Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)

What this trial studies

Graves' disease (GD) is an autoimmune thyroid disorder in which stimulating antibodies against the thyrotropin receptor cause hyperthyroidism. Graves' orbitopathy (GO), also referred to as thyroid eye disease, is the most important extrathyroidal manifestation of GD. GO may cause pain, swelling, redness, proptosis, diplopia, impaired quality of life, and, in severe cases, visual impairment. Although treatment of established GO has improved, there are currently limited options for preventing the development of GO in patients with newly diagnosed GD. Observational studies have suggested that treatment with statins may be associated with a lower risk of developing GO in patients with GD. Statins have anti-inflammatory and immunomodulatory effects in addition to their lipid-lowering properties, providing a biological rationale for evaluating whether statin treatment can prevent GO. However, the preventive effect of statins has not been established in a sufficiently large randomized controlled trial. ATORGO is a multicenter, randomized, controlled clinical trial designed to evaluate whether treatment with atorvastatin reduces the risk of developing active GO in adults with newly diagnosed GD. Participants are randomized in a 1:1 ratio to receive atorvastatin 40 mg once daily for 12 months in addition to standard treatment for GD, or standard treatment for GD alone. Participants are followed for 18 months after randomization. Clinical assessments are performed at predefined stud…

Who can join: the full rules

Inclusion Criteria:

* Age 18-85 years.
* Newly diagnosed Graves' disease, defined as TSH \<0.1 with elevated free T4 and/or free T3 and positive TSH-receptor antibodies (TRAb).
* Ability to understand medical information in Swedish.

Exclusion Criteria:

* Pregnancy, planned pregnancy within 12 months, or lactation.
* Mental inability, reluctance, or language difficulties resulting in difficulty understanding the meaning of participation in the trial.
* Prior treatment with statins, other lipid-lowering drugs, selenium, corticosteroids, or other immunosuppressive medications for more than 7 days within the 3 months preceding Graves' disease diagnosis.
* Existing Graves' ophthalmopathy at the time of Graves' disease diagnosis.
* Known hypersensitivity to atorvastatin or other statins.
* Active liver disease.
* Alcohol abuse.
* Elevated liver enzymes (AST/ALT \>3 times the upper limit of normal) in two consecutive tests.
* Creatine kinase (CK) \>5 times the upper limit of normal at screening/baseline.
* Concurrent use of medications that interact with statins, particularly CYP3A4 inhibitors or inducers.
* Need for corticosteroid prophylaxis in connection with planned radioiodine therapy.

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden
• Skåne University Hospital - Lund
  Lund, Sweden
• Skåne University Hospital - Malmö
  Malmö, Sweden
• Örebro University Hospital
  Örebro, Sweden
• Karolinska University Hospital
  Stockholm, Sweden
• Norrland University Hospital
  Umeå, Sweden

Study contacts

• Principal investigator: Tereza Planck — Region Skåne, Endokrinologimottagning
• Study coordinator: Tereza Planck, MD, PhD
• Email: tereza.planck@med.lu.se
• Phone: +46-40-337276

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.