Journal Article

Meta-Analysis of a Possible Signal of Increased Mortality Associated with Cefepime Use

Peter W. Kim, Yu-te Wu, Charles Cooper, George Rochester, Thamban Valappil, Yan Wang, Cynthia Kornegay and Sumathi Nambiar

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 51, issue 4, pages 381-389
Published in print August 2010 | ISSN: 1058-4838
Published online August 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/655131
Meta-Analysis of a Possible Signal of Increased Mortality Associated with Cefepime Use

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Background. On the basis of meta-analyses, concern has been raised regarding a possible signal of increased mortality associated with the use of cefepime versus other β-lactam antibiotics. To further investigate this possible signal, we accessed findings and data from published and unpublished cefepime clinical trials.

Methods. We performed meta-analyses using trial-and patient-level data from comparative trials. Trial-level analyses were performed using summary data from all patients in the trials, and patient-level analyses were performed on trials for which patient-level data were available. Thirty-day, all-cause mortality was analyzed using the Mantel-Haenszel adjusted risk difference (ARD) method.

Results. The trial-level meta-analysis was based on 88 trials (9467 cefepime patients and 8288 comparator patients). The 30-day, all-cause mortality rates were 6.21% (588/9467) for the cefepime patients and 6.00% (497/ 8288) for comparator patients (ARD per 1000 population, 5.38; 95% confidence interval [CI], 1.53 to 12.28). In the patient-level analysis (35 trials, 5058 cefepime patients, and 3976 comparator patients), 30-day, all-cause mortality rates were 5.63% (285/5058) for cefepime patients and 5.68% (226/3976) for comparator patients (ARD per 1000 population, 4.83; 95% CI, 4.72 to 14.38). A sensitivity analysis based solely on the 24 febrile neutropenia trials did not show a statistically significant increase in mortality with cefepime use (ARD per 1000 population, 9.67; 95% CI, 2.87 to 22.21).

Conclusions. In both trial-level and patient-level meta-analyses, we did not identify a statistically significant increase in mortality among cefepime-treated patients, compared with those treated with other antibacterials.

Journal Article.  3925 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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