Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.

Torres Martí, Antoni; Sibila Vidal, Oriol; Ferrer, Miquel; Polverino, Eva; Menéndez, Rosario; Mensa Pueyo, Josep; Gabarrús, Albert; Sellarés Torres, Jacobo; Restrepo, Marcos I.; Anzueto, Antonio; Niederman, Michael S.; Agustí García-Navarro, Carles

Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.

IMPORTANCE: In patients with severe community-acquired pneumonia, treatment failure is associated with excessive inflammatory response and worse outcomes. Corticosteroids may modulate cytokine release in these patients, but the benefit of this adjunctive therapy remains controversial. OBJECTIVE: To...

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Autores:	Torres Martí, Antoni, Sibila Vidal, Oriol, Ferrer, Miquel, Polverino, Eva, Menéndez, Rosario, Mensa Pueyo, Josep, Gabarrús, Albert, Sellarés Torres, Jacobo, Restrepo, Marcos I., Anzueto, Antonio, Niederman, Michael S., Agustí García-Navarro, Carles
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2015
País:	España
Institución:	Universidad de Barcelona
Repositorio:	Dipòsit Digital de la UB
OAI Identifier:	oai:diposit.ub.edu:2445/106443
Acceso en línea:	https://hdl.handle.net/2445/106443
Access Level:	acceso abierto
Palabra clave:	Pneumònia adquirida a la comunitat Inflamació Corticosteroides Assaigs clínics Community-acquired pneumonia Inflammation Adrenocortical hormones Clinical trials

