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Does Real World Use of Liraglutide Match its Use in the LEADER Cardiovascular Outcome Trial? Study Protocol

BACKGROUND: Liraglutide is an injectable therapy to treat type 2 diabetes (T2DM), belonging to the glucagon-like peptide-1 receptor agonist class of drugs. The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial established that liraglutide demonstr...

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Autores principales: Hinton, William, Feher, Michael, Munro, Neil, de Lusignan, Simon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5984905/
https://www.ncbi.nlm.nih.gov/pubmed/29605893
http://dx.doi.org/10.1007/s13300-018-0390-8
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author Hinton, William
Feher, Michael
Munro, Neil
de Lusignan, Simon
author_facet Hinton, William
Feher, Michael
Munro, Neil
de Lusignan, Simon
author_sort Hinton, William
collection PubMed
description BACKGROUND: Liraglutide is an injectable therapy to treat type 2 diabetes (T2DM), belonging to the glucagon-like peptide-1 receptor agonist class of drugs. The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial established that liraglutide demonstrated glucose-lowering benefits and improved cardiovascular outcomes in those individuals with T2DM at high cardiovascular risk. AIMS: The aim of this study is to report the prevalence and characteristics of people treated with liraglutide compared with the LEADER trial. In addition, the remaining portion of the T2DM population will be examined to determine the prevalence of those who meet the inclusion criteria for the LEADER trial but who are not treated with this medication. STUDY DESIGN AND METHODS: This is a cross-sectional analysis of routinely collected primary care data on all people with T2DM included in the Royal College of General Practitioners (RCGP) Research and Surveillance Center (RSC) network database. People with T2DM will be identified from the dataset using a well-established ontological process. Read and other clinical codes will be used to identify people prescribed liraglutide and those at high cardiovascular risk. We will use descriptive statistics to report the characteristics of people with T2DM prescribed liraglutide compared with those of the LEADER trial and the proportion of the wider T2DM cohort that matches the LEADER inclusion criteria. In terms of ethical considerations, this study used pseudonymized data, and was classed as an “Audit of current practice”. PLANNED OUTPUTS: The results of the study will be submitted for publication in a peer-reviewed journal to report the applicability of the results of the LEADER trial to real-world clinical practice. FUNDING: Novo Nordisk Limited.
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spelling pubmed-59849052018-06-13 Does Real World Use of Liraglutide Match its Use in the LEADER Cardiovascular Outcome Trial? Study Protocol Hinton, William Feher, Michael Munro, Neil de Lusignan, Simon Diabetes Ther Study Protocol BACKGROUND: Liraglutide is an injectable therapy to treat type 2 diabetes (T2DM), belonging to the glucagon-like peptide-1 receptor agonist class of drugs. The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial established that liraglutide demonstrated glucose-lowering benefits and improved cardiovascular outcomes in those individuals with T2DM at high cardiovascular risk. AIMS: The aim of this study is to report the prevalence and characteristics of people treated with liraglutide compared with the LEADER trial. In addition, the remaining portion of the T2DM population will be examined to determine the prevalence of those who meet the inclusion criteria for the LEADER trial but who are not treated with this medication. STUDY DESIGN AND METHODS: This is a cross-sectional analysis of routinely collected primary care data on all people with T2DM included in the Royal College of General Practitioners (RCGP) Research and Surveillance Center (RSC) network database. People with T2DM will be identified from the dataset using a well-established ontological process. Read and other clinical codes will be used to identify people prescribed liraglutide and those at high cardiovascular risk. We will use descriptive statistics to report the characteristics of people with T2DM prescribed liraglutide compared with those of the LEADER trial and the proportion of the wider T2DM cohort that matches the LEADER inclusion criteria. In terms of ethical considerations, this study used pseudonymized data, and was classed as an “Audit of current practice”. PLANNED OUTPUTS: The results of the study will be submitted for publication in a peer-reviewed journal to report the applicability of the results of the LEADER trial to real-world clinical practice. FUNDING: Novo Nordisk Limited. Springer Healthcare 2018-03-31 2018-06 /pmc/articles/PMC5984905/ /pubmed/29605893 http://dx.doi.org/10.1007/s13300-018-0390-8 Text en © The Author(s) 2018 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Study Protocol
Hinton, William
Feher, Michael
Munro, Neil
de Lusignan, Simon
Does Real World Use of Liraglutide Match its Use in the LEADER Cardiovascular Outcome Trial? Study Protocol
title Does Real World Use of Liraglutide Match its Use in the LEADER Cardiovascular Outcome Trial? Study Protocol
title_full Does Real World Use of Liraglutide Match its Use in the LEADER Cardiovascular Outcome Trial? Study Protocol
title_fullStr Does Real World Use of Liraglutide Match its Use in the LEADER Cardiovascular Outcome Trial? Study Protocol
title_full_unstemmed Does Real World Use of Liraglutide Match its Use in the LEADER Cardiovascular Outcome Trial? Study Protocol
title_short Does Real World Use of Liraglutide Match its Use in the LEADER Cardiovascular Outcome Trial? Study Protocol
title_sort does real world use of liraglutide match its use in the leader cardiovascular outcome trial? study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5984905/
https://www.ncbi.nlm.nih.gov/pubmed/29605893
http://dx.doi.org/10.1007/s13300-018-0390-8
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