Long-term efficacy and safety of once-monthly pasireotide in Cushing's disease: A Phase III extension study.

ABSTRACT:

Objectives

Many patients with Cushing's disease (CD) require chronic pharmacotherapy to control their hypercortisolism. We evaluated the efficacy and safety of long-acting pasireotide during a long-term extension study in patients with CD.

Design

Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).

Patients

Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.

Results

Eighty-one of 150 (54.0%) enrolled patients entered the extension. Median overall exposure to pasireotide at study end was 23.9 months; 39/81 (48.1%) patients completed the extension (received ≥ 12 months' treatm

SUBMITTER: Fleseriu M 

PROVIDER: S-EPMC6899900 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature