期刊
DIABETES-METABOLISM RESEARCH AND REVIEWS
卷 31, 期 2, 页码 204-211出版社
WILEY
DOI: 10.1002/dmrr.2588
关键词
elderly; efficacy; lixisenatide; pharmacokinetics; type 2 diabetes mellitus
资金
- Sanofi
BackgroundThe objective of this article is to evaluate the pharmacokinetics, efficacy and safety of lixisenatide (subcutaneous injection) in elderly (65years old) and very elderly (75years old) patients with type 2 diabetes mellitus. MethodsWe conducted a phase I, single-centre, open-label study to evaluate the safety and pharmacokinetics of a single lixisenatide 20 mu g dose and a pooled analysis of six randomized, placebo-controlled, phase III studies (12-month or 24-month duration) that evaluated glycaemic parameters and safety in patients receiving lixisenatide 20 mu g once daily or placebo. ResultsThe pharmacokinetics study included 36 healthy subjects, including 18 elderly healthy subjects (65years old) and 18 matched young healthy subjects (18-45years old). The pooled analysis included 3188 patients, including 2565 patients <65years old and 623 patients 65years old (including 79 patients 75years old). Mean exposure with lixisenatide 20 mu g was similar to 30% higher in elderly than in young subjects, and the terminal half-life was prolonged by similar to 1.6 times. Maximum concentration (C-max) and time to C-max (t(max)) were comparable in both groups. Equal numbers of elderly and young subjects reported treatment-emergent adverse events, the majority of which were gastrointestinal disorders. In the pooled analysis, lixisenatide 20 mu g once daily provided significant reductions in HbA(1c)versus placebo for all age groups. There was a similar incidence of treatment-emergent adverse events across all age groups (range: 69-73%). The incidence of symptomatic hypoglycaemia was generally comparable between lixisenatide-treated and placebo-treated patients. ConclusionThese data suggest that lixisenatide is effective and well tolerated in elderly and very elderly patients with type 2 diabetes mellitus. (c) 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.
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