Meropenem 1g / Vaborbactam 1g powder for solution for infusion vials

Abstract This study aimed to evaluate the effectiveness and safety of Meropenem-Vaborbactam(M-V) for treating carbapenem-resistant Enterobacterales (CRE) infections based on real-world data. A systematic search of PubMed, Embase, Cochrane Library, and Web of Science was conducted, considering studies up to October 31, 2024. Real-world evidence from registries and nonselected case series involving 10 or more adult patients treated with Meropenem-Vaborbactam for CRE infections was included. Meta-analyses using a random-effects model were performed, with the primary outcomes being clinical efficacy and survival, including 30-day and 90-day survival rates. Out of 1862 potentially relevant publications, six studies were included in the meta-analysis. The pooled clinical success rate was 75% (95% CI, 66%–82%), and the pooled 30-day and 90-day survival rates were 75% (95% CI, 71%–78%) and 69% (95% CI, 61%–76%), respectively. Importantly, no serious adverse effects were reported. In conclusion, Meropenem-Vaborbactam demonstrated both efficacy and safety in treating CRE infections in real-world settings. This study was registered with PROSPERO (CRD42022370880).

Abstract licence: CC BY-NC-ND 4.0

The global threat of the spread of carbapenem resistance in Enterobacteriaceae has led to the search for new antibacterials. Intravenous meropenem/vaborbactam (Vabomere™) is the first carbapenem/β-lactamase inhibitor combination approved in the USA for use in patients with complicated urinary tract infections (cUTIs), including pyelonephritis. Vaborbactam is a potent inhibitor of class A serine carbapenemases, which, when combined with the antibacterial meropenem, restores the activity of meropenem against β-lactamase producing Enterobacteriaceae, particularly Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae. Meropenem/vaborbactam demonstrated excellent in vitro activity against Gram-negative clinical isolates, including KPC- and extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae. In the phase 3, noninferiority TANGO I trial in patients with cUTIs, intravenous meropenem/vaborbactam was noninferior to intravenous piperacillin/tazobactam for overall success (composite of clinical cure and microbial eradication; FDA primary endpoint) and microbial eradication (EMA primary endpoint). In subsequent superiority testing, meropenem/vaborbactam was superior to piperacillin/tazobactam for overall success. Meropenem/vaborbactam was generally well tolerated, with a tolerability profile generally similar to that of piperacillin/tazobactam. TANGO I did not assess the efficacy of meropenem/vaborbactam for the treatment of infections caused by carbapenem-resistant Enterobacteriaceae and meropenem/vaborbactam is currently not indicated for these patients. Available evidence indicates that meropenem/vaborbactam is a useful treatment option for patients with cUTIs.

Abstract licence: CC BY-NC 4.0