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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The risks and benefits of corticosteroids in the setting of community-acquired pneumonia &#40;CAP&#41; have been controversial for over a decade&#46; Early studies were generally either of poor quality with significant methodological problems or failed to demonstrate clinically significant benefits&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">1</span></a> Given the deleterious effects of corticosteroids&#44; especially higher risks of infection and hyperglycemia&#44; recent guidelines for CAP recommended against their routine use noting that there may be a subset of patients who would benefit&#44; but studies had so far failed to define this group&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Two recently published multicenter&#44; randomized&#44; placebo-controlled trials in patients with severe CAP have substantially increased the quality of data available to make recommendations on corticosteroid treatment&#46; Unfortunately&#44; these studies have conflicting results that cannot be resolved by statistical techniques like meta-analysis&#44; but instead require careful analysis of the individual studies&#44; their results and the potential reasons behind the different findings&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">In a randomized trial based in 42 Veterans Affairs Medical Centers in the United States&#44; 586 patients with severe CAP requiring ICU admission were randomized to methylprednisolone &#40;starting dose of 40<span class="elsevierStyleHsp" style=""></span>mg intravenous dose per day for 7 days with tapering over a total of 20 days&#41; or placebo&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">3</span></a> There was no significant difference in the primary outcome of 60-day mortality &#40;16&#37; vs&#46; 18&#37;&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;61&#41;&#46; Prespecified and post hoc analyses also failed to identify a subgroup of patients who benefitted from steroids&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In contrast&#44; a randomized trial in 31 French centers&#44; 800 patients with severe CAP requiring ICU admission were randomized to hydrocortisone &#40;starting dose of 200<span class="elsevierStyleHsp" style=""></span>mg per day by continuous infusion for 4 days with tapering over a total of 8 or 14 days&#41; or placebo&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">4</span></a> While full enrolment was not achieved due to the COVID-19 pandemic&#44; a planned interim analysis found a significant difference in the primary outcome of 28-day mortality favoring the hydrocortisone arm &#40;6&#46;3&#37; vs&#46; 11&#46;9&#37;&#41;&#46; The mortality benefit persisted at the 90-day assessment point&#46; Secondary outcomes including initiation of vasopressors and mechanical ventilation also favored the treatment arm&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Why did the US and French trials have such different results and how do we reconcile them with prior studies&#63; There are three obvious differences between the two studies&#46; Although the dose equivalence of steroids used in both studies is similar&#44; there may be differences between hydrocortisone and methylprednisone that have not so far been demonstrated in pharmacological studies of relevance in the mechanism of benefit in severe CAP&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Gender differences in critical care are well recognized&#44; including in community-acquired pneumonia&#44; from which men are significantly more likely to die than women&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">5</span></a> The US study in the VA system was 96&#37; male&#44; whereas the French study was 69&#37; male and post hoc analysis showed the survival benefit of steroids appeared much stronger in females&#46; Similarly&#44; post hoc analyses suggested a significant difference in the impact of steroids on survival between men and women in the COVID-19 RECOVERY trial&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">6</span></a> While post hoc analyses should always be interpreted with caution&#44; gender-specific influences on the benefit and risk of steroids need to be considered in the powering and prespecified analyses of future trials&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The window of opportunity for steroids to impact positively on outcome may also be critical&#46; The French trial administered steroids within 24<span class="elsevierStyleHsp" style=""></span>h of meeting eligibility criteria whereas the US trial allowed up to 96<span class="elsevierStyleHsp" style=""></span>h&#46; The total duration of corticosteroid exposure also differed between the studies&#44; 20 days by study protocol in the US study&#44; and a median of five days in the French study&#46; Shorter durations should help reduce the side effects of corticosteroids and if their primary effect is to reduce organ damage in the acute phase&#44; longer durations may not be justified&#46; Clearly&#44; it will be vital to establish the therapeutic window for steroids in future trials&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">One further potential difference relates to the microbiological etiology of CAP&#44; with the efficacy of steroids potentially varying depending on the pathogen and resulting mechanisms of injury&#46; Unlike the US study&#44; the French study excluded patients with evidence of influenza infection due to observational studies suggesting increased mortality in patients with influenza receiving corticosteroid treatment&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">7</span></a> Confusingly while in the French