Efficacy and safety of tigecycline: a systematic review and meta-analysis

Yahav, Dafna; Lador, Adi; Paul, Mical; Leibovici, Leonard

doi:10.1093/jac/dkr242

Cited by 246 publications

(168 citation statements)

References 47 publications

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“…Carbapenems are the most effective option for nosocomial infections in areas with a high prevalence of extended-spectrum β-lactamase-producing Enterobacteriaceae. Tigecycline may be a potential alternative, although recent studies have showed increased mortality related to its low clinical efficacy and it should not, therefore, be recommended as first-line therapy in the general population [58] . Penicillin used in combination with β-lactamase inhibitors (e.g., piperacilin-tazobactam) may be an adequate alternative.…”

Section: Treatment Of Nosocomial Sbpmentioning

confidence: 99%

Diagnosis and management of bacterial infections in decompensated cirrhosis

Pleguezuelo

Benítez²,

Jurado³

et al. 2013

WJH

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Bacterial infections are one of the most frequent complications in cirrhosis and result in high mortality rates. Patients with cirrhosis have altered and impaired immunity, which favours bacterial translocation. Episodes of infections are more frequent in patients with decompensated cirrhosis than those with compensated liver disease. The most common and life-threatening infection in cirrhosis is spontaneous bacterial peritonitis followed by urinary tract infections, pneumonia, endocarditis and skin and soft-tissue infections. Patients with decompensated cirrhosis have increased risk of developing sepsis, multiple organ failure and death. Risk factors associated with the development of infections are severe liver failure, variceal bleeding, low ascitic protein level and prior episodes of spontaneous bacterial peritonitis (SBP). The prognosis of these patients is closely related to a prompt and accurate diagnosis. An appropriate treatment decreases the mortality rates. Preventive strategies are the mainstay of the management of these patients. Empirical antibiotics should be started immediately following the diagnosis of SBP and the first-line antibiotic treatment is third-generation cephalosporins. However, the efficacy of currently recommended empirical antibiotic therapy is very low in nosocomial infections including SBP, compared to community-acquired episodes. This may be associated with the emergence of infections caused by Enterococcus faecium and extended-spectrum β-lactamaseproducing Enterobacteriaceae, which are resistant to the first line antimicrobial agents used for treatment. The emergence of resistant bacteria, underlines the need to restrict the use of prophylactic antibiotics to patients with the greatest risk of infections. Nosocomial infections should be treated with wide spectrum antibiotics. Further studies of early diagnosis, prevention and treatment are needed to improve the outcomes in patients with decompensated cirrhosis.

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Section: Treatment Of Nosocomial Sbpmentioning

confidence: 99%

Diagnosis and management of bacterial infections in decompensated cirrhosis

Pleguezuelo

Benítez²,

Jurado³

et al. 2013

WJH

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“…After the FDA warning several meta-analysis were published; obviously using different methodologies and selecting different studies. Yahav et al [3] meta-analysis reported statistically higher all-cause 30-day mortality in the tigecycline arms. On the other hand, Cai et al [4] found no difference in all-cause mortality and drug-related mortality between tigecycline and the comparators, whereas Tasina et al [5] demonstrated reduced clinical efficacy and increased mortality for tigecycline, but the difference was not statistically significant.…”

mentioning

confidence: 98%

“…On the other hand, analyzed data from non-approved indications showed that the tigecycline arm was statistically less effective. Finally, meta-analyses of study-level data suggested decreased clinical efficacy as a possible explanation for the demonstrated imbalance in mortality [3,8].…”

mentioning

confidence: 99%

Is there a future for tigecycline?

2014

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“…The cause of the imbalance has not been established. One independent meta-analysis of clinical trial data suggested decreased clinical and microbiological efficacy of tigecycline combined with higher rates of superinfections as explanations [4], while others [5,6] were not able to identify any significant differences in efficacy or microbiologic eradication to account for the results.…”

Section: Introductionmentioning

confidence: 99%

An Evaluation of the Effectiveness of Risk Minimization Measures for Tigecycline in the European Union

et al. 2017

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Background Risk minimization measures (RMM) were implemented from February 2011 in the European Union to address risks of superinfection, off-label use and lack of efficacy associated with tigecycline. The objective of this study was to evaluate RMM effectiveness by describing prescription patterns among adults and children treated with any dose of tigecycline for any indication pre-and post-RMM implementation; incidence proportions of superinfection and lack of efficacy among adults treated with approved doses of tigecycline for complicated intraabdominal infection and complicated skin and soft tissue infection were also evaluated. Methods This was an observational, retrospective chartabstraction study, including charts from 777 patients (399 pre-RMM, 378 post-RMM) at 13 sites across Austria, Germany, Italy, Greece and the United Kingdom (UK). Potential superinfection and lack of efficacy cases among those using tigecycline for on-label indication, age, dose, and duration were adjudicated. The distribution of indications for tigecycline was analyzed overall (i.e. across both study periods) and stratified by study period. Numbers and incidence proportions of superinfection and lack of efficacy cases (potential and adjudicated) were calculated overall and by study period. Results Off-label use (indication or age) decreased from 54.2% [95% confidence interval (95% CI): 49.0, 59.3%] pre-RMM to 35.7% (95% CI 30.4, 41.2%) post-RMM. Overall, 45.7% (95% CI 41.9, 49.5%) of patients were prescribed tigecycline off-label; the most commonly reported off-label indications were characterized as ''other'' (25.5%), hospital acquired pneumonia (8.2%), other pneumonia (6.3%), bacteremia (5.2%) and diabetic foot infection (1.5%). Across study periods, incidence proportions of definite or probable superinfection and lack of efficacy in adults treated for approved indications, authorized treatment doses and duration were 4.5% (95% CI 2.1, 8.4%) and 5.5% (95% CI 2.8, 9.7%), respectively. Conclusions Off-label use of tigecycline decreased following RMM implementation. Overall incidence proportions of definite or probable superinfection and lack of efficacy were low. EU PAS register number: EUPAS3674 Key PointsThe proportion of off-label tigecycline use decreased across five EU countries following implementation of a healthcare provider educational program Proportions of definite and probable superinfection and lack of efficacy were low across both study periods & Vera Frajzyngier

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Efficacy and safety of tigecycline: a systematic review and meta-analysis

Abstract: In the light of the increased mortality, probably explained by decreased clinical and microbiological efficacy, clinicians should avoid tigecycline monotherapy in the treatment of severe infections and reserve it as a last-resort drug.

Cited by 246 publications

References 47 publications

Diagnosis and management of bacterial infections in decompensated cirrhosis

Diagnosis and management of bacterial infections in decompensated cirrhosis

Is there a future for tigecycline?

An Evaluation of the Effectiveness of Risk Minimization Measures for Tigecycline in the European Union

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