Long-term efficacy and safety of osilodrostat in patients with Cushing's disease: results from the LINC 4 study extension.

ABSTRACT:

Objective

To evaluate the long-term efficacy and safety of osilodrostat in patients with Cushing's disease.

Methods

The multicenter, 48-week, Phase III LINC 4 clinical trial had an optional extension period that was initially intended to continue to week 96. Patients could continue in the extension until a managed-access program or alternative treatment became available locally, or until a protocol amendment was approved at their site that specified that patients should come for an end-of-treatment visit within 4 weeks or by week 96, whichever occurred first. Study outcomes assessed in the extension included: mean urinary free cortisol (mUFC) response rates; changes in mUFC, serum cortisol and late-night salivary cortisol (LNSC); changes in cardiovascular and metabolic-relat

SUBMITTER: Gadelha M 

PROVIDER: S-EPMC10482037 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature