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    Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial.

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    Authors
    Melmed, S
    Popovic, V
    Bidlingmaier, M
    Mercado, M
    Van Der Lely, A
    Biermasz, N
    Bolanowski, M
    Coculescu, M
    Schopohl, J
    Racz, K
    Glaser, B
    Goth, M
    Greenman, Y
    Trainer, Peter J
    Mezosi, E
    Shimon, I
    Giustina, A
    Korbonits, M
    Bronstein, M
    Kleinberg, D
    Teichman, S
    Gliko-Kabir, I
    Mamluk, R
    Haviv, A
    Strasburger, C
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    Affiliation
    Cedars-Sinai Medical Center , Los Angeles, California
    Issue Date
    2015-02-09
    
    Metadata
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    Abstract
    Background: A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study for acromegaly. Methods: We enrolled 155 complete or partially controlled patients (IGF-1 < 1.3 × upper limit of normal [ULN], and 2-h integrated GH < 2.5 ng/mL) receiving injectable somatostatin receptor ligand (SRL) for ≥ 3 months. Subjects were switched to 40 mg/d oral octreotide capsules (OOCs), and the dose escalated to 60 and then up to 80 mg/d to control IGF-1. Subsequent fixed doses were maintained for a 7-month core treatment, followed by a voluntary 6-month extension. Results: Of 151 evaluable subjects initiating OOCs, 65% maintained response and achieved the primary endpoint of IGF-1 < 1.3 × ULN and mean integrated GH < 2.5 ng/mL at the end of the core treatment period and 62% at the end of treatment (up to 13 mo). The effect was durable, and 85 % of subjects initially controlled on OOCs maintained this response up to 13 months. When controlled on OOCs, GH levels were reduced compared to baseline, and acromegaly-related symptoms improved. Of 102 subjects completing the core treatment, 86% elected to enroll in the 6-month extension. Twenty-six subjects who were considered treatment failures (IGF-1 ≥ 1.3 × ULN) terminated early, and 23 withdrew for adverse events, consistent with those known for octreotide or disease related. Conclusions: OOC, an oral therapeutic peptide, achieves efficacy in controlling IGF-1 and GH after switching from injectable SRLs for up to 13 months, with a safety profile consistent with approved SRLs. OOC appears to be effective and safe as an acromegaly monotherapy.
    Citation
    Safety and Efficacy of Oral Octreotide in Acromegaly: Results of a Multicenter Phase III Trial. 2015:jc20144113 J Clin Endocrinol Metab
    Journal
    The Journal of Clinical Endocrinology and Metabolism
    URI
    http://hdl.handle.net/10541/345295
    DOI
    10.1210/jc.2014-4113
    PubMed ID
    25664604
    Type
    Article
    Language
    en
    ISSN
    1945-7197
    ae974a485f413a2113503eed53cd6c53
    10.1210/jc.2014-4113
    Scopus Count
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    All Christie Publications

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