title: Tigecycline versus levofloxacin in hospitalized patients with community-acquired pneumonia: an analysis of risk factors.
abstract: BACKGROUND
  This study was conducted to evaluate the efficacy of tigecycline (TGC) versus levofloxacin (LEV) in hospitalized patients with community-acquired pneumonia (CAP) using pooled data and to perform exploratory analyses of risk factors associated with poor outcome.
  
  
  METHODS
  Pooled analyses of 2 phase 3 studies in patients randomized to intravenous (IV) TGC (100 mg, then 50 mg q12h) or IV LEV (500 mg q24h or q12h). Clinical responses at test of cure visit for the clinically evaluable (CE) and clinical modified intention to treat populations were assessed for patients with risk factors including aged ≥65 years, prior antibiotic failure, bacteremia, multilobar disease, chronic obstructive pulmonary disease, alcohol abuse, altered mental status, hypoxemia, renal insufficiency, diabetes mellitus, white blood cell count >30 x 10(9)/L or <4 x 10(9)/L, CURB-65 score ≥2, Fine score category of III to V and at least 2 clinical instability criteria on physical examination.
  
  
  RESULTS
  In the CE population of 574 patients, overall cure rates were similar: TGC (253/282, 89.7%); LEV (252/292, 86.3%). For all but one risk factor, cure rates for TGC were similar to or higher than those for LEV. For individual risk factors, the greatest difference between treatment groups was observed in patients with diabetes mellitus (difference of 22.9 for TGC versus LEV; 95% confidence interval, 4.8 - 39.9).
  
  
  CONCLUSIONS
  TGC achieved cure rates similar to those of LEV in hospitalized patients with CAP. For patients with risk factors, TGC provided generally favorable clinical outcomes.
authors.affiliation: Pfizer Global Research and Development, Paris, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Dartois
authors.forename: C Angel
authors.initials: CA
authors.lastname: Cooper
authors.forename: Nathalie
authors.initials: N
authors.lastname: Castaing
authors.forename: Hassan
authors.initials: H
authors.lastname: Gandjini
authors.forename: Denise
authors.initials: D
authors.lastname: Sarkozy
keywords: Community-acquired pneumonia; glycylcycline; risk factors; tigecycline.