RESEARCH ARTICLE


Tigecycline Versus Levofloxacin in Hospitalized Patients With Community-Acquired Pneumonia: An Analysis of Risk Factors



Nathalie Dartois*, 1, C Angel Cooper 2, Nathalie Castaing 1, Hassan Gandjini 1, , Denise Sarkozy 2, Author Comment: on behalf of the 308 and 313 Study Groups

1 Pfizer Global Research and Development, Paris, France
2 Pfizer Inc, Collegeville, PA, USA


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© Dartois et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at Pfizer Global Research and Development, 23-25 avenue du Docteur Lannelongue, 75668 Paris Cedex 14, France; Tel: + 33 1 58 07 34 31; E-mail: nathalie.dartois@pfizer.com
Former employee of Pfizer Inc.


Abstract

Introduction:

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.

Materials and Methodology:

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 109/L or <4 x 109/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.

Keywords: Community-acquired pneumonia, glycylcycline, risk factors, tigecycline..