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spelling	Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.Torres Martí, AntoniSibila Vidal, OriolFerrer, MiquelPolverino, EvaMenéndez, RosarioMensa Pueyo, JosepGabarrús, AlbertSellarés Torres, JacoboRestrepo, Marcos I.Anzueto, AntonioNiederman, Michael S.Agustí García-Navarro, CarlesPneumònia adquirida a la comunitatInflamacióCorticosteroidesAssaigs clínicsCommunity-acquired pneumoniaInflammationAdrenocortical hormonesClinical trialsIMPORTANCE: In patients with severe community-acquired pneumonia, treatment failure is associated with excessive inflammatory response and worse outcomes. Corticosteroids may modulate cytokine release in these patients, but the benefit of this adjunctive therapy remains controversial. OBJECTIVE: To assess the effect of corticosteroids in patients with severe community-acquired pneumonia and high associated inflammatory response. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, double-blind, placebo-controlled trial conducted in 3 Spanish teaching hospitals involving patients with both severe community-acquired pneumonia and a high inflammatory response, which was defined as a level of C-reactive protein greater than 150 mg/L at admission. Patients were recruited and followed up from June 2004 through February 2012. INTERVENTIONS: Patients were randomized to receive either an intravenous bolus of 0.5 mg/kg per 12 hours of methylprednisolone (n = 61) or placebo (n = 59) for 5 days started within 36 hours of hospital admission. MAIN OUTCOMES AND MEASURES: The primary outcome was treatment failure (composite outcome of early treatment failure defined as [1] clinical deterioration indicated by development of shock, [2] need for invasive mechanical ventilation not present at baseline, or [3] death within 72 hours of treatment; or composite outcome of late treatment failure defined as [1] radiographic progression, [2] persistence of severe respiratory failure, [3] development of shock, [4] need for invasive mechanical ventilation not present at baseline, or [5] death between 72 hours and 120 hours after treatment initiation; or both early and late treatment failure). In-hospital mortality was a secondary outcome and adverse events were assessed. RESULTS: There was less treatment failure among patients from the methylprednisolone group (8 patients [13%]) compared with the placebo group (18 patients [31%]) (P = .02), with a difference between groups of 18% (95% CI, 3% to 32%). Corticosteroid treatment reduced the risk of treatment failure (odds ratio, 0.34 [95% CI, 0.14 to 0.87]; P = .02). In-hospital mortality did not differ between the 2 groups (6 patients [10%] in the methylprednisolone group vs 9 patients [15%] in the placebo group; P = .37); the difference between groups was 5% (95% CI, -6% to 17%). Hyperglycemia occurred in 11 patients (18%) in the methylprednisolone group and in 7 patients (12%) in the placebo group (P = .34). CONCLUSIONS AND RELEVANCE: Among patients with severe community-acquired pneumonia and high initial inflammatory response, the acute use of methylprednisolone compared with placebo decreased treatment failure. If replicated, these findings would support the use of corticosteroids as adjunctive treatment in this clinical population.American Medical Association2015info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/106443Articles publicats en revistes (Medicina)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1001/jama.2015.88JAMA-Journal of the American Medical Association, 2015, vol. 313, num. 7, p. 677-686https://doi.org/10.1001/jama.2015.88(c) American Medical Association, 2015info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1064432026-05-27T06:46:51Z
dc.title.none.fl_str_mv	Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.
title	Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.
spellingShingle	Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial. Torres Martí, Antoni Pneumònia adquirida a la comunitat Inflamació Corticosteroides Assaigs clínics Community-acquired pneumonia Inflammation Adrenocortical hormones Clinical trials
title_short	Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.
title_full	Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.
title_fullStr	Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.
title_full_unstemmed	Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.
title_sort	Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.
dc.creator.none.fl_str_mv	Torres Martí, Antoni Sibila Vidal, Oriol Ferrer, Miquel Polverino, Eva Menéndez, Rosario Mensa Pueyo, Josep Gabarrús, Albert Sellarés Torres, Jacobo Restrepo, Marcos I. Anzueto, Antonio Niederman, Michael S. Agustí García-Navarro, Carles
author	Torres Martí, Antoni
author_facet	Torres Martí, Antoni Sibila Vidal, Oriol Ferrer, Miquel Polverino, Eva Menéndez, Rosario Mensa Pueyo, Josep Gabarrús, Albert Sellarés Torres, Jacobo Restrepo, Marcos I. Anzueto, Antonio Niederman, Michael S. Agustí García-Navarro, Carles
author_role	author
author2	Sibila Vidal, Oriol Ferrer, Miquel Polverino, Eva Menéndez, Rosario Mensa Pueyo, Josep Gabarrús, Albert Sellarés Torres, Jacobo Restrepo, Marcos I. Anzueto, Antonio Niederman, Michael S. Agustí García-Navarro, Carles
author2_role	author author author author author author author author author author author
dc.subject.none.fl_str_mv	Pneumònia adquirida a la comunitat Inflamació Corticosteroides Assaigs clínics Community-acquired pneumonia Inflammation Adrenocortical hormones Clinical trials
topic	Pneumònia adquirida a la comunitat Inflamació Corticosteroides Assaigs clínics Community-acquired pneumonia Inflammation Adrenocortical hormones Clinical trials
description	IMPORTANCE: In patients with severe community-acquired pneumonia, treatment failure is associated with excessive inflammatory response and worse outcomes. Corticosteroids may modulate cytokine release in these patients, but the benefit of this adjunctive therapy remains controversial. OBJECTIVE: To assess the effect of corticosteroids in patients with severe community-acquired pneumonia and high associated inflammatory response. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, double-blind, placebo-controlled trial conducted in 3 Spanish teaching hospitals involving patients with both severe community-acquired pneumonia and a high inflammatory response, which was defined as a level of C-reactive protein greater than 150 mg/L at admission. Patients were recruited and followed up from June 2004 through February 2012. INTERVENTIONS: Patients were randomized to receive either an intravenous bolus of 0.5 mg/kg per 12 hours of methylprednisolone (n = 61) or placebo (n = 59) for 5 days started within 36 hours of hospital admission. MAIN OUTCOMES AND MEASURES: The primary outcome was treatment failure (composite outcome of early treatment failure defined as [1] clinical deterioration indicated by development of shock, [2] need for invasive mechanical ventilation not present at baseline, or [3] death within 72 hours of treatment; or composite outcome of late treatment failure defined as [1] radiographic progression, [2] persistence of severe respiratory failure, [3] development of shock, [4] need for invasive mechanical ventilation not present at baseline, or [5] death between 72 hours and 120 hours after treatment initiation; or both early and late treatment failure). In-hospital mortality was a secondary outcome and adverse events were assessed. RESULTS: There was less treatment failure among patients from the methylprednisolone group (8 patients [13%]) compared with the placebo group (18 patients [31%]) (P = .02), with a difference between groups of 18% (95% CI, 3% to 32%). Corticosteroid treatment reduced the risk of treatment failure (odds ratio, 0.34 [95% CI, 0.14 to 0.87]; P = .02). In-hospital mortality did not differ between the 2 groups (6 patients [10%] in the methylprednisolone group vs 9 patients [15%] in the placebo group; P = .37); the difference between groups was 5% (95% CI, -6% to 17%). Hyperglycemia occurred in 11 patients (18%) in the methylprednisolone group and in 7 patients (12%) in the placebo group (P = .34). CONCLUSIONS AND RELEVANCE: Among patients with severe community-acquired pneumonia and high initial inflammatory response, the acute use of methylprednisolone compared with placebo decreased treatment failure. If replicated, these findings would support the use of corticosteroids as adjunctive treatment in this clinical population.
publishDate	2015
dc.date.none.fl_str_mv	2015
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://hdl.handle.net/2445/106443
url	https://hdl.handle.net/2445/106443
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	Reproducció del document publicat a: https://doi.org/10.1001/jama.2015.88 JAMA-Journal of the American Medical Association, 2015, vol. 313, num. 7, p. 677-686 https://doi.org/10.1001/jama.2015.88
dc.rights.none.fl_str_mv	(c) American Medical Association, 2015 info:eu-repo/semantics/openAccess
rights_invalid_str_mv	(c) American Medical Association, 2015
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.publisher.none.fl_str_mv	American Medical Association
publisher.none.fl_str_mv	American Medical Association
dc.source.none.fl_str_mv	Articles publicats en revistes (Medicina) reponame:Dipòsit Digital de la UB instname:Universidad de Barcelona
instname_str	Universidad de Barcelona
reponame_str	Dipòsit Digital de la UB
collection	Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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Effect of Corticosteroids on treatment failure among hospitalized patients with sever community-acquired pneumonia and high inflammatory response: a randomized clinical trial.

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