Tedizolid Phosphate for the Management of Acute Bacterial Skin and Skin Structure Infections: Safety Summary

被引:35
作者
Das, Debaditya [1 ]
Tulkens, Paul M. [1 ,2 ]
Mehra, Purvi [3 ]
Fang, Edward [4 ]
Prokocimer, Philippe [4 ]
机构
[1] Catholic Univ Louvain, Louvain Drug Res Inst, B-1200 Brussels, Belgium
[2] Catholic Univ Louvain, Louvain Drug Res Inst, Ctr Clin Pharm, B-1200 Brussels, Belgium
[3] eStudySite, San Diego, CA USA
[4] Cubist Pharmaceut, San Diego, CA 92121 USA
关键词
tedizolid phosphate; ABSSSI; safety; clinical trials; treatment-emergent adverse events; SOFT-TISSUE INFECTIONS; RESISTANT STAPHYLOCOCCUS; ANTIMICROBIAL USE; PHARMACOKINETICS; OXAZOLIDINONE; EPIDEMIOLOGY; EXPERIENCE; TYRAMINE; AUREUS;
D O I
10.1093/cid/cit618
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
The novel oxazolidinone tedizolid phosphate is in late-stage clinical development. In an effort to improve efficacy and safety, the adverse event profile and safety aspects of tedizolid phosphate have been evaluated in several preclinical animal models and through ongoing clinical trials. Early dose-ranging studies demonstrated a favorable overall adverse event profile and low thrombocytopenia rates, which have been consistently confirmed in phase 2 and 3 clinical trials. Pharmacokinetic modeling suggests a lower potential for monoamine oxidase interaction, and animal and human subject testing has confirmed these predictions. Studies in special patient populations showed a consistent and predictable pharmacokinetic profile across age groups and comorbid conditions, without evidence of increased incidence of adverse effects over matched controls. The favorable safety profile makes tedizolid phosphate an important new option for the management of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus.
引用
收藏
页码:S51 / S57
页数:7
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