Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Study Overview
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Brief Summary
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Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At present, the treatment is directed to identify vision threatening which requires aggressive intervention, usually with glucocorticoids. For mild cases the treatment is limited to the normalization of hyperthyroidism and support measures. Preliminary data show that pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine and pentoxifylline on the clinical course and quality of life of patients with mild to moderate ophthalmopathy associated to Graves´disease. Methods. Patients with mild to moderate ophthalmopathy, with less than one year of evolution, and naive to treatment were randomized to receive treatment during 12 months with either 1) bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400 mg twice a day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They completed 10 visits to evaluate proptosis and clinical activity score (CAS). In addition, in the first and last visit the quality of life questionnaire specific for Graves' ophthalmopathy(GO-QOL) was applied.

Official Title
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Comparison of the Effect of Bromocriptine and Pentoxifylline in Mild to Moderate Autoimmune Ophthalmopathy. A Randomized, Controlled, Single Blind, Clinical Trial.

Conditions
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Graves Ophthalmopathy

Intervention / Treatment
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* Drug: Methimazole
* Drug: Bromocriptine
* Drug: Pentoxifylline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women or men Between 18 and 45 years Autoimmune hyperthyroidism with one year or less of evolution No previous treatment Mild to moderate ophthalmopathy Exclusion Criteria: Smoking Severe ophthalmopathy Steroid treatment Asthma Diabetes or other significant disease Creatine >1.5 mg/dl Women with child bearing potential not using a birth control method Opthalmologic diseases Uncontrolled hypertension History of ischemic cardiopathy History of stroke History of gastrointestinal bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: methimazole<br>methimazole 30 mg daily during one year | Drug: Methimazole<br> <br> |
| Active Comparator: methimazole, bromocriptine<br>methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year | Drug: Bromocriptine<br> <br> |
| Active Comparator: pentoxifylline<br>methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year | Drug: Pentoxifylline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proptosis | Left and right eye proptosis by exophthalmometry | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical activity score | Clinical activity score for Graves' ophthalmopathy | One year | 
| Quality of life | Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL) | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graves ophthalmopathy, Exophthalmos, Proptosis, Quality of life