Treatment for Graves' ophthalmopathy using simvastatin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of simvastatin in treating patients with mild to moderate Graves' ophthalmopathy. It is a multicenter, randomized study where participants will either receive simvastatin or no treatment, with the aim of preventing progression to severe disease. Patients will be monitored for signs of disease progression and may undergo various laboratory investigations to assess their condition. The trial includes specific withdrawal criteria to ensure patient safety and compliance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-70 years
2. Active mild to moderate with at least one sign of mild GO (NO SPECS class 2a and b) with reference to Colour Atlas at EUGOGO website (www.eugogo.eu). Exophthalmos up to 24 mm with a disease duration of \<18 months (as recorded by the patient)
3. Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD), or 2 months treatment with ATD, or euthyroid 6 months after treatment with radioiodine, or euthyroid after total thyroidectomy. Clinical and laboratory euthyroidism is defined as normal fT4, fT3 and TSH below the upper limit of the local reference interval and no clinical symptoms or signs of hyperthyroidism. L-thyroxine is used to achieve euthyroidism during the study period.

Exclusion Criteria:

1. Pregnancy or breast-feeding
2. Previous treatment of Graves´ ophthalmopathy
3. Severe Graves ophthalmopathy requiring corticosteroid treatment, retrobulbar irradiation, orbital decompression surgery
4. Current or previous treatment with simvastatin or other statins (within 3 months)
5. Allergy (skin rash or systemic reactions) to statins
6. Congestive heart failure
7. Renal insufficiency (glomerular filtration rate \<60 ml/min)
8. ASAT or ALAT \> 2.5 times the upper limit of the local laboratory
9. Alcoholism as judged by local criteria
10. Coagulopathy including treatment with warfarin or new oral anti-coagulation drugs
11. Previous or current gastric ulcer
12. Inflammatory bowel disease diabetic retinopathy or nephropathy
13. Trauma within 10 days

Where it's running

• Dpt. of Endocrinology, SUS Malmö
  Malmö, Sweden Recruiting

Study contacts

• Principal investigator: Tereza Planck, MD, PhD — Lund University and Skåne University Hospital
• Study coordinator: Tereza Planck, MD, PhD
• Email: tereza.planck@med.lu.se
• Phone: +46-733873399

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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.