DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Randomized, single blind trial of intravenous versus oral steroid monotherapy in Graves' orbitopathy.

Author(s): Kahaly GJ, Pitz S, Hommel G, Dittmar M

Affiliation(s): Department of Medicine I, University Hospital, Mainz 55101, Germany, gkahaly@mail.uni-mainz.de

Publication date & source: 2005-09, J Clin Endocrinol Metab., 90(9):5234-40. Epub 2005 Jul 5.

Publication type: Clinical Trial; Randomized Controlled Trial

CONTEXT: Glucocorticoids are effective for severe Graves' orbitopathy (GO), which causes substantial morbidity. The question at issue is how best to use them. OBJECTIVE: The objective of this study was to optimize glucocorticoid application in GO. DESIGN: The study design was a randomized trial over 12 wk with 6-month follow-up. SETTING: The study was performed at university joint thyroid and ophthalmic clinics. PATIENTS: Seventy euthyroid out-patients with untreated, active, and severe GO were studied. Intervention: Patients received either once weekly iv methylprednisolone (0.5 g, then 0.25 g, 6 wk each) or oral prednisolone starting with 0.1 g/d, then tapering the dose by 0.01 g/wk. MAIN OUTCOME MEASURES: At 3 months, the primary end point was a composite of improvements in proptosis, lid fissure width, and rate of diplopia in primary gaze, visual acuity, eye muscle thickness, and patient's quality of life. RESULTS: Intravenous glucocorticoid therapy resulted in rapid, significant, and sustained improvement. At 3 months, 27 of 35 patients (77%) in the iv group had a treatment response compared with 18 of 35 (51%) in the oral group (P < 0.01). Improvements over baseline values for disease severity (e.g. visual acuity; P = 0.01) and activity (e.g. chemosis; P < 0.01) and for quality of life (P < 0.001) were greater in the iv group. TSH receptor antibody titers decreased during iv steroid administration (P < 0.001), and smoking had a strong impact on the therapy response (P < 0.001). Additional treatment was required less frequently in the iv group. Intravenous steroids were safe, with different rates of adverse events between the two groups (P < 0.001). CONCLUSIONS: In patients with active and severe GO, iv glucocorticoids were more effective and better tolerated than oral steroids.

Page last updated: 2006-01-31

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017