Abstract
This study reports the integrated analysis of two phase III studies of meropenem-vaborbactam in the treatment of acute bacterial infections. Targeting Antibiotic Non-Susceptible Gram-Negative Organisms (TANGO) I compared the clinical efficacy and tolerability of meropenem-vaborbactam and piperacillin-tazobactam in the treatment of complicated urinary tract infection (cUTI)/acute pyelonephritis (APN). TANGO II compared the effect and safety of meropenem-vaborbactam and best-available therapy in the treatment confirmed/suspect carbapenem-resistant Enterobacteriaceae infections. The clinical cure rates at end of treatment (EOT) and test of cure (TOC) among the meropenem-vaborbactam group were non-inferior to those of the control group (at EOT, 92.5% versus 89.3%, risk ratio (RR) 1.27, 95% CI 0.64–2.50; at TOC, 86.2% versus 81.7%, RR 1.37, 95% CI 0.62–3.01). Meropenem-vaborbactam was non-inferior to comparators for microbiological eradication at EOT and TOC (at EOT, 93.3% versus 88.3%, RR 1.21, 95% CI 0.74–1.97; at TOC, 66.5% versus 59.9%, RR 1.12, 95% CI 0.97–1.30). In the subgroup of patients with cUTI/APN, meropenem-vaborbactam had similar overall success rate to the control group at EOT (RR 1.05, 95% CI 1.01–1.09) and at TOC (RR 1.05, 95% CI 0.93–1.19). Meropenem-vaborbactam had a similar risk of treatment-emergent adverse events, events leading to discontinuation of the study drug, any serious adverse events, life-threatening adverse events, drug-related adverse events, and risk of death to comparators. In conclusion, meropenem-vaborbactam was noninferior to comparators for clinical cure and microbiological eradication in the treatment of acute bacterial infection, particularly cUTI/APN, and meropenem-vaborbactam was as tolerable as comparators.
Highlights
Prompt and appropriate administration of antibiotics is key to treating infectious disease [1,2]
Meropenem-vaborbactam is the first carbapenem-β-lactamase inhibitor combination to be approved in the USA for treating complicated urinary tract infections, including acute pyelonephritis (APN)
To better understand the usefulness of meropenem-vaborbactam, this study reports the integrated analysis of two phase III studies [17,18] of meropenem-vaborbactam in the treatment of acute bacterial infections
Summary
Prompt and appropriate administration of antibiotics is key to treating infectious disease [1,2]. Carbapenems own remarkable anti-bacterial activity and remain first-line antibiotics in the treatment of patients with severe infections. Several novel β-lactam/β-lactamase inhibitors, including ceftazidime-avibactam, ceftolozane-tazobactam, and meropenem-vaborbactam, have been developed to combat these multidrug-resistant organisms (MDRO) and have provided promising therapeutic options against Enterobacteriaceae-producing extended spectrum beta lactamases (ESBL), AmpC, and Klebsiella pneumoniae carbapenemase (KPC) [10,11,12,13,14,15]. Meropenem-vaborbactam is the first carbapenem-β-lactamase inhibitor combination to be approved in the USA for treating complicated urinary tract infections (cUTI), including acute pyelonephritis (APN). This novel antibiotic is a fixed-dose combination of meropenem—a carbapenem and vaborbactam—which is a new novel cyclic boronic acid-based β-lactamase inhibitor that can enhance the activity of meropenem [11,12]. To better understand the usefulness of meropenem-vaborbactam, this study reports the integrated analysis of two phase III studies [17,18] of meropenem-vaborbactam in the treatment of acute bacterial infections
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