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dc.contributor.authorMelmed, S
dc.contributor.authorPopovic, V
dc.contributor.authorBidlingmaier, M
dc.contributor.authorMercado, M
dc.contributor.authorVan Der Lely, A
dc.contributor.authorBiermasz, N
dc.contributor.authorBolanowski, M
dc.contributor.authorCoculescu, M
dc.contributor.authorSchopohl, J
dc.contributor.authorRacz, K
dc.contributor.authorGlaser, B
dc.contributor.authorGoth, M
dc.contributor.authorGreenman, Y
dc.contributor.authorTrainer, Peter J
dc.contributor.authorMezosi, E
dc.contributor.authorShimon, I
dc.contributor.authorGiustina, A
dc.contributor.authorKorbonits, M
dc.contributor.authorBronstein, M
dc.contributor.authorKleinberg, D
dc.contributor.authorTeichman, S
dc.contributor.authorGliko-Kabir, I
dc.contributor.authorMamluk, R
dc.contributor.authorHaviv, A
dc.contributor.authorStrasburger, C
dc.date.accessioned2015-02-25T11:57:05Z
dc.date.available2015-02-25T11:57:05Z
dc.date.issued2015-02-09
dc.identifier.citationSafety and Efficacy of Oral Octreotide in Acromegaly: Results of a Multicenter Phase III Trial. 2015:jc20144113 J Clin Endocrinol Metaben
dc.identifier.issn1945-7197
dc.identifier.pmid25664604
dc.identifier.doi10.1210/jc.2014-4113
dc.identifier.urihttp://hdl.handle.net/10541/345295
dc.description.abstractBackground: 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.
dc.languageENG
dc.language.isoenen
dc.rightsArchived with thanks to The Journal of clinical endocrinology and metabolismen
dc.titleSafety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial.en
dc.typeArticleen
dc.contributor.departmentCedars-Sinai Medical Center , Los Angeles, Californiaen
dc.identifier.journalThe Journal of Clinical Endocrinology and Metabolismen
html.description.abstractBackground: 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.


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