In patients with moderate-to-sever active eye disease who were hypercholesterolaemic, treatment with oral atorvastatin in addition to an intravenous glucocorticoids (ivGCs) regimen improved Graves’ orbitopathy outcomes, according to results of a Phase 2 clinical trial.
This study enrolled 88 patients who were randomly assigned to receive statins (ST group; n = 44) or not receive statins (NST group; n = 44). At the 12-week visit, 8 patients were lost to follow-up. The modified ITT population included 41 patients in the ST group and 39 in the NST group.
At 24 weeks, the percentage of Graves’ orbitopathy composite evaluation responders was higher in the ST group than the NST group (51% vs 28%).
In the safety population, 26 adverse events were reported in 21 patients. Treatment discontinuation was needed in 1 patient in each group.
Reference
Lanzolla G, Sabini E, Leo M, et al. Statins for Graves’ orbitopathy (STAGO): A phase 2, open-label, adaptive, single centre, randomised clinical trial. Lancet Diabetes Endocrinol. 2021; DOI:https://doi.org/10.1016/S2213-8587(21)00238-2.
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