Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing's syndrome.

Pituitary
Eliza B GeerFrancesca Pecori Giraldi

Abstract

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. 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]). 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 < 0.0001), end of Month 1 for acne (mean baseline score, 2.8; ∆ - 1.2; P = 0.0481), and Month 4 for peripheral edema (mean baseline score, 1.0; ∆ - 0.5; P = 0.0052). Significant mean improvements fro...Continue Reading

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Citations

Mar 13, 2021·Best Practice & Research. Clinical Endocrinology & Metabolism·Elena V VarlamovMaria Fleseriu
Mar 26, 2021·Current Opinion in Endocrinology, Diabetes, and Obesity·Alicia SantosEugenia Resmini
Mar 7, 2021·The Journal of Clinical Endocrinology and Metabolism·Frederic CastinettiJohn Newell-Price
Aug 13, 2021·Expert Review of Endocrinology & Metabolism·Maria FleseriuBeverly M K Biller
Oct 5, 2021·Frontiers in Endocrinology·Julia Simões Corrêa GalendiVania Dos Santos Nunes Nogueira

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Clinical Trials Mentioned

NCT01838551

Software Mentioned

SONICS

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