Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia

Antonio T. Freire; Vasyl Melnyk; Min Ja Kim; Oleksiy Datsenko; Oleksandr Dzyublik; Felix Glumcher; Yin Ching Chuang; Robert T. Maroko; Gary Dukart; C. Angel Cooper; Joan M. Korth-Bradley; Nathalie Dartois; Hassan Gandjini

doi:10.1016/j.diagmicrobio.2010.05.012

Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia

Antonio T. Freire, Vasyl Melnyk, Min Ja Kim, Oleksiy Datsenko, Oleksandr Dzyublik, Felix Glumcher, Yin Ching Chuang, Robert T. Maroko, Gary Dukart, C. Angel Cooper, Joan M. Korth-Bradley, Nathalie Dartois, Hassan Gandjini

Research output: Contribution to journal › Article › peer-review

261 Citations (Scopus)

Abstract

To compare efficacy and safety of a tigecycline regimen with an imipenem/cilastatin regimen in hospital-acquired pneumonia patients, a phase 3, multicenter, randomized, double-blind, study evaluated 945 patients. Coprimary end points were clinical response in clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure. Cure rates were 67.9% for tigecycline and 78.2% for imipenem (CE patients) and 62.7% and 67.6% (c-mITT patients), respectively. A statistical interaction occurred between ventilator-associated pneumonia (VAP) and non-VAP subgroups, with significantly lower cure rates in tigecycline VAP patients compared to imipenem; in non-VAP patients, tigecycline was noninferior to imipenem. Overall mortality did not differ between the tigecycline (14.1%) and imipenem regimens (12.2%), although more deaths occurred in VAP patients treated with tigecycline than imipenem. Overall, the tigecycline regimen was noninferior to the imipenem/cilastatin regimen for the c-mITT but not the CE population; this difference appears to have been driven by results in VAP patients.

Original language	English
Pages (from-to)	140-151
Number of pages	12
Journal	Diagnostic Microbiology and Infectious Disease
Volume	68
Issue number	2
DOIs	https://doi.org/10.1016/j.diagmicrobio.2010.05.012
Publication status	Published - 2010 Oct

Bibliographical note

Funding Information:
The statistical, programming, and managerial assistance of Jean Li Yan, Jeff Goodrich, Debbie Ruffo, Christina Auten, and Gaelle Amiard is greatly appreciated. Phil Vinall, a former Wyeth employee, assisted in the preparation of the preliminary draft of this article. Additional editorial support was provided by Upside endeavors, LLC (Sanatoga). This study was sponsored and funded by Wyeth Research, Collegeville, PA, which was acquired by Pfizer Inc in October 2009.

Keywords

Antimicrobial
Glycylcycline
Nosocomial
Pneumonia
Ventilator/non-ventilator-associated pneumonia

ASJC Scopus subject areas

Microbiology (medical)
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.diagmicrobio.2010.05.012

Cite this

Freire, A. T., Melnyk, V., Kim, M. J., Datsenko, O., Dzyublik, O., Glumcher, F., Chuang, Y. C., Maroko, R. T., Dukart, G., Cooper, C. A., Korth-Bradley, J. M., Dartois, N., & Gandjini, H. (2010). Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia. Diagnostic Microbiology and Infectious Disease, 68(2), 140-151. https://doi.org/10.1016/j.diagmicrobio.2010.05.012

Freire, AT, Melnyk, V, Kim, MJ, Datsenko, O, Dzyublik, O, Glumcher, F, Chuang, YC, Maroko, RT, Dukart, G, Cooper, CA, Korth-Bradley, JM, Dartois, N & Gandjini, H 2010, 'Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia', Diagnostic Microbiology and Infectious Disease, vol. 68, no. 2, pp. 140-151. https://doi.org/10.1016/j.diagmicrobio.2010.05.012

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abstract = "To compare efficacy and safety of a tigecycline regimen with an imipenem/cilastatin regimen in hospital-acquired pneumonia patients, a phase 3, multicenter, randomized, double-blind, study evaluated 945 patients. Coprimary end points were clinical response in clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure. Cure rates were 67.9% for tigecycline and 78.2% for imipenem (CE patients) and 62.7% and 67.6% (c-mITT patients), respectively. A statistical interaction occurred between ventilator-associated pneumonia (VAP) and non-VAP subgroups, with significantly lower cure rates in tigecycline VAP patients compared to imipenem; in non-VAP patients, tigecycline was noninferior to imipenem. Overall mortality did not differ between the tigecycline (14.1%) and imipenem regimens (12.2%), although more deaths occurred in VAP patients treated with tigecycline than imipenem. Overall, the tigecycline regimen was noninferior to the imipenem/cilastatin regimen for the c-mITT but not the CE population; this difference appears to have been driven by results in VAP patients.",

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AU - Chuang, Yin Ching

AU - Maroko, Robert T.

AU - Dukart, Gary

AU - Cooper, C. Angel

AU - Korth-Bradley, Joan M.

AU - Dartois, Nathalie

AU - Gandjini, Hassan

N1 - Funding Information: The statistical, programming, and managerial assistance of Jean Li Yan, Jeff Goodrich, Debbie Ruffo, Christina Auten, and Gaelle Amiard is greatly appreciated. Phil Vinall, a former Wyeth employee, assisted in the preparation of the preliminary draft of this article. Additional editorial support was provided by Upside endeavors, LLC (Sanatoga). This study was sponsored and funded by Wyeth Research, Collegeville, PA, which was acquired by Pfizer Inc in October 2009.

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N2 - To compare efficacy and safety of a tigecycline regimen with an imipenem/cilastatin regimen in hospital-acquired pneumonia patients, a phase 3, multicenter, randomized, double-blind, study evaluated 945 patients. Coprimary end points were clinical response in clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure. Cure rates were 67.9% for tigecycline and 78.2% for imipenem (CE patients) and 62.7% and 67.6% (c-mITT patients), respectively. A statistical interaction occurred between ventilator-associated pneumonia (VAP) and non-VAP subgroups, with significantly lower cure rates in tigecycline VAP patients compared to imipenem; in non-VAP patients, tigecycline was noninferior to imipenem. Overall mortality did not differ between the tigecycline (14.1%) and imipenem regimens (12.2%), although more deaths occurred in VAP patients treated with tigecycline than imipenem. Overall, the tigecycline regimen was noninferior to the imipenem/cilastatin regimen for the c-mITT but not the CE population; this difference appears to have been driven by results in VAP patients.

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Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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