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Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial.
JAMA. 2014 Apr 23-30; 311(16):1641-51.JAMA

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.

Authors+Show Affiliations

No affiliation info availableUniversity of Iowa, Iowa City.University of Rochester School of Medicine & Dentistry, Rochester, New York.University of Rochester School of Medicine & Dentistry, Rochester, New York.University of Mississippi Medical Center, Jackson.University of Rochester Eye Institute, Rochester, New York.University of Texas Southwestern Medical Center, Dallas.Bethesda Neurology LLC, Bethesda, Maryland.University of California, Davis Medical Center.National Eye Institute, Bethesda, Maryland.Roosevelt Hospital, New York, New York.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, American Recovery and Reinvestment Act
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

24756514

Citation

NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee, et al. "Effect of Acetazolamide On Visual Function in Patients With Idiopathic Intracranial Hypertension and Mild Visual Loss: the Idiopathic Intracranial Hypertension Treatment Trial." JAMA, vol. 311, no. 16, 2014, pp. 1641-51.
NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee, Wall M, McDermott MP, et al. Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial. JAMA. 2014;311(16):1641-51.
Wall, M., McDermott, M. P., Kieburtz, K. D., Corbett, J. J., Feldon, S. E., Friedman, D. I., Katz, D. M., Keltner, J. L., Schron, E. B., & Kupersmith, M. J. (2014). Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial. JAMA, 311(16), 1641-51. https://doi.org/10.1001/jama.2014.3312
NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee, et al. Effect of Acetazolamide On Visual Function in Patients With Idiopathic Intracranial Hypertension and Mild Visual Loss: the Idiopathic Intracranial Hypertension Treatment Trial. JAMA. 2014 Apr 23-30;311(16):1641-51. PubMed PMID: 24756514.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial. AU - ,, AU - Wall,Michael, AU - McDermott,Michael P, AU - Kieburtz,Karl D, AU - Corbett,James J, AU - Feldon,Steven E, AU - Friedman,Deborah I, AU - Katz,David M, AU - Keltner,John L, AU - Schron,Eleanor B, AU - Kupersmith,Mark J, PY - 2014/4/24/entrez PY - 2014/4/24/pubmed PY - 2014/5/3/medline SP - 1641 EP - 51 JF - JAMA JO - JAMA VL - 311 IS - 16 N2 - 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/24756514/Effect_of_acetazolamide_on_visual_function_in_patients_with_idiopathic_intracranial_hypertension_and_mild_visual_loss:_the_idiopathic_intracranial_hypertension_treatment_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2014.3312 DB - PRIME DP - Unbound Medicine ER -