Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide

Susan L. Samson, Lisa B. Nachtigall, Maria Fleseriu, Murray B. Gordon, Marek Bolanowski, Artak Labadzhyan, Ehud Ur, Mark Molitch, William H. Ludlam, Gary Patou, Asi Haviv, Nienke Biermasz, Andrea Giustina, Peter J. Trainer, Christian J. Strasburger, Laurence Kennedy, Shlomo Melmed

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

PURPOSE: The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs). METHODS: In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks. The primary end point was maintenance of biochemical control at the end of treatment (mean insulin-like growth factor 1 [IGF-1] ≤ 1.0 × upper limit of normal [ULN]; weeks 34 and 36). Time to loss of IGF-1 response and proportion requiring reversion to injectable SRLs were assessed as broader control measures. RESULTS: Mean IGF-1 measurements were 0.80 and 0.97 × ULN for OOC and 0.84 and 1.69 × ULN for placebo, at baseline and end of treatment, respectively. Mean growth hormone (GH) changed from 0.66 to 0.60 ng/mL for OOCs and 0.90 to 2.57 ng/mL for placebo. Normalization of IGF-1 levels (≤ 1.0 × ULN) was maintained in 58.2% for OOCs vs 19.4% for placebo (P = .008); GH levels were maintained (< 2.5 ng/mL) in 77.7% for OOC vs 30.4% for placebo (P = .0007). Median time to loss of response (IGF-1 > 1.0 or ≥ 1.3 × ULN definitions) for patients receiving placebo was 16 weeks; for patients receiving OOCs, it was not reached for both definitions during the 36-week trial (P < .0001). Of the patients in the OOC group, 75% completed the trial on oral therapy. The OOC safety profile was consistent with previous SRL experience. CONCLUSIONS: OOCs may be an effective therapy for patients with acromegaly who previously were treated with injectable SRLs.

Original languageEnglish (US)
JournalThe Journal of clinical endocrinology and metabolism
Volume105
Issue number10
DOIs
StatePublished - Oct 1 2020

Keywords

  • IGF-1
  • acromegaly
  • growth hormone
  • oral octreotide
  • somatostatin analogues
  • somatostatin receptor ligands

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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    Samson, S. L., Nachtigall, L. B., Fleseriu, M., Gordon, M. B., Bolanowski, M., Labadzhyan, A., Ur, E., Molitch, M., Ludlam, W. H., Patou, G., Haviv, A., Biermasz, N., Giustina, A., Trainer, P. J., Strasburger, C. J., Kennedy, L., & Melmed, S. (2020). Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide. The Journal of clinical endocrinology and metabolism, 105(10). https://doi.org/10.1210/clinem/dgaa526