study while 70&#37; of patient had an elevated c-reactive protein suggestive of bacterial infection&#44; the largest benefit of steroids was seen in patients who did not have a definitive pathogen identified&#46; A prior study showing a reduction in antibiotic use with steroids in patients with CAP also found this did not apply to patients with proven pneumococcal infection&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">8</span></a> Hopefully with increased use of pathogen diagnostic platforms future studies will be able to at least distinguish between viral and bacterial CAP and provide pathogen-specific data on the most common infecting organisms&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Of note&#44; 45&#37; of the patients in the US study had chronic obstructive pulmonary disease &#40;COPD&#41;&#46; While patients thought to be suffering from a COPD exacerbation were to be excluded from the study&#44; in the setting of pneumonia&#44; discriminating between patients with and without an acute exacerbation of COPD is subjective and likely difficult&#46; Since corticosteroids have proven benefit for patients hospitalized with acute exacerbation of COPD&#44; withholding corticosteroids might have had deleterious effects unrelated to pneumonia&#44; biasing the results in favor of corticosteroids&#46; The lack of a signal in favor of corticosteroids in the US study despite this potential confounder reinforces the credibility of the negative results&#44; and thus increases the imperative to better understand the reasons for the discordant results of the US and French studies&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Having previously been underwhelmed by the evidence for corticosteroids in CAP&#44; the authors believe that the recent high-quality studies have shifted the strength of evidence in favor of early &#40;&#60;24<span class="elsevierStyleHsp" style=""></span>h&#41; initiation of hydrocortisone in adult patients with severe CAP meeting the criteria used in the French study&#46; That is&#44; respiratory failure requiring at least high flow oxygen&#44; ICU admission and the absence of both septic shock and influenza&#46; Further ongoing trials are needed as the therapeutic window&#44; optimal corticosteroid&#44; optimal dose&#44; optimal duration&#44; and potential gender and pathogen specific effects are all yet to be determined&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of Interests</span><p id="par0055" class="elsevierStylePara elsevierViewall">The authors state that they have no conflict of interests&#46;</p></span></span>"
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Editorial
Corticosteroids and Severe Community-acquired Pneumonia: New Data, New Questions and a Swinging Pendulum
Grant W. Waterera,
Corresponding author
grant.waterer@uwa.edu.au

Corresponding author.
, Mark Meterskyb
a East Metropolitan Health Service, Royal Perth Hospital, Perth, Australia
b Division of Pulmonary, Critical Care and Sleep Medicine, University of Connecticut School of Medicine, Connecticut, United States
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The risks and benefits of corticosteroids in the setting of community-acquired pneumonia &#40;CAP&#41; have been controversial for over a decade&#46; Early studies were generally either of poor quality with significant methodological problems or failed to demonstrate clinically significant benefits&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">1</span></a> Given the deleterious effects of corticosteroids&#44; especially higher risks of infection and hyperglycemia&#44; recent guidelines for CAP recommended against their routine use noting that there may be a subset of patients who would benefit&#44; but studies had so far failed to define this group&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Two recently published multicenter&#44; randomized&#44; placebo-controlled trials in patients with severe CAP have substantially increased the quality of data available to make recommendations on corticosteroid treatment&#46; Unfortunately&#44; these studies have conflicting results that cannot be resolved by statistical techniques like meta-analysis&#44; but instead require careful analysis of the individual studies&#44; their results and the potential reasons behind the different findings&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">In a randomized trial based in 42 Veterans Affairs Medical Centers in the United States&#44; 586 patients with severe CAP requiring ICU admission were randomized to methylprednisolone &#40;starting dose of 40<span class="elsevierStyleHsp" style=""></span>mg intravenous dose per day for 7 days with tapering over a total of 20 days&#41; or placebo&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">3</span></a> There was no significant difference in the primary outcome of 60-day mortality &#40;16&#37; vs&#46; 18&#37;&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;61&#41;&#46; Prespecified and post hoc analyses also failed to identify a subgroup of patients who benefitted from steroids&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In contrast&#44; a randomized trial in 31 French centers&#44; 800 patients with severe CAP requiring ICU admission were randomized to hydrocortisone &#40;starting dose of 200<span class="elsevierStyleHsp" style=""></span>mg per day by continuous infusion for 4 days with tapering over a total of 8 or 14 days&#41; or placebo&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">4</span></a> While full enrolment was not achieved due to the COVID-19 pandemic&#44; a planned interim analysis found a significant difference in the primary outcome of 28-day mortality favoring the hydrocortisone arm &#40;6&#46;3&#37; vs&#46; 