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Statins for Graves' orbitopathy (STAGO): A phase 2, open-label, adaptive, single centre, randomised clinical trial

The Lancet Diabetes & Endocrinology Oct 26, 2021

Lanzolla G, Sabini E, Leo M, et al. - Graves' orbitopathy outcomes were improved as a result of addition of oral atorvastatin to an intravenous glucocorticoid (ivGC) regimen in patients with moderate-to-severe, active eye disease who were hypercholesterolaemic.

  • This randomised, phase 2, adaptive, clinical trial involved 88 patients with moderate-to-severe, active Graves' orbitopathy, with a low-density lipoprotein cholesterol level between 2·97 and 4·88 mmol/L.

  • Patients were randomized to either ST group [44 [50%] (ivGCs for 12 weeks and oral atorvastatin for 24 weeks) or NST group 44 [50%] (only received the ivGC regimen).

  • The modified intention-to-treat population comprised 80 (91%) patients.

  • In the ST group, there was a higher proportion of Graves' orbitopathy composite evaluation responders at 24 weeks (21 [51%] of 41 patients) vs the NST group (11 [28%] of 39 patients; attributable risk 0·23).

  • In safety analysis, only 2% of patients needed treatment cessation in each group, with no serious adverse events and no difference between groups.

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