Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing's syndrome.
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ABSTRACT: Purpose
The efficacy of levoketoconazole in treating hypercortisolism was demonstrated in an open-label phase 3 study (SONICS) of adults with endogenous Cushing's syndrome (CS) and baseline mean urinary free cortisol (mUFC)??? 1.5× ULN. Clinical signs and symptoms and patient-reported outcomes from the SONICS trial were evaluated in the current manuscript.Methods
Patients titrated to an individualized therapeutic dose entered a 6-month maintenance phase. Secondary endpoints included investigator-graded clinical signs and symptoms of CS during the maintenance phase, and patient-reported quality of life (CushingQoL questionnaire) and depression symptoms (Beck Depression Inventory II [BDI-II]).Results
Of 94 enrolled patients, 77 entered the maintenance phase following individualized dose titration. Significant mean improvements from baseline were noted at end of maintenance (Month 6) for acne, hirsutism (females only), and peripheral edema. These improvements were observed as early as Day 1 of maintenance for hirsutism (mean baseline score, 7.8; ? - 1.9; P?ConclusionsTreatment with levoketoconazole was associated with sustained, meaningful improvements in QoL, depression, and certain clinical signs and symptoms characteristic of CS. ClinialTrials.gov identifier: NCT01838551.
SUBMITTER: Geer EB
PROVIDER: S-EPMC7864823 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
Publications
Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing's syndrome.
Geer Eliza B EB Salvatori Roberto R Elenkova Atanaska A Fleseriu Maria M Pivonello Rosario R Witek Przemyslaw P Feelders Richard A RA Bex Marie M Borresen Stina W SW Puglisi Soraya S Biller Beverly M K BMK Cohen Fredric F Pecori Giraldi Francesca F
Pituitary 20201120 1
<h4>Purpose</h4>The efficacy of levoketoconazole in treating hypercortisolism was demonstrated in an open-label phase 3 study (SONICS) of adults with endogenous Cushing's syndrome (CS) and baseline mean urinary free cortisol (mUFC) ≥ 1.5× ULN. Clinical signs and symptoms and patient-reported outcomes from the SONICS trial were evaluated in the current manuscript.<h4>Methods</h4>Patients titrated to an individualized therapeutic dose entered a 6-month maintenance phase. Secondary endpoints inclu ...[more]
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