作者
Shlomo Melmed, Vera Popovic, Martin Bidlingmaier, Moises Mercado, Aart Jan van der Lely, Nienke Biermasz, Marek Bolanowski, Mihail Coculescu, Jochen Schopohl, Karoly Racz, Benjamin Glaser, Miklos Goth, Yona Greenman, Peter Trainer, Emese Mezosi, Ilan Shimon, Andrea Giustina, Márta Korbonits, Marcello D Bronstein, David Kleinberg, Sam Teichman, Irit Gliko-Kabir, Roni Mamluk, Asi Haviv, Christian Strasburger
发表日期
2015/4/1
期刊
The Journal of Clinical Endocrinology & Metabolism
卷号
100
期号
4
页码范围
1699-1708
出版商
Oxford University Press
简介
Background
A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study in patients with 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 …
学术搜索中的文章
S Melmed, V Popovic, M Bidlingmaier, M Mercado… - The Journal of Clinical Endocrinology & Metabolism, 2015