Treatment of Graves´Ophthalmopathy With Simvastatin (GO-DS)

• Status: Recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University
• Treatments: Diclofenac; Simvastatin

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