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.
RCT Entities:
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.
Authors: Sara P Modjtahedi; Bobeck S Modjtahedi; Ahmad M Mansury; Dinesh Selva; Raymond S Douglas; Robert A Goldberg; Igal Leibovitch Journal: Drugs Date: 2006 Impact factor: 9.546