Effects of Atorvastatin in Graves' Orbitopathy (GO)
Status:
Completed
Trial end date:
2021-04-30
Target enrollment:
Participant gender:
Summary
Graves' orbitopathy (GO) is the most common extra-thyroidal manifestation of Graves' disease
(GD), being observed in ~25% of patients. Besides genetic and demographical variables, risk
factors associated with the development of GO in GD patients are known to be inadequate
control of hyperthyroidism, radioiodine treatment, and smoking. In a large retrospective
study conducted in more than 8,000 individuals with GD it was observed that treatment with
3-hydroxy-3-methylglutaryl-coenzyme reductase inhibitors, better known as statins, is
associated with a ~40% reduced risk of developing GO in GD patients. The findings were
interpreted as the consequence of the anti-inflammatory action of statins, being GO
notoriously an autoimmune, inflammatory conditions.
Statins are widely used for the treatment of hypercholesterolemia, for which they are quite
effective. The possibility that their "protective" effect in terms of GO development in GD
patients, as observed by Stein et al., was simply due to their hypolipemic actions was not
considered. To evaluate the possibility that the findings reflected lowering of cholesterol
rather than a direct anti-inflammatory effect of statins a prospective, observational study
to assess the association between GO and high cholesterol levels and/or the relationship
between the degree and/or activity of GO and hypercholesterolemia is ongoing. Preliminary
findings suggest that GO is more severe and active in patients with high cholesterol levels.
On the basis of these observations, the present randomized clinical trial was designed to be
performed in hypercholesterolemic patients with GD and moderate-to-severe and active GO,
aimed at investigating if lowering of cholesterol levels with statins is associated with a
better outcome of GO.