Efficacy of Corticosteroids in Community-acquired Pneumonia: A Randomized Double-Blinded Clinical Trial

• Published in: American journal of respiratory and critical care medicine 2010-05, Vol.181 (9), p.975-982
• Main Authors: SNIJDERS, Dominic, DANIELS, Johannes M. A, DE GRAAFF, Casper S, VAN DER WERF, Tjip S, BOERSMA, Wim G
• Format: Article
• Language: English
• Subjects: Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Anti-Bacterial Agents - administration & dosage; Antibiotics; Biological and medical sciences; Blood pressure; C-Reactive Protein - analysis; Clinical outcomes; Clinical trial. Drug monitoring; Clinical trials; Community-Acquired Infections - drug therapy; Double-Blind Method; Female; Fever; General pharmacology; Hospitalization; Humans; Infections; Intensive care medicine; Length of stay; Male; Medical sciences; Middle Aged; Mortality; Pharmacology. Drug treatments; Pneumonia; Pneumonia - drug therapy; Pneumonia - microbiology; Prednisolone - administration & dosage; Prednisolone - therapeutic use; Prospective Studies; Proteins; Sepsis; Severity of Illness Index; Steroids; Treatment Outcome
• ISSN: 1073-449X; 1535-4970
• DOI: 10.1164/rccm.200905-0808OC

Some studies have shown a beneficial effect of corticosteroids in patients with community-acquired pneumonia (CAP), possibly by diminishing local and systemic antiinflammatory host response. To assess the efficacy of adjunctive prednisolone treatment in patients hospitalized with CAP. Hospitalized patients, clinically and radiologically diagnosed with CAP using standard clinical and radiological criteria, were randomized to receive 40 mg prednisolone for 7 days or placebo, along with antibiotics. Primary outcome was clinical cure at Day 7. Secondary outcomes were clinical cure at Day 30, length of stay, time to clinical stability, defervescence, and C-reactive protein. Disease severity was scored using CURB-65 (a severity index for community-acquired pneumonia evaluating Confusion, blood Urea nitrogen, Respiratory rate, Blood pressure, and age 65 or older) and Pneumonia Severity Index. We enrolled 213 patients. Fifty-four (25.4%) patients had a CURB-65 score greater than 2, and 93 (43.7%) patients were in Pneumonia Severity Index class IV-V. Clinical cure at Days 7 and 30 was 84/104 (80.8%) and 69/104 (66.3%) in the prednisolone group and 93/109 (85.3%) and 84/109 (77.1%) in the placebo group (P = 0.38 and P = 0.08). Patients on prednisolone had faster defervescence and faster decline in serum C-reactive protein levels compared with placebo. Subanalysis of patients with severe pneumonia did not show differences in clinical outcome. Late failure (>72 h after admittance) was more common in the prednisolone group (20 patients, 19.2%) than in the placebo group (10 patients, 6.4%; P = 0.04). Adverse events were few and not different between the two groups. Prednisolone (at 40 mg) once daily for a week does not improve outcome in hospitalized patients with CAP. A benefit in more severely ill patients cannot be excluded. Because of its association with increased late failure and lack of efficacy prednisolone should not be recommended as routine adjunctive treatment in CAP.