MPOWERED Trial Open-Label Extension: Long-Term Efficacy and Safety Data for Oral Octreotide Capsules in Acromegaly.

ABSTRACT:

Context

The MPOWERED core trial (NCT02685709) and open-label extension (OLE) phase investigated long-term efficacy and safety of oral octreotide capsules (OOC) in patients with acromegaly. Core trial primary endpoint data demonstrated noninferiority to injectable somatostatin receptor ligands (iSRLs). Core trial completers were invited to participate in the OLE phase.

Objective

To assess long-term efficacy and safety of OOC in patients with acromegaly who previously responded to and tolerated both OOC and injectable octreotide/lanreotide and completed the core phase. The unique study design of transitioning between OOC and iSRLs allowed within-patient evaluations.

Main outcome measure

Proportion of biochemical responders (insulin-like growth factor I < 1.3 × upper lim

SUBMITTER: Fleseriu M 

PROVIDER: S-EPMC10655542 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature