Cited by 480Pituitary Gland Disorders and TreatmentsAdrenal Hormones and DisordersAdrenal and Paraganglionic Tumors

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

Fleseriu, Maria, Biller, Beverly M. K., Findling, James W., Molitch, Mark E., Schteingart, David E., Gross, Coleman, on behalf of the SEISMIC Study Investigators, The SEISMIC Study Investigators include, Auchus, Richard, Bailey, Timothy, Biller, Beverly M. K., Carroll, Ty, Colleran, Kathleen, Fein, Henry, Findling, James W., Fleseriu, Maria, Hamrahian, Amir, Katznelson, Laurence, Kerr, Janice, Kipnes, Mark, Kirschner, Lawrence, Koch, Christian, Lerman, Sam, Lyons, Timothy, McPhaul, Michael, Molitch, Mark E., Schteingart, David E., Vaughan, T. Brooks, Weiss, Roy·2012·The Journal of Clinical Endocrinology & Metabolism

DOI 10.1210/jc.2011-3350

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Abstract

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 (AUC(glucose)) 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.

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“Dopo le prime esperienze negli anni ’90 in pazienti con sindrome di Cushing da ACTH ectopico (1) che avevano portato nel 1999 all’approvazione di tale terapia anche in Italia, vi sono ora studi, di cui uno recentissimo su oltre 40 pazienti (14), sul suo impiego nella malattia di Cushing.”
Background
The potential risk of chronic stress and the NMDA- and glucocorticoid receptor as possible targets for innovative antidepressants
Hak, D. (2014) · Utrecht University Repository (Utrecht University)

Authors: Fleseriu, M., Biller, B. M. K., Findling, J. W., Molitch, M. E., Schteingart, D. E., Gross, C., on behalf of the SEISMIC Study Investigators, The SEISMIC Study Investigators include, Auchus, R., Bailey, T., Biller, B. M. K., Carroll, T., Colleran, K., Fein, H., Findling, J. W., Fleseriu, M., Hamrahian, A., Katznelson, L., Kerr, J., Kipnes, M., Kirschner, L., Koch, C., Lerman, S., Lyons, T., McPhaul, M., Molitch, M. E., Schteingart, D. E., Vaughan, T. B., & Weiss, R.
Affiliations: Corcept Therapeutics (United States) (US)
The University of Texas Southwestern Medical Center (US)
AMCR Institute (US)
Massachusetts General Hospital (US)
Medical College of Wisconsin (US)
Oregon Health & Science University (US)
Cleveland Clinic (US)
Northwestern University (US)
The Ohio State University Wexner Medical Center (US)
University of Mississippi Medical Center (US)
University of Michigan (US)
University of Alabama at Birmingham (US)
University of Chicago (US)
ORCID: Auchus, Richard
Bailey, Timothy
Carroll, Ty
Hamrahian, Amir
Katznelson, Laurence
Kirschner, Lawrence
Koch, Christian
Lyons, Timothy
McPhaul, Michael
Weiss, Roy
Venue: The Journal of Clinical Endocrinology & Metabolism
Publisher: The Endocrine Society
Published: 2012-06-01
Volume: 97
Issue: 6
Pages: 2039-2049
ISSN: 0021-972X (ISSN-L)
1945-7197
DOI: 10.1210/jc.2011-3350
OpenAlex: W2021271765
Semantic Scholar: 40d98664c0987b1bdf2cbb43dbea52247bf04f70
Cited by: 479
References: 45
Citations by year: 2026: 19 · 2025: 28 · 2024: 22 · 2023: 28 · 2022: 33 · 2021: 29 · 2020: 30 · 2019: 41 · 2018: 35 · 2017: 35 · 2016: 38 · 2015: 45 · 2014: 39 · 2013: 39 · 2012: 16
FWCI: 35.67
Type: journal article
Language: en
Open access: closed
Locations: The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
PubMed (publishedVersion)
Research Portal (Queen's University Belfast) (submittedVersion)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pituitary Gland Disorders and Treatments
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
Health Sciences › Medicine › Surgery › Adrenal and Paraganglionic Tumors
Keywords: mifepristone, Cushing's syndrome, glucocorticoid receptor antagonist, type 2 diabetes, impaired glucose tolerance, hypertension, glycemic control, HbA1c, insulin resistance, blood pressure, weight loss, waist circumference, adverse events, drug safety, quality of life, depression, cognitive function
MeSH terms: Adult, Antihypertensive Agents, Blood Glucose, Blood Pressure, Body Composition, Body Weight, Cushing Syndrome, Diabetes Mellitus, Type 2, Female, Hormone Antagonists, Humans, Hydrocortisone, Hypertension, Male, Middle Aged, Quality of Life, Quinolines, Receptors, Glucocorticoid, Urea, Mifepristone, Glucose Intolerance

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

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