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Daptomycin for the Treatment of Infective Endocarditis: Results from European Cubicin(®) Outcomes Registry and Experience (EU-CORE)

INTRODUCTION: The European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)) was a retrospective, non-interventional, multicenter study which evaluated the safety and effectiveness of daptomycin therapy in patients with Gram-positive infections including infective endocarditis (IE). METHODS:...

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Autores principales: Guleri, Achyut, Utili, Riccardo, Dohmen, Pascal, Petrosillo, Nicola, Piper, Cornelia, Pathan, Rashidkhan, Hamed, Kamal
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4575291/
https://www.ncbi.nlm.nih.gov/pubmed/26168988
http://dx.doi.org/10.1007/s40121-015-0075-9
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author Guleri, Achyut
Utili, Riccardo
Dohmen, Pascal
Petrosillo, Nicola
Piper, Cornelia
Pathan, Rashidkhan
Hamed, Kamal
author_facet Guleri, Achyut
Utili, Riccardo
Dohmen, Pascal
Petrosillo, Nicola
Piper, Cornelia
Pathan, Rashidkhan
Hamed, Kamal
author_sort Guleri, Achyut
collection PubMed
description INTRODUCTION: The European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)) was a retrospective, non-interventional, multicenter study which evaluated the safety and effectiveness of daptomycin therapy in patients with Gram-positive infections including infective endocarditis (IE). METHODS: Data from the EU-CORE registry were collected for patients with IE who had received at least one dose of daptomycin between January 2006 and April 2012, across 18 countries in Europe (12), Latin America (5) and Asia (1). Clinical outcomes were assessed as success (cured or improved), failure or non-evaluable. Adverse events (AEs) were recorded during treatment and for up to 30 days post-treatment; follow-up data were collected for 2 years. RESULTS: Of 6075 patients included in the EU-CORE registry, 610 were diagnosed with IE as primary infection; 149 (24.4%) right-sided IE (RIE), 414 (67.9%) left-sided IE (LIE), and 47 (7.7%) with both right- and left-sided IE (BRLIE). Overall clinical success was achieved in 80.0% of patients (RIE 88.6%, LIE 76.6% and BRLIE 82.9%). Success rates for methicillin-resistant Staphylococcus aureus (MRSA) infections were 90.9%, 71.7% and 66.6% in patients with RIE, LIE and BRLIE, respectively. The overall sustained clinical success rate in patients followed for up to 2 years was 86.7% (RIE 93.5%, LIE 88.3% and BRLIE 77.8%). AEs deemed possibly related to daptomycin in the investigator’s opinion were reported in 2 (1.3%) RIE, 18 (4.3%) LIE and 1 (2.1%) BRLIE patients. There were 11 (1.8%) patients (2 with RIE, 8 with LIE and 1 with BRLIE) with AEs of creatine phosphokinase elevation reported as possibly related to daptomycin. CONCLUSION: Data from this real-world clinical setting showed that daptomycin was well tolerated and effective for the treatment of LIE and BRLIE in addition to RIE caused by Gram-positive bacteria, including MRSA. Two-year follow-up data showed that a high proportion of patients had a sustained response. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40121-015-0075-9) contains supplementary material, which is available to authorized users.
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spelling pubmed-45752912015-09-23 Daptomycin for the Treatment of Infective Endocarditis: Results from European Cubicin(®) Outcomes Registry and Experience (EU-CORE) Guleri, Achyut Utili, Riccardo Dohmen, Pascal Petrosillo, Nicola Piper, Cornelia Pathan, Rashidkhan Hamed, Kamal Infect Dis Ther Original Research INTRODUCTION: The European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)) was a retrospective, non-interventional, multicenter study which evaluated the safety and effectiveness of daptomycin therapy in patients with Gram-positive infections including infective endocarditis (IE). METHODS: Data from the EU-CORE registry were collected for patients with IE who had received at least one dose of daptomycin between January 2006 and April 2012, across 18 countries in Europe (12), Latin America (5) and Asia (1). Clinical outcomes were assessed as success (cured or improved), failure or non-evaluable. Adverse events (AEs) were recorded during treatment and for up to 30 days post-treatment; follow-up data were collected for 2 years. RESULTS: Of 6075 patients included in the EU-CORE registry, 610 were diagnosed with IE as primary infection; 149 (24.4%) right-sided IE (RIE), 414 (67.9%) left-sided IE (LIE), and 47 (7.7%) with both right- and left-sided IE (BRLIE). Overall clinical success was achieved in 80.0% of patients (RIE 88.6%, LIE 76.6% and BRLIE 82.9%). Success rates for methicillin-resistant Staphylococcus aureus (MRSA) infections were 90.9%, 71.7% and 66.6% in patients with RIE, LIE and BRLIE, respectively. The overall sustained clinical success rate in patients followed for up to 2 years was 86.7% (RIE 93.5%, LIE 88.3% and BRLIE 77.8%). AEs deemed possibly related to daptomycin in the investigator’s opinion were reported in 2 (1.3%) RIE, 18 (4.3%) LIE and 1 (2.1%) BRLIE patients. There were 11 (1.8%) patients (2 with RIE, 8 with LIE and 1 with BRLIE) with AEs of creatine phosphokinase elevation reported as possibly related to daptomycin. CONCLUSION: Data from this real-world clinical setting showed that daptomycin was well tolerated and effective for the treatment of LIE and BRLIE in addition to RIE caused by Gram-positive bacteria, including MRSA. Two-year follow-up data showed that a high proportion of patients had a sustained response. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40121-015-0075-9) contains supplementary material, which is available to authorized users. Springer Healthcare 2015-07-14 2015-09 /pmc/articles/PMC4575291/ /pubmed/26168988 http://dx.doi.org/10.1007/s40121-015-0075-9 Text en © The Author(s) 2015 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Research
Guleri, Achyut
Utili, Riccardo
Dohmen, Pascal
Petrosillo, Nicola
Piper, Cornelia
Pathan, Rashidkhan
Hamed, Kamal
Daptomycin for the Treatment of Infective Endocarditis: Results from European Cubicin(®) Outcomes Registry and Experience (EU-CORE)
title Daptomycin for the Treatment of Infective Endocarditis: Results from European Cubicin(®) Outcomes Registry and Experience (EU-CORE)
title_full Daptomycin for the Treatment of Infective Endocarditis: Results from European Cubicin(®) Outcomes Registry and Experience (EU-CORE)
title_fullStr Daptomycin for the Treatment of Infective Endocarditis: Results from European Cubicin(®) Outcomes Registry and Experience (EU-CORE)
title_full_unstemmed Daptomycin for the Treatment of Infective Endocarditis: Results from European Cubicin(®) Outcomes Registry and Experience (EU-CORE)
title_short Daptomycin for the Treatment of Infective Endocarditis: Results from European Cubicin(®) Outcomes Registry and Experience (EU-CORE)
title_sort daptomycin for the treatment of infective endocarditis: results from european cubicin(®) outcomes registry and experience (eu-core)
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4575291/
https://www.ncbi.nlm.nih.gov/pubmed/26168988
http://dx.doi.org/10.1007/s40121-015-0075-9
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