Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Not Applicable

Terminated

• Conditions: Graves Ophthalmopathy
• Interventions: Drug: Bromocriptine; Drug: Methimazole; Drug: Pentoxifylline

• Registration Number: NCT01893450
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-06-28
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-02
• Last Update Submitted: 2013-07-02
• Study First Posted: 2013-07-09
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methimazole, bromocriptine	Bromocriptine	methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year
methimazole	Methimazole	methimazole 30 mg daily during one year
pentoxifylline	Pentoxifylline	methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year

Primary Outcome Measures

Name	Time	Method
Proptosis	One year	Left and right eye proptosis by exophthalmometry

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico City, Distrito Federal, Mexico