P845 ATLAS 1: the first Phase 3 study evaluating the new lipoglycopeptide, telavancin, for the treatment of patients with complicated skin and skin structure infections

Corey, G. Ralph; Stryjewski, Martín E.; O’Riordan, William; Fowler, VG; Ross, Douglas Patrick; Hopkins, Alan R.; Kitt, M.M.; Barriere, SL

doi:10.1016/s0924-8579(07)70686-6

Cited by 4 publications

(4 citation statements)

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“…Among the remaining studies, 421 studies were excluded after reading titles, abstracts or texts. Only 23 were retrieved full text for eligibility, of which 18 studies were excluded (Corey et al, 2007b , a , 2014 ; Stryjewski et al, 2008 , 2012 , 2013 ; Wilson et al, 2009 ; Barriere, 2010 , 2014 ; Rubinstein et al, 2011a , 2014 ; Hooper and Smith, 2012 ; Nannini et al, 2012 ; Barriere et al, 2014a , b ; Torres et al, 2014 ; Lacy et al, 2015 ). Thus, five studies comparing telavancin with control regimens were included in the meta-analysis (Stryjewski et al, 2005 , 2006 , 2008 , 2014 ; Rubinstein et al, 2011b ; Figure 1 ).…”

Section: Resultsmentioning

confidence: 99%

Systematic Review and Meta-Analysis of the Efficacy and Safety of Telavancin for Treatment of Infectious Disease: Are We Clearer?

Chuan

Zhang

et al. 2016

Front. Pharmacol.

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Objective: Telavancin is approved to treat complicated skin and skin structure infections, hospital-acquired, and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus. A previous meta-analysis of randomized controlled trials suggested that it might be an alternative to vancomycin in cases of difficult-to-treat meticillin-resistant S. aureus infections. We did a meta-analysis including one new trial to access the efficacy and safety of telavancin.Methods: We searched PubMed, Cochrane Central Register of Controlled Trials, EMBASE and ClinicalTrials.gov up to December 30, 2015 to identify randomized controlled trials that assessed the clinical efficacy, eradication efficiency, adverse events and laboratory abnormalities of telavancin vs. other antibiotic agents for bacterial infection. Meta-analysis was performed using Review Manager 5.3.0.Results: Five studies (3790 participants) were included in the meta-analysis. There was no significant difference in treatment success with telavancin than with control antibiotic agents. The pooled pathogen eradication for the telavancin group was numerically higher than that for the control groups, but there was no significant difference. While all-cause mortalities and serious adverse events were comparable between telavancin and control antibiotic agents, adverse event-related withdrawals (OR 1.47, 95% CI 1.13–1.91) were higher in telavancin group. The total number adverse events were more in the telavancin group than in the control groups, especially in the digestive system (OR 1.57, 95% CI 1.37–1.79), nervous system (OR 2.14, 95% CI 1.86–2.47) and urogenital system (OR 2.54, 95% CI 1.99–3.25). Serum creatinine increase (OR 2.25, 95% Cl 1.78–2.85) and hypokalemia (OR 1.74, 95% CI 1.19–2.53) occurred more frequently in telavancin group compared to control groups.Conclusion: Telavancin may be as effective as but no better than the comparison therapy for S. aureus infection. However, because of the high risk of adverse event-related withdrawals and potential nephrotoxicity, prudence with the clinical use of telavancin in infections is required.

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Section: Resultsmentioning

confidence: 99%

Systematic Review and Meta-Analysis of the Efficacy and Safety of Telavancin for Treatment of Infectious Disease: Are We Clearer?

Chuan

Zhang

et al. 2016

Front. Pharmacol.

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“…The most frequently reported side effect is gastrointestinal upset. Of note, taste disturbance, nausea, and vomiting are more common than diarrhea (35)(36)(37)(38)(39)(40)(41)(42). However, dalbavancin administration is associated with a higher rate of nausea and vomiting compared to dalbavancina and oritavancin.…”

Section: Safetymentioning

confidence: 99%

“…Except for mild gastrointestinal upset and foamy urine in the telavancin group and pruritus in the vancomycin group, the adverse events were similar. This work demonstrated that telavancin given once daily is at least as effective as vancomycin for the treatment of patients with complicated skin and skin-structure infections, including those infected with MRSA (38,39). Besides FDA approved indications, some new case reports have provided limited experiences in other situations caused by Gram-positive pathogens.…”

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confidence: 97%

Lipoglycopeptide Antibiotics: Reliable Fighters Against Gram-Positive Pathogens

Bagheri¹,

Sohrabi

Salarian

et al. 2018

Arch Clin Infect Dis

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Multi-drug resistant (MDR) strains of staphylococci are usually difficult to treat. Vancomycin has had a time-honored niche in treating MDR Staphylococcus strains; however, during recent years, many clinical failures have been reported worldwide. Since 2014, new semisynthetic lipoglycopeptides antibiotics have been introduced to combat methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-intermediate Staphylococcus aureus (VISA), vancomycin-resistant Staphylococcus aureus (VRSA), and vancomycin-resistant enterococci (VRE). They include dalbavancin, oritavancin, and telavancin. These semisynthetic lipoglycopeptides have a considerable efficacy against MDR Staphylococcus strains. Due to the presence of a lipid side chain, the half-life is prolonged and enables them to anchor the cell membrane of a pathogen. Lipoglycopeptides display a greater potency and more consistent activity against all species of staphylococci than vancomycin. Among them, oritavancin is active against MRSA, VISA, and VRSA. However, dalbavancin and telavancin have activities against MRSA and VISA. Dalbavancin is used once weekly, telavancin is used daily, and oritavancin is usually administered one dose per treatment. Compared to vancomycin, these semisynthetic lipoglycopeptides have longer half-lives with a lower minimum inhibitory concentration (MIC) and fast bactericidal activities. In addition, lipoglycopeptides have concentration-dependent effects in vivo and in vitro. In the present paper, we review the structure, mechanism of action, microbiology, indications, safety, and important interactions of dalbavancin, oritavancin, and telavancin.

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“…In microbiologically evaluable patients with MSSA infection, clinical response rates were 84.6% in the vancomycin group and 89.9% in the telavancin group. 41 In the pooled analysis of both studies, 928 patients were included in the telavancin group and 939 patients were in the vancomycin group. Mean age was 48 years; 19% of patients were 65 years of age and older.…”

Section: Comparative Efficacymentioning

confidence: 99%

Telavancin

Cada¹,

Levien

Baker

2010

Hosp Pharm

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Each month, subscribers to The Formulary Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing inservices. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent in print and are also available online. Monographs can be customized to meet the needs of a facility. Subscribers to The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The February 2010 monograph topics are on tranexamic acid tablets; human papillomavirus bivalent vaccine, recombinant; romidepsin, diclofenac sodium solution 1.5%; and ecallantide injection. The DUE is on vigabatrin.

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P845 ATLAS 1: the first Phase 3 study evaluating the new lipoglycopeptide, telavancin, for the treatment of patients with complicated skin and skin structure infections

Cited by 4 publications

References 0 publications

Systematic Review and Meta-Analysis of the Efficacy and Safety of Telavancin for Treatment of Infectious Disease: Are We Clearer?

Systematic Review and Meta-Analysis of the Efficacy and Safety of Telavancin for Treatment of Infectious Disease: Are We Clearer?

Lipoglycopeptide Antibiotics: Reliable Fighters Against Gram-Positive Pathogens

Telavancin

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