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Low-dose methylprednisolone treatment in critically ill patients with severe community-acquired pneumonia
G Umberto Meduri1,2, Mei-Chiung Shih3,4, Lisa Bridges5,6
1Pulmonary, Critical Care and Sleep Medicine Services, Memphis VA Medical Center, Memphis, USA. gmeduri@uthsc.edu.
Purpose:
Severe 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.
Methods:
This 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.
Results:
Between 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.
Conclusions:
In patients with severe CAP, prolonged low-dose methylprednisolone treatment did not significantly reduce 60-day mortality. Treatment was not associated with increased complications.
Insights
Prolonged low-dose methylprednisolone did not improve 60-day survival for severe community-acquired pneumonia (CAP) patients. The treatment did not increase complications, but also did not accelerate pneumonia resolution or improve outcomes.
Area of Science:
- Critical Care Medicine
- Pulmonology
- Pharmacology
Background:
- Severe community-acquired pneumonia (CAP) requiring intensive care is linked to high morbidity and mortality.
- Effective treatments to improve outcomes for severe CAP are crucial.
Purpose of the Study:
- To investigate if prolonged low-dose methylprednisolone reduces inflammation and improves outcomes in severe CAP.
- To evaluate the effect of methylprednisolone on 60-day mortality and long-term morbidity in severe CAP patients.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving adult patients with severe CAP.
- Patients received methylprednisolone (40mg loading dose, then 40mg/day with tapering) or placebo for 20 days.
- Primary endpoint was 60-day all-cause mortality; secondary endpoints included morbidity and mortality up to 1 year.
Main Results:
- No significant difference in 60-day mortality between methylprednisolone (16%) and placebo (18%) arms.
- The study was underpowered due to low recruitment (586 patients randomized vs. target of 1420).
- No significant differences were observed in secondary outcomes or complications between groups.
Conclusions:
- Prolonged low-dose methylprednisolone treatment did not significantly reduce 60-day mortality in severe CAP.
- The treatment regimen was safe and not associated with increased complications.
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