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Mifepristone, a Glucocorticoid Receptor Antagonist, Produces Clinical and Metabolic Benefits in Patients with Cushing's Syndrome
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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“Overt adrenal insufficiency is rare under treatment with mifepristone (326).”
From Adrenocortical carcinoma (2014) · cites this paper as [326]
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Next Generation Medical Therapy for Cushing's Syndrome—Can We Measure a Benefit?
Trainer, P. J. (2014) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2014-1054 · Cited by 8
Pivonello, R., Arnaldi, G., Auchus, R. J., Badiu, C., Busch, R. S., Cannavò, S., Dischinger, U., Dobri, G. A., Donegan, D. M., Elenkova, A. P., et al. (2026) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(25)00362-6 · Cited by 8
Self-citationGulyaeva, N. V. (2024) · Journal of Evolutionary Biochemistry and Physiology · doi:10.1134/s0022093024040203 · Cited by 10
Mifepristone-Induced Hypothyroidism
Kalara, N., & Manzano, A. J. (2023) · Journal of Investigative Medicine High Impact Case Reports · doi:10.1177/23247096231191874 · Cited by 7
“The mechanism by which different medications could affect the thyroid is as follows: (1) inhibition of synthesis and/or release of thyroid hormones, (2) immune mechanisms, (3) drug-induced thyroiditis, (4) inhibition of thyroid-stimulating hormone (TSH), or (5) treatment interactions leading to decreased levothyroxine…”
BackgroundMonitoring Patient Improvement Parameters following Pasireotide Treatment in Cushing’s Disease
Yedinak, C. G., Brzana, J. A., & Fleseriu, M. (2013) · Case Reports in Endocrinology · doi:10.1155/2013/735489 · Cited by 7
“Mifepristone usage can result in endometrial thickening in women, or in hypertension and hypokalemia secondary to high circulating levels of cortisol [10].”
BackgroundSelf-citationMoloney, K. J., Mercado, J. U., Ludlam, W., & Mayberg, M. (2012) · Expert Review of Endocrinology & Metabolism · doi:10.1586/eem.12.49 · Cited by 7
Saroka, R. M., Kane, M. P., Robinson, L. R., & Busch, R. S. (2016) · Clinical Medicine Insights Endocrinology and Diabetes · doi:10.4137/cmed.s39997 · Cited by 7
Mifepristone as Bridge or Adjunct Therapy in the Management of Challenging Cushing Disease Cases
Chang, A. Y., Mirfakhraee, S., King, E. E., Mercado, J. U., Donegan, D. M., & Yuen, K. C. J. (2021) · Clinical Medicine Insights Endocrinology and Diabetes · doi:10.1177/1179551421994102 · Cited by 7
Adrenocortical carcinoma in a 17th-century girl
Else, T., Auchus, R. J., & Miller, W. L. (2016) · The Journal of Steroid Biochemistry and Molecular Biology · doi:10.1016/j.jsbmb.2016.03.008 · Cited by 7
Self-citationObesity and Depression: Shared Pathophysiology and Translational Implications
Huet, L., Delgado, I., Aouizerate, B., Castanon, N., & Capuron, L. (2019) · Elsevier eBooks · doi:10.1016/b978-0-12-813333-0.00016-0 · Cited by 8
José, P. G. S., Arenas, C., Alonso‐Miguel, D., Moral, I. C., Cuesta-Álvaro, P., & Alenza, M. D. P. (2020) · Journal of Veterinary Internal Medicine · doi:10.1111/jvim.15978 · Cited by 7
“In people with pituitary-dependent CS (ie, Cushing's disease [CD]) treated medically, treatment with pasireotide, mifepristone, metyrapone or ketoconazole improved blood pressure in 20% to 70% of patients.(22-27)”
BackgroundResultHormone circuit explains why most HPA drugs fail for mood disorders and predicts the few that work
Milo, T., Halber, S. N., Raz, M., Danan, D., Mayo, A., & Alon, U. S. (2025) · Molecular Systems Biology · doi:10.1038/s44320-024-00083-0 · Cited by 8
Mooney, M. A., Simon, E. D., & Little, A. S. (2016) · Frontiers in Surgery · doi:10.3389/fsurg.2016.00045 · Cited by 6
“It has demonstrated efficacy in long-term symptom resolution in a multicenter trial (68); however, its use is contraindicated in pregnant women, and it may be associated with adenoma enlargement (69).”
