title: The effect of simvastatin on inflammatory cytokines in community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  It has been suggested that statins have an effect on the modulation of the cytokine cascade and on the outcome of patients with community-acquired pneumonia (CAP). The aim of this prospective, randomised, double-blind, placebo-controlled trial was to determine whether statin therapy given to hospitalised patients with CAP improves clinical outcomes and reduces the concentration of inflammatory cytokines.
  
  
  METHODS
  A tertiary teaching hospital in Barcelona, Spain.
  
  
  METHODS
  Thirty-four patients were randomly assigned and included in an intention-to-treat analysis (19 to the simvastatin group and 15 to the placebo group).
  
  
  METHODS
  Patients were randomly assigned to receive 20 mg of simvastatin or placebo administered in the first 24 h of hospital admission and once daily thereafter for 4 days.
  
  
  RESULTS
  Primary end point was the time from hospital admission to clinical stability. The secondary end points were serum concentrations of inflammatory cytokines and partial pressure of arterial oxygen/fractional inspired oxygen (PaO2/FiO2) at 48 h after treatment administration.
  
  
  RESULTS
  The trial was stopped because enrolment was much slower than originally anticipated. The baseline characteristics of the patients and cytokine concentrations at the time of enrolment were similar in the two groups. No significant differences in the time from hospital admission to clinical stability were found between study groups (median 3 days, IQR 2-5 vs 3 days, IQR 2-5; p=0.47). No significant differences in PaO2/FiO2 (p=0.37), C reactive protein (p=0.23), tumour necrosis factor-α (p=0.58), interleukin 6 (IL-6; p=0.64), and IL-10 (p=0.61) levels at 48 h of hospitalisation were found between simvastatin and placebo groups. Similarly, transaminase and total creatine kinase levels were similar between study groups at 48 h of hospitalisation (p=0.19, 0.08 and 0.53, respectively).
  
  
  CONCLUSIONS
  Our results suggest that the use of simvastatin, 20 mg once daily for 4 days, since hospital admission did not reduce the time to clinical stability and the levels of inflammatory cytokines in hospitalised patients with CAP.
  
  
  BACKGROUND
  ISRCTN91327214.
authors.affiliation: Biotechnology and Clinical Research Groups, Department of Internal Medicine, Faculty of Medicine, Universidad del Norte, Barranquilla, Colombia Department of Infectious Diseases, Hospital Universitari de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Diego
authors.initials: D
authors.lastname: Viasus
authors.affiliation: Department of Infectious Diseases, Hospital Universitari de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Carolina
authors.initials: C
authors.lastname: Garcia-Vidal
authors.affiliation: Department of Infectious Diseases, Hospital Universitari de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Antonella F
authors.initials: AF
authors.lastname: Simonetti
authors.affiliation: Department of Respiratory Medicine, Hospital Universitari de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain Department of Clinical Sciences, Faculty of Medicine, University of Barcelona, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Dorca
authors.affiliation: Department of Clinical Sciences, Faculty of Medicine, University of Barcelona, Barcelona, Spain Department of Emergency Medicine, Hospital Universitari de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Ferran
authors.initials: F
authors.lastname: Llopis
authors.affiliation: Department of Immunology, Hospital Universitari de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Mariona
authors.initials: M
authors.lastname: Mestre
authors.affiliation: Department of Immunology, Hospital Universitari de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Morandeira-Rego
authors.affiliation: Department of Infectious Diseases, Hospital Universitari de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain Department of Emergency Medicine, Hospital Universitari de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Carratalà
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D002097:C-Reactive Protein / Q000032:analysis; D017714:Community-Acquired Infections / Q000097:blood / Q000188:drug therapy; D016207:Cytokines / Q000097:blood*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000097:blood; D010313:Partial Pressure; D011014:Pneumonia / Q000097:blood / Q000188:drug therapy*; D011446:Prospective Studies; D019821:Simvastatin / Q000627:therapeutic use*; D013030:Spain
chemical_list: D016207:Cytokines; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D002097:C-Reactive Protein; D019821:Simvastatin; D010100:Oxygen
keywords: IMMUNOLOGY; INFECTIOUS DISEASES