Title: How do clinicians integrate oral octreotide into their treatment plan for acromegaly?
Abstract: Since the late 1980s, injectable somatostatin receptor ligands (iSRLs) have been well established as treatment for acromegaly, and oral formulations of octreotide have more recently become available. 1 Gomes-Porras M Cárdenas-Salas J Álvarez-Escolá C Somatostatin analogs in clinical practice: a review. Int J Mol Sci. 2020; 211682 Crossref Scopus (37) Google Scholar , 2 Melmed S Bronstein MD Chanson P et al. A consensus statement on acromegaly therapeutic outcomes. Nat Rev Endocrinol. 2018; 14: 552-561 Crossref PubMed Scopus (212) Google Scholar In June, 2020, the US Food and Drug Administration approved the first oral octreotide capsules for long-term maintenance treatment in acromegaly patients who have tolerated and responded to treatment with iSRLs. Approval was prompted by the results of a multicentre phase 3 trial 3 Samson SL Nachtigall LB Fleseriu M et al. Maintenance of acromegaly control in patients switching from injectable somatostatin receptor ligands to oral octreotide. J Clin Endocrinol Metab. 2020; 105: e3785-e3797 Crossref Scopus (14) Google Scholar in which 56 adults with acromegaly previously controlled by iSRLs were randomly assigned to octreotide capsules or placebo. The primary endpoint was IGF-1 concentration 1 × upper limit of normal (ULN) or less at the end of 9 months, and was met by 58% of patients taking oral octreotide compared with 19% of those on placebo (p=0·008). In another phase 3 open-label multicentre trial, published in 2015, 4 Melmed S Popovic V Bidlingmaier M et al. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015; 100: 1699-1708 Crossref PubMed Scopus (108) Google Scholar 65% of 151 participants maintained response with oral octreotide, with a safety profile comparable to iSRLs. Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trialOral octreotide was non-inferior to iSRL treatment, and might be a favourable alternative to iSRLs for many patients with acromegaly. Full-Text PDF
Publication Year: 2022
Publication Date: 2022-02-01
Language: en
Type: letter
Indexed In: ['crossref', 'pubmed']
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Cited By Count: 1
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