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Evaluation Of Evidence Of Adrenal Insufficiency In Trials Of Normocortisolemic Patients Treated With Mifepristone., Kevin C J Yuen, Andreas Moraitis, Dat Nguyen
Evaluation Of Evidence Of Adrenal Insufficiency In Trials Of Normocortisolemic Patients Treated With Mifepristone., Kevin C J Yuen, Andreas Moraitis, Dat Nguyen
Articles, Abstracts, and Reports
Context: Adrenal insufficiency (AI) is an important medical concern for clinicians when normocortisolemia is achieved during treatment of endogenous Cushing syndrome (CS).
Objective: To examine symptoms of potential AI in a large population of normocortisolemic patients without CS treated with mifepristone, a glucocorticoid receptor antagonist indicated for the treatment of patients with CS.
Methods: We conducted a pooled safety analysis of five phase 3, placebo-controlled clinical trials of normocortisolemic adults without CS but diagnosed with psychotic depression (n = 1460). Patients were treated with once-daily mifepristone 300 mg (n = 110), 600 mg (n = 471), or 1200 mg (n …