Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: methimazole methimazole 30 mg daily during one year |
Drug: Methimazole
|
Active Comparator: methimazole, bromocriptine methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year |
Drug: Bromocriptine
|
Active Comparator: pentoxifylline methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year |
Drug: Pentoxifylline
|
Outcome Measures
Primary Outcome Measures
- Proptosis [One year]
Left and right eye proptosis by exophthalmometry
Secondary Outcome Measures
- Clinical activity score [One year]
Clinical activity score for Graves' ophthalmopathy
- Quality of life [One year]
Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women or men
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Between 18 and 45 years
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Autoimmune hyperthyroidism with one year or less of evolution
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No previous treatment
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Mild to moderate ophthalmopathy
Exclusion Criteria:
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Smoking
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Severe ophthalmopathy
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Steroid treatment
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Asthma
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Diabetes or other significant disease
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Creatine >1.5 mg/dl
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Women with child bearing potential not using a birth control method
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Opthalmologic diseases
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Uncontrolled hypertension
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History of ischemic cardiopathy
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History of stroke
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History of gastrointestinal bleeding
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City | Distrito Federal | Mexico | 14000 |
Sponsors and Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DIA19508091