- |||||||||| Journal: New Trends in Treating Cushing's Disease. (Pubmed Central) - Nov 15, 2024
Levoketoconazole and osilodrostat are novel steroid inhibitors, and relacorilant overcomes the adverse effects of mifepristone. Adrenal ACTH receptor blockage and immunotherapy could also play a role.
- |||||||||| Recorlev (levoketoconazole) / Xeris Biopharma
Trial completion, Trial completion date, Trial primary completion date: OPTICS: Open-label Treatment in Cushing's Syndrome (clinicaltrials.gov) - May 10, 2023
P3, N=51, Completed,
Importantly, more than half of the VTE events were diagnosed in patients with normocortisolaemia. Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Dec 2022 | Trial primary completion date: Jun 2023 --> Dec 2022
- |||||||||| Journal: An evaluation of pharmacological options for Cushing's disease: what are the state-of-the-art options? (Pubmed Central) - Apr 17, 2023
: Since there is still no standardized pharmacological approach and the superiority of one drug over another has not been established yet due to the lack of comparative studies, each time clinicians' choices should be patient-tailored. Age, gender, tumor features, severity of hypercortisolism, comorbidities/complications, rapidity of action of each drug, side effects, drug-drug interactions, contraindications, availability, patients' preferences and costs should be all taken into account.
- |||||||||| Review, Journal, Adverse events: How best to monitor the specific side effects of medical treatments of Cushing's disease. (Pubmed Central) - Nov 27, 2022
The efficacy of these drugs will not be detailed in this review, nor their roles in the therapeutic algorithm of Cushing's disease. This review will rather focus specifically on adverse events associated with these drugs (ketoconazole, levoketoconazole, metyrapone, osilodrostat, pasireotide, cabergoline and mifepristone), and the way in which to monitor and treat them, based on retrospective studies and the most recently published prospective studies.
- |||||||||| Recorlev (levoketoconazole) / Xeris Biopharma
Enrollment change: A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. (clinicaltrials.gov) - Nov 8, 2022
P3, N=84, Completed,
This review will rather focus specifically on adverse events associated with these drugs (ketoconazole, levoketoconazole, metyrapone, osilodrostat, pasireotide, cabergoline and mifepristone), and the way in which to monitor and treat them, based on retrospective studies and the most recently published prospective studies. N=44 --> 84
- |||||||||| Recorlev (levoketoconazole) / Strongbridge, Metopirone (metyrapone) / HRA Pharma, Isturisa (osilodrostat) / Novartis, Recordati
Review, Journal: Cushing's disease: adrenal steroidogenesis inhibitors. (Pubmed Central) - Oct 26, 2022
Steroidogenesis inhibitors may be used alone or in combination, and associated with pituitary directed drugs, to improve the efficacy of the single drugs, allowing a potential use of lower doses for each drug, and hypothetically reducing the rate of adverse events associated with the single drugs. Clinicians may tailor medical therapy on the specific clinical scenario, considering disease history together with patients' characteristics and hypercortisolism's degree, addressing the needs of each patient in order to improve the therapeutic outcome and to reduce the burden of illness, particularly in patients with persistent or recurrent CD.
- |||||||||| Recorlev (levoketoconazole) / Strongbridge
Journal: Levoketoconazole treatment in endogenous Cushing's syndrome: extended evaluation of clinical, biochemical, and radiologic outcomes. (Pubmed Central) - Oct 18, 2022
Clinicians may tailor medical therapy on the specific clinical scenario, considering disease history together with patients' characteristics and hypercortisolism's degree, addressing the needs of each patient in order to improve the therapeutic outcome and to reduce the burden of illness, particularly in patients with persistent or recurrent CD. In the first long-term levoketoconazole study, continued treatment through 12-month maintenance period sustained the early clinical and biochemical benefits in most patients completing EE, without new adverse effects.
