Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)

Launched by LUND UNIVERSITY · Apr 24, 2017

Keywords

ClinConnect Summary

This clinical trial, called the GO-S trial, is looking into the effects of a medication called simvastatin on people with Graves' ophthalmopathy, a condition that can cause swelling and discomfort around the eyes. The study is specifically focusing on patients who have mild to moderate symptoms of this condition and want to see if taking simvastatin can help improve their eye health and prevent the condition from getting worse. The trial is taking place in several locations, including Malmö, Odense, and Århus, and is currently recruiting participants.

To be eligible for this trial, participants must be between 18 and 70 years old and have active, mild to moderate Graves' ophthalmopathy with specific symptoms. They should also be in a stable state regarding their thyroid health, meaning their thyroid hormone levels are normal. However, certain individuals, like those who are pregnant, have severe symptoms, or have taken simvastatin recently, cannot participate. If you join the trial, you will be monitored closely to assess how well the treatment works and what effects it may have on your eye condition. This study aims to provide valuable information that could help improve treatments for Graves' ophthalmopathy in the future.

Gender

ALL

Eligibility criteria

• 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