Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial.
dc.contributor.author | Melmed, S | |
dc.contributor.author | Popovic, V | |
dc.contributor.author | Bidlingmaier, M | |
dc.contributor.author | Mercado, M | |
dc.contributor.author | Van Der Lely, A | |
dc.contributor.author | Biermasz, N | |
dc.contributor.author | Bolanowski, M | |
dc.contributor.author | Coculescu, M | |
dc.contributor.author | Schopohl, J | |
dc.contributor.author | Racz, K | |
dc.contributor.author | Glaser, B | |
dc.contributor.author | Goth, M | |
dc.contributor.author | Greenman, Y | |
dc.contributor.author | Trainer, Peter J | |
dc.contributor.author | Mezosi, E | |
dc.contributor.author | Shimon, I | |
dc.contributor.author | Giustina, A | |
dc.contributor.author | Korbonits, M | |
dc.contributor.author | Bronstein, M | |
dc.contributor.author | Kleinberg, D | |
dc.contributor.author | Teichman, S | |
dc.contributor.author | Gliko-Kabir, I | |
dc.contributor.author | Mamluk, R | |
dc.contributor.author | Haviv, A | |
dc.contributor.author | Strasburger, C | |
dc.date.accessioned | 2015-02-25T11:57:05Z | |
dc.date.available | 2015-02-25T11:57:05Z | |
dc.date.issued | 2015-02-09 | |
dc.identifier.citation | Safety and Efficacy of Oral Octreotide in Acromegaly: Results of a Multicenter Phase III Trial. 2015:jc20144113 J Clin Endocrinol Metab | en |
dc.identifier.issn | 1945-7197 | |
dc.identifier.pmid | 25664604 | |
dc.identifier.doi | 10.1210/jc.2014-4113 | |
dc.identifier.uri | http://hdl.handle.net/10541/345295 | |
dc.description.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. | |
dc.language | ENG | |
dc.language.iso | en | en |
dc.rights | Archived with thanks to The Journal of clinical endocrinology and metabolism | en |
dc.title | Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. | en |
dc.type | Article | en |
dc.contributor.department | Cedars-Sinai Medical Center , Los Angeles, California | en |
dc.identifier.journal | The Journal of Clinical Endocrinology and Metabolism | en |
html.description.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. |