Teduglutide for Safe Reduction of Parenteral Nutrient and/or Fluid Requirements in Adults: A Systematic Review.

Jane K Naberhuis, Kelly A Tappenden
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Abstract

Background: Teduglutide (Gattex; NPS Pharma, Bedminster, NJ), a recombinant analogue of human glucagon-like peptide 2 (GLP-2), is the first long-term medical therapy approved for the treatment of adults dependent on parenteral nutrition (PN).

Objective: To assess the efficacy and safety of teduglutide in reducing PN (parenteral nutrient and/or fluid) requirements in PN-dependent adults.

Methods: Studies were identified using predefined search criteria and multiple databases, including Medline and Embase. The search was completed to November 30, 2014, in the absence of date or study design restrictions. Citation inclusion criteria and methodological quality were assessed by 2 independent reviewers. Outcomes of interest were changes in parenteral nutrient or fluid requirements and adverse event incidence. From 2693 unique citations, 76 abstracts were reviewed. Fourteen reports met the inclusion criteria, including data from 2 phase III, double-blind, placebo-controlled clinical trials and their respective extension studies. Data extraction was performed by 2 reviewers using a standardized form.

Results: Teduglutide reduced PN requirements compared with placebo, whereas adverse event incidence was similar.

Limitations: Number of subjects studied and length of follow-up.

Conclusions: Teduglutide appears to be a safe and well-tolerated means to reduce PN dependence in adults, regardless of PN dependence duration.

替杜葡肽安全降低成人肠外营养和/或液体需要量:系统综述。
背景:Teduglutide (Gattex;NPS Pharma, Bedminster, NJ)是一种重组人胰高血糖素样肽2 (GLP-2)类似物,是首个被批准用于治疗依赖肠外营养(PN)的成人的长期药物治疗。目的:评价特杜葡肽降低PN依赖成人肠外营养和/或液体需要量的有效性和安全性。方法:使用预定义的搜索标准和多个数据库(包括Medline和Embase)对研究进行识别。在没有日期或研究设计限制的情况下,检索完成至2014年11月30日。引用纳入标准和方法学质量由2名独立审稿人评估。关注的结果是肠外营养或液体需要量的变化和不良事件发生率。对2693篇唯一引用的76篇摘要进行了综述。14份报告符合纳入标准,包括来自2项III期、双盲、安慰剂对照临床试验及其相应扩展研究的数据。数据提取由2名审稿人使用标准化表格进行。结果:与安慰剂相比,Teduglutide减少了PN需求,而不良事件发生率相似。局限性:研究对象的数量和随访时间。结论:Teduglutide似乎是一种安全且耐受性良好的减少成人PN依赖的方法,无论PN依赖持续时间如何。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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