Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 2 g/vial [1 g meropenem (equivalent to 1.14 g meropenem trihydrate) and 1 g vaborbactam]) |
Drug Class | Penem antibacterials and beta lactamase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria.
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Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Clinical Response: Meropenem-vaborbactam (MV) demonstrated no significant difference in clinical response compared to the best available therapy (BAT) at the test of cure (TOC) (relative risk (RR) 1.29, 95% confidence interval (CI) [0.92, 1.80]) or end of treatment (EOT) (RR 1.66, 95% CI [0.58, 4.76]). However, MV showed a higher clinical cure rate at TOC (odds ratio (OR) 1.37, 95% CI [1.08, 1.74], p = 0.01) compared to other antibiotics.
- Microbiological Response: No significant difference was observed in microbiological eradication between MV and BAT at TOC (RR 1.63, 95% CI [0.85, 3.11]) and EOT (RR 1.16, 95% CI [0.88, 1.54]). However, MV demonstrated a higher microbiological eradication rate at TOC (OR 1.79, 95% CI [1.46, 2.20]).
- Mortality: MV was associated with a significant reduction in 28-day all-cause mortality (RR 0.47, 95% CI [0.24, 0.92], p = 0.03) compared to other treatments, particularly in patients with carbapenem-resistant Enterobacterales (CRE) or multidrug-resistant Pseudomonas aeruginosa (MDRPA) infections.
- Adverse Events (AEs): MV had a similar risk of adverse events compared to other treatments (RR = 0.79, 95% CI [0.53, 1.17]). It demonstrated no significant difference in treatment-emergent adverse events when compared to standard therapies (OR 0.95, p = 0.57).
- Renal-related Adverse Events: MV was associated with significantly fewer renal-related adverse events compared to other therapies (RR = 0.32, 95% CI [0.15, 0.66], p = 0.002), highlighting a favorable renal safety profile.
- MV demonstrated greater clinical success in patients with CRE and multidrug-resistant Pseudomonas aeruginosa (MDRPA) infections, as well as higher treatment success rates in patients with complicated urinary tract infections (cUTIs), particularly those caused by carbapenem-resistant uropathogens.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Vabomere (meropenem and vaborbactam) Prescribing Information. | 2023 | Melinta Therapeutics, LLC., Lincolnshire, IL |