6/28/23, 11:34 PM IIHTT Pathway Feedback Search Clinical Topics Home Studies IIHTT IIHTT Disease Idiopathic intracranial hypertens Trial question What is the effect of acetazolamide in patients with idiopathic intracranial hypertension and mild visual loss? Study design Multi-center Double blinded RCT Population Characteristics of study participants 98.0% female N = 165 2.0% male 165 patients (161 female, 4 male) Inclusion criteria: patients with idiopathic intracranial hypertension and mild visual loss who received a low-sodium weight-reduction diet Key exclusion criteria: total treatment of idiopathic intracranial hypertension > 2 weeks; previous surgery for idiopathic intracranial hypertension; abnormal cerebrovascular fluid contents; abnormalities on neurologic examination aside from papilledema Interventions N=86 acetazolamide (maximally tolerated dosage of up to 4 g/day for 6 months) N=79 placebo (matching placebo for 6 months) Primary outcome Improvement in perimetric mean deviation in most affected eye at 6 months 1.4 dB 1.43 https://web.pathway.md/studies/recoxGsf65OfOisqv 1/2 6/28/23, 11:34 PM IIHTT Pathway 1.1 dB 0.7 dB 0.71 0.4 dB Borderline significant increase 0.0 dB Acetazolamide Placebo Borderline significant increase in improvement in perimetric mean deviation in the most affected eye at 6 months (1.43 dB vs. 0.71 dB; AD 0.71 dB, 95% CI 0 to 1.43) Secondary outcomes Significant decrease in improvement in papilledema grade (-1.31 vs. -0.61; AD -0.7, 95% CI -0.99 to -0.41) Significant increase in vision-related quality of life (8.33 vs. 1.98; AD 6.35, 95% CI 2.22 to 10.47) Significant increase in weight reduction (7.5 kg vs. 3.45 kg; AD 4.05 kg, 95% CI 1.83 to 6.27) Safety outcomes No significant differences in dizziness, dyspnea, headache. Significant differences in diarrhea (14.0% vs. 3.8%), vomiting (14.0% vs. 3.8%), dysgeusia (15.1% vs. 0%), paresthesia (47.7% vs. 6.3%), reduction in CO2 level (10.5% vs. 0%). Conclusion In patients with idiopathic intracranial hypertension and mild visual loss who received a low- sodium weight-reduction diet, acetazolamide was superior to placebo with respect to improvement in perimetric mean deviation in the most affected eye at 6 months. Reference NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee, Michael Wall, Michael P McDermott 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. Open reference URL https://web.pathway.md/studies/recoxGsf65OfOisqv 2/2