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Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes

It is important for patients that treatments for diabetes not increase cardiovascular (CV) risk. The objective of this analysis was to examine retrospectively the CV safety of exenatide BID, a GLP-1 receptor agonist approved for treating hyperglycemia in patients with type 2 diabetes not adequately...

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Autores principales: Ratner, Robert, Han, Jenny, Nicewarner, Dawn, Yushmanova, Irina, Hoogwerf, Byron J, Shen, Larry
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3070629/
https://www.ncbi.nlm.nih.gov/pubmed/21410975
http://dx.doi.org/10.1186/1475-2840-10-22
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author Ratner, Robert
Han, Jenny
Nicewarner, Dawn
Yushmanova, Irina
Hoogwerf, Byron J
Shen, Larry
author_facet Ratner, Robert
Han, Jenny
Nicewarner, Dawn
Yushmanova, Irina
Hoogwerf, Byron J
Shen, Larry
author_sort Ratner, Robert
collection PubMed
description It is important for patients that treatments for diabetes not increase cardiovascular (CV) risk. The objective of this analysis was to examine retrospectively the CV safety of exenatide BID, a GLP-1 receptor agonist approved for treating hyperglycemia in patients with type 2 diabetes not adequately controlled with diet and exercise. Individual participant data was pooled to assess the relative risk (RR) of CV events with exenatide BID versus a pooled comparator (PC) group treated with either placebo or insulin from 12 controlled, randomized, clinical trials ranging from 12-52 weeks. Mean baseline values for HbA(1c )(8.33-8.38%), BMI (31.3-31.5 kg/m(2)), and duration of diabetes (8 y) were similar between groups. Trials included patients with histories of microvascular and/or macrovascular disease. Customized primary major adverse CV events (MACE) included stroke, myocardial infarction, cardiac mortality, acute coronary syndrome, and revascularization procedures. The Primary MACE RR (0.7; 95% CI 0.38, 1.31), calculated by the Mantel-Haenszel method (stratified by study), suggested that exenatide use (vs. PC) did not increase CV risk; this result was consistent across multiple analytic methods. Because the trials were not designed to assess CV outcomes, events were identified retrospectively from a list of preferred terms by physicians blinded to treatment. Other limitations included the low number of CV events, the short duration of trials (≤1 y), and a single active comparator (insulin). The results of these analyses are consistent with those of a recent retrospective analysis of a large insurance database that found that patients treated with exenatide twice daily were less likely to have a CV event than were patients treated with other glucose-lowering therapies. Keywords: GLP-1 receptor agonist, diabetes, cardiovascular safety
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spelling pubmed-30706292011-04-05 Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes Ratner, Robert Han, Jenny Nicewarner, Dawn Yushmanova, Irina Hoogwerf, Byron J Shen, Larry Cardiovasc Diabetol Original Investigation It is important for patients that treatments for diabetes not increase cardiovascular (CV) risk. The objective of this analysis was to examine retrospectively the CV safety of exenatide BID, a GLP-1 receptor agonist approved for treating hyperglycemia in patients with type 2 diabetes not adequately controlled with diet and exercise. Individual participant data was pooled to assess the relative risk (RR) of CV events with exenatide BID versus a pooled comparator (PC) group treated with either placebo or insulin from 12 controlled, randomized, clinical trials ranging from 12-52 weeks. Mean baseline values for HbA(1c )(8.33-8.38%), BMI (31.3-31.5 kg/m(2)), and duration of diabetes (8 y) were similar between groups. Trials included patients with histories of microvascular and/or macrovascular disease. Customized primary major adverse CV events (MACE) included stroke, myocardial infarction, cardiac mortality, acute coronary syndrome, and revascularization procedures. The Primary MACE RR (0.7; 95% CI 0.38, 1.31), calculated by the Mantel-Haenszel method (stratified by study), suggested that exenatide use (vs. PC) did not increase CV risk; this result was consistent across multiple analytic methods. Because the trials were not designed to assess CV outcomes, events were identified retrospectively from a list of preferred terms by physicians blinded to treatment. Other limitations included the low number of CV events, the short duration of trials (≤1 y), and a single active comparator (insulin). The results of these analyses are consistent with those of a recent retrospective analysis of a large insurance database that found that patients treated with exenatide twice daily were less likely to have a CV event than were patients treated with other glucose-lowering therapies. Keywords: GLP-1 receptor agonist, diabetes, cardiovascular safety BioMed Central 2011-03-16 /pmc/articles/PMC3070629/ /pubmed/21410975 http://dx.doi.org/10.1186/1475-2840-10-22 Text en Copyright ©2011 Ratner et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Investigation
Ratner, Robert
Han, Jenny
Nicewarner, Dawn
Yushmanova, Irina
Hoogwerf, Byron J
Shen, Larry
Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes
title Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes
title_full Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes
title_fullStr Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes
title_full_unstemmed Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes
title_short Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes
title_sort cardiovascular safety of exenatide bid: an integrated analysis from controlled clinical trials in participants with type 2 diabetes
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3070629/
https://www.ncbi.nlm.nih.gov/pubmed/21410975
http://dx.doi.org/10.1186/1475-2840-10-22
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