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A study to test if atorvastatin can prevent eye disease in patients newly diagnosed with Graves' disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines Graves' disease, a condition where the thyroid gland becomes overactive and produces too much thyroid hormone. People with Graves' disease can develop a related eye condition called Graves ophthalmopathy, which causes inflammation and swelling around the eyes and can lead to bulging eyes, double vision, pain, and other eye problems. The treatment being tested is atorvastatin, a medication commonly used to lower cholesterol levels, which researchers believe might help prevent the eye problems from developing in people newly diagnosed with Graves' disease.

The purpose of the study is to find out if atorvastatin can prevent the development of active Graves ophthalmopathy in patients who have just been diagnosed with Graves' disease. Participants will take atorvastatin tablets by mouth for a period of 12 months. The maximum daily dose will be 40 milligrams. During the study, patients will be monitored at several time points over 18 months to check if they develop eye problems and to measure the activity level of any eye inflammation using a scoring system. The study will also look at how the treatment affects quality of life and measure certain antibodies in the blood that are related to the disease.

Throughout the study period, researchers will collect information about whether patients need additional treatments for eye problems, such as corticosteroids or other medications. Blood samples will be analyzed to look for biological markers that might help predict who will respond well to the treatment. The study will also examine genetic differences between people who respond to atorvastatin and those who do not. Patients will complete questionnaires about their quality of life at the beginning of the study, after 12 months, and after 18 months to see how the treatment affects their daily living and well-being.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment period begins
Upon joining the study, treatment with atorvastatin will begin. This medication is provided in the form of film-coated tablets and is taken by mouth.
The dosage is 40 mg per tablet. Specific instructions regarding how often to take the medication and the total duration of treatment will be provided by the study physician.
Atorvastatin is being tested to determine if it can prevent the development of active eye disease related to the thyroid condition.
Step 2
Assessment at 3 months
At 3 months after starting treatment, an assessment will be conducted to check for any signs of eye disease.
The evaluation will include checking for symptoms such as eye redness, swelling, or discomfort that may indicate active eye involvement.
Step 3
Assessment at 6 months
At 6 months, another assessment will be performed to monitor for the development of eye disease.
The same type of evaluation will be conducted to detect any changes in eye condition.
Step 4
Assessment at 9 months
At 9 months, a further assessment will take place to continue monitoring for eye disease.
This evaluation follows the same procedures as previous assessments.
Step 5
Primary assessment at 12 months
At 12 months, a comprehensive assessment will be conducted. This is the main evaluation point of the study.
The examination will determine if active eye disease has developed, using a scoring system called Clinical Activity Score, which measures signs of inflammation and disease activity in the eyes.
Blood samples will be taken to measure levels of thyroid-stimulating hormone receptor antibodies, which are proteins in the blood related to the thyroid condition.
Quality of life will be assessed using questionnaires that evaluate how the condition affects daily activities and well-being.
Step 6
Assessment at 15 months
At 15 months, another assessment will be performed to check for any development of eye disease.
This evaluation continues the monitoring process to track any changes over time.
Step 7
Final assessment at 18 months
At 18 months, the final assessment will be conducted.
Blood samples will again be taken to measure thyroid-stimulating hormone receptor antibodies.
Quality of life will be assessed again using the same questionnaires as at the 12-month visit.
This marks the completion of the study period.
Step 8
Additional monitoring throughout the study
Throughout the study period, any need for additional treatments will be monitored. These may include medications such as corticosteroids, radiation therapy to the eye area, or other specialized medications.
Blood samples may be collected at various points for laboratory analysis to identify markers related to eye disease and to study genetic factors that may influence response to treatment.
The time from the initial thyroid disease diagnosis to any development of eye disease will be recorded.

Who can join the trial?