- |||||||||| Recorlev (levoketoconazole) / Strongbridge
Characteristics of disorders of reproductive function in women of fertile age with Cushing syndrome in the Republic of Uzbekistan () - Oct 1, 2022 - Abstract #ENEA2022ENEA_240;
on the 14th day of the cycle, an unreliable decrease in basal levels of LH, FSH and ovarian hormones was characteristic (p> 0.05) against the background of a significant increase in blood cortisol with normocorticotropenemia and hyperandrogenemia (p <0.05)...Primary Pigmented Nodular Adrenocortical Disease (PPNAD) as an Underlying Cause of Symptoms in a Patient Presenting With Hirsutism and Secondary Amenorrhea //Gynecol Endocrinol, 34 (12), 1022-1026 Dec 2018. 2.Szczepanek-Parulska E. , Cyranska-Chyrek E., Nowaczyk M. , Kamiński Grzegorz 2, Diagnostic Difficulties In a Young Women With Symptoms of Cushing Syndrome Endocr Pract, 24 (8), 766 Aug 2018 ,
- |||||||||| Recorlev (levoketoconazole) / Strongbridge
Journal: Levoketoconazole. (Pubmed Central) - Sep 13, 2022
Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433.
- |||||||||| Recorlev (levoketoconazole) / Strongbridge
Cyclic Cushing Disease: A Diagnostic Challenge () - Jul 16, 2022 - Abstract #ENDO2022ENDO_2793;
We present a case of a 27 year old that presented with a cyclic Cushing disease. We evaluate our patient during a 6 month period documenting a periodic hypercortisolemia with shifting normocortisolemia.
- |||||||||| Recorlev (levoketoconazole) / Strongbridge
Journal: Levoketoconazole. (Pubmed Central) - Apr 6, 2022
We evaluate our patient during a 6 month period documenting a periodic hypercortisolemia with shifting normocortisolemia. No abstract available
- |||||||||| Metopirone (metyrapone) / HRA Pharma
Retrospective data, Review: Effectiveness of Medical Treatment of Cushing's Disease: A Systematic Review and Meta-Analysis. (Pubmed Central) - Feb 15, 2022
New therapeutic options should be investigated due to the limited efficacy and tolerability of the currently available medical treatment for patients with Cushing's disease. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020205567, identifier CRD42020205567.
- |||||||||| Recorlev (levoketoconazole) / Strongbridge
Journal: Levoketoconazole: a novel treatment for endogenous Cushing's syndrome. (Pubmed Central) - Jan 29, 2022
Levoketoconazole had an acceptable safety profile with no unexpected safety signals. The favorable pharmacology, efficacy, and safety profile of levoketoconazole supports its use as medical therapy for CS, if approved.
- |||||||||| Recorlev (levoketoconazole) / Strongbridge
Review, Journal: Cyclic Cushing's Syndrome - A Diagnostic Challenge. (Pubmed Central) - Jan 26, 2022
Cyclic Cushing's syndrome is one of the greatest challenges in modern endocrinology due to its diverse clinical picture, unpredictable duration and frequency of phases, and various etiologies. We discuss a diagnostic algorithm for periodic hypercortisolemia with special regard to hair cortisol analysis and desmopressin stimulation test which both seem to be helpful in finding the correct answer.
- |||||||||| Metopirone (metyrapone) / HRA Pharma
Review, Journal: Management and Medical Therapy of Mild Hypercortisolism. (Pubmed Central) - Dec 18, 2021
In the more frequently adrenal mHC, encouraging data are available for metyrapone, a steroidogenesis inhibitor acting mainly against the adrenal 11-βhydroxylase, while data on osilodrostat and levoketoconazole, other new steroidogenesis inhibitors, are still needed in patients with mHC. Finally, on the basis of promising data with mifepristone, a non-selective glucocorticoid receptor antagonist, in patients with mild cortisol hypersecretion, a randomized placebo-controlled study is ongoing for assessing the efficacy and safety of relacorilant, a selective glucocorticoid receptor antagonist, for patients with mild adrenal hypercortisolism and diabetes mellitus/impaired glucose tolerance and/or uncontrolled systolic hypertension.
- |||||||||| Metopirone (metyrapone) / HRA Pharma
Clinical, Journal: Approach to the Patient Treated with Steroidogenesis Inhibitors. (Pubmed Central) - Oct 6, 2021
Various points will be discussed such as initial dose of treatment, dose schedule, monitoring of efficacy and side effects of monotherapy. The combination of steroidogenesis inhibitors will also be discussed.
