Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment
Status:
Terminated
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran