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Mifepristone, a Glucocorticoid Receptor Antagonist, Produces Clinical and Metabolic Benefits in Patients with Cushing's Syndrome

Context: Cushing's syndrome (CS) is a disorder associated with significant morbidity and mortality due to prolonged exposure to high cortisol concentrations. Objective: Our objective was to evaluate the safety and efficacy of mifepristone, a glucocorticoid receptor antagonist, in endogenous CS. Desi... Full description

Journal Title: The journal of clinical endocrinology and metabolism 2012-06, Vol.97 (6), p.2039-2049
Main Author: Fleseriu, Maria
Other Authors: Biller, Beverly M. K , Findling, James W , Molitch, Mark E , Schteingart, David E , Gross, Coleman , on behalf of the SEISMIC Study Investigators
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: Bethesda, MD: Endocrine Society
ID: ISSN: 0021-972X
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title: Mifepristone, a Glucocorticoid Receptor Antagonist, Produces Clinical and Metabolic Benefits in Patients with Cushing's Syndrome
format: Article
creator:
  • Fleseriu, Maria
  • Biller, Beverly M. K
  • Findling, James W
  • Molitch, Mark E
  • Schteingart, David E
  • Gross, Coleman
  • on behalf of the SEISMIC Study Investigators
subjects:
  • Abridged Index Medicus
  • Adrenals. Adrenal axis. Renin-angiotensin system (diseases)
  • Adult
  • Antihypertensive Agents - therapeutic use
  • Biological and medical sciences
  • Blood Glucose - drug effects
  • Blood Glucose - metabolism
  • Blood Pressure - drug effects
  • Blood Pressure - physiology
  • Body Composition - drug effects
  • Body Composition - physiology
  • Body Weight - drug effects
  • Body Weight - physiology
  • Cushing Syndrome - complications
  • Cushing Syndrome - drug therapy
  • Cushing Syndrome - metabolism
  • Diabetes Mellitus, Type 2 - complications
  • Diabetes Mellitus, Type 2 - drug therapy
  • Diabetes Mellitus, Type 2 - metabolism
  • Endocrinopathies
  • Feeding. Feeding behavior
  • Female
  • Fundamental and applied biological sciences. Psychology
  • Glucose Intolerance - complications
  • Glucose Intolerance - drug therapy
  • Glucose Intolerance - metabolism
  • Hormone Antagonists - administration & dosage
  • Hormone Antagonists - adverse effects
  • Humans
  • Hydrocortisone - blood
  • Hypertension - complications
  • Hypertension - drug therapy
  • Hypertension - metabolism
  • Male
  • Medical sciences
  • Middle Aged
  • Mifepristone - administration & dosage
  • Mifepristone - adverse effects
  • Non tumoral diseases. Target tissue resistance. Benign neoplasms
  • Quality of Life
  • Quinolines - blood
  • Receptors, Glucocorticoid - antagonists & inhibitors
  • Urea - analogs & derivatives
  • Urea - blood
  • Vertebrates: anatomy and physiology, studies on body, several organs or systems
  • Vertebrates: endocrinology
ispartof: The journal of clinical endocrinology and metabolism, 2012-06, Vol.97 (6), p.2039-2049
description: Context: Cushing's syndrome (CS) is a disorder associated with significant morbidity and mortality due to prolonged exposure to high cortisol concentrations. Objective: Our objective was to evaluate the safety and efficacy of mifepristone, a glucocorticoid receptor antagonist, in endogenous CS. Design and Setting: We conducted a 24-wk multicenter, open-label trial after failed multimodality therapy at 14 U.S. academic medical centers and three private research centers. Participants: Participants included 50 adults with endogenous CS associated with type 2 diabetes mellitus/impaired glucose tolerance (C-DM) or a diagnosis of hypertension alone (C-HT). Intervention: Mifepristone was administered at doses of 300-1200 mg daily. Main Outcome Measures: We evaluated change in area under the curve for glucose on 2-h oral glucose test for C-DM and change in diastolic blood pressure from baseline to wk 24 for C-HT. Results: In the C-DM cohort, an area under the curve for glucose (AUCglucose) response was seen in 60% of patients (P < 0.0001). Mean ± sd glycated hemoglobin (HbA1c) decreased from 7.43 ± 1.52% to 6.29 ± 0.99% (P < 0.001); fasting plasma glucose decreased from 149.0 ± 75.7 mg/dl (8.3 ± 4.1 mmol/liter) to 104.7 ± 37.5 mg/dl (5.8 ± 2.1 mmol/liter, P < 0.03). In C-HT cohort, a diastolic blood pressure response was seen in 38% of patients (P < 0.05). Mean weight change was −5.7 ± 7.4% (P < 0.001) with waist circumference decrease of −6.78 ± 5.8 cm (P < 0.001) in women and −8.44 ± 5.9 cm (P < 0.001) in men. Overall, 87% (P < 0.0001) had significant improvement in clinical status. Insulin resistance, depression, cognition, and quality of life also improved. Common adverse events were fatigue, nausea, headache, low potassium, arthralgia, vomiting, edema, and endometrial thickening in women. Conclusions: Mifepristone produced significant clinical and metabolic improvement in patients with CS with an acceptable risk-benefit profile during 6 months of treatment.
language: eng
source:
identifier: ISSN: 0021-972X
fulltext: no_fulltext
issn:
  • 0021-972X
  • 1945-7197
url: Link


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titleMifepristone, a Glucocorticoid Receptor Antagonist, Produces Clinical and Metabolic Benefits in Patients with Cushing's Syndrome
creatorFleseriu, Maria ; Biller, Beverly M. K ; Findling, James W ; Molitch, Mark E ; Schteingart, David E ; Gross, Coleman ; on behalf of the SEISMIC Study Investigators
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subjectAbridged Index Medicus ; Adrenals. Adrenal axis. Renin-angiotensin system (diseases) ; Adult ; Antihypertensive Agents - therapeutic use ; Biological and medical sciences ; Blood Glucose - drug effects ; Blood Glucose - metabolism ; Blood Pressure - drug effects ; Blood Pressure - physiology ; Body Composition - drug effects ; Body Composition - physiology ; Body Weight - drug effects ; Body Weight - physiology ; Cushing Syndrome - complications ; Cushing Syndrome - drug therapy ; Cushing Syndrome - metabolism ; Diabetes Mellitus, Type 2 - complications ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - metabolism ; Endocrinopathies ; Feeding. Feeding behavior ; Female ; Fundamental and applied biological sciences. Psychology ; Glucose Intolerance - complications ; Glucose Intolerance - drug therapy ; Glucose Intolerance - metabolism ; Hormone Antagonists - administration & dosage ; Hormone Antagonists - adverse effects ; Humans ; Hydrocortisone - blood ; Hypertension - complications ; Hypertension - drug therapy ; Hypertension - metabolism ; Male ; Medical sciences ; Middle Aged ; Mifepristone - administration & dosage ; Mifepristone - adverse effects ; Non tumoral diseases. Target tissue resistance. Benign neoplasms ; Quality of Life ; Quinolines - blood ; Receptors, Glucocorticoid - antagonists & inhibitors ; Urea - analogs & derivatives ; Urea - blood ; Vertebrates: anatomy and physiology, studies on body, several organs or systems ; Vertebrates: endocrinology
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authorFleseriu, Maria ; Biller, Beverly M. K ; Findling, James W ; Molitch, Mark E ; Schteingart, David E ; Gross, Coleman ; on behalf of the SEISMIC Study Investigators
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