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Journal of Antimicrobial Chemotherapy (2004) 53, ii75-ii81
© 2004 The British Society for Antimicrobial Chemotherapy

Supplement

Safety and tolerability of ertapenem

Hedy Teppler, Richard M. Gesser, Ian R. Friedland, Gail L. Woods*, Anne Meibohm, Gary Herman, Goutam Mistry and Robin Isaacs

Merck Research Laboratories, West Point, PA, USA

Abstract

Ertapenem is a Group 1 carbapenem that was licensed in the USA in November 2001 and in Europe in April 2002. Its safety profile has been assessed in 240 healthy volunteers participating in 12 clinical pharmacology studies and in 2046 patients enrolled in five Phase IIa and eight Phase IIb/III clinical trials. The most common drug-related adverse events (AEs) reported in trials comparing ertapenem and piperacillin–tazobactam and in trials comparing ertapenem and ceftriaxone were: diarrhoea (ertapenem versus piperacillin–tazobactam 5.0% versus 7.0%; ertapenem versus ceftriaxone 5.6% versus 5.9%); infused vein complications (ertapenem versus piperacillin–tazobactam 4.5% versus 7.9%; ertapenem versus ceftriaxone 3.2% versus 4.6%); nausea (ertapenem versus piperacillin–tazobactam 2.5% versus 3.4%; ertapenem versus ceftriaxone 3.4% versus 3.3%); and elevations in alanine aminotransferase levels (ertapenem versus piperacillin–tazobactam 8.8% versus 7.3%; ertapenem versus ceftriaxone 8.3% versus 6.9%). Most ertapenem-related AEs were reported as mild-to-moderate in intensity. Ertapenem was not associated with prolongation of the QTc interval. Local reactions of moderate-to-severe intensity at the infusion site were infrequent and occurred with similar frequency in the ertapenem and comparator treatment groups. No overall differences in safety were observed between elderly (aged >=65 years and >=75 years) and younger patients. Ertapenem, 1 g once a day given by intravenous infusion or intramuscular injection, was generally well tolerated and had overall safety and tolerability profiles similar to those of piperacillin–tazobactam and ceftriaxone.

Keywords: clinical trials, carbapenems, adverse events, nephrotoxicity, hepatotoxicity

Footnotes

* Corresponding author. Present address: Department of Pathology, University of Utah, ARUP Laboratories, 500 Chipeta Way, Salt Lake City, UT 84108, USA. Tel: +1-801-583-2787 ext. 2337; Fax: +1-801-584-5207; E-mail: gail.woods{at}aruplab.com


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