OBJECTIVE: To determine the incidence of side effects from short-term glucocorticoid therapy prescribed for treatment of optic neuritis in the Optic Neuritis Treatment Trial. DESIGN: Randomized, placebo-controlled, multicenter clinical trial. SETTING:Fifteen university- or hospital-based centers throughout the United States. PATIENTS: A total of 457 patients between the ages of 18 and 46 years with acute demyelinative optic neuritis were studied. INTERVENTIONS: (1) Intravenous methylprednisolone (250 mg every 6 hours) for 3 days while hospitalized followed by oral prednisone (1 mg/kg per day) for 11 days; (2) oral prednisone (1 mg/kg per day) for 14 days; and (3) oral placebo for 14 days. Each regimen was followed by a short taper. RESULTS: Only two patients experienced major side effects, psychotic depression in one and acute pancreatitis in the other. Both of these patients were from the intravenous methylprednisolone group and both of the side effects resolved without sequelae. Patients in both groups receiving active drugs more often reported sleep disturbances, mood change, stomach upset, and facial flushing and gained more weight during the treatment period than patients in the placebo group (P < .001 for each comparison). CONCLUSIONS: Although minor side effects are common, short-term glucocorticoid therapy in young, healthy adults is relatively safe. Because of the infrequency of serious side effects, outpatient administration of high-dose intravenous glucocorticoids may be feasible.
RCT Entities:
OBJECTIVE: To determine the incidence of side effects from short-term glucocorticoid therapy prescribed for treatment of optic neuritis in the Optic Neuritis Treatment Trial. DESIGN: Randomized, placebo-controlled, multicenter clinical trial. SETTING: Fifteen university- or hospital-based centers throughout the United States. PATIENTS: A total of 457 patients between the ages of 18 and 46 years with acute demyelinative optic neuritis were studied. INTERVENTIONS: (1) Intravenous methylprednisolone (250 mg every 6 hours) for 3 days while hospitalized followed by oral prednisone (1 mg/kg per day) for 11 days; (2) oral prednisone (1 mg/kg per day) for 14 days; and (3) oral placebo for 14 days. Each regimen was followed by a short taper. RESULTS: Only two patients experienced major side effects, psychotic depression in one and acute pancreatitis in the other. Both of these patients were from the intravenous methylprednisolone group and both of the side effects resolved without sequelae. Patients in both groups receiving active drugs more often reported sleep disturbances, mood change, stomach upset, and facial flushing and gained more weight during the treatment period than patients in the placebo group (P < .001 for each comparison). CONCLUSIONS: Although minor side effects are common, short-term glucocorticoid therapy in young, healthy adults is relatively safe. Because of the infrequency of serious side effects, outpatient administration of high-dose intravenous glucocorticoids may be feasible.
Authors: Emily M Fredericks; Dawn Dore-Stites; Sheyla Y Calderon; Andrew Well; Sally J Eder; John C Magee; M James Lopez Journal: Liver Transpl Date: 2012-06 Impact factor: 5.799
Authors: Andreas R Baudy; Erica K M Reeves; Jesse M Damsker; Christopher Heier; Lindsay M Garvin; Blythe C Dillingham; John McCall; Sree Rayavarapu; Zuyi Wang; Jack H Vandermeulen; Arpana Sali; Vanessa Jahnke; Stephanie Duguez; Debra DuBois; Mary C Rose; Kanneboyina Nagaraju; Eric P Hoffman Journal: J Pharmacol Exp Ther Date: 2012-06-28 Impact factor: 4.030