Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results

Artak Labadzhyan, L. B. Nachtigall, M. Fleseriu, M. B. Gordon, M. Molitch, L. Kennedy, S. L. Samson, Y. Greenman, N. Biermasz, M. Bolanowski, A. Haviv, W. Ludlam, G. Patou, C. J. Strasburger

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: Results are presented from 2 to 3 trials investigating oral octreotide capsules (OOC) as an alternative to injectable somatostatin receptor ligands (iSRLs) in the treatment of acromegaly. Methods: CH-ACM-01 was an open-label trial (N = 155) and CHIASMA OPTIMAL was a double-blind placebo-controlled (DPC) trial (N = 56), both investigating OOC as maintenance therapy for patients with acromegaly who were biochemical responders receiving iSRLs. Results: Baseline characteristics in both trials reflected those expected of patients with acromegaly responding to treatment and were similar between trials, despite differences in inclusion criteria. OOC demonstrated a consistent degree of biochemical response across trials, with 65% of patients in CH-ACM-01 maintaining response during the core period and 64% of patients in CHIASMA OPTIMAL at the end of the DPC. Mean insulin-like growth factor I (IGF-I) levels remained within inclusion criteria at the end of treatment in both trials. Of 110 patients entering the fixed-dose phase in CH-ACM-01, 80% maintained or improved acromegaly symptoms from baseline to the end of treatment. Over 85% of patients in both trials elected to continue into the extension phases. OOC were found to be well tolerated across both trials, and no dose-related adverse events were observed. Conclusions: OOC demonstrated remarkably consistent results for biochemical response, durability of response, and preference to continue with oral treatment across these 2 complementary landmark phase 3 trials, despite differences in the design of each. Trial registration NCT03252353 (August 2017), NCT01412424 (August 2011).

Original languageEnglish (US)
Pages (from-to)943-953
Number of pages11
JournalPituitary
Volume24
Issue number6
DOIs
StatePublished - Dec 2021

Keywords

  • Acromegaly
  • Growth hormone
  • IGF-I
  • Oral octreotide
  • Somatostatin analogs
  • Somatostatin receptor ligands

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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