The trial tests the hypothesis that, in adults with active, moderate-to-severe Graves' orbitopathy, 24 weeks of oral atorvastatin 20 mg daily added to a standard 12-week course of intravenous methylprednisolone produces a greater reduction in extraocular muscle size than intravenous methylprednisolone alone, and that any such reduction is accompanied by lower expression of TSH receptor, IGF-1 receptor, PDGF receptor, PI3K/AKT and miR-155 transcripts, and higher expression of miR-146a. The prespecified direction for miR-146a follows its reported suppression in CD4+ T cells in active disease \[26\]. Reported directions of change are compartment-specific and not unanimous, so the transcript analyses are exploratory.
Age 18 to 75 years inclusive
Graves' orbitopathy graded moderate-to-severe by EUGOGO criteria
Active disease, clinical activity score ≥ 3 of 7
Rehabilitative orbital decompression anticipated after completion of glucocorticoid therapy, on the usual clinical grounds
Sight-threatening disease at screening: dysthyroid optic neuropathy or corneal breakdown
Any other autoimmune disease requiring systemic immunosuppresion
Known hypersensitivity to atorvastatin or to any statin
Current or recent (within 3 months) use of any lipid-lowering drug
Banu Aji Dibyasakti
Lead sponsor
Gadjah Mada University
Sponsor institution