11&#46;9&#37;&#41;&#46; The mortality benefit persisted at the 90-day assessment point&#46; Secondary outcomes including initiation of vasopressors and mechanical ventilation also favored the treatment arm&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Why did the US and French trials have such different results and how do we reconcile them with prior studies&#63; There are three obvious differences between the two studies&#46; Although the dose equivalence of steroids used in both studies is similar&#44; there may be differences between hydrocortisone and methylprednisone that have not so far been demonstrated in pharmacological studies of relevance in the mechanism of benefit in severe CAP&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Gender differences in critical care are well recognized&#44; including in community-acquired pneumonia&#44; from which men are significantly more likely to die than women&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">5</span></a> The US study in the VA system was 96&#37; male&#44; whereas the French study was 69&#37; male and post hoc analysis showed the survival benefit of steroids appeared much stronger in females&#46; Similarly&#44; post hoc analyses suggested a significant difference in the impact of steroids on survival between men and women in the COVID-19 RECOVERY trial&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">6</span></a> While post hoc analyses should always be interpreted with caution&#44; gender-specific influences on the benefit and risk of steroids need to be considered in the powering and prespecified analyses of future trials&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The window of opportunity for steroids to impact positively on outcome may also be critical&#46; The French trial administered steroids within 24<span class="elsevierStyleHsp" style=""></span>h of meeting eligibility criteria whereas the US trial allowed up to 96<span class="elsevierStyleHsp" style=""></span>h&#46; The total duration of corticosteroid exposure also differed between the studies&#44; 20 days by study protocol in the US study&#44; and a median of five days in the French study&#46; Shorter durations should help reduce the side effects of corticosteroids and if their primary effect is to reduce organ damage in the acute phase&#44; longer durations may not be justified&#46; Clearly&#44; it will be vital to establish the therapeutic window for steroids in future trials&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">One further potential difference relates to the microbiological etiology of CAP&#44; with the efficacy of steroids potentially varying depending on the pathogen and resulting mechanisms of injury&#46; Unlike the US study&#44; the French study excluded patients with evidence of influenza infection due to observational studies suggesting increased mortality in patients with influenza receiving corticosteroid treatment&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">7</span></a> Confusingly while in the French study while 70&#37; of patient had an elevated c-reactive protein suggestive of bacterial infection&#44; the largest benefit of steroids was seen in patients who did not have a definitive pathogen identified&#46; A prior study showing a reduction in antibiotic use with steroids in patients with CAP also found this did not apply to patients with proven pneumococcal infection&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">8</span></a> Hopefully with increased use of pathogen diagnostic platforms future studies will be able to at least distinguish between viral and bacterial CAP and provide pathogen-specific data on the most common infecting organisms&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Of note&#44; 45&#37; of the patients in the US study had chronic obstructive pulmonary disease &#40;COPD&#41;&#46; While patients thought to be suffering from a COPD exacerbation were to be excluded from the study&#44; in the setting of pneumonia&#44; discriminating between patients with and without an acute exacerbation of COPD is subjective and likely difficult&#46; Since corticosteroids have proven benefit for patients hospitalized with acute exacerbation of COPD&#44; withholding corticosteroids might have had deleterious effects unrelated to pneumonia&#44; biasing the results in favor of corticosteroids&#46; The lack of a signal in favor of corticosteroids in the US study despite this potential confounder reinforces the credibility of the negative results&#44; and thus increases the imperative to better understand the reasons for the discordant results of the US and French studies&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Having previously been underwhelmed by the evidence for corticosteroids in CAP&#44; the authors believe that the recent high-quality studies have shifted the strength of evidence in favor of early &#40;&#60;24<span class="elsevierStyleHsp" style=""></span>h&#41; initiation of hydrocortisone in adult patients with severe CAP meeting the criteria used in the French study&#46; That is&#44; respiratory failure requiring at least high flow oxygen&#44; ICU admission and the absence of both septic shock and influenza&#46; Further ongoing trials are needed as the therapeutic window&#44; optimal corticosteroid&#44; optimal dose&#44; optimal duration&#44; and potential gender and pathogen specific effects are all yet to be determined&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of Interests</span><p id="par0055" class="elsevierStylePara elsevierViewall">The authors state that they have no conflict of interests&#46;</p></span></span>"
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ISSN: 03002896
Original language: English
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