Cho Jonathan C, Zmarlicka Monika T, Shaeer Kristy M, Pardo Joe
1 The University of Texas at Tyler, Tyler, TX, USA.
2 Maricopa Medical Center, Phoenix, AZ, USA.
Ann Pharmacother. 2018 Aug;52(8):769-779. doi: 10.1177/1060028018763288. Epub 2018 Mar 7.
To review the pharmacology, spectrum of activity, pharmacokinetics, pharmacodynamics, safety, efficacy, administration, and considerations for clinical use of meropenem/vaborbactam (M/V).
A literature search using PubMed and clinicaltrials.gov (June 2013 to December 2017) was conducted using the search terms meropenem, vaborbactam, RPX7009, biapenem, RPX2003, and carbavance. References from relevant articles and conference abstracts were also reviewed.
Preclinical, phase I studies, and phase III studies written in the English language were evaluated.
M/V is a novel carbapenem/β-lactamase inhibitor antimicrobial with in vitro activity against nearly 99% of Klebsiella pneumoniae carbapenemase-producing Enterobacteriaceae. M/V is approved for the treatment of adults with complicated urinary tract infections (cUTIs), including pyelonephritis. In a phase III cUTI trial (TANGO I), 98.4% of patients treated with M/V experienced overall clinical success compared with 94% of patients treated with piperacillin/tazobactam (95% CI = 0.7 to 9.1). When compared with best available therapy for carbapenem-resistant Enterobacteriaceae (CRE) infections in TANGO II, patients receiving M/V were more likely to achieve clinical cure at both the end of therapy (64.3% vs 33.3%, P = 0.04) as well as at the test of cure (57.1% vs 26.7%, P = 0.04). The most common adverse effects associated with M/V were headache, infusion-site reactions, and diarrhea.
M/V has a valuable role in the treatment of CRE and should be used judiciously to preserve its use for resistant infections.
综述美罗培南/瓦博巴坦(M/V)的药理学、活性谱、药代动力学、药效学、安全性、疗效、给药方法及临床应用注意事项。
利用检索词美罗培南、瓦博巴坦、RPX7009、比阿培南、RPX2003和卡巴万斯,在PubMed和clinicaltrials.gov网站(2013年6月至2017年12月)进行文献检索。还查阅了相关文章和会议摘要中的参考文献。
对用英语撰写的临床前研究、Ⅰ期研究和Ⅲ期研究进行评估。
M/V是一种新型碳青霉烯类/β-内酰胺酶抑制剂抗菌药物,对近99%产肺炎克雷伯菌碳青霉烯酶的肠杆菌科细菌具有体外活性。M/V已获批用于治疗成人复杂性尿路感染(cUTI),包括肾盂肾炎。在一项Ⅲ期cUTI试验(TANGO I)中,接受M/V治疗的患者中有98.4%获得总体临床成功,而接受哌拉西林/他唑巴坦治疗的患者为94%(95%CI=0.7至9.1)。在TANGO II中,与碳青霉烯类耐药肠杆菌科细菌(CRE)感染的最佳可用治疗方法相比,接受M/V治疗的患者在治疗结束时(64.3%对33.3%,P=0.04)以及治愈检测时(57.1%对26.7%,P=0.04)更有可能实现临床治愈。与M/V相关的最常见不良反应为头痛、输注部位反应和腹泻。
M/V在CRE治疗中具有重要作用,应谨慎使用以保留其用于耐药感染的用途。