- |||||||||| Recorlev (levoketoconazole) / Xeris Biopharma
Enrollment closed: OPTICS: Open-label Treatment in Cushing's Syndrome (clinicaltrials.gov) - Mar 22, 2021
P3, N=60, Active, not recruiting,
The current review provides a summary of the available evidences from current and recent clinical trials on CD, with a specific focus on preliminary data. Recruiting --> Active, not recruiting
- |||||||||| Review, Journal: What is the role of medical therapy in adrenal-dependent Cushing's syndrome? (Pubmed Central) - Jan 2, 2021
Mitotane can be used as well but is considered second-line therapy because of its high toxicity...New drugs are tested in prospective trials (levoketoconazole, osilidrostat and relacorilant) and might become effective alternatives to common drugs. Oher drugs - adrenal steroidogenesis inhibitors as well as glucocorticoid receptor antagonists - are currently tested in vitro.
- |||||||||| Recorlev (levoketoconazole) / Xeris Biopharma
Trial completion date, Trial primary completion date: OPTICS: Open-label Treatment in Cushing's Syndrome (clinicaltrials.gov) - Aug 8, 2020
P3, N=60, Recruiting,
Active, not recruiting --> Completed Trial completion date: Jun 2021 --> Jun 2023 | Trial primary completion date: Apr 2021 --> Jun 2023
- |||||||||| Recorlev (levoketoconazole) / Strongbridge
[VIRTUAL] Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome (LOGICS): A Double-Blind, Placebo-Controlled, Withdrawal Study () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_1508;
P3
Secondary endpoints include changes from baseline to all postbaseline visits in R-W phase for mUFC, late-night salivary cortisol, CS cardiovascular biomarkers (fasting glucose, fasting insulin, hemoglobin A1c, homeostatic model assessment-insulin resistance, total and LDL cholesterol, high-sensitivity C-reactive protein), CS clinical signs and symptoms (acne, hirsutism [women only], and peripheral edema scores), and patient-reported outcomes of QoL (Cushing QoL questionnaire score) and depression (Beck Depression Inventory II). Potential liver toxicity, QT prolongation, and adrenal insufficiency are prespecified adverse events of special interest.
- |||||||||| Recorlev (levoketoconazole) / Xeris Biopharma
Enrollment closed, Trial completion date, Trial primary completion date: A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. (clinicaltrials.gov) - May 14, 2020
P3, N=44, Active, not recruiting,
Levoketoconazole might represent a useful therapeutic option for the medical treatment of Cushing's syndrome. Recruiting --> Active, not recruiting | Trial completion date: Feb 2020 --> Aug 2020 | Trial primary completion date: Dec 2019 --> Jul 2020
- |||||||||| Review, Journal: Advances in the medical treatment of Cushing's syndrome. (Pubmed Central) - May 7, 2020
CORT125134 is a new selective glucocorticoid receptor antagonist under investigation. We summarise the drug therapies for various forms of Cushing's syndrome and focus on emerging drugs and drug targets that have the potential for new and effective tailor-made pharmacotherapy for patients with Cushing's syndrome.
- |||||||||| Review, Journal: Medical Management of Cushing Disease. (Pubmed Central) - Feb 24, 2020
Steroidogenesis inhibitors, centrally acting agents, and glucocorticoid receptor antagonists are currently available to treat hypercortisolism, and several novel agents are in development. Given the absence of head-to-head clinical trials, choice between treatments has to be individualized based on careful consideration of patient, tumor, and disease characteristics.
- |||||||||| Recorlev (levoketoconazole) / Strongbridge
Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome (LOGICS): A Double-Blind, Placebo-Controlled, Withdrawal Study (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_3328;
P3
Secondary endpoints include changes from baseline to all postbaseline visits in R-W phase for mUFC, late-night salivary cortisol, CS cardiovascular biomarkers (fasting glucose, fasting insulin, hemoglobin A1c, homeostatic model assessment-insulin resistance, total and LDL cholesterol, high-sensitivity C-reactive protein), CS clinical signs and symptoms (acne, hirsutism [women only], and peripheral edema scores), and patient-reported outcomes of QoL (Cushing QoL questionnaire score) and depression (Beck Depression Inventory II). Potential liver toxicity, QT prolongation, and adrenal insufficiency are prespecified adverse events of special interest.
- |||||||||| Recorlev (levoketoconazole) / Xeris Biopharma
Trial completion: Bioavailability of Levoketoconazole and Ketoconazole Tablets (clinicaltrials.gov) - Jan 30, 2020
P1, N=34, Completed,
Potential liver toxicity, QT prolongation, and adrenal insufficiency are prespecified adverse events of special interest. Active, not recruiting --> Completed
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