prieto MG, Pass A, Holdeman NR, Lee MS, Roemhild H, Elasky W, Holleschau A, Fissgus J, Walski J, Harrison A, Falardeau J, Hills W, Bryant C, Kim D, Armour R, Higginbotham L, Newman SA, Holbrook K, Cook LD, Bacon H, Beall J, Goddard T, Hall W, Hamilton D, Lyon A, Fletcher W, Subramaniam S, Reimer J, Nickerson J, Costello F, Rismondo-Stankovich V, Flanagan M, Jensen A, Sibony P, Lavorna AM, Mladek M, Tenzler R, Honkanen R, Miller-Horn J, Krupp L, Rizzo J, Cestari D, Snebold N, Vatcher B, Matera C, Miretsky E, Oakley J, Dumser J, Alperen T, Baptista-Pires S, Bator U, Barrett B, Callahan C, Brett S, Zimmerman K, Grillo M, Capaccioli K, Bhatti M, Greene L, Santiago-Turla MC, McClain N, El-Dairi M, Schatz M, Carter JE, O'Connor P, Mojica D, Smith J, Trigo Y, Kellogg SS, Martinez A, Comeau P, Sanchez A, McCarthy N, Perez E, Bazan C, Maitland C, Brooks H Jr, Gorsica R, Sherman B, Kramer J, Frohman L, Ribeiro A, Boschert K, Tu Yf, Rivera S, Turbin R, ten Hove M, Breen A, Simms C, Kemp M, Farmer J, Granadier R, Osentoski T, Cumming K, Lewis B, Stec L, Kattah JC, Pula J, Buttice MR, DuPage K, Cooley K, Beck J, Bannon L, Guede C, Mejico L, Ko M, Jubelt B, Grosso M, Chilton M, Watson ML, Moore J, Martin T, Everhart C, Fish J, Cooke L, Dickinson J, Acierno MD, Watts R, Thomassie A, Rao A, Chiasson TM, Rucker JC, Hannigan C, Katz-Sand I, Rajguru D, Kedar S, Vega N, Morris S, Pearson A, Hanson M, Kovacs B, Weil R, Pi-Sunyer X, Feldon S, Fisher W, Castillo D, Davis V, Fagan L, Hollar R, Keenan T, MacDowell P, Keltner J, Plumb K, Leming L, Werner J, Harvey D, Johnson C, Keltner J, Werner J, Plumb K, Leming L, Bausch J, Gao S, He H, Tu X, Baker D, Constantinescu R, Helles K, McMullen N, Olsen B, Preston L, Snively V, Stoutenburg A, Friedman D, Ayanru O, Moss EA, Patel P, Mills R, Maguire M, Hart W Jr, Katz J, Kaufman D, McCarthy C, Selhorst J, Digre K, Corbett J, Miller NR, Mills R.

Author information

1
University of Iowa, Iowa City.
2
University of Rochester School of Medicine & Dentistry, Rochester, New York.
3
University of Mississippi Medical Center, Jackson.
4
University of Rochester Eye Institute, Rochester, New York.
5
University of Texas Southwestern Medical Center, Dallas.
6
Bethesda Neurology LLC, Bethesda, Maryland.
7
University of California, Davis Medical Center.
8
National Eye Institute, Bethesda, Maryland.
9
Roosevelt Hospital, New York, New York.

Abstract

IMPORTANCE:

Acetazolamide is commonly used to treat idiopathic intracranial hypertension (IIH), but there is insufficient information to establish an evidence base for its use.

OBJECTIVE:

To determine whether acetazolamide is beneficial in improving vision when added to a low-sodium weight reduction diet in patients with IIH and mild visual loss.

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:

Low-sodium weight-reduction diet plus the maximally tolerated dosage of acetazolamide (up to 4 g/d) or matching placebo for 6 months.

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.

PMID:
24756514
PMCID:
PMC4362615
DOI:
10.1001/jama.2014.3312
[Indexed for MEDLINE]
Free PMC Article

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