5 criteria

You must be between 18 and 85 years old
You must have a diagnosis of Graves' Disease, which is a condition where the thyroid gland produces too much thyroid hormone. This diagnosis requires:
- A TSH level below 0.1 μU/L. TSH is a hormone that controls your thyroid gland, and a very low level suggests your thyroid is overactive
- Elevated free T4 or free T3 levels. These are thyroid hormones, and high levels mean your thyroid is making too much hormone
- Positive TSH receptor antibodies. These are proteins in your blood that attack your thyroid gland and cause it to be overactive
- You must have sufficient knowledge of Swedish to understand medical information and be able to participate in telephone or video calls

Who cannot join the trial?

10 criteria

Pregnancy or breastfeeding: Women who are pregnant or nursing a baby cannot participate in this study.
Active Graves' eye disease: Patients who already have active Graves' Ophthalmopathy (an eye condition related to Graves' disease where the eyes become swollen, bulging, or irritated) cannot join this trial.
Current use of statins: Patients already taking statin medications (medicines used to lower cholesterol, such as atorvastatin) are not eligible.
Allergy to atorvastatin: Patients with a known allergic reaction to atorvastatin or similar medications cannot participate.
Severe liver disease: Patients with serious liver problems or abnormal liver function tests cannot join the study.
Muscle disorders: Patients with certain muscle diseases or unexplained muscle pain cannot participate.
Uncontrolled thyroid levels: Patients whose thyroid hormone levels are not stable or controlled cannot join at this time.
Other serious medical conditions: Patients with severe heart disease, kidney disease, or other serious health problems that could interfere with the study may not be eligible.
Use of certain medications: Patients taking specific medications that could interact badly with atorvastatin may not be able to participate.
Inability to follow study requirements: Patients who cannot attend regular study visits or follow the treatment plan as required cannot join.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Karolinska University Hospital
Verified
Solna, Sweden
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Verified
Gothenburg, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

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Investigated drugs

Atorvastatin is a medication commonly used to lower cholesterol levels in the blood. In this trial, it is being studied to see if it can prevent the development of active eye disease in patients who have been newly diagnosed with Graves' disease. The medication works by reducing certain substances in the body that may contribute to inflammation and other processes that could affect the eyes.

Atorvastatin

What is already known about the treatment

Atorvastatin – Atorvastatin is a medication commonly taken as an oral tablet that belongs to a group of drugs called statins, which are primarily used to lower cholesterol levels in the blood and reduce the risk of heart disease and stroke. In this clinical trial, researchers are studying whether atorvastatin can prevent the development of active Graves ophthalmopathy, an eye condition that can occur in patients with Graves' disease, which is an autoimmune disorder affecting the thyroid gland. The medication works by blocking an enzyme in the liver that produces cholesterol, and scientists believe it may also have anti-inflammatory properties that could help protect the eyes from inflammation and swelling associated with Graves ophthalmopathy. This represents an investigational use of atorvastatin, as it is not currently approved specifically for preventing or treating eye problems related to Graves' disease.

Investigated diseases

Graves Ophthalmopathy
Graves ophthalmopathy is an eye condition that occurs in people with Graves disease, an autoimmune disorder affecting the thyroid gland. The immune system mistakenly attacks the tissues around the eyes, causing inflammation and swelling of the muscles and fat behind the eyeballs. This leads to the eyes appearing to bulge forward, a condition known as proptosis or exophthalmos. Patients may experience double vision, eye pain, redness, excessive tearing, and sensitivity to light. The condition can affect one or both eyes and may cause difficulty closing the eyelids completely. Over time, the inflammation can become chronic, leading to changes in eye movement and appearance that may persist even after the active phase of the disease subsides.
Graves Disease
Graves disease is an autoimmune disorder in which the immune system produces antibodies that stimulate the thyroid gland to produce excessive amounts of thyroid hormones. This leads to a condition called hyperthyroidism, where the body's metabolism speeds up significantly. Common symptoms include rapid heartbeat, weight loss despite increased appetite, nervousness, trembling hands, increased sweating, and heat intolerance. Patients may also develop an enlarged thyroid gland, known as a goiter, which can be visible as swelling in the neck. The condition can affect multiple body systems including the heart, bones, and muscles. Women are more likely to develop Graves disease than men, and it typically appears in adults between the ages of 30 and 50.