PMON166 Safety Comparison of 40- vs 60-mg/day Doses of Oral Octreotide Capsules for Treatment of Acromegaly in the CHIASMA OPTIMAL Trial

ABSTRACT: Abstract

Background

Oral octreotide capsules (OOC) are a treatment option for patients with acromegaly in the United States who have previously responded to injectable somatostatin receptor ligands (iSRLs, octreotide or lanreotide). In previous phase 3 studies, the safety of OOC was shown to be consistent with iSRLs, without dose-dependent adverse reactions. In the double-blind, placebo-controlled period (DPC) of the CHIASMA OPTIMAL trial (NCT03252353), patients were randomized to twice-daily OOC at 40-mg/day, with the option for up-titration to 80-mg/day. In contrast, patients entered the open-label extension (OLE) at a 60-mg/day dose.

Objective

Examine the safety of 40-mg/day versus 60-mg/day OOC doses.

Methods

Eligible patients had the option to enroll in the

SUBMITTER:  

PROVIDER: S-EPMC9625665 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature