title: Systematic review and meta-analysis of the effectiveness and safety of tigecycline for treatment of infectious disease.
abstract: The aim of this study was to compare the efficacy and safety of tigecycline, a newly developed glycylcycline antibiotic, with those of empirical antibiotic regimens which have been reported to possess good efficacy for complicated skin and skin structure infections (cSSSIs), complicated intra-abdominal infections (cIAIs), community-acquired pneumonia (CAP), and other infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE). A meta-analysis of randomized controlled trials (RCTs) identified in PubMed, the Cochrane Library, and Embase was performed. Eight RCTs involving 4,651 patients were included in the meta-analysis. Compared with therapy with empirical antibiotic regimens, tigecycline monotherapy was associated with similar clinical treatment success rates (for the clinically evaluable [CE] population, odds ratio [OR] = 0.92, 95% confidence interval [CI] = 0.76 to 1.12, P = 0.42; for the clinical modified intent-to-treat [c-mITT] population, OR = 0.86, 95% CI = 0.74 to 1.01, P = 0.06) and similar microbiological treatment success rates (for the microbiologically evaluable [ME] population, OR = 0.86, 95% CI = 0.69 to 1.07, P = 0.19). The incidence of adverse events in the tigecycline group was significantly higher than that in the other therapy groups with a statistical margin (for the modified intent-to-treat [mITT] population, OR = 1.33, 95% CI = 1.17 to 1.52, P < 0.0001), especially in the digestive system (mITT population, OR = 2.41, 95% CI = 1.67 to 3.46, P < 0.00001). No difference regarding all-cause mortality and drug-related mortality between tigecycline and the other regimens was found, although numerically higher mortality was found in the tigecycline group. This meta-analysis provides evidence that tigecycline monotherapy may be used as effectively as the comparison therapy for cSSSI, cIAIs, CAP, and infections caused by MRSA/VRE. However, because of the high risk of mortality, AEs, and emergence of resistant isolates, prudence with the clinical use of tigecycline monotherapy in infections is required.
authors.affiliation: Department of Clinical Pharmacology, the PLA General Hospital, 28 Fu Xing Road, Beijing 100853, People's Republic of China. caicaihh@sohu.com
authors.forename: Yun
authors.initials: Y
authors.lastname: Cai
authors.forename: Rui
authors.initials: R
authors.lastname: Wang
authors.forename: Beibei
authors.initials: B
authors.lastname: Liang
authors.forename: Nan
authors.initials: N
authors.lastname: Bai
authors.forename: Youning
authors.initials: Y
authors.lastname: Liu
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D003141:Communicable Diseases / Q000188:drug therapy* / Q000382:microbiology; D024881:Drug Resistance, Bacterial; D016983:Enterococcus / Q000187:drug effects / Q000472:pathogenicity; D006801:Humans; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects / Q000472:pathogenicity; D008911:Minocycline / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017192:Skin Diseases, Bacterial / Q000188:drug therapy / Q000382:microbiology; D000078304:Tigecycline; D014640:Vancomycin / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D014640:Vancomycin; D000078304:Tigecycline; D008911:Minocycline