Treatment for Graves' ophthalmopathy using simvastatin

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

This study is testing if simvastatin can help people with mild to moderate Graves' ophthalmopathy avoid getting worse.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Lund University (other)
• Locations: 1 site (Malmö)
• Trial ID: NCT03131726 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with mild to moderate Graves' ophthalmopathy and specific clinical criteria.

Not a fit: Patients with severe Graves' ophthalmopathy or those who have previously received treatment for the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for managing Graves' ophthalmopathy and preventing its progression.

How similar studies have performed: While the use of simvastatin for this condition is novel, other studies have explored similar approaches with varying degrees of success.

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

Where this trial is running

Malmö

• 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

Conditions: Graves Ophthalmopathy, Thyroid Associated Ophthalmopathy, Thyroid Associated Orbitopathy, simvastatin, diclofenac