1. Low-dose methylprednisolone treatment in critically ill patients with severe community-acquired pneumonia
- Author
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Meduri, G Umberto, Shih, Mei-Chiung, Bridges, Lisa, Martin, Thomas J, El-Solh, Ali, Seam, Nitin, Davis-Karim, Anne, Umberger, Reba, Anzueto, Antonio, Sriram, Peruvemba, Lan, Charlie, Restrepo, Marcos I, Guardiola, Juan J, Buck, Teresa, Johnson, David P, Suffredini, Anthony, Bell, W Andrew, Lin, Julia, Zhao, Lan, Uyeda, Lauren, Nielsen, Lori, and Huang, Grant D
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Pneumonia ,Lung ,Clinical Research ,Pneumonia & Influenza ,Clinical Trials and Supportive Activities ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Respiratory ,Good Health and Well Being ,Adult ,Community-Acquired Infections ,Critical Illness ,Humans ,Methylprednisolone ,Respiration ,Artificial ,Treatment Outcome ,ESCAPe Study Group ,Community-acquired pneumonia ,Glucocorticoids ,Intensive care ,Randomized clinical trial ,Public Health and Health Services ,Emergency & Critical Care Medicine ,Clinical sciences - Abstract
PurposeSevere community-acquired pneumonia (CAP) requiring intensive care unit admission is associated with significant acute and long-term morbidity and mortality. We hypothesized that downregulation of systemic and pulmonary inflammation with prolonged low-dose methylprednisolone treatment would accelerate pneumonia resolution and improve clinical outcomes.MethodsThis double-blind, randomized, placebo-controlled clinical trial recruited adult patients within 72-96 h of hospital presentation. Patients were randomized in 1:1 ratio; an intravenous 40 mg loading bolus was followed by 40 mg/day through day 7 and progressive tapering during the 20-day treatment course. Randomization was stratified by site and need for mechanical ventilation (MV) at the time of randomization. Outcomes included a primary endpoint of 60-day all-cause mortality and secondary endpoints of morbidity and mortality up to 1 year of follow-up.ResultsBetween January 2012 and April 2016, 586 patients from 42 Veterans Affairs Medical Centers were randomized, short of the 1420 target sample size because of low recruitment. 584 patients were included in the analysis. There was no significant difference in 60-day mortality between the methylprednisolone and placebo arms (16% vs. 18%; adjusted odds ratio 0.90, 95% CI 0.57-1.40). There were no significant differences in secondary outcomes or complications.ConclusionsIn patients with severe CAP, prolonged low-dose methylprednisolone treatment did not significantly reduce 60-day mortality. Treatment was not associated with increased complications.
- Published
- 2022