Durable biochemical response and safety with oral octreotide capsules in acromegaly.

ABSTRACT:

Objective

The objective of this study is to report results from the open-label extension (OLE) of the OPTIMAL trial of oral octreotide capsules (OOC) in adults with acromegaly, evaluating the long-term durability of therapeutic response.

Design

The study design is an OLE of a double-blind placebo-controlled (DPC) trial.

Methods

Patients completing the 36-week DPC period on the study drug (OOC or placebo) or meeting predefined withdrawal criteria were eligible for OLE enrollment at 60 mg/day OOC dose, with the option to titrate to 40 or 80 mg/day. The OLE is ongoing; week 48 results are reported.

Results

Forty patients were enrolled in the OLE, 20 each having received OOC or placebo, with 14 and 5 patients completing the DPC period as responders, respectively. N

SUBMITTER: Samson SL 

PROVIDER: S-EPMC9641789 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature