Page last updated: 2024-10-29

ketoconazole and Adrenal Insufficiency

ketoconazole has been researched along with Adrenal Insufficiency in 16 studies

1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively.

Adrenal Insufficiency: Conditions in which the production of adrenal CORTICOSTEROIDS falls below the requirement of the body. Adrenal insufficiency can be caused by defects in the ADRENAL GLANDS, the PITUITARY GLAND, or the HYPOTHALAMUS.

Research Excerpts

ExcerptRelevanceReference
"Levoketoconazole is a ketoconazole stereoisomer in development for treatment of Cushing's syndrome and has not been assessed previously in a clinical trial in patients with Cushing's syndrome."9.30Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. ( Auchus, RJ; Biller, BMK; Cohen, F; Elenkova, A; Feelders, RA; Fleseriu, M; Geer, EB; Greenman, Y; Pivonello, R; Salvatori, R; Witek, P, 2019)
"Orally administered ketoconazole may rarely induce liver injury and adrenal insufficiency."8.12Arylacetamide deacetylase knockout mice are sensitive to ketoconazole-induced hepatotoxicity and adrenal insufficiency. ( Fukami, T; Hirosawa, K; Honda, S; Kisui, F; Konishi, K; Nagaoka, M; Nakajima, M; Nakano, M; Ogiso, T; Sakai, Y; Tashiro, K; Yamada, T, 2022)
"Persistent adrenal insufficiency secondary to ketoconazole therapy has not previously been documented."7.67Persistent adrenal insufficiency secondary to low-dose ketoconazole therapy. ( Best, TR; Bussell, KL; Jenkins, JK; Murphy, FY; Nicks, SA; Vesely, DL, 1987)
"Ketoconazole is a common and effective adjuvant therapy for hypercortisolism, but the major concern is liver enzyme dysfunction."5.37Pseudotumor cerebri during Cushing's disease treatment with ketoconazole. ( Boschi, V; Costa, TG; Costenaro, F; Czepielewski, MA; Ferreira, NP; Rodrigues, TC; Schuch, T, 2011)
"Levoketoconazole is a ketoconazole stereoisomer in development for treatment of Cushing's syndrome and has not been assessed previously in a clinical trial in patients with Cushing's syndrome."5.30Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. ( Auchus, RJ; Biller, BMK; Cohen, F; Elenkova, A; Feelders, RA; Fleseriu, M; Geer, EB; Greenman, Y; Pivonello, R; Salvatori, R; Witek, P, 2019)
"Orally administered ketoconazole may rarely induce liver injury and adrenal insufficiency."4.12Arylacetamide deacetylase knockout mice are sensitive to ketoconazole-induced hepatotoxicity and adrenal insufficiency. ( Fukami, T; Hirosawa, K; Honda, S; Kisui, F; Konishi, K; Nagaoka, M; Nakajima, M; Nakano, M; Ogiso, T; Sakai, Y; Tashiro, K; Yamada, T, 2022)
"Persistent adrenal insufficiency secondary to ketoconazole therapy has not previously been documented."3.67Persistent adrenal insufficiency secondary to low-dose ketoconazole therapy. ( Best, TR; Bussell, KL; Jenkins, JK; Murphy, FY; Nicks, SA; Vesely, DL, 1987)
"Ketoconazole was administered as a single daily oral dose of 200 mg to 12 patients with chronic mucocutaneous candidosis (CMC) of autoimmune polyendocrinopathy-candidosis-ectodermal dystrophy (APECED)."2.66Ketoconazole is effective against the chronic mucocutaneous candidosis of autoimmune polyendocrinopathy-candidosis-ectodermal dystrophy (APECED). ( Ahonen, P; Kahanpää, A; Myllärniemi, S; Perheentupa, J, 1986)
"Ketoconazole is a common and effective adjuvant therapy for hypercortisolism, but the major concern is liver enzyme dysfunction."1.37Pseudotumor cerebri during Cushing's disease treatment with ketoconazole. ( Boschi, V; Costa, TG; Costenaro, F; Czepielewski, MA; Ferreira, NP; Rodrigues, TC; Schuch, T, 2011)

Research

Studies (16)

TimeframeStudies, this research(%)All Research%
pre-19906 (37.50)18.7374
1990's3 (18.75)18.2507
2000's0 (0.00)29.6817
2010's5 (31.25)24.3611
2020's2 (12.50)2.80

Authors

AuthorsStudies
Nagaoka, M1
Fukami, T1
Kisui, F1
Yamada, T1
Sakai, Y1
Tashiro, K1
Ogiso, T1
Konishi, K1
Honda, S1
Hirosawa, K1
Nakano, M1
Nakajima, M1
Hernandez-Bures, A1
White, AG1
Riordan, L1
Fleseriu, M1
Pivonello, R1
Elenkova, A1
Salvatori, R1
Auchus, RJ1
Feelders, RA1
Geer, EB1
Greenman, Y1
Witek, P1
Cohen, F1
Biller, BMK1
Sullivant, AM1
Lathan, P1
Delivanis, DA1
Athimulam, S1
Bancos, I1
Chou, DW1
Chung, KM1
Lee, CT1
Costenaro, F1
Rodrigues, TC1
Ferreira, NP1
Costa, TG1
Schuch, T1
Boschi, V1
Czepielewski, MA1
Gallais, V1
Lacour, JP1
Ortonne, JP1
Angeli, A1
Masera, RG1
Gatti, G1
Portilla Sogorb, J1
Plana, C1
Mauri, M1
Picó, A1
White, MC1
Kendall-Taylor, P1
McCance, DR1
Ritchie, CM1
Sheridan, B1
Atkinson, AB1
Ahonen, P1
Myllärniemi, S1
Kahanpää, A1
Perheentupa, J1
Lamberts, SW1
Best, TR1
Jenkins, JK1
Murphy, FY1
Nicks, SA1
Bussell, KL1
Vesely, DL1
Tucker, WS1
Snell, BB1
Island, DP1
Gregg, CR1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome[NCT01838551]Phase 394 participants (Actual)Interventional2014-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Normalization in Urinary Free Cortisol in Patients With Endogenous Cushing's Syndrome.

"The response to COR-003 is defined as mean UFC concentration ≤ULN following 6 months of maintenance phase therapy without a prior dose increase during that phase. The proportion of responders at the End of Maintenance Phase visit, following 6 months of treatment in the Maintenance Phase, for all dose groups combined was estimated using a generalized linear model with repeated measurements based on a binomial distribution with a logit link function and with region (US vs. non-US), concurrent CS medical conditions (diabetes [Yes/No], hypertension [Yes/No]), age (rounded median split based on the ITT population), sex, disease duration (years), prior CS medication (Yes/No), prior radiation therapy (Yes/No) as Baseline covariates and visit as an independent factor.~The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented." (NCT01838551)
Timeframe: 6 months of maintenance phase therapy without a prior dose increase during that phase

Interventionproportion of subjects meeting endpoint (Least Squares Mean)
Levoketoconazole All Doses.30

Reviews

2 reviews available for ketoconazole and Adrenal Insufficiency

ArticleYear
[Cutaneous pigmentation disorders in human immunodeficiency virus infection].
    Annales de dermatologie et de venereologie, 1992, Volume: 119, Issue:6-7

    Topics: Acquired Immunodeficiency Syndrome; Adrenal Insufficiency; Antiviral Agents; Bleomycin; Clofazimine;

1992
[Mycoses and adrenocortical function. New pathogenetic aspects of adrenal hypofunction].
    Recenti progressi in medicina, 1991, Volume: 82, Issue:12

    Topics: Acquired Immunodeficiency Syndrome; Adrenal Cortex Hormones; Adrenal Glands; Adrenal Insufficiency;

1991

Trials

2 trials available for ketoconazole and Adrenal Insufficiency

ArticleYear
Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial.
    The lancet. Diabetes & endocrinology, 2019, Volume: 7, Issue:11

    Topics: Adolescent; Adrenal Insufficiency; Adult; Aged; Alanine Transaminase; Chemical and Drug Induced Live

2019
Ketoconazole is effective against the chronic mucocutaneous candidosis of autoimmune polyendocrinopathy-candidosis-ectodermal dystrophy (APECED).
    Acta medica Scandinavica, 1986, Volume: 220, Issue:4

    Topics: Adolescent; Adrenal Insufficiency; Adult; Autoimmune Diseases; Candidiasis; Candidiasis, Chronic Muc

1986

Other Studies

12 other studies available for ketoconazole and Adrenal Insufficiency

ArticleYear
Arylacetamide deacetylase knockout mice are sensitive to ketoconazole-induced hepatotoxicity and adrenal insufficiency.
    Biochemical pharmacology, 2022, Volume: 195

    Topics: Adrenal Insufficiency; Animals; Area Under Curve; Carboxylic Ester Hydrolases; Chemical and Drug Ind

2022
Presumptive iatrogenic hypoadrenocorticism induced by high-dose ketoconazole administration in a dog.
    Journal of veterinary internal medicine, 2019, Volume: 33, Issue:5

    Topics: Adrenal Insufficiency; Adrenocorticotropic Hormone; Animals; Antifungal Agents; Dermatomycoses; Dog

2019
Ketoconazole-induced transient hypoadrenocorticism in a dog.
    The Canadian veterinary journal = La revue veterinaire canadienne, 2020, Volume: 61, Issue:4

    Topics: Adrenal Insufficiency; Adrenocorticotropic Hormone; Animals; Dog Diseases; Dogs; Female; Ketoconazol

2020
Modern Management of Mild Autonomous Cortisol Secretion.
    Clinical pharmacology and therapeutics, 2019, Volume: 106, Issue:6

    Topics: 14-alpha Demethylase Inhibitors; Adrenal Cortex Neoplasms; Adrenal Insufficiency; Adrenalectomy; Adr

2019
Prototheca wickerhamii cutaneous and systemic infections.
    The American journal of tropical medicine and hygiene, 2014, Volume: 91, Issue:4

    Topics: Adrenal Insufficiency; Aged, 80 and over; Cytochrome P-450 CYP3A; Fever; Humans; Infections; Ketocon

2014
Pseudotumor cerebri during Cushing's disease treatment with ketoconazole.
    Arquivos brasileiros de endocrinologia e metabologia, 2011, Volume: 55, Issue:4

    Topics: Adrenal Insufficiency; Child; Diagnosis, Differential; Female; Humans; Ketoconazole; Pituitary ACTH

2011
[Adrenal gland insufficiency induced by ketoconazole in a patient with acquired immunodeficiency syndrome].
    Medicina clinica, 1991, Jan-19, Volume: 96, Issue:2

    Topics: Acquired Immunodeficiency Syndrome; Adrenal Insufficiency; Adult; Humans; Ketoconazole; Male

1991
Adrenal hypofunction in patients taking ketoconazole.
    Lancet (London, England), 1985, Jan-05, Volume: 1, Issue:8419

    Topics: Adrenal Insufficiency; Humans; Hydrocortisone; Ketoconazole; Male; Prostatic Neoplasms

1985
Acute hypoadrenalism and hepatotoxicity after treatment with ketoconazole.
    Lancet (London, England), 1987, Mar-07, Volume: 1, Issue:8532

    Topics: Acute Disease; Adrenal Insufficiency; Adult; Chemical and Drug Induced Liver Injury; Cushing Syndrom

1987
[Adrenal cortex insufficiency caused by drugs].
    Nederlands tijdschrift voor geneeskunde, 1987, May-23, Volume: 131, Issue:21

    Topics: Adrenal Insufficiency; Etomidate; Humans; Ketoconazole

1987
Persistent adrenal insufficiency secondary to low-dose ketoconazole therapy.
    The American journal of medicine, 1987, Mar-23, Volume: 82, Issue:3 Spec No

    Topics: Adrenal Insufficiency; Blastomycosis; Female; Glucocorticoids; Humans; Ketoconazole; Lung Diseases,

1987
Reversible adrenal insufficiency induced by ketoconazole.
    JAMA, 1985, Apr-26, Volume: 253, Issue:16

    Topics: 17-Hydroxycorticosteroids; Adrenal Insufficiency; Cortodoxone; Cosyntropin; Humans; Hydrocortisone;

1985