RecruitingPhase 3NCT03131726

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

Sponsor

Lund University

Enrollment

80 participants

Start Date

Jan 26, 2018

Study Type

INTERVENTIONAL

Conditions

Thyroid Associated Ophthalmopathy Graves Ophthalmopathy Thyroid Associated Orbitopathy

Summary

In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients with mild to moderate Graves´ ophthalmopathy treated with simvastatin or no treatment.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

Age 18-70 years
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)
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 Criteria13

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