BackgroundStructural and functional brain alterations in Cushing’s disease: A narrative review
Liu, Y.-F., Pan, L., & Feng, M. (2022) · Frontiers in Neuroendocrinology · doi:10.1016/j.yfrne.2022.101033 · Cited by 6
Determinants of Clinical Behavior and Prognosis in Cushing's Disease: A Quest for Useful Biomarkers.
Hernández-Ramírez, L. C. (2022) · Revista de investigacion clinica; organo del Hospital de Enfermedades de la Nutricion · doi:10.24875/ric.22000184 · Cited by 6
“The glucocorticoid antagonists mifepristone (GR and progesterone receptor antagonist) and relacorilant (selective GR antagonist) are useful in the treatment of cardiovascular and metabolic effects of hypercortisolemia 25,26 .”
BackgroundNewell-Price, J. D. C. (2017) · Elsevier eBooks · doi:10.1016/b978-0-12-804169-7.00017-9 · Cited by 6
Osilodrostat‐induced adrenal insufficiency in a patient with Cushing's disease
Ekladios, C., Khoury, J., Mehr, S., & Feghali, K. (2022) · Clinical Case Reports · doi:10.1002/ccr3.6607 · Cited by 6
Ježková, J., Ďurovcová, V., Wenchich, L., Hansíková, H., Zeman, J., Hána, V., Marek, J., Lacinová, Z., Haluzı́k, M., & Kršek, M. (2019) · Diabetes Metabolic Syndrome and Obesity · doi:10.2147/dmso.s209095 · Cited by 5
Evaluating Patient-Reported Outcomes in Cushing’s Syndrome
Gumaste, N., Shah, L., Cheesman, K. C., & Geer, E. B. (2022) · Endocrinology and Metabolism Clinics of North America · doi:10.1016/j.ecl.2022.05.002 · Cited by 5
Different patient versus provider perspectives on living with Cushing’s disease
Halstrom, A., Lin, I., Lin, A. L., Cohen, M. A., Tabar, V. S., & Geer, E. B. (2024) · Pituitary · doi:10.1007/s11102-024-01381-4 · Cited by 5
Schaduangrat, N., Chuntakaruk, H., Rungrotmongkol, T., Mookdarsanit, P., & Shoombuatong, W. (2025) · BMC Bioinformatics · doi:10.1186/s12859-025-06132-1 · Cited by 5
“Mifepristone effectively alleviates the clinical effects of elevated cortisol by acting as a GR antagonist, improving patients’ overall condition [5].”
Hypertension in Patients with Cushing’s Syndrome
Kantorovich, V., Koch, C. A., & Chrousos, G. P. (2012) · Humana Press eBooks · doi:10.1007/978-1-60761-548-4_3 · Cited by 5
Self-citationMcGinn, M. A., & Pahng, A. R. (2016) · Journal of Neurophysiology · doi:10.1152/jn.01065.2015 · Cited by 5
“Mifepristone also has demonstrated efficacy in reducing symptoms of mild depression and cognitive disruption in patients suffering from Cushing’s syndrome (Fleseriu et al. 2012), and newer, more selective GR antagonists are now available.”
BackgroundKuznetsova, N. V., Александровна, П. Н., Selyatitskaya, V. G., & Кузьминова, О. И. (2017) · Bulletin of Experimental Biology and Medicine · doi:10.1007/s10517-017-3607-3 · Cited by 5
Nguyen, D., & Mizne, S. (2017) · Advances in Therapy · doi:10.1007/s12325-017-0621-9 · Cited by 5
“In addition, because mifepristone use is associated with increases in cortisol and adrenocorticotropic hormone (ACTH) levels [1], we examined the effects of concomitant administration of mifepristone and ketoconazole on these parameters in comparison with mifepristone alone.”
BackgroundAdvances in the Diagnosis and Medical Management of Cushing's Syndrome
Delivanis, D. A., Sharma, A. R., Hamidi, O., Shah, M., & Bancos, I. (2019) · Elsevier eBooks · doi:10.1016/b978-0-323-66195-9.00015-7 · Cited by 5
Mifepristone enhances the neural efficiency of human visuospatial memory encoding and recall
Yalın, N., Kempton, M. J., Mazibuko, N., Mehta, M. A., Young, A. H., & Stokes, P. R. A. (2020) · Psychoneuroendocrinology · doi:10.1016/j.psyneuen.2020.105116 · Cited by 5
Aydin, B., Yıldırım, E., Erdogan, O., Arğa, K., Yilmaz, B., Bozkurt, S., Bayraklı, F., & Turanli, B. (2022) · Omics · doi:10.1089/omi.2021.0221 · Cited by 4
Metadata
- 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
- 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
- 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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