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“To assess the efficacy and safety of teduglutide in reducing PN (parenteral nutrient and/or fluid) requirements in PN-dependent adults” Naberhuis and Tappenden (2015).

Reference:

Naberhuis, J.K. and Tappenden, K.A. (2015) Teduglutide for Safe Reduction of Parenteral Nutrient and/or Fluid Requirements in Adults. Journal of Parenteral & Enteral Nutrition. April 16th. [epub ahead of print].

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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.

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