Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Terminated

Conditions: Graves Ophthalmopathy

Treatments: Drug: Methimazole; Drug: Pentoxifylline; Drug: Bromocriptine

Study type: Interventional

Funder types: Other

Identifiers

NCT01893450

DIA19508091

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 3 patient groups

methimazole

Active Comparator group

Description:

methimazole 30 mg daily during one year

Treatment:

Drug: Methimazole

methimazole, bromocriptine

Active Comparator group

Description:

methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year

Treatment:

Drug: Bromocriptine

pentoxifylline

Active Comparator group

Description:

methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year

Treatment:

Drug: Pentoxifylline