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Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry

INTRODUCTION: The aim of this study was to evaluate the clinical outcomes and safety of daptomycin therapy in patients with serious Gram-positive infections. METHODS: Patients were enrolled in the European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)), a non-interventional, multicenter,...

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Autores principales: Gonzalez-Ruiz, Armando, Gargalianos-Kakolyris, Panayiotis, Timerman, Artur, Sarma, Jayanta, José González Ramallo, Víctor, Bouylout, Kamel, Trostmann, Uwe, 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/PMC4486780/
https://www.ncbi.nlm.nih.gov/pubmed/26108157
http://dx.doi.org/10.1007/s12325-015-0220-6
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author Gonzalez-Ruiz, Armando
Gargalianos-Kakolyris, Panayiotis
Timerman, Artur
Sarma, Jayanta
José González Ramallo, Víctor
Bouylout, Kamel
Trostmann, Uwe
Pathan, Rashidkhan
Hamed, Kamal
author_facet Gonzalez-Ruiz, Armando
Gargalianos-Kakolyris, Panayiotis
Timerman, Artur
Sarma, Jayanta
José González Ramallo, Víctor
Bouylout, Kamel
Trostmann, Uwe
Pathan, Rashidkhan
Hamed, Kamal
author_sort Gonzalez-Ruiz, Armando
collection PubMed
description INTRODUCTION: The aim of this study was to evaluate the clinical outcomes and safety of daptomycin therapy in patients with serious Gram-positive infections. METHODS: Patients were enrolled in the European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)), a non-interventional, multicenter, observational registry. The real-world data were collected across 18 countries (Europe, Latin America, and Asia) for patients who had received at least one dose of daptomycin between January 2006 and April 2012. Two-year follow-up data were collected until 2014 for patients with endocarditis, intracardiac/intravascular device infection, osteomyelitis, or orthopedic device infection. RESULTS: A total of 6075 patients were enrolled. The most common primary infections were complicated skin and soft tissue infection (31.7%) and bacteremia (20.7%). Staphylococcus aureus was the most frequently reported pathogen (42.9%; methicillin-resistant S. aureus [MRSA], 23.2%), followed by Staphylococcus epidermidis and other coagulase-negative staphylococci (CoNS, 28.5%). The most commonly prescribed dose of daptomycin was 6 mg/kg/day (43.6%), and the median duration of therapy was 11 (range 1–300) days. Overall clinical success rate was 80.5%, and was similar whether daptomycin was used as first-line (82.9%) or second-line (79.2%) therapy. Clinical success rates were high in patients with S. aureus (83.9%; MRSA 83.0%) and CoNS (including S. epidermidis, 82.5%) infections. The majority of patients with endocarditis or intracardiac/intravascular device infection (86.7%) or osteomyelitis/orthopedic device infection (85.9%) had a sustained response during the 2-year follow-up period. There were no new or unexpected safety findings. CONCLUSION: Results from real-world clinical experience showed that daptomycin is a valuable therapeutic option in the management of various difficult-to-treat Gram-positive infections. FUNDING: This study was funded by Novartis Pharma AG. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-015-0220-6) contains supplementary material, which is available to authorized users.
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spelling pubmed-44867802015-07-02 Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry Gonzalez-Ruiz, Armando Gargalianos-Kakolyris, Panayiotis Timerman, Artur Sarma, Jayanta José González Ramallo, Víctor Bouylout, Kamel Trostmann, Uwe Pathan, Rashidkhan Hamed, Kamal Adv Ther Original Research INTRODUCTION: The aim of this study was to evaluate the clinical outcomes and safety of daptomycin therapy in patients with serious Gram-positive infections. METHODS: Patients were enrolled in the European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)), a non-interventional, multicenter, observational registry. The real-world data were collected across 18 countries (Europe, Latin America, and Asia) for patients who had received at least one dose of daptomycin between January 2006 and April 2012. Two-year follow-up data were collected until 2014 for patients with endocarditis, intracardiac/intravascular device infection, osteomyelitis, or orthopedic device infection. RESULTS: A total of 6075 patients were enrolled. The most common primary infections were complicated skin and soft tissue infection (31.7%) and bacteremia (20.7%). Staphylococcus aureus was the most frequently reported pathogen (42.9%; methicillin-resistant S. aureus [MRSA], 23.2%), followed by Staphylococcus epidermidis and other coagulase-negative staphylococci (CoNS, 28.5%). The most commonly prescribed dose of daptomycin was 6 mg/kg/day (43.6%), and the median duration of therapy was 11 (range 1–300) days. Overall clinical success rate was 80.5%, and was similar whether daptomycin was used as first-line (82.9%) or second-line (79.2%) therapy. Clinical success rates were high in patients with S. aureus (83.9%; MRSA 83.0%) and CoNS (including S. epidermidis, 82.5%) infections. The majority of patients with endocarditis or intracardiac/intravascular device infection (86.7%) or osteomyelitis/orthopedic device infection (85.9%) had a sustained response during the 2-year follow-up period. There were no new or unexpected safety findings. CONCLUSION: Results from real-world clinical experience showed that daptomycin is a valuable therapeutic option in the management of various difficult-to-treat Gram-positive infections. FUNDING: This study was funded by Novartis Pharma AG. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-015-0220-6) contains supplementary material, which is available to authorized users. Springer Healthcare 2015-06-25 2015 /pmc/articles/PMC4486780/ /pubmed/26108157 http://dx.doi.org/10.1007/s12325-015-0220-6 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
Gonzalez-Ruiz, Armando
Gargalianos-Kakolyris, Panayiotis
Timerman, Artur
Sarma, Jayanta
José González Ramallo, Víctor
Bouylout, Kamel
Trostmann, Uwe
Pathan, Rashidkhan
Hamed, Kamal
Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry
title Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry
title_full Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry
title_fullStr Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry
title_full_unstemmed Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry
title_short Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry
title_sort daptomycin in the clinical setting: 8-year experience with gram-positive bacterial infections from the eu-core(sm) registry
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4486780/
https://www.ncbi.nlm.nih.gov/pubmed/26108157
http://dx.doi.org/10.1007/s12325-015-0220-6
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